1
|
Stafylis C, Hernandez-Tamayo C, Bhardwaj L, Shah R, Becerra T, Bruce D, Saini R, Saremi N, Thomas I, Manansala-Tan K, Vij AP, Li A, Sudeep N, Gizamba J, Hosseini B, Navarro S, Ufret-Rivera S, Jewell MP, Gounder P, Klausner JD. Project HCV Connect: Using a County Surveillance Registry to Link Hepatitis C Virus-Infected Residents to Cure-Los Angeles County, April 2023 to March 2024. JOURNAL OF PUBLIC HEALTH MANAGEMENT AND PRACTICE 2025; 31:610-613. [PMID: 40073089 DOI: 10.1097/phh.0000000000002139] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/14/2025]
Abstract
Los Angeles County has a high prevalence of chronic hepatitis C virus (HCV) infection, but resources and infrastructure to notify and increase treatment uptake among county residents are absent. Through an innovative academic-public partnership, we developed a linkage-to-cure program utilizing the Department of Public Health's HCV surveillance registry. Case workers contacted reported cases via phone, to offer education, and treatment referral. Three months after the initial communication, individuals that reported that they were untreated were recontacted to evaluate treatment status. Between April 2023 and March 2024, a total of 639 individuals with HCV were interviewed; 84% of them were aware of their infection status, and 70% were untreated. Among those interviewed three months after initial communication (n = 260), 22% started or completed treatment and 30% were under evaluation for treatment. Leveraging existing resources and new partnerships Public Health Departments could mobilize individuals to seek medical care and lead the effort towards elimination of HCV.
Collapse
Affiliation(s)
- Chrysovalantis Stafylis
- Author Affiliations: Keck School of Medicine,Department of Population and Public Health Sciences, University of Southern California, Los Angeles, California (Dr Stafylis, Ms Hernandez-Tamayo, Mr Bhardwaj, Ms Shah, Ms Becerra, Ms Bruce, Ms Saini, Ms Saremi, Mr Thomas, Ms Manansala-Tan, Mr Vij, Ms Li, Mr Sudeep, Mr Gizamba, Mr Hosseini, Ms Navarro, Ms Ufret-Rivera, Dr Gounder, and Dr Klausner); and Los Angeles County Department of Public Health, Acute Communicable Disease Control, Viral Hepatitis Unit, Los Angeles, California (Ms Jewell)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Collapse
|
2
|
Mollenkopf S, Rosenthal E, Teferi G, Silk R, George N, Masur H, Kottilil S, Kattakuzhy S. Sustained Impact of Task-shifting HCV Treatment to Nonspecialist Providers: 5-Year Follow Up of the ASCEND Investigation. Open Forum Infect Dis 2025; 12:ofaf174. [PMID: 40256044 PMCID: PMC12006796 DOI: 10.1093/ofid/ofaf174] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/07/2025] [Accepted: 03/20/2025] [Indexed: 04/22/2025] Open
Abstract
Background Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) has ushered in an era of short-duration treatment with high effectiveness across varied patient populations. In the ASCEND investigation, treatment with DAA was efficacious when delivered by nonspecialist and specialist providers. However, long-term outcomes after initial treatment are unknown. Objective To determine the long-term outcomes after DAA treatment independently provided by nurse practitioners, primary care physicians, or specialist physicians using DAA therapy. Design Retrospective cohort study. Setting Twelve urban, federally qualified health centers in the District of Columbia. Participants A total of 551 patients treated for HCV in the ASCEND investigation (A Phase IV Pilot Study to Assess of Community-based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection with HIV in the District of Columbia). Interventions None. Measurements Sustained viral response (SVR12), reinfection, retreatment, death. Results In this large sample of majority Black individuals receiving care at community-based centers, there was an initial 87% rate of SVR, and after 5 years of follow up, an additional 6.5% of participants were found to be cured. This included individuals originally lost to follow up whose subsequent testing confirmed SVR12, and those with successful retreatment after initial treatment failure. There was a 70% rate of testing for reinfection, with 2 identified reinfections. Treatment outcomes were not associated with original treating provider type. Limitations As a retrospective analysis, these findings are limited by the availability of data in the electronic medical record. Conclusions DAA is an effective treatment for HCV and can safely be prescribed by multiple provider types, with favorable long-term outcomes.
Collapse
Affiliation(s)
- Sarah Mollenkopf
- Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Elana Rosenthal
- Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine, Baltimore, Maryland, USA
| | - Geb Teferi
- Unity Healthcare, Inc., Washington, DC, USA
| | - Rachel Silk
- Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine, Baltimore, Maryland, USA
| | - Nivya George
- Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine, Baltimore, Maryland, USA
| | - Henry Masur
- Division of Critical Care Medicine, National Institutes of Health, Bethesda, Maryland, USA
| | - Shyam Kottilil
- Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine, Baltimore, Maryland, USA
| | - Sarah Kattakuzhy
- Division of Clinical Care and Research, Institute of Human Virology at the University of Maryland School of Medicine, Baltimore, Maryland, USA
| |
Collapse
|
3
|
Tarfa A, Di Paola A, Frank CA, Schultheis AM, Brooks R, Shenoi SV, Springer SA. Pilot Findings From the First Legalized Mobile Retail Pharmacy Clinic in the United States for Infectious Disease Treatment and Prevention Tailored to Reach People Who Use Drugs. Open Forum Infect Dis 2025; 12:ofaf200. [PMID: 40276721 PMCID: PMC12019630 DOI: 10.1093/ofid/ofaf200] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2024] [Accepted: 04/05/2025] [Indexed: 04/26/2025] Open
Abstract
Background Mobile retail pharmacies were legalized in Connecticut in 2023 to provide primary care, human immunodeficiency virus (HIV) and hepatitis C virus (HCV) testing, preexposure prophylaxis (PrEP), immediate HIV antiretroviral therapy (ART), and medications for substance use disorders directly to people who use drugs (PWUD). Methods InMOTION mobile pharmacy and clinic (MPC) pilot findings describe services provided by pharmacists, clinicians, and community health workers. Results From 13 December 2023 through 5 November 2024, the MPC engaged with 414 participants, of whom 43% were female, 26% Black/African American, 32% uninsured, and 37% unhoused or unstably housed. Fifty-one had a previous diagnosis of an opioid use disorder (OUD), 163 accepted screening, 1 received a new diagnosis of moderate to severe OUD, and 37 received medication for OUD. Nine participants requested sexually transmitted infection testing; 3 people had positive results, all were prescribed treatment, and 1 received doxycycline postexposure prophylaxis. Four people had existing HIV diagnoses; 166 accepted rapid point-of-care (POC) testing, resulting in 1 positive test; all received ART (2 oral, 3 injectable); 9 who tested HIV negative accepted PrEP, and 1 accepted the injectable formulation. Twenty-two had known HCV, 157 accepted rapid POC HCV testing, 9 tested positive for HCV antibodies, and 11 underwent HCV viral load (VL) testing; 1 self-cleared, and 8 of 10 with detectable HCV VL received direct-acting antivirals from the MPC. Six were treated for xylazine-related wounds. Conclusions Health services delivered through an MPC demonstrate the potential to address healthcare gaps for PWUD and warrant exploration and expansion.
Collapse
Affiliation(s)
- Adati Tarfa
- AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
- Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, Connecticut, USA
| | - Angela Di Paola
- AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
- Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, Connecticut, USA
| | - Cynthia A Frank
- AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
| | - Alysse M Schultheis
- AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
| | - Ralph Brooks
- AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
| | - Sheela V Shenoi
- AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
- Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, Connecticut, USA
- Veterans Affairs Connecticut Healthcare System, Division of Infectious Disease, Department of Internal Medicine, West Haven, Connecticut, USA
| | - Sandra A Springer
- AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA
- Center for Interdisciplinary Research on AIDS, Yale University School of Public Health, New Haven, Connecticut, USA
- Veterans Affairs Connecticut Healthcare System, Division of Infectious Disease, Department of Internal Medicine, West Haven, Connecticut, USA
| |
Collapse
|
4
|
Seaman A, Cook R, Leichtling G, Herink MC, Gailey T, Cooper J, Spencer HC, Babiarz J, Fox C, Thomas A, Leahy JM, Larsen JE, Korthuis PT. Peer-Assisted Telemedicine for Hepatitis C in People Who Use Drugs: A Randomized Controlled Trial. Clin Infect Dis 2025; 80:501-508. [PMID: 39602441 PMCID: PMC11912958 DOI: 10.1093/cid/ciae520] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2024] [Accepted: 11/25/2024] [Indexed: 11/29/2024] Open
Abstract
BACKGROUND Hepatitis C virus (HCV) elimination requires treating people who use drugs (PWUD), yet <10% of PWUD in the United States access HCV treatment; access is especially limited in rural communities. METHODS We randomized PWUD with HCV viremia and past 90-day injection drug or nonprescribed opioid use in 7 rural Oregon counties to peer-assisted telemedicine HCV treatment (TeleHCV) versus peer-assisted referral to local providers (enhanced usual care [EUC]). Peers supported screening and pretreatment laboratory evaluation for all participants and facilitated telemedicine visits, medication delivery, and adherence for TeleHCV participants. Generalized linear models estimated group differences in HCV viral clearance (primary outcome) and HCV treatment initiation and completion (secondary outcomes). RESULTS Of the 203 randomized participants (100 TeleHCV, 103 EUC), most were male (62%), White (88%), with recent houselessness (70%), and used methamphetamines (88%) or fentanyl/heroin (58%) in the past 30 days. Eighty-five of 100 TeleHCV participants (85%) initiated treatment versus 13 of 103 (12%) EUC participants (relative risk [RR], 6.7 [95% confidence interval {CI}, 4.0-11.3]; P < .001). Sixty-three of 100 (63%) TeleHCV participants versus 16 of 103 (16%) EUC participants achieved viral clearance 12 weeks after anticipated treatment completion date (RR, 4.1 [95% CI: 2.5-6.5]; P < .001). CONCLUSIONS The Peer TeleHCV treatment model substantially increased HCV treatment initiation and viral clearance compared to EUC. Replication in other rural and low-resource settings could further World Health Organization HCV elimination goals by expanding and decentralizing treatment access for PWUD. Clinical Trials Registration. NCT04798521.
Collapse
Affiliation(s)
- Andrew Seaman
- Section of Addiction Medicine, Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | - Ryan Cook
- Section of Addiction Medicine, Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | | | | | - Tonhi Gailey
- Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | - Joanna Cooper
- Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | - Hunter C Spencer
- Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | - Jane Babiarz
- Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | - Christopher Fox
- Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | | | - Judith M Leahy
- Health Systems Division, Behavioral Health Services, Oregon Health Authority, Portland
| | - Jessica E Larsen
- Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| | - P Todd Korthuis
- Section of Addiction Medicine, Division of General Internal Medicine and Geriatrics, Department of Medicine, Oregon Health & Science University
| |
Collapse
|
5
|
Michaels M, Botts NE, Hassell S, Mardon R, Pan ECR, Flanigan M, Chehab C, Liu S, Bocour A, Alexander M, Aponte A, Thompson ND. Initial Real-World Pilot of the MedMorph Reference Architecture: Hepatitis C Surveillance and Research. Appl Clin Inform 2025; 16:234-244. [PMID: 40073858 PMCID: PMC11903105 DOI: 10.1055/a-2441-6100] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/11/2024] [Accepted: 10/14/2024] [Indexed: 03/14/2025] Open
Abstract
OBJECTIVES This study aimed to demonstrate real-world use of the Making Electronic Data More Available for Research and Public Health (MedMorph) Reference Architecture (RA) for automated exchange of hepatitis C-related data for public health surveillance and research using Fast Healthcare Interoperability Resources (FHIR). METHODS Pilot participants included a public health authority (PHA), research organization (RO), clinical sites, and electronic health record (EHR) vendors. The RA was tested for hepatitis C public health surveillance and research data exchange. A mixed methods evaluation used multiple data sources to assess impact of the RA compared with usual methods. RESULTS After implementation of the RA components, there was no burden on clinical staff to report data for public health surveillance or research purposes. Data were successfully transferred and passed from EHR to PHA and RO, which revealed the value of receiving clinical data in addition to laboratory data via electronic laboratory reporting for the PHA and limitations in the Bulk FHIR standard. CONCLUSION Initial results indicate potential for long-term reduction of level of effort of reporting while improving the availability and completeness of clinical data for public health surveillance and research. Using a FHIR-based approach that aligns with regulatory health information technology certification requirements and existing infrastructure may reduce implementation burden. The MedMorph approach can enhance public health surveillance and research, resulting in improved data completeness and reduced reporting burden through automated data exchange using industry standards. MedMorph will continue to inform Centers for Disease Control and Prevention's Public Health Data Strategy, which provides the agency's direction for data modernization.
Collapse
Affiliation(s)
- Maria Michaels
- Centers for Disease Control and Prevention, Office of Public Health Data, Surveillance, and Technology, Atlanta, Georgia, United States
| | | | | | | | | | - Mike Flanigan
- Carradora Health, Inc., Rockville, Maryland, United States
| | - Chirine Chehab
- Centers for Disease Control and Prevention, Office of Public Health Data, Surveillance, and Technology, Atlanta, Georgia, United States
| | - Sara Liu
- MDLand International Corporation, New York City, New York, United States
| | - Angelica Bocour
- New York City Department of Health and Mental Hygiene, New York City, New York, United States
| | - Mark Alexander
- New York City Department of Health and Mental Hygiene, New York City, New York, United States
| | - Angel Aponte
- New York City Department of Health and Mental Hygiene, New York City, New York, United States
| | - Nicola D. Thompson
- Centers for Disease Control and Prevention, Atlanta, Georgia, United States
| |
Collapse
|
6
|
Danpanichkul P, Duangsonk K, Kalligeros M, Fallon MB, Vuthithammee C, Pan CW, Saokhieo P, Derrick W, Pang Y, Chen VL, Kim D, Singal AG, Yang JD, Wijarnpreecha K. Alcohol-Related Liver Disease, Followed by Metabolic Dysfunction-Associated Steatotic Liver Disease, Emerges as the Fastest-Growing Aetiologies for Primary Liver Cancer in the United States. Aliment Pharmacol Ther 2025; 61:959-970. [PMID: 39757456 DOI: 10.1111/apt.18473] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2024] [Revised: 11/27/2024] [Accepted: 12/20/2024] [Indexed: 01/07/2025]
Abstract
OBJECTIVE Primary liver cancer (PLC) is projected to be the third leading cause of cancer mortality in the United States in 2040. We examine the burden of PLC in the United States, stratified by sex, state and aetiological risk factors. METHODS Data on PLC prevalence, incidence, death and disability-adjusted life years (DALYs) were extracted from the Global Burden of Disease Study 2021. Changes in these parameters were calculated using the Joinpoint regression model. RESULTS There were 47,970 cases, 31,450 incident cases, 24,770 deaths and 576,920 DALYs from PLC in the United States. The highest prevalence (16,980), incidence (12,040), death (9840) and DALYs (213,410) from PLC were due to chronic hepatitis C virus infection. From 2000 to 2021, PLC incidences increased by 141%, and PLC deaths increased by 136%. Age-standardised incidence rates (ASIRs) and death rates (ASDRs) per 100,000 population for PLC increased, primarily driven by alcohol-related liver disease (ALD) (ASIR: annual percent change [APC]: +2.40%; ASDR: APC: +2.22%) and metabolic dysfunction-associated steatotic liver disease (MASLD) (ASIR: APC: +2.32%; ASDR: APC: +2.04%). CONCLUSION The burden of PLC in the United States has risen in the past two decades, driven mainly by ALD and followed by MASLD. These findings offer policymakers an accurate assessment of the PLC burden and emphasise the need for targeted risk factor mitigation, especially regarding alcohol related policy.
Collapse
Affiliation(s)
- Pojsakorn Danpanichkul
- Department of Internal Medicine, Texas Tech University Health Sciences Center, Lubbock, Texas, USA
| | - Kwanjit Duangsonk
- Department of Microbiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
| | - Markos Kalligeros
- Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
| | - Michael B Fallon
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Arizona College of Medicine, Phoenix, Arizona, USA
- Department of Internal Medicine, Banner University Medical Center, Phoenix, Arizona, USA
| | | | - Chun Wei Pan
- Department of Medicine, John H. Stroger Jr Hospital of Cook County, Chicago, Illinois, USA
| | | | - William Derrick
- Texas Tech University Health Sciences Center School of Medicine, Lubbock, Texas, USA
| | - Yanfang Pang
- Affiliated Hospital of Youjiang Medical University for Nationalities, Baise, Guangxi, China
- National Immunological Laboratory of Traditional Chinese Medicine, Baise, Guangxi, China
- Center for Medical Laboratory Science, Affiliated Hospital of Youjiang Medical University for Nationalities, Baise, Guangxi, China
| | - Vincent L Chen
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA
| | - Donghee Kim
- Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, USA
| | - Amit G Singal
- Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA
| | - Ju Dong Yang
- Karsh Division of Gastroenterology and Hepatology, Comprehensive Transplant Center, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, California, Los Angeles, USA
| | - Karn Wijarnpreecha
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Arizona College of Medicine, Phoenix, Arizona, USA
- Department of Internal Medicine, Banner University Medical Center, Phoenix, Arizona, USA
- BIO5 Institute, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona, USA
| |
Collapse
|
7
|
Epstein RL, Munroe S, Taylor LE, Duryea PR, Buzzee B, Pramanick T, Feld JJ, Baptiste D, Carroll M, Castera L, Sterling RK, Thomas A, Chan PA, Linas BP. Clinical- and Cost-Effectiveness of Liver Disease Staging in Hepatitis C Virus Infection: A Microsimulation Study. Clin Infect Dis 2025; 80:300-313. [PMID: 39535186 PMCID: PMC11848265 DOI: 10.1093/cid/ciae485] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/03/2024] [Indexed: 11/16/2024] Open
Abstract
BACKGROUND Liver disease assessment is a key aspect of chronic hepatitis C virus (HCV) infection pre-treatment evaluation but guidelines differ on the optimal testing modality given trade-offs in availability and accuracy. We compared clinical outcomes and cost-effectiveness of common fibrosis staging strategies. METHODS We simulated adults with chronic HCV receiving care at US health centers through a lifetime microsimulation across five strategies: (1) no staging or treatment (comparator), (2) indirect serum biomarker testing (Fibrosis-4 index [FIB-4]) only, (3) transient elastography (TE) only, (4) staged approach: FIB-4 for all, TE only for intermediate FIB-4 scores (1.45-3.25), and (5) both tests for all. Outcomes included infections cured, cirrhosis cases, liver-related deaths, costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). We used literature-informed loss to follow-up (LTFU) rates and 2021 Medicaid perspective and costs. RESULTS FIB-4 alone generated the best clinical outcomes: 87.7% cured, 8.7% developed cirrhosis, and 4.6% had liver-related deaths. TE strategies cured 58.5%-76.6%, 16.8%-29.4% developed cirrhosis, and 11.6%-22.6% had liver-related deaths. All TE strategies yielded worse clinical outcomes at higher costs per QALY than FIB-4 only, which had an ICER of $12 869 per QALY gained compared with no staging or treatment. LTFU drove these findings: TE strategies were only cost-effective with no LTFU. In a point-of-care HCV test-and-treat scenario, treatment without any staging was most clinically and cost-effective. CONCLUSIONS FIB-4 staging alone resulted in optimal clinical outcomes and was cost-effective. Treatment for chronic HCV should not be delayed while awaiting fibrosis staging with TE.
Collapse
Affiliation(s)
- Rachel L Epstein
- Department of Medicine, Section of Infectious Diseases, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA
- Department of Pediatrics, Section of Infectious Diseases, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| | - Sarah Munroe
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| | - Lynn E Taylor
- Department of Pharmacy Practice and Clinical Research, University of Rhode Island, Kingston, Rhode Island, USA
- Department of Primary Care, HealthFirst Family Care Center Inc., Fall River, Massachusetts, USA
| | - Patrick R Duryea
- Department of Pharmacy Practice and Clinical Research, University of Rhode Island, Kingston, Rhode Island, USA
| | - Benjamin Buzzee
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| | - Tannishtha Pramanick
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| | - Jordan J Feld
- Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Dimitri Baptiste
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| | - Matthew Carroll
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| | - Laurent Castera
- Department of Hepatology, Beaujon Hospital, Assistance Publique-Hopitaux de Paris, Université Paris Cité, Clichy, France
| | - Richard K Sterling
- Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, Virginia, USA
| | - Aurielle Thomas
- Department of Pharmacy Practice and Clinical Research, University of Rhode Island, Kingston, Rhode Island, USA
| | - Philip A Chan
- Rhode Island Department of Health, Providence, Rhode Island, USA
- Department of Medicine, Brown University, Providence, Rhode Island, USA
| | - Benjamin P Linas
- Department of Medicine, Section of Infectious Diseases, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts, USA
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| |
Collapse
|
8
|
Hayden M, Kishore S, Bradford D, Dedona M, Hunter M, Luck ME, Pratt R. Building a Low-Threshold Model for HCV Diagnosis and Treatment Among Formerly Incarcerated Patients in Alabama. J Gen Intern Med 2025:10.1007/s11606-025-09411-y. [PMID: 39939496 DOI: 10.1007/s11606-025-09411-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2024] [Accepted: 01/28/2025] [Indexed: 02/14/2025]
Abstract
BACKGROUND Millions of Americans remain infected with hepatitis C (HCV). Innovation in care delivery is required to achieve the goal of national elimination. AIM Develop a low-threshold HCV treatment program. SETTING Free clinic with mobile unit providing transitional care to people leaving jails and prisons across Alabama. PARTICIPANTS Formerly incarcerated persons, many of whom are uninsured and live in rural areas. PROGRAM DESCRIPTION We utilized point-of-care diagnostics to condense the HCV screening and pre-treatment evaluation into a single encounter. Patient assistance programs were used to obtain medications for uninsured patients. Clinical support was provided through in-person and telehealth care. PROGRAM EVALUATION From January 2023 to December 2024, 369 patients were screened for HCV; 104 (28.1%) were HCV antibody positive, and 71 (19.2%) were viremic. Of these patients, 70 completed pre-treatment diagnostics, 54 started treatment, 41 confirmed completion, 20 had SVR12 collected, with 19 achieving cure (94% cure rate). The median time from diagnosis to treatment initiation was 27 days. DISCUSSION It is possible to both diagnose HCV and complete the entire pre-treatment evaluation in a single encounter and initiate treatment within 1 month, even for predominantly uninsured populations in rural areas.
Collapse
Affiliation(s)
- Margaret Hayden
- University of Virginia Medical Center: UVA Health University Hospital, Charlottesville, VA, USA.
- Equal Justice Initiative, Montgomery, AL, USA.
| | - Sanjay Kishore
- University of Virginia Medical Center: UVA Health University Hospital, Charlottesville, VA, USA
- Equal Justice Initiative, Montgomery, AL, USA
| | - Davis Bradford
- University of Virginia Medical Center: UVA Health University Hospital, Charlottesville, VA, USA
- University of Alabama Birmingham Heersink School of Medicine, Birmingham, AL, USA
| | | | | | | | - Ryan Pratt
- Equal Justice Initiative, Montgomery, AL, USA
| |
Collapse
|
9
|
Razavi HA, Waked I, Qureshi H, Kondili LA, Duberg AS, Aleman S, Tanaka J, Lazarus JV, Low-Beer D, Abbas Z, Rached AA, Aghemo A, Aho I, Akarca US, Al-Busafi SA, Al-Hamoudi WK, Al-Naamani K, Alaama AS, Aldar MM, Alghamdi M, Gonzalez MA, Alserehi H, Anand AC, Asselah T, Assiri AM, Athanasakis K, Atugonza R, Ben-Ari Z, Berg T, Brandão-Mello CE, Brown AS, Brown KA, Brown RS, Bruggmann P, Brunetto MR, Buti M, Cheinquer H, Christensen PB, Chulanov V, Cisneros Garza LE, Coffin CS, Coppola N, Craxi A, Crespo J, Cui F, Dalgard O, De La Torre A, De Ledinghen V, Dieterich D, Drazilova S, Dufour JF, El-Kassas M, Elbadri M, Esmat G, Mur RE, Eurich B, Faini D, Ferreira PR, Flisiak R, Frankova S, Gaeta GB, Gamkrelidze I, Gane EJ, Garcia V, García-Samaniego J, Gemilyan M, Gottfredsson M, Gschwantler M, Gurski AP, Hajarizadeh B, Hamid SS, Hatzakis A, Hercun J, Hockicková I, Huang JF, Hunyady B, Hutchinson SJ, Ishikawa N, Izumi K, Izzi A, Janicko M, Jarcuska P, Jeruma A, Johannessen A, Kaliaskarova KS, Kao JH, Kielland KB, Kodjoh N, Kottilil S, Kristian P, Kwo PY, Lagging M, Lam H, Lázaro P, Lee MH, Lens S, Liakina V, Lim YS, Makara M, Manns M, et alRazavi HA, Waked I, Qureshi H, Kondili LA, Duberg AS, Aleman S, Tanaka J, Lazarus JV, Low-Beer D, Abbas Z, Rached AA, Aghemo A, Aho I, Akarca US, Al-Busafi SA, Al-Hamoudi WK, Al-Naamani K, Alaama AS, Aldar MM, Alghamdi M, Gonzalez MA, Alserehi H, Anand AC, Asselah T, Assiri AM, Athanasakis K, Atugonza R, Ben-Ari Z, Berg T, Brandão-Mello CE, Brown AS, Brown KA, Brown RS, Bruggmann P, Brunetto MR, Buti M, Cheinquer H, Christensen PB, Chulanov V, Cisneros Garza LE, Coffin CS, Coppola N, Craxi A, Crespo J, Cui F, Dalgard O, De La Torre A, De Ledinghen V, Dieterich D, Drazilova S, Dufour JF, El-Kassas M, Elbadri M, Esmat G, Mur RE, Eurich B, Faini D, Ferreira PR, Flisiak R, Frankova S, Gaeta GB, Gamkrelidze I, Gane EJ, Garcia V, García-Samaniego J, Gemilyan M, Gottfredsson M, Gschwantler M, Gurski AP, Hajarizadeh B, Hamid SS, Hatzakis A, Hercun J, Hockicková I, Huang JF, Hunyady B, Hutchinson SJ, Ishikawa N, Izumi K, Izzi A, Janicko M, Jarcuska P, Jeruma A, Johannessen A, Kaliaskarova KS, Kao JH, Kielland KB, Kodjoh N, Kottilil S, Kristian P, Kwo PY, Lagging M, Lam H, Lázaro P, Lee MH, Lens S, Liakina V, Lim YS, Makara M, Manns M, Manzengo CM, Memon S, Mendes-Correa MC, Messina V, Midgard H, Murphy N, Musabaev E, Naveira MC, Nde H, Negro F, Nim N, Ocama P, Olafsson S, Omuemu CE, Pamplona JJ, Pan CQ, Papatheodoridis GV, Pimenov N, Poustchi H, Quaranta MG, Ramji A, Rautiainen H, Razavi-Shearer DM, Razavi-Shearer K, Ridruejo E, Ríos-Hincapié CY, Sadirova S, Sanai FM, Sarrazin C, Sarybayeva G, Schréter I, Seguin-Devaux C, Sereno LS, Shiha G, Smith J, Soliman R, Sonderup MW, Spearman CW, Stauber RE, Stedman CA, Sypsa V, Tacke F, Terrault NA, Tolmane I, Van Welzen B, Voeller AS, Waheed Y, Wallace C, Whittaker RN, W-S Wong V, Ydreborg M, Yesmembetov K, Yu ML, Zeuzem S, Zuckerman E. Number of people treated for hepatitis C virus infection in 2014-2023 and applicable lessons for new HBV and HDV therapies. J Hepatol 2025:S0168-8278(25)00020-0. [PMID: 39914746 DOI: 10.1016/j.jhep.2025.01.013] [Show More Authors] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/03/2024] [Revised: 01/09/2025] [Accepted: 01/10/2025] [Indexed: 03/20/2025]
Abstract
BACKGROUND & AIMS The year 2023 marked the 10-year anniversary of the launch of direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV). Monitoring HCV treatment trends by country, region, and globally is important to assess progress toward the World Health Organization's 2030 elimination targets. Additionally, the historical patterns can help predict the treatment uptake for future therapies for other liver diseases. METHODS The number of people living with HCV (PLHCV) treated between 2014-2023 across 119 countries was estimated using national HCV registries, reported DAA sales data, pharmaceutical companies' reports, and estimates provided by national experts. For the countries with no available data, the average estimate of the corresponding Global Burden of Disease region was used. RESULTS An estimated 13,816,000 (95% uncertainty intervals: 13,221,000-16,415,000) PLHCV were treated, of whom 12,748,000 (12,226,000-15,231,000) were treated with DAAs, of which 11,081,000 (10,542,000-13,338,000) were sofosbuvir-based DAA regimens. Country-level data accounted for 97% of these estimates. In high-income countries, there was a 41% drop in treatment from its peak, and reimbursement was a large predictor of treatment. In low- and middle-income countries, price played an important role in expanding treatment access through the public and private markets, and treatment continues to increase slowly after a sharp drop at the end of the Egyptian national program. CONCLUSIONS In the last 10 years, 21% of all HCV infections were treated with DAAs. Regional and temporal variations highlight the importance of active screening strategies. Without program enhancements, the number of treated PLHCV stalled in every country/region, which may not reflect a lower prevalence but may instead reflect the diminishing returns of existing strategies. IMPACT AND IMPLICATIONS Long-term hepatitis C virus (HCV) infection can lead to cirrhosis and liver cancer. Since 2014, these infections can be effectively treated with 8-12 weeks of oral therapies. In 2015, the World Health Organization established targets to eliminate HCV by 2030, which included treatment targets for member countries. The current study examines HCV treatment patterns across 119 countries and regions from 2014 to 2023 to assess the impact of national programs. This study can assist physicians and policymakers in understanding treatment patterns within similar regions or income groups and in utilizing historical data to refine their strategies in the future.
Collapse
|
10
|
Goldberg D, Wilder J, Terrault N. Health disparities in cirrhosis care and liver transplantation. Nat Rev Gastroenterol Hepatol 2025; 22:98-111. [PMID: 39482363 DOI: 10.1038/s41575-024-01003-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/02/2024] [Indexed: 11/03/2024]
Abstract
Morbidity and mortality from cirrhosis are substantial and increasing. Health disparities in cirrhosis and liver transplantation are reflective of inequities along the entire spectrum of chronic liver disease care, from screening and diagnosis to prevention and treatment of liver-related complications. The key populations experiencing disparities in health status and healthcare delivery include racial and ethnic minority groups, sexual and gender minorities, people of lower socioeconomic status and underserved rural communities. These disparities lead to delayed diagnosis of chronic liver disease and complications of cirrhosis (for example, hepatocellular carcinoma), to differences in treatment of chronic liver disease and its complications, and ultimately to unequal access to transplantation for those with end-stage liver disease. Calling out these disparities is only the first step towards implementing solutions that can improve health equity and clinical outcomes for everyone. Multi-level interventions along the care continuum for chronic liver disease are needed to mitigate these disparities and provide equitable access to care.
Collapse
Affiliation(s)
- David Goldberg
- Division of Digestive Health and Liver Diseases, University of Miami, Miami, FL, USA
| | - Julius Wilder
- Division of Gastroenterology, Duke University, Durham, NC, USA
| | - Norah Terrault
- Division of GI and Liver Diseases, University of Southern California, Los Angeles, CA, USA.
| |
Collapse
|
11
|
Stopka TJ, Whitney BM, de Gijsel D, Brook DL, Friedmann PD, Taylor LE, Feinberg J, Young AM, Evon DM, Herink M, Westergaard R, Koepke R, Havens JR, Zule WA, Delaney JA, Pho MT. Medicaid Policy and Hepatitis C Treatment Among Rural People Who Use Drugs. Med Care 2025; 63:77-88. [PMID: 39791842 PMCID: PMC11731889 DOI: 10.1097/mlr.0000000000002095] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/12/2025]
Abstract
BACKGROUND Restrictive Medicaid policies regarding hepatitis C virus (HCV) treatment may exacerbate rural health care disparities for people who use drugs (PWUD). We assessed associations between Medicaid restrictions and HCV treatment among rural PWUD. METHODS We compiled state-specific Medicaid treatment policies across 8 US rural sites in 10 states and merged these with participant survey data. We hypothesized that local restrictions regarding prescriber type, sobriety, and fibrosis estimates were associated with HCV treatment outcomes. We conducted a cross-sectional, ecological analysis of treatment restrictions and HCV treatment outcomes using bivariate analyses to characterize differences between PWUD who initiated HCV treatment and unadjusted logistic regressions to assess associations between restrictions and treatment. RESULTS Among 944 participants, 111 (12%) reported receiving HCV treatment. Participants receiving treatment were older [median age (interquartile range): 42 (34-53) vs. 35 (29-42), P<0.001], more likely to receive disability support (32% vs. 20%, P=0.002), and less likely to be Medicaid-insured (57% vs. 71%, P < 0.001). More PWUD in states without any restrictions reported receiving treatment (17% vs. 11%, P=0.08) and achieving HCV cure/clearance (42% vs. 30%, P=0.01) than in states with restrictions. Restrictions were associated with lower odds of receiving HCV treatment (odds ratio=0.61, 95% CI: 0.35-1.06, P=0.08). Sensitivity analyses showed a similar association with HCV cure/clearance (odds ratio=0.60, 95% CI: 0.40-0.91, P=0.02). CONCLUSIONS We identified significant unadjusted associations between Medicaid restrictions and receipt of HCV treatment and cure, which has substantial implications for health outcomes among rural PWUD. Lifting remaining Medicaid restrictions will be critical to achieving HCV elimination.
Collapse
Affiliation(s)
- Thomas J. Stopka
- Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Avenue, Boston, MA, United States, 02111
| | | | - David de Gijsel
- Department of Medicine, Section of Infectious Diseases & International Health, Dartmouth Hitchcock Medical Center, Lebanon, NH
| | - Daniel L. Brook
- College of Public Health, Division of Epidemiology, Ohio State University, Columbus, OH
| | - Peter D. Friedmann
- University of Massachusetts Chan Medical School–Baystate, 55 N Lake Ave, Worcester, MA 01655, United States, and Baystate Health, 759 Chestnut St, Springfield, MA, United States, 01199
| | - Lynn E. Taylor
- Department of Pharmacy Practice and Clinical Research, University of Rhode Island, Kingston, RI, 02881
| | - Judith Feinberg
- Departments of Behavioral Medicine and Psychiatry & Medicine/Infectious Diseases, West Virginia University School of Medicine, 930 Chestnut Ridge Rd, Morgantown, WV 26505
| | - April M. Young
- Department of Epidemiology and Environmental Health, University of Kentucky, Lexington, KY
| | - Donna M. Evon
- Department of Medicine, University of North Carolina, Chapel Hill, NC
| | - Megan Herink
- College of Pharmacy, Oregon State University/Oregon Health & Science University, Portland, OR
| | | | | | - Jennifer R. Havens
- Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY
| | | | - Joseph A. Delaney
- Department of Medicine, University of Washington, Seattle, WA
- College of Pharmacy, University of Manitoba, Winnipeg, MB, Canada
| | - Mai T. Pho
- Department of Medicine, Section of Infectious Diseases & Global Health, University of Chicago, Chicago, IL
| |
Collapse
|
12
|
Tan M, Kuncio D, Addish E, Nassau T, Higgins D, Miller M, Brady K. People With HIV Are More Likely to Clear Hepatitis C: Role of Ryan White Services, Philadelphia, Pennsylvania, United States. Open Forum Infect Dis 2025; 12:ofaf043. [PMID: 39935962 PMCID: PMC11811900 DOI: 10.1093/ofid/ofaf043] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Accepted: 01/24/2025] [Indexed: 02/13/2025] Open
Abstract
Background HIV coinfection worsens health outcomes for persons with chronic hepatitis C virus (HCV) infection; however, access to comprehensive Ryan White (RW) HIV care may improve the health of persons with HIV and HCV. Methods In a retrospective cohort study, we used surveillance data from Philadelphia's hepatitis and HIV registries for newly reported HCV infections from November 2015 to October 2021. We plotted Kaplan-Meier curves and performed Cox regressions on time to HCV clearance by HIV coinfection status, adjusting for demographic characteristics and HCV report year. Results A total of 10 251 persons with newly reported HCV infection were included, of whom 9898 (96.6%) had HCV monoinfection and 353 (3.4%) had HIV coinfection. HCV reports were mostly among residents who were non-Hispanic/Latine White (n = 3609, 35.2%) and non-Hispanic/Latine Black (n = 3221, 31.4%) and assigned male sex at birth (n = 6931, 67.8%). At every month of follow-up, having HIV was associated with a higher likelihood of HCV clearance as compared with HCV monoinfection (adjusted hazard ratio, 1.2; 95% CI, 1.1-1.4; P < .05). For persons with HIV coinfection, participation in RW support services 2 to 6 times monthly was associated with an increased likelihood (adjusted hazard ratio, 1.7-3.1) of HCV clearance at every month of follow-up as compared with persons without RW participation (P < .05). Conclusions Among newly reported HCV infections, the likelihood of HCV clearance was higher among persons with HIV coinfection who participated in RW support services. Frequent receipt of supportive services, such as those provided by the national, federally funded RW system, is crucial for HCV elimination.
Collapse
Affiliation(s)
- Marissa Tan
- Cooper Center for Healing, Cooper University Health Care, Camden, New Jersey, USA
- Epidemiology Intelligence Service, Division of Workforce Development, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
- Hepatitis, Division of Disease Control, Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA
| | - Danica Kuncio
- Hepatitis, Division of Disease Control, Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA
| | - Eman Addish
- Hepatitis, Division of Disease Control, Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA
| | - Tanner Nassau
- Division of HIV Health, Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA
| | - Dana Higgins
- Division of Substance Use Prevention and Harm Reduction, Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA
| | - Melissa Miller
- Division of HIV Health, Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA
| | - Kathleen Brady
- Division of HIV Health, Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA
| |
Collapse
|
13
|
Lane BL, Seal DW, Robertson DJ, Kendall C, Xavier Hall CD, Mgbere O, Kissinger PJ. Hepatitis C Care in the Greater New Orleans Area: Patient Perspectives on the Barriers and Facilitators to Care. J Health Care Poor Underserved 2025; 36:257-283. [PMID: 39957649 PMCID: PMC11932733 DOI: 10.1353/hpu.2025.a951596] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/18/2025]
Abstract
Increasing engagement in hepatitis C virus (HCV) care and treatment will help mitigate HCV incidence, morbidity, and mortality in the United States. This study aimed to understand the multilevel factors affecting engagement in HCV care after implementation of a subscription-based payment model for HCV treatment. Semi-structured interviews were conducted with patients with chronic HCV from a federally qualified health center in New Orleans, Louisiana. We used a convenience sampling method to recruit patients for the study. The interviews conducted between May 2020 and February 2021 explored factors influencing linkage to and retention in HCV care, using the socio-ecological model as the guiding framework. An analysis of the interviews with 39 patients revealed multilevel barriers to care, including instability, provider attitudes, prior care experiences, and the corrections system. Facilitators identified included personal health journey, network HCV experiences, and HCV awareness. A multilevel approach to facilitate engagement in HCV care is imperative.
Collapse
Affiliation(s)
- Brittany L. Lane
- Florida State University, College of Nursing, 98 Varsity Way, Tallahassee, Florida, 32306, United States
- Center of Population Sciences for Health Equity, Florida State University, College of Nursing, 2010 Levy Avenue, Innovation Park, Building B, Suite 3600, Tallahassee, Florida, 32310, United States
| | - David W. Seal
- Tulane University, Celia Scott Weatherhead School Public Health and Tropical Medicine, Department of Social, Behavioral, and Population Sciences, 1440 Canal Street, New Orleans, Louisiana, 70112, United States
| | - Dielda J. Robertson
- Louisiana Office of Public Health, Immunization Program, 1450 Poydras Street, #400 New Orleans, Louisiana, 70112, United States
| | - Carl Kendall
- Tulane University, Celia Scott Weatherhead School Public Health and Tropical Medicine, Department of Social, Behavioral, and Population Sciences, 1440 Canal Street, New Orleans, Louisiana, 70112, United States
| | - Casey D. Xavier Hall
- Florida State University, College of Nursing, 98 Varsity Way, Tallahassee, Florida, 32306, United States
- Center of Population Sciences for Health Equity, Florida State University, College of Nursing, 2010 Levy Avenue, Innovation Park, Building B, Suite 3600, Tallahassee, Florida, 32310, United States
- Florida State University, College of Social Work, 296 Champions Way, Tallahassee, FL, 32304, United States
| | - Osaro Mgbere
- Tilman J. Fertitta Family College of Medicine, Department of Health Systems and Population Health Sciences, University of Houston, 5055 Medical Circle, Houston, Texas, 77204, United States
| | - Patricia J. Kissinger
- Tulane University, Celia Scott Weatherhead School Public Health and Tropical Medicine, Department of Epidemiology, 1440 Canal Street, 70112 New Orleans, Louisiana, United States
| |
Collapse
|
14
|
Crawford JM, Penberthy L, Pinto LA, Althoff KN, Assimon MM, Cohen O, Gillim L, Hammonds TL, Kapur S, Kaufman HW, Kwasny D, Liew JW, Meyer WA, Reynolds SL, Schleicher CB, Subbiah S, Theruviparampil C, Wallace ZS, Warner JL, Yoon S, Ziemba YC. Coronavirus Disease 2019 (COVID-19) Real World Data Infrastructure: A Big-Data Resource for Study of the Impact of COVID-19 in Patient Populations With Immunocompromising Conditions. Open Forum Infect Dis 2025; 12:ofaf021. [PMID: 39850579 PMCID: PMC11756308 DOI: 10.1093/ofid/ofaf021] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2024] [Accepted: 01/09/2025] [Indexed: 01/25/2025] Open
Abstract
Background We developed a United States-based real-world data resource to better understand the continued impact of the coronavirus disease 2019 (COVID-19) pandemic on immunocompromised patients, who are typically underrepresented in prospective studies and clinical trials. Methods The COVID-19 Real World Data infrastructure (CRWDi) was created by linking and harmonizing de-identified HealthVerity medical and pharmacy claims data from 1 December 2018 to 31 December 2023, with severe acute respiratory syndrome coronavirus 2 virologic and serologic laboratory data from major commercial laboratories and Northwell Health; COVID-19 vaccination data; and, for patients with cancer, 2010 to 2021 National Cancer Institute Surveillance, Epidemiology, and End Results registry data. Results The CRWDi contains 4 cohorts: patients with cancer; patients with rheumatic diseases receiving pharmacotherapy; noncancer solid organ and hematopoietic stem cell transplant recipients; and people from the general population including adults and pediatric patients. The project successfully linked and harmonized longitudinal, de-identified data on 5.2 million unique patients using privacy-preserving record lineage techniques. The system was developed in early 2024 and rapidly deployed, enabling longitudinal analysis of patient healthcare over the full geography of delivery settings and exploration of novel questions for populations at high risk for adverse outcomes. Conclusions The successful development of the CRWDi enables researchers to address unanswered questions that have arisen during the COVID-19 pandemic. By making the data broadly and freely available to academic researchers, this real-world data system represents an important complement to existing consortia and clinical trials that have emerged during the healthcare crisis and is readily reproducible for future purposing.
Collapse
Affiliation(s)
- James M Crawford
- Northwell, Department of Pathology and Laboratory Medicine, New Hyde Park, New York, USA
| | - Lynne Penberthy
- Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA
| | - Ligia A Pinto
- Vaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
| | - Keri N Althoff
- John Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, Maryland, USA
| | | | - Oren Cohen
- Laboratory Corporation of America, Burlington, North Carolina, USA
| | - Laura Gillim
- Laboratory Corporation of America, Burlington, North Carolina, USA
| | | | - Shilpa Kapur
- Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA
| | | | | | - Jean W Liew
- Boston University Chobanian and Avedisian School of Medicine, Section of Rheumatology, Boston, Massachusetts, USA
| | | | | | - Cheryl B Schleicher
- Northwell, Department of Pathology and Laboratory Medicine, New Hyde Park, New York, USA
| | - Suki Subbiah
- Louisiana State University Health Sciences Center, Section of Hematology/Oncology, New Orleans, Louisiana, USA
| | | | - Zachary S Wallace
- Massachusetts General Hospital, Division of Rheumatology, Allergy, and Immunology, Boston, Massachusetts, USA
| | - Jeremy L Warner
- Brown University, Department of Medicine, Providence, Rhode Island, USA
- Rhode Island Hospital, Providence, Rhode Island, USA
| | - Suhyeon Yoon
- Integrated Data Sciences Section, Research Technologies Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA
| | - Yonah C Ziemba
- Northwell, Department of Pathology and Laboratory Medicine, New Hyde Park, New York, USA
| |
Collapse
|
15
|
Moein M, Fioramonti P, Lieb K, Golkarieh A, Forouzan A, Leipman J, Bahreini A, Moallem Shahri M, Jamshidi A, Saidi R. Improved Outcomes of Liver Transplantation in Patients With Hepatitis C, Following the Introduction of Innovative Antiviral Therapies. J Clin Exp Hepatol 2025; 15:102428. [PMID: 39564427 PMCID: PMC11570942 DOI: 10.1016/j.jceh.2024.102428] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/03/2024] [Accepted: 10/10/2024] [Indexed: 11/21/2024] Open
Abstract
Background The treatment landscape for hepatitis C virus (HCV) underwent a significant shift with the introduction of direct-acting antiviral (DAA) medications in late 2013. This study aimed to evaluate the impact of DAAs on liver transplantation outcomes, examining both the benefits and any potential drawbacks associated with their use. Methods and materials A retrospective registry analysis of the United Network for Organ Sharing database was done for liver transplants in patients diagnosed with hepatitis C, that were performed in the United States from January 2000 to May 2020. Results The study was divided into two subgroups, based on the timing of the new DAA medication that FDA approved. The only significant difference between the two cohorts is the recipient's age. The data analysis showed a significant overall 5-year graft survival improvement in the 2014-2020 group compared with the 2000-2013 group, from a mean of 64.8% in 2000-2013 to a mean of 76% in 2014-2020 (P < 0.001). Interestingly, when we compared the 5-year graft survivals with recipients who had a donor above age 50, the graft survival rate difference was even more significant (74% vs. 56%, P < 0.001) as some studies have shown a suboptimal graft outcome when the donor age is above 40 years old. Not only has the utilization of donation after circulatory death livers increased significantly after 2014 but the graft survival in this cohort has also been significantly higher (P < 0.001). Conclusion The emergence of DAAs in 2013 marked a watershed moment in the management of HCV offering high cure rates, minimal side effects, and shorter treatment durations to a point that the short- and long-term outcomes of liver transplantation for HCV is almost equal to the other causes of liver transplantation.
Collapse
Affiliation(s)
- Mahmoudreza Moein
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Peter Fioramonti
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Kayla Lieb
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Alireza Golkarieh
- University of Michigan, Department of Mechanical Engineering and Data Science, Ann Arbor, MI, USA
| | - Artin Forouzan
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Jessica Leipman
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Amin Bahreini
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Matin Moallem Shahri
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Abolfazl Jamshidi
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| | - Reza Saidi
- SUNY Upstate Medical University, Division of Transplant Services, Department of Surgery, Syracuse, NY, USA
| |
Collapse
|
16
|
Abboud Y, Malhotra R, Maan MHA, Mathew A, Abboud I, Pan CW, Alsakarneh S, Jaber F, Mohamed I, Kim D, Pyrsopoulos NT. Hepatocellular carcinoma national burden across different geographical regions in the United States between 2001 and 2020. World J Methodol 2024; 14:95598. [PMID: 39712566 PMCID: PMC11287541 DOI: 10.5662/wjm.v14.i4.95598] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/13/2024] [Revised: 05/12/2024] [Accepted: 06/03/2024] [Indexed: 07/26/2024] Open
Abstract
BACKGROUND While prior data showed an increasing incidence of hepatocellular carcinoma (HCC) in the United States, there are limited comprehensive and comparative data on the geographical variations of HCC trends in different demographic-specific populations. AIM To evaluate sex and age-specific incidence rates and time trends in different geographical regions in the United States. METHODS Age-adjusted HCC incidence rates were collected from the United States Cancer Statistics (USCS) database which covers approximately 98% of the population in the United States. HCC rates were stratified by sex, age, and geographical region. annual percentage change (APC) and average APC (AAPC) were estimated using Joinpoint Regression. A pairwise comparison was conducted between sex-specific trends. RESULTS There were 467344 patients diagnosed with HCC in the United States in the USCS database between 2001 and 2020. The rates and trends varied by geographical region. When looking at the West region (115336 patients), incidence rates of HCC were overall increasing and also increasing in older adults. However, when evaluating younger adults, HCC incidence rates decreased in men but not in women with a sex-specific absolute AAPC-difference of 2.15 (P = 0.005). When evaluating the Midwest region (84612 patients), similar results were seen. While incidence rates were increasing in the overall population and in older adults as well, they were decreasing in younger men but not in women with a sex-specific absolute AAPC-difference of 1.61 (P < 0.001). For the Northeast region (87259 patients), the analysis showed similar results with decreasing HCC incidence rates in younger men but not counterpart women (Sex-specific AAPC-difference = 3.26, P < 0.001). Lastly, when evaluating the south (180137 patients), the results were also decreasing in younger men but not in women (Sex-specific AAPC-difference = 2.55, P < 0.001). CONCLUSION Nationwide analysis covering around 98% of the United States population shows an increasing incidence of HCC across all geographical regions, most notably in the South. While younger men experienced decreasing HCC incidence, younger women had a stable trend and this was noted across all regions as well. Our study offers insight into the epidemiology of HCC in different demographic groups across various United States geographical regions. While the reasons contributing to our findings are unclear, they can be related to sex and regional disparities in healthcare access and utilization. Future research is warranted to characterize the temporal change in HCC risk factors across different United States regions.
Collapse
Affiliation(s)
- Yazan Abboud
- Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ 07103, United States
| | - Raj Malhotra
- Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ 07103, United States
| | | | - Anna Mathew
- Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ 07103, United States
| | - Ibrahim Abboud
- University of California Riverside School of Medicine, Riverside, CA 92521, United States
| | - Chun-Wei Pan
- Department of Internal Medicine, John H Stroger Hospital of Cook County, Chicago, IL 60612, United States
| | - Saqr Alsakarneh
- Department of Internal Medicine, University of Missouri-Kansas City, Kansas, MO 64108, United States
| | - Fouad Jaber
- Department of Internal Medicine, University of Missouri-Kansas City, Kansas, MO 64108, United States
| | - Islam Mohamed
- Department of Internal Medicine, University of Missouri-Kansas City, Kansas, MO 64108, United States
| | - David Kim
- Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ 07103, United States
| | - Nikolaos T Pyrsopoulos
- Division of Gastroenterology and Hepatology, Rutgers New Jersey Medical School, Newark, NJ 07101, United States
| |
Collapse
|
17
|
De La Hoz A, Graves K, Bernstein JA, Assoumou SA. HIV and hepatitis C virus-related misinformation may contribute to rising rates of infection and suboptimal clinical outcomes among persons with substance use. AIDS Care 2024; 36:1771-1780. [PMID: 38991115 PMCID: PMC11560648 DOI: 10.1080/09540121.2024.2372730] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2023] [Accepted: 06/21/2024] [Indexed: 07/13/2024]
Abstract
HIV and hepatitis C virus (HCV) infection rates among persons, who use drugs, have risen during the US overdose crisis. We elicited patient perspectives about these interconnected infections to identify the areas of misinformation that might prevent appropriate management. We used in-depth interviews and thematic analysis of coded data collected from patients (N = 24) at detox and from key informants (N = 10). Seventy-one per cent reported injecting drugs. We found that patient narratives included misinformation about HIV and HCV transmission, natural history and treatment. Some participants thought that activities such as sharing drinkware or food with persons with HIV could lead to infection, while others believed that mainly men who have sex with men were at risk. Despite significant improvements in treatment, some participants still believed that HIV was a fatal condition, while others noted that treatment was only necessary at later stages. Some participants thought that HCV was a common, mild infection that might not need immediate attention, and others stated that individuals who were actively using drugs were ineligible for treatment. The current study exposes a considerable level of misinformation about HIV prevention and about the importance and benefits of HCV therapy. Educational interventions are necessary to counter misinformation identified.
Collapse
Affiliation(s)
- Alejandro De La Hoz
- Section of General Internal Medicine, Department of Medicine, Boston Medical Center, Boston, MA, USA
- Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA
| | - Kristin Graves
- Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA
| | - Judith A Bernstein
- Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA
| | - Sabrina A Assoumou
- Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, MA, USA
- Section of Infectious Diseases, Department of Medicine, Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA
| |
Collapse
|
18
|
Li LX, Lin JS, Tackett S, Bertram A, Sisson SD, Rastegar D, Buresh ME. Closing the Gaps in Hepatitis C Knowledge Among Internal Medicine Residents in the United States. AMERICAN JOURNAL OF MEDICINE OPEN 2024; 12:100077. [PMID: 39469060 PMCID: PMC11513476 DOI: 10.1016/j.ajmo.2024.100077] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/17/2024] [Accepted: 08/05/2024] [Indexed: 10/30/2024]
Abstract
Background The introduction of direct-acting antivirals (DAA) has revolutionized hepatitis C virus (HCV) treatment but has not translated into an appreciable decline in HCV prevalence, which is estimated to be 2.4 million in the United States. Efforts are thought to be limited by the lack of experience among nonspecialist providers in managing HCV. However, there have been no comprehensive surveys assessing HCV knowledge among medical trainees to determine if trends have shifted since the discovery of DAAs. Methods We performed a retrospective observational study of internal medicine (IM) residents in the United States (n = 1763) who completed the Physician Education and Assessment Center HCV learning module between 2021 and 2022. Participant pre- and post-test performance was compared with further stratified analysis by training year, geography, training program type, and local HCV prevalence using ANOVA and Chi-squared tests of proportions, respectively. Results IM residents universally lacked baseline HCV knowledge (average score ± standard deviation, 43% ± 19%); less than 50% of participants answered correctly in the majority of tested domains. There were no consistent trends in performance regardless of resident characteristic used to stratify the participants. Knowledge gaps improved after completing an online educational training module (P < .001). Conclusions HCV knowledge remains limited among IM residents despite expansion of treatment options. Addressing these gaps during clinical training may substantially increase the availability of HCV treatment in the community, and online modules may be one means by which to integrate these efforts into medical training.
Collapse
Affiliation(s)
- Lucy X. Li
- Department of Medicine, Division of Infectious Disease, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Jessica S. Lin
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Sean Tackett
- Biostatistics, Epidemiology, and Data Management Core, Johns Hopkins School of Medicine, Baltimore, Maryland
- Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Amanda Bertram
- Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Stephen D. Sisson
- Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Darius Rastegar
- Department of Medicine, Division of Addiction Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Megan E. Buresh
- Department of Medicine, Division of Addiction Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
| |
Collapse
|
19
|
Martin MT, Hietpas AR, Novak JL, Deming P. A National Survey of Pharmacist Involvement in Hepatitis C Virus Management in the United States. J Viral Hepat 2024; 31:890-897. [PMID: 39435734 DOI: 10.1111/jvh.14014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/22/2024] [Revised: 08/31/2024] [Accepted: 09/19/2024] [Indexed: 10/23/2024]
Abstract
Models estimate that the United States will not meet its 2030 hepatitis C virus (HCV) elimination goal. Engagement of healthcare providers including pharmacists is critical for HCV elimination efforts. We aimed to characterise the involvement of pharmacists in HCV management. The study design was a cross-sectional survey. Investigators sent the questionnaire to pharmacy and HCV organisations' listservs and limited responses to licensed pharmacists with direct patient care. Questions assessed setting, HCV screening, prescribing, and management; and opinions, and perceived barriers and facilitators to pharmacists' HCV management. Two hundred and nine survey respondents across 45 states reported managing 24 patients/month, with 5.3 (±4.4) years' experience in HCV, and identified pharmacist-managed HCV at their site since 2013 (±5.8 years). Most practice at academic medical centres (29%, 58/203) under collaborative practice agreements (67%, 127/189), as ambulatory care pharmacists (70%, 131/187), in primary care (50%, 65/131). Many pharmacists provide screening, linkage to care, and/or referral (81%, 157/194); 99.5% (190/191) perform treatment evaluation and selection; 98% (180/183) provide treatment education, 93% (171/183) initiate treatment, and 90% (162/180) provide on- and/or post-treatment monitoring. Respondents indicated collaboration with prescribers as most helpful in their role in HCV management, whereas lack of reimbursement was a main barrier. Satisfying components include HCV cure, care and education provision; frustrations include socioeconomic factors impeding patients' follow-up and prior authorisations/insurance barriers. Survey results show the variety of pharmacists' roles in direct HCV patient care and may be used to increase other providers' awareness of pharmacists' services and contributions to HCV elimination efforts.
Collapse
Affiliation(s)
- Michelle T Martin
- University of Illinois Hospital and Health Sciences System, Chicago, Illinois, USA
- University of Illinois Chicago College of Pharmacy, Chicago, Illinois, USA
| | | | | | - Paulina Deming
- University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA
- University of New Mexico College of Pharmacy, Albuquerque, New Mexico, USA
| |
Collapse
|
20
|
Estadt AT, Kline D, Miller WC, Feinberg J, Hurt CB, Mixson LS, Friedmann PD, Lowe K, Tsui JI, Young AM, Cooper H, Korthuis PT, Pho MT, Jenkins W, Westergaard RP, Go VF, Brook D, Smith G, Rice DR, Lancaster KE. Differences in hepatitis C virus (HCV) testing and treatment by opioid, stimulant, and polysubstance use among people who use drugs in rural U.S. communities. Harm Reduct J 2024; 21:214. [PMID: 39614319 PMCID: PMC11606200 DOI: 10.1186/s12954-024-01131-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2024] [Accepted: 11/19/2024] [Indexed: 12/01/2024] Open
Abstract
BACKGROUND People who use drugs (PWUD) in rural communities increasingly use stimulants, such as methamphetamine and cocaine, with opioids. We examined differences in hepatitis C virus (HCV) testing and treatment history among rural PWUD with opioids, stimulants, and other substance use combinations. METHODS PWUD were enrolled from ten rural U.S. communities from 2018 to 2020. Participants self-reporting a positive HCV result were asked about their HCV treatment history and drug use history. Drug use was categorized as opioids alone, stimulants alone, both, or other drug(s) within the past 30 days. Prevalence ratios (PR) were yielded using adjusted multivariable log-binomial regression with generalized linear mixed models. RESULTS Of the 2,705 PWUD, most reported both opioid and stimulant use (74%); while stimulant-only (12%), opioid-only (11%), and other drug use (2%) were less common. Most (76%) reported receiving HCV testing. Compared to other drug use, those who reported opioid use alone had a lower prevalence of HCV testing (aPR = 0.80; 95% CI: 0.63, 1.02). Among participants (n = 944) who self-reported an HCV diagnosis in their lifetime, 111 (12%) ever took anti-HCV medication; those who used both opioids and stimulants were less likely to have taken anti-HCV medication compared with other drug(s) (aPR = 0.41; 95% CI: 0.19, 0.91). CONCLUSIONS In this pre-COVID study of U.S. rural PWUD, those who reported opioid use alone had a lower prevalence of reported HCV testing. Those diagnosed with HCV and reported both opioid and stimulant use were less likely to report ever taking anti-HCV medication.
Collapse
Affiliation(s)
- Angela T Estadt
- College of Public Health, Division of Epidemiology, Ohio State University, 1841 Neil Avenue, Columbus, OH, 43210, USA.
| | - David Kline
- Division of Public Health Sciences, Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA
| | - William C Miller
- Gillings School of Global Public Health, Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Judith Feinberg
- Departments of Behavioral Medicine and Psychiatry & Medicine/Infectious Diseases, West Virginia University School of Medicine, Morgantown, WV, USA
| | - Christopher B Hurt
- Institute for Global Health & Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - L Sarah Mixson
- Department of Medicine, University of Washington, Seattle, WA, USA
| | - Peter D Friedmann
- University of Massachusetts Medical School-Baystate and Baystate Health, Springfield, MA, USA
| | - Kelsa Lowe
- Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA
| | - Judith I Tsui
- Division of General Internal Medicine, Department of Medicine, University of Washington, Seattle, WA, USA
| | - April M Young
- Department of Epidemiology, Center on Drug and Alcohol Research, University of Kentucky, Lexington, KY, USA
| | - Hannah Cooper
- Rollins School of Public Health, Emory University, Atlanta, GA, USA
| | - P Todd Korthuis
- Department of Medicine, Section of Addiction Medicine, Oregon Health & Science University, Portland, OR, USA
| | - Mai T Pho
- Department of Medicine, University of Chicago, Chicago, IL, USA
| | - Wiley Jenkins
- Department of Public Health Sciences, Clemson University, Clemson, SC, USA
| | - Ryan P Westergaard
- Department of Medicine, Division of Infectious Disease, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, USA
| | - Vivian F Go
- Gillings School of Global Public Health, Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
| | - Daniel Brook
- College of Medicine, Ohio State University, Columbus, OH, USA
| | - Gordon Smith
- Department of Epidemiology and Biostatistics, West Virginia University School of Public Health, Morgantown, WV, USA
| | - Dylan R Rice
- University of Massachusetts Chan School of Medicine, Worcester, MA, USA
| | - Kathryn E Lancaster
- Division of Public Health Sciences, Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA
| |
Collapse
|
21
|
O'Brien TR, Witt DJ, Saxena V, Morrissey KG, Chen S, Baker FS, Prokunina-Olsson L, Pfeiffer RM, Lai JB. IFNL4 genotype and other personal characteristics to predict response to 8-week sofosbuvir-based treatment for chronic hepatitis C. J Infect 2024; 89:106258. [PMID: 39216831 PMCID: PMC11490369 DOI: 10.1016/j.jinf.2024.106258] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/17/2024] [Revised: 08/15/2024] [Accepted: 08/23/2024] [Indexed: 09/04/2024]
Abstract
BACKGROUND Shorter duration therapy for hepatitis C virus (HCV) infection might reduce treatment costs and increase the number of patients treated and cured. We determined factors associated with treatment response after an 8-week sofosbuvir-based therapy and developed a simple model to predict an individual's likelihood of treatment success. METHODS Among 2907 patients who received ledipasvir/sofosbuvir for 8 weeks, we determined failure rates by demographic and clinical characteristics, and IFNL4-∆G/TT genotype. We estimated the average IFNL4 genotype-related treatment failure rate in major ancestry groups by applying our IFNL4 genotype results to genotype distributions from reference populations. We created a treatment response model based on three personal characteristics. RESULTS Overall, 4.4% of the patients failed treatment. We observed significantly lower failure rates for persons <50 years (1.6%), females (2.6%), those carrying the IFNL4-TT/TT genotype (1.8%), those with HCV RNA <5.8 log10 copies/mL (2.0%) or HCV genotype-1B infection (2.6%). In a model based on ancestry, age and sex, the predicted probability of treatment failure ranged from 0.5% among females of East Asian ancestry <50 years of age to 8.5% among males of African ancestry age ≥65 years. CONCLUSION Applying this algorithm at the point-of-care might facilitate HCV elimination, especially in low- and middle-income countries.
Collapse
Affiliation(s)
- Thomas R O'Brien
- Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, United States.
| | - David J Witt
- Kaiser Permanente San Rafael Medical Center, San Rafael, CA, United States.
| | - Varun Saxena
- Kaiser Permanente South San Francisco Medical Center, South San Francisco, CA, United States; University of California San Francisco, San Francisco, CA, United States.
| | | | - Sabrina Chen
- Information Management Services, Inc, Calverton, MD, United States.
| | - Francine S Baker
- Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, United States; Laboratory of Translational Genomics, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, United States.
| | - Ludmila Prokunina-Olsson
- Laboratory of Translational Genomics, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, United States.
| | - Ruth M Pfeiffer
- Biostatistics Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, United States.
| | - Jennifer B Lai
- Kaiser Permanente San Rafael Medical Center, San Rafael, CA, United States.
| |
Collapse
|
22
|
Adepoju VA, Udah DC, Ezenwa CA, Ganiyu J, Lawal SM, Haruna JA, Adnani QES, Ibrahim AA. Toward Universal Health Coverage: What Socioeconomic and Clinical Factors Influence Health Insurance Coverage and Restrictions in Access to Viral Hepatitis Services in Nasarawa State, Nigeria? INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2024; 21:1373. [PMID: 39457346 PMCID: PMC11508061 DOI: 10.3390/ijerph21101373] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/14/2024] [Revised: 10/10/2024] [Accepted: 10/14/2024] [Indexed: 10/28/2024]
Abstract
Background: Viral hepatitis B and C (HBV and HCV) pose significant public health concern in Nigeria, where access to healthcare and treatment affordability are limited. This study investigated sociodemographic and clinical predictors of health insurance coverage and access to care among patients with HBV and HCV in Nasarawa State, Nigeria. Methods: A cross-sectional facility-based study was conducted at two secondary hospitals in Nasarawa State, Nigeria. Participants included patients diagnosed with HBV, HCV, or both who were ≥18 years old. Data were collected using a structured questionnaire covering sociodemographic and clinical information, health insurance details, and economic impact. Binary logistic regression was used to analyze the relationship between sociodemographic/clinical factors and health insurance status. Results: Out of 303 participants, 68% had health insurance, which mostly covered hepatitis screening and vaccination. Significant predictors of health insurance coverage included being aged 36-40 years (adjusted odds ratio [aOR]: 11.01, 95% confidence interval [CI]: 2.38-50.89, p = 0.002), having post-secondary education (aOR: 25.2, 95% CI: 9.67-65.68, p < 0.001), being employed (aOR: 27.83, 95% CI: 8.85-87.58, p < 0.001), and being HIV-positive (aOR: 4.06, 95% CI: 1.55-10.61, p = 0.004). Nearly all those insured (99%) faced restrictions in insurance coverage for viral hepatitis services. Conclusions: This study reveals that while health insurance coverage is relatively high among viral hepatitis patients in Nasarawa State, significant restrictions hinder access to comprehensive services, especially for vulnerable groups like younger adults, the unemployed, and PLHIV. Key factors influencing coverage include age, education, employment, and HIV status. Expanding benefit packages to include viral hepatitis diagnosis and treatment, raising awareness about viral hepatitis as part of insurance strategy, improving access for underserved populations, and integrating hepatitis services into existing HIV programs with strong policy implementation monitoring frameworks are crucial to advancing universal health coverage and meeting the WHO's 2030 elimination goals.
Collapse
Affiliation(s)
- Victor Abiola Adepoju
- Department of HIV and Infectious Diseases, Jhpiego Nigeria, Affiliate of Johns Hopkins University, Abuja 900911, Nigeria
| | - Donald C. Udah
- JSI Research & Training Institute Inc. (JSI), Abuja 900911, Nigeria;
| | - Chinonye Alioha Ezenwa
- Department of Strategic Information, Jhpiego Nigeria, Affiliate of Johns Hopkins University, Abuja 900911, Nigeria;
| | - Jamiu Ganiyu
- National AIDS/STI and Viral Hepatitis Control Program, Federal Ministry of Health, Abuja 900911, Nigeria;
| | | | - James Ambo Haruna
- Our Ladies of Apostles Hospital, Akwanga 960101, Nasarawa State, Nigeria;
| | | | - Adamu Alhassan Ibrahim
- Director of Public Health Services, Nasarawa State Ministry of Health, Lafia 950101, Nasarawa State, Nigeria;
| |
Collapse
|
23
|
Islami F, Marlow EC, Thomson B, McCullough ML, Rumgay H, Gapstur SM, Patel AV, Soerjomataram I, Jemal A. Proportion and number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States, 2019. CA Cancer J Clin 2024; 74:405-432. [PMID: 38990124 DOI: 10.3322/caac.21858] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2024] [Revised: 05/14/2024] [Accepted: 05/15/2024] [Indexed: 07/12/2024] Open
Abstract
In 2018, the authors reported estimates of the number and proportion of cancers attributable to potentially modifiable risk factors in 2014 in the United States. These data are useful for advocating for and informing cancer prevention and control. Herein, based on up-to-date relative risk and cancer occurrence data, the authors estimated the proportion and number of invasive cancer cases (excluding nonmelanoma skin cancers) and deaths, overall and for 30 cancer types among adults who were aged 30 years and older in 2019 in the United States, that were attributable to potentially modifiable risk factors. These included cigarette smoking; second-hand smoke; excess body weight; alcohol consumption; consumption of red and processed meat; low consumption of fruits and vegetables, dietary fiber, and dietary calcium; physical inactivity; ultraviolet radiation; and seven carcinogenic infections. Numbers of cancer cases and deaths were obtained from data sources with complete national coverage, risk factor prevalence estimates from nationally representative surveys, and associated relative risks of cancer from published large-scale pooled or meta-analyses. In 2019, an estimated 40.0% (713,340 of 1,781,649) of all incident cancers (excluding nonmelanoma skin cancers) and 44.0% (262,120 of 595,737) of all cancer deaths in adults aged 30 years and older in the United States were attributable to the evaluated risk factors. Cigarette smoking was the leading risk factor contributing to cancer cases and deaths overall (19.3% and 28.5%, respectively), followed by excess body weight (7.6% and 7.3%, respectively), and alcohol consumption (5.4% and 4.1%, respectively). For 19 of 30 evaluated cancer types, more than one half of the cancer cases and deaths were attributable to the potentially modifiable risk factors considered in this study. Lung cancer had the highest number of cancer cases (201,660) and deaths (122,740) attributable to evaluated risk factors, followed by female breast cancer (83,840 cases), skin melanoma (82,710), and colorectal cancer (78,440) for attributable cases and by colorectal (25,800 deaths), liver (14,720), and esophageal (13,600) cancer for attributable deaths. Large numbers of cancer cases and deaths in the United States are attributable to potentially modifiable risk factors, underscoring the potential to substantially reduce the cancer burden through broad and equitable implementation of preventive initiatives.
Collapse
Affiliation(s)
- Farhad Islami
- Surveillance and Health Equity Science, American Cancer Society, Atlanta, Georgia, USA
| | - Emily C Marlow
- Surveillance and Health Equity Science, American Cancer Society, Atlanta, Georgia, USA
| | - Blake Thomson
- Surveillance and Health Equity Science, American Cancer Society, Atlanta, Georgia, USA
- Stanford University School of Medicine, Stanford, California, USA
| | | | - Harriet Rumgay
- Cancer Surveillance Branch, International Agency for Research on Cancer, Lyon, France
| | | | - Alpa V Patel
- Population Science, American Cancer Society, Atlanta, Georgia, USA
| | | | - Ahmedin Jemal
- Surveillance and Health Equity Science, American Cancer Society, Atlanta, Georgia, USA
| |
Collapse
|
24
|
Lam JT, Xavioer S. Impact of a Pharmacist-Led HCV Treatment Program at a Federally Qualified Health Center. PHARMACY 2024; 12:115. [PMID: 39195844 PMCID: PMC11359132 DOI: 10.3390/pharmacy12040115] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/12/2024] [Revised: 07/18/2024] [Accepted: 07/22/2024] [Indexed: 08/29/2024] Open
Abstract
Pharmacists are key players who can help to eliminate the hepatitis C virus (HCV) epidemic in the United States. This pilot retrospective study evaluated the impact of a pharmacist-led HCV treatment program in a federally qualified health center (FQHC) primary care clinic setting. The primary outcome was to assess sustained virologic response (SVR) rates 12 weeks after patients were initiated and completed their oral direct acting antiviral (DAA) treatment regimens. METHODS This pilot retrospective study included historical analyses of patients who received DAA treatment in the pharmacist-led HCV treatment program in a FQHC clinic between 1 January 2019 and 31 January 2021. SVR was the primary outcome measure for treatment response. RESULTS Sixty-seven patients with HCV mono- and HIV co-infection were referred, and 59 patients were initiated on DAA regimens after treatment. Fifty of those who were started on DAA regimens completed their treatment, and 38 achieved SVR (modified intention to treat [mITT] SVR rate of 76%). CONCLUSION Our study's findings demonstrated SVR rates that were comparable with other pharmacist-directed HCV treatment services in the United States despite the impact of the COVID-19 pandemic. Our study included a higher proportion of individuals with HCV/HIV co-infection and of Hispanic ethnicity.
Collapse
Affiliation(s)
- Jerika T. Lam
- Department of Pharmacy Practice, Chapman University School of Pharmacy, 9401 Jeronimo Rd. Ste 207, Ste 296, Irvine, CA 92618, USA;
| | | |
Collapse
|
25
|
Kennedy BS, Richeson RP, Houde AJ. Hepatitis C Virus Care Cascade by Race/Ethnicity in a Statewide Correctional Population, 2019-2023. J Racial Ethn Health Disparities 2024:10.1007/s40615-024-02058-1. [PMID: 38951368 DOI: 10.1007/s40615-024-02058-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2024] [Revised: 06/14/2024] [Accepted: 06/17/2024] [Indexed: 07/03/2024]
Abstract
IMPORTANCE Hepatitis C virus (HCV) care cascade data by race/ethnicity for US correctional populations are sparse. OBJECTIVE To evaluate the HCV care cascade by race/ethnicity for a state correctional population. DESIGN, SETTING, AND PARTICIPANTS This retrospective cohort study used Connecticut Department of Correction data for incarcerated individuals tested, diagnosed, and treated for chronic HCV infection with direct-acting antivirals (DAAs) from 2019 to 2023. MAIN OUTCOMES AND MEASURES HCV care cascade outcomes, including testing, treatment, and cure rates, were compared by race/ethnicity. Poisson regression was used to estimate prevalence ratios (PRs), with adjustment for demographic and legal status factors. RESULTS A total of 24,867 patients tested for HCV (88.9% men, mean (SD) age 35.6 (11.8), 32.7% White, 37.9% Black, 28.4% Hispanic, 0.6% Asian, 0.4% American Indian/Alaska Native (AIAN), 34.7% sentenced ≥ 1 year). Both HCV exposure and chronic HCV were highest for White (27.1% and 15.2%) and lowest for Black individuals (4.6% and 2.6%) (P < 0.01, for both outcomes). While incarcerated, 63.2% of chronic HCV patients started DAAs, and treatment rates did not significantly differ by race/ethnicity (P > 0.05). For those treated and having post-treatment lab data available, cure rates were 98.8% or better for all racial/ethnic groups (P > 0.05). In the adjusted regression analyses, HCV treatment initiation was lower for those sentenced < 1 year (PR, 0.76; 95% CI, 0.67-0.87) and unsentenced (PR, 0.85; 95% CI, 0.80-0.91) than those sentenced ≥ 1 year. The adjusted prevalence of advanced fibrosis stage/activity grade was not significantly associated with race/ethnicity. CONCLUSIONS In this cohort study, less than two-thirds of chronic HCV patients initiated DAA treatment during their incarceration, and for those with available data, nearly all were cured. While there were disparities in HCV exposure and chronic HCV infection, significant racial/ethnic differences were not observed for treatment initiation or cure rates. Further efforts are needed to increase HCV treatment, especially for patients with shorter incarceration periods.
Collapse
Affiliation(s)
- Byron S Kennedy
- Connecticut Department of Correction, 24 Wolcott Hill Rd, Wethersfield, CT, 06109, USA.
| | - Robert P Richeson
- Connecticut Department of Correction, 24 Wolcott Hill Rd, Wethersfield, CT, 06109, USA
| | - Amy J Houde
- Connecticut Department of Correction, 24 Wolcott Hill Rd, Wethersfield, CT, 06109, USA
| |
Collapse
|
26
|
Evans KN, Wortley PM, Gandhi A, Bradley H. Trends in Hepatitis C Virus and HIV Care Outcomes Among People With HIV in Georgia, United States, 2014-2019. Public Health Rep 2024; 139:476-483. [PMID: 37924243 DOI: 10.1177/00333549231205341] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2023] Open
Abstract
OBJECTIVE If untreated, hepatitis C virus (HCV) leads to poor health outcomes, including liver disease and death, particularly among people with HIV (PWH). We describe trends over time in incidence rates of HCV diagnoses among PWH in the state of Georgia. METHODS We constructed a retrospective cohort of PWH in Georgia by using matched HIV and HCV case surveillance data from people diagnosed with HCV infection from January 1, 2014, through December 31, 2019. We calculated annual incidence rates per 1000 person-years and estimated trends over time in HCV diagnoses among the cohort of PWH by demographic characteristics and HIV care outcomes using Poisson regression analysis, with α = .05 considered significant. RESULTS From 2014 through 2019, among 49 530 PWH in Georgia, 1945 (3.9%) were diagnosed with HCV infection. During this period, overall incidence per 1000 person-years of newly diagnosed HCV infection among PWH decreased from 8.7 to 4.5 (P for trend < .001). However, from 2014 through 2019, the annual incidence rates of PWH who were newly diagnosed with HCV infection increased from 4.6 to 7.1 (P for trend = .003) among people born from 1980 through 1989 and from 3.3 to 12.8 (P for trend < .001) among people born in 1990 or later. CONCLUSION Strategies are needed to increase prevention, diagnosis, and treatment of HIV/HCV coinfection, particularly among PWH born in 1980 and later. Routine linkage of state surveillance data can inform prioritization of PWH at highest risk of HCV infection.
Collapse
Affiliation(s)
- Kimberly N Evans
- Department of Population Health Sciences, School of Public Health, Georgia State University, Atlanta, GA, USA
| | - Pascale M Wortley
- HIV/AIDS Epidemiology Section, Georgia Department of Public Health, Atlanta, GA, USA
| | - Ami Gandhi
- Viral Hepatitis Program, Georgia Department of Public Health, Atlanta, GA, USA
| | - Heather Bradley
- Department of Population Health Sciences, School of Public Health, Georgia State University, Atlanta, GA, USA
| |
Collapse
|
27
|
Lo Re V, Price JC, Schmitt S, Terrault N, Bhattacharya D, Aronsohn A. The obstacle is the way: Finding a path to hepatitis C elimination. Hepatology 2024; 80:3-7. [PMID: 38752360 DOI: 10.1097/hep.0000000000000807] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/15/2024] [Accepted: 02/15/2024] [Indexed: 05/27/2024]
Affiliation(s)
- Vincent Lo Re
- Department of Medicine, Division of Infectious Diseases, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
- Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Jennifer C Price
- Department of Medicine, Division of Gastroenterology, University of California San Francisco, San Francisco, California, USA
| | - Steven Schmitt
- Department of Infectious Disease, Cleveland Clinic, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, USA
| | - Norah Terrault
- Department of Medicine, Division of Gastrointestinal and Liver Diseases, University of Southern California, Los Angeles, California, USA
| | - Debika Bhattacharya
- Department of Medicine, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, California, USA
| | - Andrew Aronsohn
- Department of Medicine, Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, Illinois, USA
| |
Collapse
|
28
|
Furukawa NW, Ingber SZ, Symum H, Rapposelli KK, Teshale EH, Thompson WW, Zhu W, Roberts HW, Gupta N. Medicaid Expansion and Restriction Policies for Hepatitis C Treatment. JAMA Netw Open 2024; 7:e2422406. [PMID: 39012632 PMCID: PMC11252896 DOI: 10.1001/jamanetworkopen.2024.22406] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/31/2024] [Accepted: 05/16/2024] [Indexed: 07/17/2024] Open
Abstract
Importance Hepatitis C can be cured with direct-acting antivirals (DAAs), but Medicaid programs have implemented fibrosis, sobriety, and prescriber restrictions to control costs. Although restrictions are easing, understanding their association with hepatitis C treatment rates is crucial to inform policies that increase access to lifesaving treatment. Objective To estimate the association of jurisdictional (50 states and Washington, DC) DAA restrictions and Medicaid expansion with the number of Medicaid recipients with filled prescriptions for DAAs. Design, Setting, and Participants This cross-sectional study used publicly available Medicaid documents and claims data from January 1, 2014, to December 31, 2021, to compare the number of unique Medicaid recipients treated with DAAs in each jurisdiction year with Medicaid expansion status and categories of fibrosis, sobriety, and prescriber restrictions. Medicaid recipients from all 50 states and Washington, DC, during the study period were included. Multilevel Poisson regression was used to estimate the association between Medicaid expansion and DAA restrictive policies on jurisdictional Medicaid DAA prescription fills. Data were analyzed initially from August 15 to November 15, 2023, and subsequently from April 15 to May 9, 2024. Exposures Jurisdictional Medicaid expansion status and fibrosis, sobriety, and prescriber DAA restrictions. Main Outcomes and Measures Number of people treated with DAAs per 100 000 Medicaid recipients per year. Results A total of 381 373 Medicaid recipients filled DAA prescriptions during the study period (57.3% aged 45-64 years; 58.7% men; 15.2% non-Hispanic Black and 52.2% non-Hispanic White). Medicaid nonexpansion jurisdictions had fewer filled DAA prescriptions per 100 000 Medicaid recipients per year than expansion jurisdictions (38.6 vs 86.6; adjusted relative risk [ARR], 0.56 [95% CI, 0.52-0.61]). Jurisdictions with F3 to F4 (34.0 per 100 000 Medicaid recipients per year; ARR, 0.39 [95% CI, 0.37-0.66]) or F1 to F2 fibrosis restrictions (61.9 per 100 000 Medicaid recipients per year; ARR, 0.62 [95% CI, 0.59-0.66]) had lower treatment rates than jurisdictions without fibrosis restrictions (94.8 per 100 000 Medicaid recipients per year). Compared with no sobriety restrictions (113.5 per 100 000 Medicaid recipients per year), 6 to 12 months of sobriety (38.3 per 100 000 Medicaid recipients per year; ARR, 0.65 [95% CI, 0.61-0.71]) and screening and counseling requirements (84.7 per 100 000 Medicaid recipients per year; ARR, 0.87 [95% CI, 0.83-0.92]) were associated with reduced treatment rates, while 1 to 5 months of sobriety was not statistically significantly different. Compared with no prescriber restrictions (97.8 per 100 000 Medicaid recipients per year), specialist consult restrictions was associated with increased treatment (66.2 per 100 000 Medicaid recipients per year; ARR, 1.05 [95% CI, 1.00-1.10]), while specialist required restrictions were not statistically significant. Conclusions and Relevance In this cross-sectional study, Medicaid nonexpansion status, fibrosis, and sobriety restrictions were associated with a reduction in the number of people with Medicaid who were treated for hepatitis C. Removing DAA restrictions might facilitate treatment of more people diagnosed with hepatitis C.
Collapse
Affiliation(s)
- Nathan W. Furukawa
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Susan Z. Ingber
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Hasan Symum
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Karina K. Rapposelli
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Eyasu H. Teshale
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - William W. Thompson
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Weiming Zhu
- Division of HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Henry W. Roberts
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Neil Gupta
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia
| |
Collapse
|
29
|
Varley CD, Lowy E, Cartwright EJ, Morgan TR, Ross DB, Rozenberg-Ben-Dror K, Beste LA, Maier MM. Success of the US Veterans Health Administration's Hepatitis C Virus Care Continuum in the Direct-acting Antiviral Era. Clin Infect Dis 2024; 78:1571-1579. [PMID: 38279939 DOI: 10.1093/cid/ciae025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2023] [Revised: 11/17/2023] [Accepted: 01/23/2024] [Indexed: 01/29/2024] Open
Abstract
BACKGROUND Estimated hepatitis C prevalence within the Veterans Health Administration is higher than the general population and is a risk factor for advanced liver disease and subsequent complications. We describe the hepatitis C care continuum within the Veterans Health Administration 1 January 2014 to 31 December 2022. METHODS We included individuals in Veterans Health Administration care 2021-2022 who were eligible for direct-acting antiviral treatment 1 January 2014 to 31 December 2022. We evaluated the proportion of Veterans who progressed through each step of the hepatitis C care continuum, and identified factors associated with initiating direct-acting antivirals, achieving sustained virologic response, and repeat hepatitis C viremia. RESULTS We identified 133 732 Veterans with hepatitis C viremia. Hepatitis C treatment was initiated in 107 134 (80.1%), with sustained virologic response achieved in 98 136 (91.6%). In those who achieved sustained virologic response, 1097 (1.1%) had repeat viremia and 579 (52.8%) were retreated for hepatitis C. Veterans of younger ages were less likely to initiate treatment and achieve sustained virologic response, and more likely to have repeat viremia. Stimulant use and unstable housing were negatively associated with each step of the hepatitis C care continuum. CONCLUSIONS The Veterans Health Administration has treated 80% of Veterans with hepatitis C in care 2021-2022 and achieved sustained virologic response in more than 90% of those treated. Repeat viremia is rare and is associated with younger age, unstable housing, opioid use, and stimulant use. Ongoing efforts are needed to reach younger Veterans, and Veterans with unstable housing or substance use disorders.
Collapse
Affiliation(s)
- Cara D Varley
- Department of Medicine, Division of Infectious Diseases, Oregon Health & Science University, Portland, Oregon, USA
- School of Public Health, Oregon Health & Science University-Portland State University, Portland, Oregon, USA
| | - Elliott Lowy
- Health Systems Research, Veterans Affairs Puget Sound Healthcare System, Seattle, Washington, USA
- Department of Health Systems and Population Health, University of Washington, Seattle, Washington, USA
| | - Emily J Cartwright
- Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, USA
- Department of Medicine, Veteran Affairs Atlanta Health Care System, Atlanta, Georgia, USA
| | - Timothy R Morgan
- Gastroenterology Section, Veterans Affairs Long Beach Healthcare System, Long Beach, California, USA
| | - David B Ross
- Department of Veterans Affairs, HIV, Hepatitis, and Public Health Pathogens Programs, Washington, District of Columbia, USA
| | | | - Lauren A Beste
- Division of General Internal Medicine, Veterans Affairs Puget Sound Healthcare System, Seattle, Washington, USA
| | - Marissa M Maier
- Department of Medicine, Division of Infectious Diseases, Oregon Health & Science University, Portland, Oregon, USA
- Infectious Diseases Section, Veteran Affairs Portland Health Care System, Portland, Oregon, USA
| |
Collapse
|
30
|
Epstein RL, Buzzee B, White LF, Feld JJ, Castera L, Sterling RK, Linas BP, Taylor LE. Test characteristics for combining non-invasive liver fibrosis staging modalities in individuals with Hepatitis C virus. J Viral Hepat 2024; 31:277-292. [PMID: 38326950 PMCID: PMC11102317 DOI: 10.1111/jvh.13925] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2023] [Revised: 12/27/2023] [Accepted: 01/17/2024] [Indexed: 02/09/2024]
Abstract
Non-invasive methods have largely replaced biopsy to identify advanced fibrosis in hepatitis C virus (HCV). Guidelines vary regarding testing strategy to balance accuracy, costs and loss to follow-up. Although individual test characteristics are well-described, data comparing the accuracy of using two tests together are limited. We calculated combined test characteristics to determine the utility of combined strategies. This study synthesizes empirical data from fibrosis staging trials and the literature to estimate test characteristics for Fibrosis-4 (FIB4), APRI or a commercial serum panel (FibroSure®), followed by transient elastography (TE) or FibroSure®. We simulated two testing strategies: (1) second test only for those with intermediate first test results (staged approach), and (2) second test for all. We summarized empiric data with multinomial distributions and used this to estimate test characteristics of each strategy on a simulated population of 10,000 individuals with 4.2% cirrhosis prevalence. Negative predictive value (NPV) for cirrhosis from a single test ranged from 98.2% (95% CB 97.6-98.8%) for FIB-4 to 99.4% (95% CB 99.0-99.8%) for TE. Using a staged approach with TE second, sensitivity for cirrhosis rose to 93.3-96.9%, NPV to 99.7-99.8%, while PPV dropped to <32%. Using TE as a second test for all minimally changed estimated test characteristics compared with the staged approach. Combining two non-invasive fibrosis tests barely improves NPV and decreases or does not change PPV compared with a single test, challenging the utility of serial testing modalities. These calculated combined test characteristics can inform best methods to identify advanced fibrosis in various populations.
Collapse
Affiliation(s)
- Rachel L. Epstein
- Department of Medicine, Section of Infectious Diseases, Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA
- Department of Pediatrics, Section of Infectious Diseases, Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA
| | - Benjamin Buzzee
- Section of Infectious Diseases, Boston Medical Center, Boston, Massachusetts, USA
| | - Laura F. White
- Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA
| | - Jordan J. Feld
- Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada
| | - Laurent Castera
- Department of Hepatology, Beaujon Hospital, Assistance Publique-Hopitaux de Paris, Université Paris Cité, Clichy, France
| | - Richard K. Sterling
- Department of Internal Medicine, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, Virginia, USA
| | - Benjamin P. Linas
- Department of Medicine, Section of Infectious Diseases, Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA
- Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA
| | - Lynn E. Taylor
- College of Pharmacy, University of Rhode Island, Kingston, Rhode Island, USA
| |
Collapse
|
31
|
Havens JR, Lofwall MR, Young AM, Staton M, Schaninger T, Fraser H, Vickerman P, Walsh SL. Predictors of engagement in screening for a hepatitis C virus (HCV) treatment trial in a rural Appalachian community. J Viral Hepat 2024; 31:293-299. [PMID: 38436098 PMCID: PMC11102319 DOI: 10.1111/jvh.13933] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/08/2024] [Revised: 01/29/2024] [Accepted: 02/21/2024] [Indexed: 03/05/2024]
Abstract
An HCV treatment trial was initiated in September 2019 to address the opioid/hepatitis C virus (HCV) syndemic in rural Kentucky. The focus of the current analysis is on participation in diagnostic screening for the trial. Initial eligibility (≥18 years of age, county resident) was established by phone followed by in-person HCV viremia testing. 900 rural residents met the inclusion criteria and comprised the analytic sample. Generalized linear models were specified to estimate the relative risk of non-attendance at the in-person visit determining HCV eligibility. Approximately one-quarter (22.1%) of scheduled participants were no-shows. People who inject drugs were no more likely than people not injecting drugs to be a no-show; however, participants ≤35 years of age were significantly less likely to attend. While the median time between phone screening and scheduled in-person screening was only 2 days, each additional day increased the odds of no-show by 3% (95% confidence interval: 2%-3%). Finally, unknown HCV status predicted no-show even after adjustment for age, gender, days between screenings and injection status. We found that drug injection did not predict no-show, further justifying expanded access to HCV treatment among people who inject drugs. Those 35 years and younger were more likely to no-show, suggesting that younger individuals may require targeted strategies for increasing testing and treatment uptake. Finally, streamlining the treatment cascade may also improve outcomes, as participants in the current study were more likely to attend if there were fewer days between phone screening and scheduled in-person screening.
Collapse
Affiliation(s)
- Jennifer R. Havens
- Center on Drug and Alcohol Research, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY USA
| | - Michelle R. Lofwall
- Center on Drug and Alcohol Research, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY USA
| | - April M. Young
- Center on Drug and Alcohol Research, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY USA
- Department of Epidemiology, University of Kentucky College of Public Health, Lexington, KY USA
| | - Michele Staton
- Center on Drug and Alcohol Research, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY USA
| | - Takako Schaninger
- Division of Infectious Disease, Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY USA
| | - Hannah Fraser
- Bristol Population Health Sciences Institute, Bristol Medical School, Bristol, United Kingdom
| | - Peter Vickerman
- Bristol Population Health Sciences Institute, Bristol Medical School, Bristol, United Kingdom
| | - Sharon L. Walsh
- Center on Drug and Alcohol Research, Department of Behavioral Science, University of Kentucky College of Medicine, Lexington, KY USA
| |
Collapse
|
32
|
Tsang CA, Tonzel J, Symum H, Kaufman HW, Meyer WA, Osinubi A, Thompson WW, Wester C. State-Specific Hepatitis C Virus Clearance Cascades - United States, 2013-2022. MMWR. MORBIDITY AND MORTALITY WEEKLY REPORT 2024; 73:495-500. [PMID: 38814852 DOI: 10.15585/mmwr.mm7321a4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/01/2024]
|
33
|
Johnson LN, Gaynor AM, Wroblewski K, Buss SN. Maximizing Reflexive Hepatitis C Virus (HCV) RNA Testing of HCV Antibody-Reactive Samples Within United States Public Health Laboratories. J Infect Dis 2024; 229:S357-S361. [PMID: 37739790 PMCID: PMC11078303 DOI: 10.1093/infdis/jiad191] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2023] [Revised: 05/08/2023] [Accepted: 05/26/2023] [Indexed: 09/24/2023] Open
Abstract
Hepatitis C virus (HCV) infection can have serious consequences when untreated and diagnosis is the first step in any treatment regimen. In the Unites States a 2-step algorithm consisting of HCV antibody screening and HCV RNA testing of HCV antibody-reactive specimens is recommended for detection of current HCV infection. We conducted a survey of HCV diagnostic practices in US public health laboratories and convened a meeting of HCV subject matter experts to identify opportunities for improvement in HCV diagnosis. Automatic reflexive HCV RNA testing of HCV antibody-reactive specimens was identified as a gap in laboratory practice. Only 54% of respondent laboratories always automatically reflexed or referred an anti-HCV-reactive specimen to an HCV RNA test. To facilitate diagnosis and ensure patients are not lost to follow-up, laboratories should ensure that the entire HCV testing algorithm can be completed with a sample(s) collected during a single patient visit.
Collapse
Affiliation(s)
- Lauren N Johnson
- The Association of Public Health Laboratories, Silver Spring, Maryland, USA
| | - Anne M Gaynor
- The Association of Public Health Laboratories, Silver Spring, Maryland, USA
| | - Kelly Wroblewski
- The Association of Public Health Laboratories, Silver Spring, Maryland, USA
| | - Sarah N Buss
- The Association of Public Health Laboratories, Silver Spring, Maryland, USA
| |
Collapse
|
34
|
Cartwright EJ, Patel PR. Opportunities for Enhanced Prevention and Control of Hepatitis C Through Improved Screening and Testing Efforts. J Infect Dis 2024; 229:S350-S356. [PMID: 37739791 PMCID: PMC10961945 DOI: 10.1093/infdis/jiad199] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2023] [Revised: 05/11/2023] [Accepted: 05/31/2023] [Indexed: 09/24/2023] Open
Abstract
An estimated 2.4 million people in the United States are living with hepatitis C virus (HCV) infection. In 2020, the Centers for Disease Control and Prevention updated hepatitis C screening recommendations to test adults aged ≥18 years at least once in a lifetime and pregnant persons during each pregnancy. For those with ongoing exposure to HCV, periodic testing is recommended. The recommended testing sequence is to obtain an HCV antibody test and, when positive, perform an HCV RNA test. Examination of HCV care cascades has found that incomplete HCV testing occurs when a separate visit is required to obtain the HCV RNA test. Hepatitis C core antigen testing has been shown to be a useful tool for diagnosing current HCV infection in some settings. Hepatitis C testing that is completed, accurate, and efficient is necessary to achieve hepatitis C elimination goals.
Collapse
Affiliation(s)
- Emily J. Cartwright
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC
- Emory University, Atlanta Georgia
- Atlanta VA Health Care System, Decatur, Georgia
| | - Priti R. Patel
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, CDC
| |
Collapse
|
35
|
Chirunomula S, Muscarella A, Whelchel K, Gispen F, Marcovitz D, White K, Chastain C. Hepatitis C Cascade of Care in a Multidisciplinary Substance Use Bridge Clinic Model in Tennessee. Open Forum Infect Dis 2024; 11:ofae205. [PMID: 38770209 PMCID: PMC11103616 DOI: 10.1093/ofid/ofae205] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2024] [Accepted: 04/15/2024] [Indexed: 05/22/2024] Open
Abstract
Many barriers prevent individuals with substance use disorders from receiving hepatitis C virus (HCV) treatment. This study describes 96 patients with active HCV treated in an opioid use disorder bridge clinic model. Of 33 patients who initiated treatment, 25 patients completed treatment, and 13 patients achieved sustained virologic response.
Collapse
Affiliation(s)
- Samantha Chirunomula
- Division of Infectious Diseases, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA
| | - Anahit Muscarella
- Department of Pharmacy, Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, Nashville, Tennessee, USA
| | - Kristen Whelchel
- Department of Pharmacy, Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, Nashville, Tennessee, USA
| | - Fiona Gispen
- Division of Infectious Diseases, Weill Cornell Medicine, New York, New York, USA
| | - David Marcovitz
- Division of Addiction Psychiatry, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
| | - Katie White
- Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
| | - Cody Chastain
- Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
| |
Collapse
|
36
|
Talal AH, Markatou M, Liu A, Perumalswami PV, Dinani AM, Tobin JN, Brown LS. Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial. JAMA 2024; 331:1369-1378. [PMID: 38568601 PMCID: PMC10993166 DOI: 10.1001/jama.2024.2452] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/11/2023] [Accepted: 02/13/2024] [Indexed: 04/06/2024]
Abstract
Importance Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. Objective To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Design, Setting, and Participants Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Intervention Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). Main Outcomes and Measures The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Results Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Conclusions and Relevance Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. Trial Registration ClinicalTrials.gov Identifier: NCT02933970.
Collapse
Affiliation(s)
- Andrew H. Talal
- Division of Gastroenterology, Hepatology, and Nutrition, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York
| | | | - Anran Liu
- Department of Biostatistics, University at Buffalo, Buffalo, New York
| | - Ponni V. Perumalswami
- Division of Liver Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor
| | - Amreen M. Dinani
- Division of Liver Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Jonathan N. Tobin
- Clinical Directors Network, Inc (CDN), New York, New York
- The Rockefeller University Center for Clinical and Translational Science, New York, New York
| | - Lawrence S. Brown
- START Treatment & Recovery Centers, Brooklyn, New York
- Weill Cornell Medicine, New York, New York
| |
Collapse
|
37
|
Davey S, Costello K, Russo M, Davies S, Lalani HS, Kesselheim AS, Rome BN. Changes in Use of Hepatitis C Direct-Acting Antivirals After Access Restrictions Were Eased by State Medicaid Programs. JAMA HEALTH FORUM 2024; 5:e240302. [PMID: 38578628 PMCID: PMC10998155 DOI: 10.1001/jamahealthforum.2024.0302] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2023] [Accepted: 02/02/2024] [Indexed: 04/06/2024] Open
Abstract
Importance Direct-acting antivirals (DAAs) are safe and highly effective for curing hepatitis C virus (HCV) infection, but their high cost led certain state Medicaid programs to impose coverage restrictions. Since 2015, many of these restrictions have been lifted voluntarily in response to advocacy or because of litigation. Objective To estimate how the prescribing of DAAs to Medicaid patients changed after states eased access restrictions. Design, Setting, and Participants This modified difference-in-differences analysis of 39 state Medicaid programs included Medicaid beneficiaries who were prescribed a DAA from January 1, 2015, to December 31, 2019. DAA coverage restrictions were measured based on a series of cross-sectional assessments performed from 2014 through 2022 by the US National Viral Hepatitis Roundtable and the Center for Health Law and Policy Innovation. Exposure Calendar quarter when states eased or eliminated 3 types of DAA coverage restrictions: limiting treatment to patients with severe liver disease, restricting use among patients with active substance use, and requiring prescriptions to be written by or in consultation with specialists. States with none of these restrictions at baseline were excluded. Main Outcomes and Measures Quarterly number of HCV DAA treatment courses per 100 000 Medicaid beneficiaries. Results Of 39 states, 7 (18%) eliminated coverage restrictions, 25 (64%) eased restrictions, and 7 (18%) maintained the same restrictions from 2015 to 2019. During this period, the average quarterly use of DAAs increased from 669 to 3601 treatment courses per 100 000 Medicaid beneficiaries. After states eased or eliminated restrictions, the use of DAAs increased by 966 (95% CI, 409-1523) treatment courses per 100 000 Medicaid beneficiaries each quarter compared with states that did not ease or eliminate restrictions. Conclusions and Relevance The results of this study suggest that there was greater use of DAAs after states relaxed coverage restrictions related to liver disease severity, sobriety, or prescriber specialty. Further reductions or elimination of these rules may improve access to a highly effective public health intervention for patients with HCV.
Collapse
Affiliation(s)
- Sonya Davey
- Program On Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
| | - Kevin Costello
- Center for Health Law and Policy Innovation, Harvard Law School, Cambridge, Massachusetts
| | | | - Suzanne Davies
- Center for Health Law and Policy Innovation, Harvard Law School, Cambridge, Massachusetts
| | - Hussain S. Lalani
- Program On Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
| | - Aaron S. Kesselheim
- Program On Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
| | - Benjamin N. Rome
- Program On Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
| |
Collapse
|
38
|
Cooke GS, Flower B, Cunningham E, Marshall AD, Lazarus JV, Palayew A, Jia J, Aggarwal R, Al-Mahtab M, Tanaka Y, Jeong SH, Poovorawan K, Waked I, Hiebert L, Khue PM, Grebely J, Alcantara-Payawal D, Sanchez-Avila JF, Mbendi C, Muljono DH, Lesi O, Desalegn H, Hamid S, de Araujo A, Cheinquer H, Onyekwere CA, Malyuta R, Ivanchuk I, Thomas DL, Pimenov N, Chulanov V, Dirac MA, Han H, Ward JW. Progress towards elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission update. Lancet Gastroenterol Hepatol 2024; 9:346-365. [PMID: 38367629 DOI: 10.1016/s2468-1253(23)00321-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2023] [Revised: 09/11/2023] [Accepted: 09/14/2023] [Indexed: 02/19/2024]
Abstract
The top 20 highest burdened countries (in disability-adjusted life years) account for more than 75% of the global burden of viral hepatitis. An effective response in these 20 countries is crucial if global elimination targets are to be achieved. In this update of the Lancet Gastroenterology & Hepatology Commission on accelerating the elimination of viral hepatitis, we convene national experts from each of the top 20 highest burdened countries to provide an update on progress. Although the global burden of diseases is falling, progress towards elimination varies greatly by country. By use of a hepatitis elimination policy index conceived as part of the 2019 Commission, we measure countries' progress towards elimination. Progress in elimination policy has been made in 14 of 20 countries with the highest burden since 2018, with the most substantial gains observed in Bangladesh, India, Indonesia, Japan, and Russia. Most improvements are attributable to the publication of formalised national action plans for the elimination of viral hepatitis, provision of publicly funded screening programmes, and government subsidisation of antiviral treatments. Key themes that emerged from discussion between national commissioners from the highest burdened countries build on the original recommendations to accelerate the global elimination of viral hepatitis. These themes include the need for simplified models of care, improved access to appropriate diagnostics, financing initiatives, and rapid implementation of lessons from the COVID-19 pandemic.
Collapse
Affiliation(s)
- Graham S Cooke
- Department of Infectious Disease, Faculty of Medicine, Imperial College London, London, UK; Department of Health Metrics Sciences, University of Washington, Seattle, WA, USA.
| | - Barnaby Flower
- Department of Infectious Disease, Faculty of Medicine, Imperial College London, London, UK
| | | | | | - Jeffrey V Lazarus
- CUNY Graduate School of Public Health and Health Policy, New York, NY, USA; Barcelona Institute for Global Health, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Adam Palayew
- Department of Epidemiology, University of Washington, Seattle, WA, USA
| | - Jidong Jia
- Liver Research Centre, Beijing Friendship Hospital, Capital Medical University, Beijing, China
| | - Rakesh Aggarwal
- Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
| | - Mamum Al-Mahtab
- Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
| | - Yashuito Tanaka
- Department of Gastroenterology and Hepatology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
| | - Sook-Hyang Jeong
- Department of Internal Medicine, Seoul National University Bundang Hospital, College of Medicine, Seoul National University, Seongnam, South Korea
| | - Kittiyod Poovorawan
- Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Mahidol Oxford Research Unit, Faculty of Tropical Medicine, Mahidol University, Thailand
| | - Imam Waked
- Hepatology Department, National Liver Institute, Shibin El Kom, Egypt
| | - Lindsey Hiebert
- Coalition for Global Hepatitis Elimination, Task Force for Global Health, Decatur, GA, USA
| | - Pham M Khue
- Faculty of Public Health, Haiphong University of Medicine and Pharmacy, Haiphong, Viet Nam
| | - Jason Grebely
- The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
| | - Diana Alcantara-Payawal
- Department of Internal Medicine, Fatima University Medical Center, Valenzuela, Philippines; Committee on Hepatology, Section of Gastroenterology, Cardinal Santos Medical Center, San Juan, Philippines
| | - Juan F Sanchez-Avila
- Global Health and Emerging Diseases Investigation Group, Escuela de Medicina y Ciencias de la Salud, Tecnologico de Monterrey Monterrey, Mexico
| | - Charles Mbendi
- Service of Gastroenterology, Internal Medicine, University Clinic of Kinshasa, Faculty of Medicine, University of Kinshasa, Kinshasha, DR Congo
| | - David H Muljono
- Ministry of Health, Jakarta, Indonesia; Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia; Indonesian Academy of Sciences, Jakarta, Indonesia
| | - Olufunmilayo Lesi
- Gastroenterology and Hepatology Unit, College of Medicine, University of Lagos and Lagos University Teaching Hospital, Lagos, Nigeria
| | - Hailemichael Desalegn
- Department of Internal Medicine, St Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia
| | - Saeed Hamid
- Clinical Trials Unit, Aga Khan University, Karachi, Pakistan
| | - Alexandre de Araujo
- Universidade Federal do Rio Grande do Sul, Gastroenterology and Hepatology Unit of Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
| | - Hugo Cheinquer
- Universidade Federal do Rio Grande do Sul, Gastroenterology and Hepatology Unit of Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
| | - Charles A Onyekwere
- Deparment Of Medicine, Lagos State University College of Medicine, Lagos, Nigeria
| | | | - Iryna Ivanchuk
- Department of Viral Hepatitis Control at National Institute of Public Health, Kyiv, Ukraine
| | - David L Thomas
- Divison of Infectious Diseases, John Hopkins School of Medicine, Baltimore, MD, USA
| | - Nikolay Pimenov
- National Medical Research Center of Tuberculosis and Infectious Diseases, Moscow, Russia
| | | | - Mae Ashworth Dirac
- Institute for Health Metrics and Evaluation, University of Washington, Seattle, WA, USA; Department of Health Metrics Sciences, University of Washington, Seattle, WA, USA; Department of Family Medicine, University of Washington, Seattle, WA, USA
| | - Hannah Han
- Department of Epidemiology, University of Washington, Seattle, WA, USA; Institute for Health Metrics and Evaluation, University of Washington, Seattle, WA, USA
| | - John W Ward
- Coalition for Global Hepatitis Elimination, Task Force for Global Health, Decatur, GA, USA; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA
| |
Collapse
|
39
|
Falade-Nwulia O, Lesko CR, Fojo AT, Keruly JC, Moore RD, Sutcliffe CG, Mehta SH, Chander G, Thomas DL, Sulkowski M. Hepatitis C Treatment in People With HIV: Potential to Eliminate Disease and Disparity. J Infect Dis 2024; 229:775-779. [PMID: 37793170 PMCID: PMC10938212 DOI: 10.1093/infdis/jiad433] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2023] [Revised: 09/20/2023] [Accepted: 10/02/2023] [Indexed: 10/06/2023] Open
Abstract
Access to direct acting antivirals (DAAs) may be associated with reductions in hepatitis C virus (HCV) viremia prevalence among people with human immunodeficiency virus (PWH). Among 3755 PWH, estimated HCV viremia prevalence decreased by 94.0% from 36% (95% confidence interval [CI], 27%-46%) in 2009 (pre-DAA era) to 2% (95% CI, 0%-4%) in 2021 (DAA era). Male sex, black race, and older age were associated with HCV viremia in 2009 but not in 2021. Injection drug use remained associated with HCV viremia in 2009 and 2021. Targeted interventions are needed to meet the HCV care needs of PWH who use drugs.
Collapse
Affiliation(s)
- Oluwaseun Falade-Nwulia
- Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Catherine R Lesko
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - Anthony T Fojo
- Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Jeanne C Keruly
- Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Richard D Moore
- Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Catherine G Sutcliffe
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - Shruti H Mehta
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
| | - Geetanjali Chander
- Division of General Internal Medicine, University of Washington, Seattle, Washington, USA
| | - David L Thomas
- Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| | - Mark Sulkowski
- Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
| |
Collapse
|
40
|
Wissel K, Vernazza P, Kuster S, Hensel-Koch K, Bregenzer A. Hepatitis C prevalence and cascade of care among patients in the decentralised opioid agonist therapy programme of the canton of St Gallen, Switzerland: a cross-sectional study. Swiss Med Wkly 2024; 154:3352. [PMID: 38579293 DOI: 10.57187/s.3352] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/07/2024] Open
Abstract
BACKGROUND To eliminate chronic hepatitis C virus (HCV) infection by 2030, 90% of those infected must be diagnosed and 80% treated. In Switzerland, >40% of the estimated 32,000 infected people are still undiagnosed. In the canton of St Gallen, HCV prevalence and cascade of care have only been studied in the centralised opioid agonist therapy (OAT) setting (institutions), although about 80% of OAT patients are treated decentrally (general practitioner [GP] or pharmacy). AIM To describe HCV prevalence and cascade of care among patients in the decentralised OAT programme of the canton of St Gallen, Switzerland, and compare it to contemporaneous data from the centralised setting. METHODS For each patient receiving his/her OAT from a GP or pharmacy on 1 April 2021, the cantonal medical office sent a questionnaire to the prescribing GP. Patient characteristics, HCV antibody (Ab)/RNA screening uptake, HCV Ab/RNA prevalence and HCV treatment uptake were obtained and compared to those of patients of the Medizinisch-soziale Hilfsstelle 1 in St Gallen (centralised setting). RESULTS Of the 563 OAT patients under the care of 127 GPs, 107 patients from 41 GPs could be analysed (median age: 48 years [IQR: 40-56]; ongoing intravenous drug use: 25%; OAT provider: 66% GP, 34% pharmacy). HCV Ab screening uptake was 68% (73/107) with an HCV Ab prevalence of 68% (50/73) among those tested. Of the HCV Ab-positive patients, 84% (42/50) were HCV RNA-tested, among whom 57% (24/42) were viraemic. HCV treatment uptake was 83% (20/24), with 95% (19/20) achieving a sustained virological response. Non-uptake of HCV screening and treatment tended to be higher among patients receiving OAT at the pharmacy vs at the GP's office: 37% vs 26% (p = 0.245) for screening and 30% vs 7% (p = 0.139) for treatment. The proportion never HCV Ab-tested and the proportion of HCV Ab-positives never HCV RNA-tested was significantly higher in the decentralised compared to the centralised setting: 32% vs 3% (p <0.001) never Ab-tested and 16% vs 0% (p = 0.002) never RNA-tested. In contrast, HCV treatment uptake (83% vs 78%), sustained virological response rate (95% vs 100%) and residual HCV RNA prevalence among the HCV Ab-positive (12% vs 14%) were comparable for both settings. CONCLUSION In the decentralised OAT setting of the canton of St Gallen, HCV Ab prevalence is high. Since HCV Ab and RNA screening uptake are markedly lower than in the centralised setting, potentially >40% of patients with chronic HCV are not diagnosed yet. HCV screening in the decentralised setting needs improvement, e.g. by increasing awareness and simplifying testing. High HCV treatment uptake and cure rates are possible in centralised and decentralised settings.
Collapse
Affiliation(s)
| | - Pietro Vernazza
- Division of Infectious Diseases, Infection Prevention and Travel Medicine, Cantonal Hospital St Gallen, St Gallen, Switzerland
| | - Stefan Kuster
- Division of Infectious Diseases, Infection Prevention and Travel Medicine, Cantonal Hospital St Gallen, St Gallen, Switzerland
| | | | - Andrea Bregenzer
- Division of Infectious Diseases, Infection Prevention and Travel Medicine, Cantonal Hospital St Gallen, St Gallen, Switzerland
- Department of Infectious Diseases and Infection Prevention, Cantonal Hospital Aarau, Aarau, Switzerland
| |
Collapse
|
41
|
Ratnapradipa KL, Li T, Hsieh MC, Tenner L, Peters ES. Most deprived Louisiana census tracts have higher hepatocellular carcinoma incidence and worse survival. Front Oncol 2024; 14:1331049. [PMID: 38380357 PMCID: PMC10878418 DOI: 10.3389/fonc.2024.1331049] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Accepted: 01/16/2024] [Indexed: 02/22/2024] Open
Abstract
Background Liver cancer incidence increased in the US from 1975 through 2015 with heterogeneous rates across subpopulations. Upstream or distal area-level factors impact liver cancer risks. Objective The aim of this study was to examine the association between area-level deprivation and hepatocellular carcinoma (HCC) incidence and survival. We also explored the association between area deprivation and treatment modalities. Methods Louisiana Tumor Registry identified 4,151 adult patients diagnosed with malignant HCC from 2011 to 2020 and linked residential address to census tract (CT)-level Area Deprivation Index (ADI) categorized into quartiles (Q1 = least deprived). ANOVA examined the association between ADI quartile and CT age-adjusted incidence rate (AAIR) per 100,000. Chi-square tested the distribution of demographic and clinical characteristics across ADI quartiles. Kaplan-Meier and proportional hazard models evaluated survival by deprivation quartile. Results Among the 1,084 CTs with incident HCC, the average (SD) AAIR was 8.02 (7.05) HCC cases per 100,000 population. ADI was observed to be associated with incidence, and the mean (SD) AAIR increased from 5.80 (4.75) in Q1 to 9.26 (7.88) in Q4. ADI was also associated with receipt of surgery (p < 0.01) and radiation (p < 0.01) but not chemotherapy (p = 0.15). However, among those who received chemotherapy, people living in the least deprived areas began treatment approximately 10 days sooner than those living in other quartiles. Q4 patients experienced the worst survival with a median of 247 (95% CI 211-290) days vs. Q1 patients with a median of 474 (95% CI 407-547) days (p < 0.0001). Q4 had marginally poorer survival (HR 1.20, 1.05-1.37) than Q1 but the association became non-significant (HR 1.12, 0.96-1.30) when adjusted for rurality, liquor store density, sex, race/ethnicity, age, insurance, BMI, stage, hepatitis diagnosis, and comorbidities. Conclusion Increasing neighborhood (CT) deprivation (ADI) was observed to be associated with increased HCC incidence and poorer HCC survival. However, the association with poorer survival becomes attenuated after adjusting for putative confounders.
Collapse
Affiliation(s)
- Kendra L. Ratnapradipa
- Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE, United States
| | - Tingting Li
- Louisiana Tumor Registry, Epidemiology Program, School of Public Health at Louisiana State University (LSU) Health Sciences Center-New Orleans, New Orleans, LA, United States
| | - Mei-Chin Hsieh
- Louisiana Tumor Registry, Epidemiology Program, School of Public Health at Louisiana State University (LSU) Health Sciences Center-New Orleans, New Orleans, LA, United States
| | - Laura Tenner
- Department of Internal Medicine, Division of Oncology/Hematology, College of Medicine, University of Nebraska Medical Center, Omaha, NE, United States
| | - Edward S. Peters
- Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE, United States
| |
Collapse
|
42
|
Scialli A, Saab S, Salimian A, Bhattacharya D, Goodman-Meza D. Hepatitis C Treatment Among Primary Care and Specialty Providers: A Single Center Study, 2015 to 2022. J Prim Care Community Health 2024; 15:21501319241253521. [PMID: 38727179 PMCID: PMC11088289 DOI: 10.1177/21501319241253521] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2024] [Revised: 04/17/2024] [Accepted: 04/18/2024] [Indexed: 05/13/2024] Open
Abstract
INTRODUCTION Despite national goals to eliminate Hepatitis C (HCV) and the advancement of curative, well-tolerated direct-acting antiviral (DAAs) regimens, rates of HCV treatment have declined nationally since 2015. Current HCV guidelines encourage treatment of HCV by primary care providers (PCPs). Payors have reduced restrictions to access DAAs nationally and in California however it remains unclear if the removal of these restrictions has impacted the proportion of PCPs prescribing DAAs at a health system level. Our objective was to examine the proportion of DAAs prescribed by PCPs and specialists and to describe the population receiving treatment in a single health system from 2015 to 2022. METHODS We examined the proportion of DAAs prescribed by PCPs and specialists and the population receiving treatment through a retrospective analysis of claims data in the University of California, Los Angeles (UCLA) Health System from 2015 to 2022. We described number of prescriptions for HCV medication prescribed by PCPs and specialists by year, medication type, and physician specialty. We also described numbers of prescriptions by patient demographics and comorbidities. RESULTS A total of 1515 adult patients received a prescription for HCV medication through the UCLA Health System between 2015 and 2022. The proportion of patients receiving prescriptions for PCPs peaked at 19% in 2016, yet decreased to 5.7% in 2022, an average of 13% across all years. Median age of patients receiving treatment was 60 years old, and 56% of patients receiving HCV treatment had commercial insurance as their primary payer. CONCLUSIONS HCV treatment declined from 2015 to 2022 among specialists and PCPs in our health system. Older patients comprised the majority of patients receiving treatment, suggesting a need for novel approaches to reach patients under 40, an age group with significant increases in HCV transmission.
Collapse
Affiliation(s)
| | - Sammy Saab
- University of California, Los Angeles, CA, USA
- Pfleger Liver Institute, Los Angeles, CA, USA
| | | | | | | |
Collapse
|
43
|
Baumann L, Braun DL, Cavassini M, Stoeckle M, Bernasconi E, Schmid P, Calmy A, Haerry D, Béguelin C, Fux CA, Wandeler G, Surial B, Rauch A. Long-term trends in hepatitis C prevalence, treatment uptake and liver-related events in the Swiss HIV Cohort Study. Liver Int 2024; 44:169-179. [PMID: 37850685 DOI: 10.1111/liv.15754] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/06/2023] [Revised: 09/15/2023] [Accepted: 09/19/2023] [Indexed: 10/19/2023]
Abstract
BACKGROUND AND AIMS Treatment for chronic hepatitis C virus (HCV) infections changed dramatically in the last decade. We assessed changes in the prevalence of replicating HCV infection, treatment uptake and liver-related morbidity and mortality in persons with HIV (PWH) and hepatitis C in the Swiss HIV cohort study. METHODS We included all cohort participants between 2002 and 2021. We assessed yearly prevalence of replicating HCV infection, overall and liver-related mortality, as well as the yearly incidence of liver-related events in persons with at least one documented positive HCV-RNA. RESULTS Of 14 652 participants under follow-up, 2294 had at least one positive HCV-RNA measurement. Of those, 1316 (57%) ever received an HCV treatment. Treatment uptake increased from 8.1% in 2002 to a maximum of 32.6% in 2016. Overall, prevalence of replicating HCV infection declined from 16.5% in 2004 to 1.3% in 2021. HCV prevalence declined from 63.2% to 7.1% in persons who inject drugs, and from 4.1% to 0.6% in men who have sex with men. Among the 2294 persons with replicating HCV infection, overall mortality declined from a maximum of 3.3 per 100 patient-years (PY) to 1.1 per 100 PY, and incidence of liver-related events decreased from 1.4/100 PY to 0.2/100 PY. CONCLUSIONS The introduction of DAA therapy was associated with a more than 10-fold reduction in prevalence of replicating HCV infection in PWH, approaching the estimates in the general population. Overall mortality and liver-related events declined substantially in persons living with HIV and hepatitis C.
Collapse
Affiliation(s)
- Lukas Baumann
- Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Dominique L Braun
- Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland
- Institute of Medical Virology, University of Zurich, Zurich, Switzerland
| | - Matthias Cavassini
- Division of Infectious Diseases, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland
| | - Marcel Stoeckle
- Division of Infectious Diseases and Hospital Epidemiology, University of Basel, Basel, Switzerland
| | - Enos Bernasconi
- Division of Infectious Diseases, Ente Ospedaliero Cantonale, Lugano, University of Geneva and University of Southern Switzerland, Lugano, Switzerland
| | - Patrick Schmid
- Division of Infectious Diseases, Cantonal Hospital St. Gallen, St. Gallen, Switzerland
| | - Alexandra Calmy
- HIV/AIDS Unit, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland
| | | | - Charles Béguelin
- Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- Division of Infectious Diseases, Regional Hospital Biel, Biel, Switzerland
| | - Christoph A Fux
- Division of Infectious Diseases and Infection Prevention, Cantonal Hospital Aarau, Aarau, Switzerland
| | - Gilles Wandeler
- Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Bernard Surial
- Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Andri Rauch
- Department of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| |
Collapse
|
44
|
Hundt MA, Kardashian AA. Increasing pharmacoequity for people with cirrhosis. Clin Liver Dis (Hoboken) 2024; 23:e0203. [PMID: 38860125 PMCID: PMC11164002 DOI: 10.1097/cld.0000000000000203] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/12/2024] [Accepted: 04/12/2024] [Indexed: 06/12/2024] Open
Affiliation(s)
- Melanie A. Hundt
- Department of Medicine, Los Angeles General Hospital, Los Angeles, California, USA
- Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA
| | - Ani A. Kardashian
- Department of Medicine, Los Angeles General Hospital, Los Angeles, California, USA
- Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA
| |
Collapse
|
45
|
Hofmeister MG, Zhong Y, Moorman AC, Samuel CR, Teshale EH, Spradling PR. Temporal Trends in Hepatitis C-Related Hospitalizations, United States, 2000-2019. Clin Infect Dis 2023; 77:1668-1675. [PMID: 37463305 PMCID: PMC11017377 DOI: 10.1093/cid/ciad425] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2023] [Revised: 07/06/2023] [Accepted: 07/13/2023] [Indexed: 07/20/2023] Open
Abstract
BACKGROUND Hospitalization burden related to hepatitis C virus (HCV) infection is substantial. We sought to describe temporal trends in hospitalization rates before and after release of direct-acting antiviral (DAA) agents. METHODS We analyzed 2000-2019 data from adults aged ≥18 years in the National Inpatient Sample. Hospitalizations were HCV-related if (1) hepatitis C was the primary diagnosis, or (2) hepatitis C was any secondary diagnosis with a liver-related primary diagnosis. We analyzed characteristics of HCV-related hospitalizations nationally and examined trends in age-adjusted hospitalization rates. RESULTS During 2000-2019, there were an estimated 1 286 397 HCV-related hospitalizations in the United States. The annual age-adjusted hospitalization rate was lowest in 2019 (18.7/100 000 population) and highest in 2012 (29.6/100 000 population). Most hospitalizations occurred among persons aged 45-64 years (71.8%), males (67.1%), White non-Hispanic persons (60.5%), and Medicaid/Medicare recipients (64.0%). The national age-adjusted hospitalization rate increased during 2000-2003 (annual percentage change [APC], 9.4%; P < .001) and 2003-2013 (APC, 1.8%; P < .001) before decreasing during 2013-2019 (APC, -7.6%; P < .001). Comparing 2000 to 2019, the largest increases in hospitalization rates occurred among persons aged 55-64 years (132.9%), Medicaid recipients (41.6%), and Black non-Hispanic persons (22.3%). CONCLUSIONS Although multiple factors likely contributed, overall HCV-related hospitalization rates declined steadily after 2013, coinciding with the release of DAAs. However, the declines were not observed equally among age, race/ethnicity, or insurance categories. Expanded access to DAA treatment is needed, particularly among Medicaid and Medicare recipients, to reduce disparities and morbidity and eliminate hepatitis C as a public health threat.
Collapse
Affiliation(s)
- Megan G Hofmeister
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Yuna Zhong
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Anne C Moorman
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Christina R Samuel
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Eyasu H Teshale
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
| | - Philip R Spradling
- Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia
| |
Collapse
|
46
|
Falade-Nwulia O, Kelly SM, Amanor-Boadu S, Nnodum BN, Lim JK, Sulkowski M. Hepatitis C in Black Individuals in the US: A Review. JAMA 2023; 330:2200-2208. [PMID: 37943553 DOI: 10.1001/jama.2023.21981] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/10/2023]
Abstract
IMPORTANCE In the US, the prevalence of hepatitis C virus (HCV) is 1.8% among people who are Black and 0.8% among people who are not Black. Mortality rates due to HCV are 5.01/100 000 among people who are Black and 2.98/100 000 among people who are White. OBSERVATIONS While people of all races and ethnicities experienced increased rates of incident HCV between 2015 and 2021, Black individuals experienced the largest percentage increase of 0.3 to 1.4/100 000 (367%) compared with 1.8 to 2.7/100 000 among American Indian/Alaska Native (50%), 0.3 to 0.9/100 000 among Hispanic (200%), and 0.9 to 1.6/100 000 among White (78%) populations. Among 47 687 persons diagnosed with HCV in 2019-2020, including 37 877 (79%) covered by Medicaid (7666 Black and 24 374 White individuals), 23.5% of Black people and 23.7% of White people with Medicaid insurance initiated HCV treatment. Strategies to increase HCV screening include electronic health record prompts for universal HCV screening, which increased screening tests from 2052/month to 4169/month in an outpatient setting. Awareness of HCV status can be increased through point-of-care testing in community-based settings, which was associated with increased likelihood of receiving HCV test results compared with referral for testing off-site (69% on-site vs 19% off-site, P < .001). Access to HCV care can be facilitated by patient navigation, in which an individual is assigned to work with a patient to help them access care and treatments; this was associated with greater likelihood of HCV care access (odds ratio, 3.7 [95% CI, 2.9-4.8]) and treatment initiation within 6 months (odds ratio, 3.2 [95% CI, 2.3-4.2]) in a public health system providing health care to individuals regardless of their insurance status or ability to pay compared with usual care. Eliminating Medicaid's HCV treatment restrictions, including removal of a requirement for advanced fibrosis or a specialist prescriber, was associated with increased treatment rates from 2.4 persons per month to 72.3 persons per month in a retrospective study of 10 336 adults with HCV with no significant difference by race (526/1388 [37.8%] for Black vs 2706/8277 [32.6%] for White patients; adjusted odds ratio, 1.02 [95% CI, 0.8-1.3]). CONCLUSIONS AND RELEVANCE In the US, the prevalence of HCV is higher in people who are Black than in people who are not Black. Point-of-care HCV tests, patient navigation, electronic health record prompts, and unrestricted access to HCV treatment in community-based settings have potential to increase diagnosis and treatment of HCV and improve outcomes in people who are Black.
Collapse
Affiliation(s)
- Oluwaseun Falade-Nwulia
- Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, Maryland
| | - Sharon M Kelly
- Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, Maryland
| | | | | | | | - Mark Sulkowski
- Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, Maryland
| |
Collapse
|
47
|
Cheedalla A, Hinely K, Roby L, Hall OT, Malvestutto C, Rood KM. Postpartum Hepatitis C Linkage to Care Program in a Co-located Substance Use Disorders Treatment Model. Matern Child Health J 2023; 27:87-93. [PMID: 37768533 PMCID: PMC10691992 DOI: 10.1007/s10995-023-03770-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/31/2023] [Indexed: 09/29/2023]
Abstract
PURPOSE Hepatitis C virus (HCV) is increasingly prevalent in pregnancy and among people with substance use disorders (SUD). Highly effective treatments are now available for chronic HCV. Qualifying for HCV treatment often requires preauthorization and several clinical criteria, including laboratory assessment of liver function and other infectious diseases and liver imaging to assess for fibrosis. Linkage to care (LTC) models have been shown to assist with obtaining the necessary clinical information (laboratory assessment/liver imaging) and improving HCV treatment rates in non-pregnant individuals. DESCRIPTION Beginning in December 2020, a specialized LTC team identified patients with HCV viremia who were interested in postpartum treatment. The LTC team assisted patients with completing the necessary clinical criteria (laboratory assessment and liver imaging) for HCV treatment. Patients were then linked to infectious disease specialists who prescribed treatment to patients via telemedicine. Most patients identified with HCV were enrolled in our institution's co-located obstetric and SUD program, which provides continued care until 1 year postpartum. ASSESSMENT In 2019, an internal review identified that none of the 26 pregnant patients with HCV viremia in our co-located obstetric and SUD program were prescribed direct-acting antiviral (DAA) treatment within 12 months postpartum. Between December 2020 and July 2022, our HCV LTC team identified 34 patients with HCV who were eligible for treatment. Of these patients, 55% (19/34) obtained all necessary laboratory and liver imaging requirements and 79% (15/19) were prescribed DAA treatment after a telehealth visit with an infectious disease specialist. All fifteen patients who were prescribed treatment participated in the co-located obstetric and SUD program. The largest barrier to obtaining treatment was completing the necessary laboratory and liver imaging requirements for prescribing DAA. Only one patient who did not receive care in our co-located obstetric and SUD program had completed the necessary laboratory and liver imaging requirements to proceed with treatment but did not follow up with the infectious disease specialist for DAA treatment. CONCLUSION Our HCV LTC program was successful in treating postpartum patients for HCV if they participated in the co-located obstetric and SUD program at our institution. Creating a partnership with an infectious disease specialist and utilizing telemedicine were beneficial strategies to connect patients to treatment for HCV during the postpartum period.
Collapse
Affiliation(s)
- Aneesha Cheedalla
- Department of Obstetrics and Gynecology, McCampbell Hall, Ohio State University Wexner Medical Center, Columbus, OH, USA.
| | - Katherine Hinely
- Department of Obstetrics and Gynecology, McCampbell Hall, Ohio State University Wexner Medical Center, Columbus, OH, USA
| | - Lauren Roby
- Department of Obstetrics and Gynecology, McCampbell Hall, Ohio State University Wexner Medical Center, Columbus, OH, USA
| | - O Trent Hall
- Department of Psychiatry and Behavioral Health, Talbot Hall, Ohio State University Wexner Medical Center, Columbus, OH, USA
| | - Carlos Malvestutto
- Department of Infectious Diseases, McCampbell Hall, Ohio State University Wexner Medical Center, Columbus, OH, USA
| | - Kara M Rood
- Department of Obstetrics and Gynecology, McCampbell Hall, Ohio State University Wexner Medical Center, Columbus, OH, USA
| |
Collapse
|
48
|
Lewis KC, Barker LK, Jiles RB, Gupta N. Estimated Prevalence and Awareness of Hepatitis C Virus Infection Among US Adults: National Health and Nutrition Examination Survey, January 2017-March 2020. Clin Infect Dis 2023; 77:1413-1415. [PMID: 37417196 PMCID: PMC11000503 DOI: 10.1093/cid/ciad411] [Citation(s) in RCA: 25] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2023] [Revised: 06/08/2023] [Accepted: 06/30/2023] [Indexed: 07/08/2023] Open
Abstract
During January 2017-March 2020, approximately 2.2 million noninstitutionalized civilian US adults had hepatitis C; one-third were unaware of their infection. Prevalence was substantially higher among persons who were uninsured or experiencing poverty. Unrestricted access to testing and curative treatment is needed to reduce disparities and achieve 2030 elimination goals.
Collapse
Affiliation(s)
- Karon C Lewis
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
| | - Laurie K Barker
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
| | - Ruth B Jiles
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
| | - Neil Gupta
- Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
| |
Collapse
|
49
|
O'Brien TR, Devesa SS, Koshiol J, Marrero JA, Shiels MS. Decreasing incidence of hepatocellular carcinoma among most racial groups: SEER-22, 2000-2019. Cancer Med 2023; 12:19960-19967. [PMID: 37776201 PMCID: PMC10587941 DOI: 10.1002/cam4.6537] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2023] [Accepted: 09/04/2023] [Indexed: 10/02/2023] Open
Abstract
BACKGROUND Hepatocellular carcinoma (HCC) incidence was rising in the United States. Previously, using data collected by the Surveillance, Epidemiology, and End Results (SEER) Program through 2017, we found that overall incidence had begun to decline, although not in Black and American Indian/Alaska Native (AI/AN) populations. Utilizing expanded SEER data encompassing ~50% of the population, we examined secular trends and demographic differences in HCC incidence through 2019. METHODS We included cases of HCC diagnosed in adults aged ≥20 years residing in SEER-22 registry areas. We examined case counts, incidence rates (per 100,000 person-years), annual percent changes (APCs), and calendar years when APCs changed significantly. RESULTS HCC incidence increased from 5.56 in 2000 to 8.89 in 2009 (APC, 5.17%), then rose more slowly during 2009-2015 (APC, 2.28%). After peaking at 10.03 in 2015, incidence fell to 9.20 in 2019 (APC, -2.26%). In Asian/Pacific Islanders (A/PI), the decline began in 2007 and accelerated in 2015 (APCs: 2007-2015, -1.84%; 2015-2019, -5.80%). In 2014, incidence began to fall in the White (APC: 2014-2019, -1.11%) and Hispanic populations (APC: 2014-2019, -1.72%). In 2016, rates began to fall in Black individuals (APC: 2016-2019, -6.05%). In the AI/AN population, incidence was highest in 2017, although the subsequent decline was not statistically significant. In 2019, population-specific rates were: White, 6.94; Black, 10.74; A/PI, 12.11; AI/AN, 14.56; Hispanic, 15.48. CONCLUSION HCC incidence is now decreasing in most US racial/ethnic populations, including among Black individuals. The onset of decline differed among racial/ethnic groups and wide disparities in HCC rates remain.
Collapse
Affiliation(s)
- Thomas R. O'Brien
- Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and GeneticsNational Cancer InstituteBethesdaMarylandUSA
| | - Susan S. Devesa
- Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and GeneticsNational Cancer InstituteBethesdaMarylandUSA
| | - Jill Koshiol
- Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and GeneticsNational Cancer InstituteBethesdaMarylandUSA
| | - Jorge A. Marrero
- Division of Gastroenterology and HepatologyPerelman School of Medicine at the University of PennsylvaniaPhiladelphiaPennsylvaniaUSA
| | - Meredith S. Shiels
- Infections and Immunoepidemiology Branch, Division of Cancer Epidemiology and GeneticsNational Cancer InstituteBethesdaMarylandUSA
| |
Collapse
|
50
|
Cartwright EJ, Pierret C, Minassian C, Esserman DA, Tate JP, Goetz MB, Bhattacharya D, Fiellin DA, Justice AC, Lo Re V, Rentsch CT. Alcohol Use and Sustained Virologic Response to Hepatitis C Virus Direct-Acting Antiviral Therapy. JAMA Netw Open 2023; 6:e2335715. [PMID: 37751206 PMCID: PMC10523171 DOI: 10.1001/jamanetworkopen.2023.35715] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/01/2023] [Accepted: 08/21/2023] [Indexed: 09/27/2023] Open
Abstract
Importance Some payers and clinicians require alcohol abstinence to receive direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection. Objective To evaluate whether alcohol use at DAA treatment initiation is associated with decreased likelihood of sustained virologic response (SVR). Design, Setting, and Participants This retrospective cohort study used electronic health records from the US Department of Veterans Affairs (VA), the largest integrated national health care system that provides unrestricted access to HCV treatment. Participants included all patients born between 1945 and 1965 who were dispensed DAA therapy between January 1, 2014, and June 30, 2018. Data analysis was completed in November 2020 with updated sensitivity analyses performed in 2023. Exposure Alcohol use categories were generated using responses to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire and International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses for alcohol use disorder (AUD): abstinent without history of AUD, abstinent with history of AUD, lower-risk consumption, moderate-risk consumption, and high-risk consumption or AUD. Main Outcomes and Measures The primary outcome was SVR, which was defined as undetectable HCV RNA for 12 weeks or longer after completion of DAA therapy. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% CIs of SVR associated with alcohol category. Results Among 69 229 patients who initiated DAA therapy (mean [SD] age, 62.6 [4.5] years; 67 150 men [97.0%]; 34 655 non-Hispanic White individuals [50.1%]; 28 094 non-Hispanic Black individuals [40.6%]; 58 477 individuals [84.5%] with HCV genotype 1), 65 355 (94.4%) achieved SVR. A total of 32 290 individuals (46.6%) were abstinent without AUD, 9192 (13.3%) were abstinent with AUD, 13 415 (19.4%) had lower-risk consumption, 3117 (4.5%) had moderate-risk consumption, and 11 215 (16.2%) had high-risk consumption or AUD. After adjustment for potential confounding variables, there was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or AUD (OR, 0.95; 95% CI, 0.85-1.07). There was no evidence of interaction by stage of hepatic fibrosis measured by fibrosis-4 score (P for interaction = .30). Conclusions and Relevance In this cohort study, alcohol use and AUD were not associated with lower odds of SVR. Restricting access to DAA therapy according to alcohol use creates an unnecessary barrier to patients and challenges HCV elimination goals.
Collapse
Affiliation(s)
- Emily J. Cartwright
- Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia
- Atlanta Veterans Affairs Medical Center, Decatur, Georgia
| | - Chloe Pierret
- Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom
| | - Caroline Minassian
- Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom
| | - Denise A. Esserman
- Veterans Affairs Connecticut Healthcare System, US Department of Veterans Affairs, West Haven
| | - Janet P. Tate
- Veterans Affairs Connecticut Healthcare System, US Department of Veterans Affairs, West Haven
- Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Matthew B. Goetz
- Department of Internal Medicine, David Geffen School of Medicine, University of California, Los Angeles
- Veterans Affairs Greater Los Angeles Health Care System, US Department of Veterans Affairs, Los Angeles, California
| | - Debika Bhattacharya
- Department of Internal Medicine, David Geffen School of Medicine, University of California, Los Angeles
- Veterans Affairs Greater Los Angeles Health Care System, US Department of Veterans Affairs, Los Angeles, California
| | - David A. Fiellin
- Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Yale Program in Addiction Medicine, Yale School of Medicine, New Haven, Connecticut
- Yale School of Public Health, New Haven, Connecticut
| | - Amy C. Justice
- Veterans Affairs Connecticut Healthcare System, US Department of Veterans Affairs, West Haven
- Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Yale Program in Addiction Medicine, Yale School of Medicine, New Haven, Connecticut
- Yale School of Public Health, New Haven, Connecticut
| | - Vincent Lo Re
- Division of Infectious Diseases, Department of Medicine and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia
| | - Christopher T. Rentsch
- Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom
- Veterans Affairs Connecticut Healthcare System, US Department of Veterans Affairs, West Haven
- Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| |
Collapse
|