|
1
|
Flisiak R, Rzymski P, Flisiak-Jackiewicz M, Brzdęk M, Zarębska-Michaluk D. Treatment of chronic hepatitis C infection: strategies to address poor therapy adherence. Expert Rev Anti Infect Ther 2025:1-9. [PMID: 40156354 DOI: 10.1080/14787210.2025.2486353] [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: 03/17/2025] [Accepted: 03/20/2025] [Indexed: 04/01/2025]
Abstract
INTRODUCTION Non-adherence to any therapy may be related to skipping drug doses, discontinuation of therapy, or loss of follow-up. It leads to the ineffectiveness of treatment, which is associated with obvious individual health losses, significant social and financial costs, and, in the case of infectious diseases, epidemiological consequences resulting from the possibility of further spread of infection. AREAS COVERED This review article analyses the causes and effects of non-adherence to treatment in patients infected with the hepatitis C virus (HCV). It also presents strategies to reduce the risk of non-adherence, which can be implemented by simplifying the treatment process, improving the flow of information between the doctor and the patient, as well as improving patients' knowledge about hepatitis C infection, and facilitating the understanding of the risks associated with non-adherence. EXPERT OPINION Since the treatment of HCV infections is highly effective in almost all patients who complete medication, no new drugs are to be expected in the coming years. Therefore, the primary attention in the global elimination of HCV will be focused on screening programs, improving the availability of drugs, and reducing the risk of non-adherence.
Collapse
Affiliation(s)
- Robert Flisiak
- Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland
| | - Piotr Rzymski
- Department of Environmental Medicine, Poznan University of Medical Sciences, Poznań, Poland
| | - Marta Flisiak-Jackiewicz
- Department of Pediatrics, Gastroenterology, Hepatology, Nutrition and Allergology, Medical University of Bialystok, Bialystok, Poland
| | - Michał Brzdęk
- Collegium Medicum, Jan Kochanowski University, Kielce, Poland
| | | |
Collapse
|
|
2
|
Manley HN, Riback LR, Nyakowa M, Akiyama MJ, Cherutich P, Lizcano J, Kurth A, Muller A. Barriers to and impacts of hepatitis C treatment among people who inject drugs in Kenya: A qualitative study. PLOS GLOBAL PUBLIC HEALTH 2025; 5:e0003284. [PMID: 39821143 PMCID: PMC11737709 DOI: 10.1371/journal.pgph.0003284] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/23/2024] [Accepted: 12/10/2024] [Indexed: 01/19/2025]
Abstract
Hepatitis C (HCV) disproportionately affects people who inject drugs (PWID). Despite availability of safe and effective treatment, HCV treatment access and uptake among PWID in low- and middle-income countries (LMICs) has been limited. Understanding the lived experiences of PWID in these settings who have undergone treatment provides the opportunity to gain insight into how to implement treatment programs that meet the needs of this population. Using Rhodes' Risk Environment Framework to guide our work, we conducted semi-structured interviews with 35 PWID who received HCV treatment in methadone clinics and drop-in-centers (DICs) in Nairobi and coastal Kenya supported by peer case managers from August to September 2019. Translated and transcribed interviews were analyzed thematically. Three overarching themes emerged in our thematic analysis: 1) Financial constraints as a barrier to HCV treatment, 2) HCV-related stigma, and 3) HCV treatment impacts on health and risk behaviors. These data signal unique challenges faced by PWID seeking HCV treatment in this LMIC setting and highlight the importance of interventions to reduce barriers to treatment. In order for positive treatment outcomes to be sustained, HCV treatment programs must address the barriers patients face at multiple levels and implement system-level changes.
Collapse
Affiliation(s)
- Hannah N. Manley
- Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, United States of America
| | - Lindsey R. Riback
- Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, United States of America
| | - Mercy Nyakowa
- Kenya Ministry of Health, National AIDS & STI Control Programme (NASCOP), Nairobi, Kenya
| | - Matthew J. Akiyama
- Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, United States of America
| | - Peter Cherutich
- Kenya Ministry of Health, National AIDS & STI Control Programme (NASCOP), Nairobi, Kenya
| | - John Lizcano
- Yale School of Nursing, Yale University, New Haven, Connecticut, United States of America
| | - Ann Kurth
- Yale School of Nursing, Yale University, New Haven, Connecticut, United States of America
| | - Abbe Muller
- Yale School of Nursing, Yale University, New Haven, Connecticut, United States of America
| |
Collapse
|
|
3
|
Yi S, Truong D, Conway B. A comparison of sofosbuvir/velpatasvir and glecaprevir/pibrentasvir for the treatment of hepatitis C infection among people who inject drugs. J Virus Erad 2024; 10:100388. [PMID: 39319041 PMCID: PMC11420441 DOI: 10.1016/j.jve.2024.100388] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2024] [Revised: 08/14/2024] [Accepted: 08/29/2024] [Indexed: 09/26/2024] Open
Abstract
Background To eliminate hepatitis C (HCV) infection as a public health concern by 2030, there is a need to develop comprehensive programs among key populations such as people who use drugs (PWUD). Two highly effective regimens are available for initial therapy: glecaprevir/pibrentasvir (G/P) given as 3 tablets/day for 8 weeks and sofosbuvir/velpatasvir (S/V) given as 1 tablet/day for 12 weeks. Data evaluating the safety and efficacy comparing one regimen over another in a population of PWUD is limited. Methods Patients were identified through outreach events. Viremic patients were offered HCV treatment within a multidisciplinary program. This retrospective comparison analysis focuses on the first 120 sequential individuals who chose either treatment and in whom a definitive outcome of treatment was available between March 1, 2019 and February 29, 2024. The primary outcomes of the analysis were cure of HCV infection and its corelates, as well as safety of the individual regimens. Results We successfully identified 120 within each of the G/P and S/V treatment groups. Of those on G/P, we note 28.3 % female, 20.9 % Indigenous, 70.8 % using fentanyl, and 51.3 % with unstable housing. Of those on S/V, we note 25.8 % female, 20.8 % Indigenous, and 75 % using fentanyl and 56.7 % with unstable housing. Overall, 118 and 115 patients completed therapy on G/P and S/V, respectively. A total of 118 and 115 completed therapy on G/P and S/V, with virologic relapse documented in 3 and 2 participants on G/P and S/V, respectively. The ITT/mITT cure rates for G/P and S/V were 95.0 %/97.4 % and 94.2 %/98.3 %, respectively. There were 5 drug overdose deaths among those who initiated treatment, one on G/P and 4 on S/V. Conclusion: We have evaluated two highly effective regimens in a group of inner-city PWUD, with comparable success rates well in excess of 90 %. Our data supports the offer of both options for the treatment of PWUD with HCV infection.
Collapse
Affiliation(s)
- Shana Yi
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
| | - David Truong
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
| | - Brian Conway
- Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada
- Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada
| |
Collapse
|
|
4
|
McKenzie AJ, Noble BN, Herink MC, Viehmann MM, Furuno JP. Adherence to Hepatitis C Treatment Among Underserved Patients With Substance Use Disorder in a Pharmacist-led Treatment Model. J Pharm Pract 2024; 37:637-643. [PMID: 36927254 DOI: 10.1177/08971900231165172] [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: 03/18/2023]
Abstract
BackgroundTreatment with medications for opioid use disorder (MOUD) may improve hepatitis C virus (HCV) treatment outcomes by providing additional contact with health care professionals to support patient engagement. Objective: We describe a pharmacist-led HCV treatment model and assessed the effect of MOUD on adherence to direct-acting antivirals (DAAs) in an underserved patient population. Methods: This was a retrospective cohort study of adults (age≥18 years) treated for HCV infection with DAAs at a Federally Qualified Health Center in Portland, Oregon, between March 1, 2019, and March 16, 2020. Patients were followed to 12 weeks to assess adherence to DAAs by MOUD status. Results: Among 59 eligible patients, 16 (27%) were prescribed MOUD. Baseline characteristics were similar between patients who did and did not receive MOUD. Adherence to DAAs was overall high and not significantly different between the groups (median: 98.5% vs median: 100%; P = .06). Five patients missed at least one dose due to an adverse drug effect and two of these patients discontinued HCV therapy due to these effects. Conclusion: Adherence to HCV therapy was nearly 100% among underserved patients in a pharmacist-led HCV treatment model and did not differ by MOUD engagement.
Collapse
Affiliation(s)
- Anthony J McKenzie
- PGY2 Ambulatory Care Pharmacy Resident, Pharmacy Services, Family Medicine at Richmond Clinic, Oregon Health & Science University, Portland, OR, USA
| | - Brie N Noble
- Senior Faculty Research Assistant, Department of Pharmacy Practice, Oregon State University College of Pharmacy, Portland, OR, USA
| | - Megan C Herink
- Clinical Associate Professor, Department of Pharmacy Practice, Oregon State University College of Pharmacy, Portland, OR, USA
| | - Megan M Viehmann
- Pharmacy Operations Manager Family Medicine at Richmond Clinic, Oregon Health & Science University, Portland, OR, USA
| | - Jon P Furuno
- Professor, Department of Pharmacy Practice, Oregon State University College of Pharmacy, Portland, OR, USA
| |
Collapse
|
|
5
|
Heo M, Norton BL, Pericot-Valverde I, Mehta SH, Tsui JI, Taylor LE, Lum PJ, Feinberg J, Kim AY, Arnsten JH, Sprecht-Walsh S, Page K, Murray-Krezan C, Anderson J, Litwin AH. Optimal hepatitis C treatment adherence patterns and sustained virologic response among people who inject drugs: The HERO study. J Hepatol 2024; 80:702-713. [PMID: 38242324 DOI: 10.1016/j.jhep.2023.12.020] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2023] [Revised: 11/27/2023] [Accepted: 12/20/2023] [Indexed: 01/21/2024]
Abstract
BACKGROUND & AIMS Direct-acting antivirals (DAAs) are highly effective for treating HCV infection even among people who inject drugs (PWID). Yet, little is known about patients' adherence patterns and their association with sustained virologic response (SVR) rates. We aimed to summarize various adherence patterns and determine their associations with SVR. METHODS Electronic blister packs were used to measure daily adherence to once-a-day sofosbuvir/velpatasvir during the 12-week treatment period among active PWIDs. Blister pack data were available for 496 participants who initiated DAAs for whom SVR status was known. Adherence was summarized in multiple patterns, such as total adherent days, consecutive missed days, and early discontinuations. Thresholds for adherence patterns associated with >90% SVR rates were also determined. RESULTS The overall SVR rate was 92.7%, with a median adherence rate of 75%. All adherence patterns indicating greater adherence were significantly associated with achieving SVR. Participant groups with ≥50% (>42/84) adherent days or <26 consecutive missed days achieved an SVR rate of >90%. Greater total adherent days during 9-12 weeks and no early discontinuation were significantly associated with higher SVR rates only in those with <50% adherence. Participants with first month discontinuation and ≥2 weeks of treatment interruption had low SVR rates, 25% and 85%, respectively. However, greater adherent days were significantly associated with SVR (adjusted odds ratio 1.10; 95% CI 1.04-1.16; p <0.001) even among participants with ≥14 consecutive missed days. CONCLUSIONS High SVR rates can be achieved in the PWID population despite suboptimal adherence. Encouraging patients to take as much medication as possible, with <2 weeks consecutive missed days and without early discontinuation, was found to be important for achieving SVR. IMPACT AND IMPLICATIONS People who inject drugs can be cured of HCV in >90% of cases, even with relatively low adherence to direct-acting antivirals, but early discontinuations and long treatment interruptions can significantly reduce the likelihood of achieving cure. Clinicians should encourage people who inject drugs who are living with HCV to adhere daily to direct-acting antivirals as consistently as possible, but if any days are interrupted, to continue and complete treatment. These results from the HERO study are important for patients living with HCV, clinicians, experts writing clinical guidelines, and payers. CLINICAL TRIAL NUMBER NCT02824640.
Collapse
Affiliation(s)
- Moonseong Heo
- Department of Public Health Sciences, Clemson University, Clemson, SC 29605, USA.
| | - Brianna L Norton
- Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, 3330 Kossuth Avenue Bronx, NY 10467, USA
| | - Irene Pericot-Valverde
- Department of Psychology, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC 29634, USA
| | - Shruti H Mehta
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E6546, Baltimore, MD 21205, USA
| | - Judith I Tsui
- Department of Medicine, University of Washington, 325 9th Ave., Seattle, WA 98104, USA
| | - Lynn E Taylor
- Department of Pharmacy, University of Rhode Island, Avedesian Hall, 7 Greenhouse Rd, Kingston, RI 02881, USA
| | - Paula J Lum
- Division of HIV, Infectious Disease and Global Medicine, University of California, San Francisco and San Francisco General Hospital, 2540 23rd Street, San Francisco, CA 94110, USA
| | - Judith Feinberg
- Department of Behavioral Medicine and Psychiatry, and Department of Medicine, Section of Infectious Diseases, West Virginia University School of Medicine, 930 Chestnut Ridge Road, Morgantown, WV 26505, USA
| | - Arthur Y Kim
- Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, 55 Fruit St., Boston, MA 02114, USA
| | - Julia H Arnsten
- Department of Medicine, Albert Einstein College of Medicine/Montefiore Medical Center, 3330 Kossuth Avenue Bronx, NY 10467, USA
| | | | - Kimberly Page
- Department of Internal Medicine, University of New Mexico Health Sciences Center, University of New Mexico MSC 10 5550, Albuquerque, NM 87131, USA
| | - Cristina Murray-Krezan
- Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, 200 Meyran Avenue, Suite 300, Pittsburgh, PA 15213, USA
| | - Jessica Anderson
- Department of Internal Medicine, University of New Mexico Health Sciences Center, University of New Mexico MSC 10 5550, Albuquerque, NM 87131, USA
| | - Alain H Litwin
- School of Health Research, Clemson University, Clemson, SC 29605, USA; Department of Medicine, University of South Carolina School of Medicine, 876 W Faris Rd, Greenville, SC 29605, USA; Department of Medicine, Prisma Health, Greenville, SC 29605, USA.
| |
Collapse
|
|
6
|
Gupta A, Ashour D, Shebl FM, Platt L, Chiosi JJ, Nelson SB, Ard KL, Kim AY, Bassett IV. Evaluation of Hepatitis C Treatment Outcomes Among Patients Enrolled in Outpatient Parenteral Antibiotic Therapy-Boston, Massachusetts, 2016-2021. Open Forum Infect Dis 2023; 10:ofad342. [PMID: 37496604 PMCID: PMC10368317 DOI: 10.1093/ofid/ofad342] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2023] [Accepted: 07/03/2023] [Indexed: 07/28/2023] Open
Abstract
In our Boston-based outpatient parenteral antibiotic therapy (OPAT) program between 2016 and 2021, we found that a low proportion of patients with active hepatitis C virus (HCV) were prescribed HCV treatment by their OPAT provider and few achieved sustained virologic response. Clinicians should consider concurrent HCV treatment during OPAT.
Collapse
Affiliation(s)
- Akash Gupta
- Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA
- Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Dina Ashour
- Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Fatma M Shebl
- Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Laura Platt
- Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA
- Division of Infectious Diseases, Brigham & Women's Hospital, Boston, Massachusetts, USA
| | - John J Chiosi
- Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA
- Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Sandra B Nelson
- Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Kevin L Ard
- Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Arthur Y Kim
- Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Ingrid V Bassett
- Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA
- Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA
| |
Collapse
|
|
7
|
Tsui JI, Lum PJ, Taylor LE, Mehta SH, Feinberg J, Kim AY, Norton BL, Niu J, Heo M, Arnsten J, Pericot-Valverde I, Thomas A, Blalock KL, Radick A, Murray-Krezan C, Page K, Litwin AH. Injecting practices during and after hepatitis C treatment and associations with not achieving cure among persons who inject drugs. Drug Alcohol Depend 2023; 247:109878. [PMID: 37150144 DOI: 10.1016/j.drugalcdep.2023.109878] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/13/2023] [Revised: 04/07/2023] [Accepted: 04/13/2023] [Indexed: 05/09/2023]
Abstract
BACKGROUND Persons who inject drugs (PWID) are a key population for hepatitis C virus (HCV) treatment. Study aims were to describe injection practices of PWID during HCV treatment with direct-acting antivirals (DAAs) and assess whether injection practices were associated with not achieving a sustained virologic response (SVR). METHODS Secondary analysis of the HERO Study (ClinicalTrials.gov, NCT02824640), a pragmatic randomized trial in 8 U.S. states to evaluate the effectiveness of HCV care models among active PWID seen in opioid treatment programs and community clinics. Frequency, sharing and reuse of injecting equipment were assessed at baseline, end-of-treatment (EOT) and quarterly visits up to 60 weeks post-treatment. Generalized Estimating Equations logistic regression models with linear spline were used to compare trends in injecting behaviors during vs. post-treatment. Multivariable logistic regression models explored associations between injecting behaviors during treatment and lack of SVR. RESULTS Among 501 participants, 27% were female, 35% were non-white, mean age was 44 (SD 11.5) years and nearly half (49%) were unhoused. At baseline, 41% reported receptive sharing of injecting equipment, declining to 16% at EOT visit. Receptive sharing of cookers, rinses, or needles/syringes during treatment was associated with a nearly 5-fold increase in not achieving SVR (adjusted odds ratio (aOR)=4.83; 95% CI: 2.26, 10.28) as was reuse of one's own needles/syringes (aOR=2.37; 95% CI: 1.11, 4.92). CONCLUSIONS PWID in the HERO study adopted safer injecting behaviors during DAA treatment; receptive sharing of injecting equipment and reuse of one's own equipment during treatment were associated with not achieving cure.
Collapse
Affiliation(s)
- Judith I Tsui
- Division of General Internal Medicine, University of Washington, 325 9th Ave, Seattle, WA98104, USA.
| | - Paula J Lum
- Department of Medicine, University of California, San Francisco, 1001 Potrero Ave, San Francisco, CA94110, USA
| | - Lynn E Taylor
- College of Pharmacy, University of Rhode Island, 80 Washington Street, Providence, RI02903, USA; HIV and Viral Hepatitis Services, CODAC Behavioral Health, Providence, RI02909, USA
| | - Shruti H Mehta
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615N. Wolfe Street, Room E6546, Baltimore, MD21205, USA
| | - Judith Feinberg
- Department of Behavioral Medicine & Psychiatry and Department of Medicine, Infectious Diseases, West Virginia University School of Medicine, 930 Chestnut Ridge Road, Morgantown, WV26505, USA
| | - Arthur Y Kim
- Division of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, 55 Fruit St, Boston, MA02114, USA
| | - Brianna L Norton
- Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, 3330 Kossuth Avenue Bronx, NY10467, USA
| | - Jiajing Niu
- Department of Public Health Sciences, Clemson University, 605 Grove Road, Clemson, SC29605, USA
| | - Moonseong Heo
- Department of Public Health Sciences, Clemson University, 605 Grove Road, Clemson, SC29605, USA
| | - Julia Arnsten
- Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, 3330 Kossuth Avenue Bronx, NY10467, USA
| | - Irene Pericot-Valverde
- Department of Psychology, Clemson University, 418 Bracket Hall, Clemson, SC29634, USA; Clemson University School of Health Research605 Grove RoadGreenvilleSC29605, USA
| | - Aurielle Thomas
- College of Pharmacy, University of Rhode Island, 80 Washington Street, Providence, RI02903, USA
| | - Kendra L Blalock
- Division of General Internal Medicine, University of Washington, 325 9th Ave, Seattle, WA98104, USA
| | - Andrea Radick
- Division of General Internal Medicine, University of Washington, 325 9th Ave, Seattle, WA98104, USA
| | - Cristina Murray-Krezan
- Department of Medicine, University of Pittsburgh, 200 Meyran Ave., Pittsburgh, PA15213, USA
| | - Kimberly Page
- Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA
| | - Alain H Litwin
- Clemson University School of Health Research605 Grove RoadGreenvilleSC29605, USA; Department of Medicine, University of South Carolina School of Medicine, 876 W Faris Rd, Greenville, SC29605, USA; Department of Medicine, Prisma Health, 876 W Faris Rd, Greenville, SC29605, USA
| |
Collapse
|
|
8
|
Park H, Brown C, Wilson DL, Huang PL, Hernández-Con P, Horne P, Goodin A, Joseph A, Segal R, Cabrera R, Cook RL. Clinician barriers, perceptions, and practices in treating patients with hepatitis C virus and substance use disorder in the United States. Prev Med Rep 2023; 32:102138. [PMID: 36865395 PMCID: PMC9971512 DOI: 10.1016/j.pmedr.2023.102138] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2022] [Revised: 12/19/2022] [Accepted: 02/10/2023] [Indexed: 02/16/2023] Open
Abstract
The likelihood of clinicians prescribing direct-acting antiviral (DAA) therapy for patients with chronic hepatitis C virus (HCV) and substance use disorder (SUD) was assessed via a survey emailed throughout the United States to clinicians (physicians and advanced practice providers) in gastroenterology, hepatology, and infectious disease specialties. Clinicians' perceived barriers and preparedness and actions associated with current and future DAA prescribing practices of HCV-infected patients with SUD were assessed. Of 846 clinicians presumably receiving the survey, 96 completed and returned it. Exploratory factor analyses of perceived barriers indicated a highly reliable (Cronbach alpha = 0.89) model with five factors: HCV stigma and knowledge, prior authorization requirements, and patient- clinician-, and system-related barriers. In multivariable analyses, after controlling for covariates, patient-related barriers (P < 0.01) and prior authorization requirements (P < 0.01) were negatively associated with the likelihood of prescribing DAAs. Exploratory factor analyses of clinician preparedness and actions indicated a highly reliable (Cronbach alpha = 0.75) model with three factors: beliefs and comfort level; action; and perceived limitations. Clinician beliefs and comfort levels were negatively associated with the likelihood of prescribing DAAs (P = 0.01). Composite scores of barriers (P < 0.01) and clinician preparedness and actions (P < 0.05) were also negatively associated with the intent to prescribe DAAs. Conclusion These findings underscore the importance of addressing patient-related barriers and prior authorization requirements-significant problematic barriers-and improving clinicians' beliefs (e.g., medication-assisted therapy should be prescribed before DAAs) and comfort levels for treating patients with HCV and SUD to enhance treatment access for patients with both HCV and SUD.
Collapse
Affiliation(s)
- Haesuk Park
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Carolyn Brown
- Health Outcomes, College of Pharmacy, University of Texas, Austin, TX, United States
| | - Debbie L Wilson
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Pei-Lin Huang
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Pilar Hernández-Con
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Patrick Horne
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Amie Goodin
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Amanda Joseph
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Rich Segal
- Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, United States
| | - Roniel Cabrera
- Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, United States
| | - Robert L Cook
- Department of Epidemiology, College of Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, United States
| |
Collapse
|
|
9
|
Losikoff P, Bosse JD, Martin SA, Wilson A, Chiodo LM. Integrated hepatitis C treatment is associated with improved retention and success in outpatient treatment for opioid use disorder at a private clinic. Front Psychiatry 2022; 13:932306. [PMID: 36186876 PMCID: PMC9515307 DOI: 10.3389/fpsyt.2022.932306] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2022] [Accepted: 08/18/2022] [Indexed: 11/26/2022] Open
Abstract
Background Direct acting antiretrovirals (DAA) are effective for individuals who are infected with chronic hepatitis C virus (HCV), yet many people go without access to these lifesaving treatments. Materials and methods We conducted a non-randomized study evaluating treatment data for patients in outpatient treatment for opioid use disorder (OUD) at a private clinic. Patients who were HCV-positive, had been in OUD treatment for at least 4 weeks, and engaged in integrated HCV treatment with DAA (co-located within their treatment for OUD) were compared to patients with HCV who only received OUD treatment. We evaluated HCV cure; OUD medication adherence, treatment utilization and retention; and illicit substance use for those engaged in treatment between 9/2016 and 1/2018. Results Seventy-four patients completed integrated HCV-OUD treatment with DAA, with 87.8% achieving cure. Of the 66 who completed treatment and were subsequently evaluated for sustained viral response 98.5% were cured. Patients who received integrated HCV and OUD treatment in our clinic, stayed in OUD treatment longer, demonstrated higher OUD medication adherence, and used less opioids or cocaine compared to HCV-infected patients (n = 572) being treated only for OUD. Discussion We have reported on a reproducible intervention that lends itself to outpatient OUD treatment. Analyses demonstrate the potential positive impact HCV treatment has on OUD recovery, including reduction in opioid and cocaine use and increased retention in care. Conclusion Co-locating HCV treatment with existing OUD treatment is feasible, effective, and demonstrates positive outcomes for the treatment of both conditions.
Collapse
Affiliation(s)
- Phyllis Losikoff
- CleanSlate Outpatient Addiction Medicine, New Bedford, MA, United States
- Division of Pediatric Infectious Disease, The Warren Alpert Medical School of Brown University, Providence, RI, United States
| | - Jordon D. Bosse
- School of Nursing, Bouvè College of Health Sciences, Northeastern University, Boston, MA, United States
- Massachusetts General Hospital, Boston, MA, United States
| | - Stephen A. Martin
- Barre Family Health Center, Barre, MA, United States
- Department of Family Medicine and Community Health, UMass Chan Medical School, Worcester, MA, United States
| | - Amanda Wilson
- Addiction Research and Education Foundation, Gig Harbor, WA, United States
| | - Lisa M. Chiodo
- Addiction Research and Education Foundation, Gig Harbor, WA, United States
- Elaine Marieb College of Nursing, University of Massachusetts, Amherst, MA, United States
| |
Collapse
|
|
10
|
Country versus pharmaceutical company interests for hepatitis C treatment. Health Care Manag Sci 2022; 25:725-749. [PMID: 36001218 PMCID: PMC9399601 DOI: 10.1007/s10729-022-09607-2] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2020] [Accepted: 07/06/2022] [Indexed: 11/04/2022]
Abstract
Hepatitis C virus (HCV) is one of the leading causes of liver disease and is responsible for massive health and economic burden worldwide. The disease is asymptomatic in its early stages, but it can progress over time to fatal end-stage liver disease. Thus, the majority of individuals infected with HCV are unaware of their chronic condition. Recent treatment options for HCV can completely cure the infection but are costly. We developed a game model between a pharmaceutical company (PC) and a country striving to maximize its citizens' utility. First, the PC determines the price of HCV treatment; then, the country responds with corresponding screening and treatment strategies. We employed an analytical framework to calculate the utility of the players for each selected strategy. Calibrated to detailed HCV data from Israel, we found that the PC will gain higher revenue by offering a quantity discount rather than using standard fixed pricing per treatment, by indirectly forcing the country to conduct more screening than it desired. By contrast, risk-sharing agreements, in which the country pays only for successful treatments are beneficial for the country. Our findings underscore that policy makers worldwide should prudently consider recent offers by PCs to increase screening either directly, via covering HCV screening, or indirectly, by providing discounts following a predetermined volume of sales. More broadly, our approach is applicable in other healthcare settings where screening is essential to determine treatment strategies.
Collapse
|
|
11
|
Jiang X, Vouri SM, Diaby V, Lo-Ciganic W, Parker R, Park H. Health care utilization and costs associated with direct-acting antivirals for patients with substance use disorders and chronic hepatitis C. J Manag Care Spec Pharm 2021; 27:1388-1402. [PMID: 34595949 DOI: 10.18553/jmcp.2021.27.10.1388] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Abstract
BACKGROUND: Patients with substance use disorders (SUD) and chronic hepatitis C virus infection (HCV) have limited access to direct-acting antivirals (DAAs) due to multilevel issues related to providers (eg, concern about reinfection); patients (eg, refusal); payers (eg, prior authorization); and health system structure, although clinical guidelines recommend timely DAA treatment for patients with SUD and HCV. Effects of DAAs on real-world health care utilization and costs among these patients is unknown. OBJECTIVE: To compare changes in medical service utilization and costs related to liver, SUD, and all-cause morbidity in patients with SUD and HCV treated with DAAs (DAA group) vs not treated with DAAs (non-DAA group). METHODS: We conducted a retrospective cohort study using MarketScan Commercial and Medicare Supplemental Claims databases (2012-2018) for newly diagnosed HCV treatment-naive adults with SUD. We used difference-in-differences analyses, stratified by cirrhosis status, to determine the adjusted ratio of rate ratio (RoRR) to assess the difference in the relative changes from the pre- to posttreatment periods between the 2 groups. RESULTS: 6,266 patients with SUD and HCV were identified. Of these patients who also had cirrhosis (n = 607), 49% (n = 298) initiated DAA therapy for HCV, whereas of those without cirrhosis (n = 5,659), 22% (n = 1,219) initiated DAAs. For patients with cirrhosis (n = 607), the liver-related costs decreased by $6,213 (95% CI = -$8,571, -$3,856) for the DAA group and $1,585 (95% CI = -$4,659, $1,490) for the non-DAA group. The relative decreases in the rate of liver-related costs were larger for the DAA group than for the non-DAA group, and the relative changes between groups were significantly different (RoRR = 0.37, 95% CI = 0.19-0.73). There was no difference in the relative changes after DAAs in the rate of SUD-related visits/costs or all-cause costs between the 2 groups. For patients without cirrhosis (n = 5,659), a similar association was observed. Besides, the relative decreases in the rate of SUD-related emergency department (ED) visits (RoRR = 0.54, 95% CI = 0.38-0.77); SUD-related long-term care visits (RoRR = 0.30, 95% CI = 0.13-0.73); all-cause ED visits (RoRR = 0.75, 95% CI = 0.64-0.88); and all-cause long term-care visits (RoRR = 0.36, 95% CI = 0.18-0.72) were larger in the DAA group than in the non-DAA group. CONCLUSIONS: DAAs are associated with a significant decrease in the rate of SUD-related ED visits and liver-related costs without increasing the rate of all-cause costs among patients with SUD and HCV, suggesting that the benefits of DAAs extended beyond liver-related outcomes, especially in this disadvantaged population. DISCLOSURES: Research reported in this publication was supported in part by the National Institute on Drug Abuse of the National Institutes of Health (K01DA045618). The funder did not have a role in the design, the execution, the analyses, the interpretation of the data, or the decision to submit the results of this study. The authors have no potential conflicts of interest.
Collapse
Affiliation(s)
- Xinyi Jiang
- Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Florida, Gainesville
| | - Scott Martin Vouri
- Department of Pharmaceutical Outcomes & Policy, Center for Drug Evaluation and Safety (CoDES), College of Pharmacy, University of Florida, Gainesville
| | - Vakaramoko Diaby
- Department of Pharmaceutical Outcomes & Policy, Center for Drug Evaluation and Safety (CoDES), College of Pharmacy, University of Florida, Gainesville
| | - Weihsuan Lo-Ciganic
- Department of Pharmaceutical Outcomes & Policy, Center for Drug Evaluation and Safety (CoDES), College of Pharmacy, University of Florida, Gainesville
| | - Robert Parker
- Department of Biostatistics, College of Public Health & Health Professions, College of Medicine, University of Florida, Gainesville
| | - Haesuk Park
- Department of Pharmaceutical Outcomes & Policy, Center for Drug Evaluation and Safety (CoDES), College of Pharmacy, University of Florida, Gainesville
| |
Collapse
|
|
12
|
Fernández de Cañete Camacho JC, Mancebo Martínez A, García Mena MA, Moreno Planas JM. Influence of psychiatric disorders and opioid substitution therapy on hepatitis C treatment with direct-acting antivirals in people who inject drugs. GASTROENTEROLOGIA Y HEPATOLOGIA 2021; 45:265-273. [PMID: 34543719 DOI: 10.1016/j.gastrohep.2021.09.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/02/2021] [Revised: 08/25/2021] [Accepted: 09/01/2021] [Indexed: 11/29/2022]
Abstract
INTRODUCTION The effectiveness of the hepatitis C virus (HCV) treatment seems to be lower in people who inject drugs (PWID). We analyze the influence of various factors as psychiatric disorders and opioid substitution therapy (OST) on the treatment with direct-acting antivirals (DAA) in this collective. PATIENTS AND METHODS Three hundred thirty-two PWID patients were treated with DAA in 12 Spanish hospitals between 2004 and 2020. They were catalogued in recent and former consumers (if the last consumption was in the last 3 years) and several variables were included, evaluating the effectiveness of the treatment according to the viral load 12 weeks after the end of the treatment with the parameter «sustained viral response» (SVR12). RESULTS 23.4% were recent consumers and 27.7% were on OST. The 41.5% had any diagnosis of psychiatric disorder. SVR12 was 84.04%, ascending to 96.21% when excluded from the analyses the patients lost to follow-up (12.7%). SVR12 was lower due to an increase in the loss to follow-up in recent consumers and other factors like OST, being in prison the last 5 years, naïve patients, generalized anxiety disorder and benzodiazepine consumption. CONCLUSIONS The effectiveness of the HCV treatment with DAA in PWID is similar than in general population in patients whit an appropriate follow-up. It is important to maintain a closer follow-up in patients on OST, recent consumers and those with psychiatric disorders.
Collapse
Affiliation(s)
| | - Antonio Mancebo Martínez
- Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Albacete, Albacete, España
| | | | - José María Moreno Planas
- Servicio de Aparato Digestivo, Complejo Hospitalario Universitario de Albacete, Albacete, España; Universidad de Castilla-La Mancha, Albacete, España
| |
Collapse
|
|
13
|
Park H, Jiang X, Song HJ, Lo Re V, Childs-Kean LM, Lo-Ciganic WH, Cook RL, Nelson DR. The Impact of Direct-Acting Antiviral Therapy on End-Stage Liver Disease Among Individuals with Chronic Hepatitis C and Substance Use Disorders. Hepatology 2021; 74:566-581. [PMID: 33544904 PMCID: PMC8339171 DOI: 10.1002/hep.31732] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2020] [Revised: 12/22/2020] [Accepted: 01/19/2021] [Indexed: 12/16/2022]
Abstract
BACKGROUND AND AIMS Our aim was to evaluate the impact of direct-acting antivirals (DAAs) on decompensated cirrhosis (DCC) and HCC in patients with chronic HCV and substance use disorder (SUD) compared with those without an SUD. APPROACH AND RESULTS This retrospective cohort study used the MarketScan database (2013-2018) to identify 29,228 patients with chronic HCV, where 22% (n = 6,385) had ≥1 SUD diagnosis. The inverse probability of treatment weighted multivariable Cox proportional hazard models were used to compare the risk of developing DCC and HCC. Among the those who were noncirrhotic, treatment reduced the DCC risk among SUD (adjusted hazard ratio [aHR] 0.13; 95% CI, 0.06-0.30) and non-SUD (aHR 0.11; 95% CI, 0.07-0.18), whereas the risk for HCC was not reduced for the SUD group (aHR 0.91; 95% CI, 0.33-2.48). For those with cirrhosis, compared with patients who were untreated, treatment reduced the HCC risk among SUD (aHR, 0.33; 95% CI, 0.13-0.88) and non-SUD (aHR, 0.40; 95% CI, 0.25-0.65), whereas the risk for DCC was not reduced for the SUD group (aHR, 0.64; 95% CI, 0.37-1.13). Among patients with cirrhosis who were untreated, the SUD group had a higher risk of DCC (aHR, 1.52; 95% CI, 1.03-2.24) and HCC (aHR, 1.69; 95% CI, 1.05-2.72) compared with non-SUD group. CONCLUSIONS Among the HCV SUD group, DAA treatment reduced the risk of DCC but not HCC for those who were noncirrhotic, whereas DAA treatment reduced the risk of HCC but not DCC for those with cirrhosis. Among the nontreated, patients with an SUD had a significantly higher risk of DCC and HCC compared with those without an SUD. Thus, DAA treatment should be considered for all patients with HCV and an SUD while also addressing the SUD.
Collapse
Affiliation(s)
- Haesuk Park
- Pharmaceutical Outcomes and PolicyCollege of PharmacyUniversity of FloridaGainesvilleFL
| | - Xinyi Jiang
- Pharmaceutical Outcomes and PolicyCollege of PharmacyUniversity of FloridaGainesvilleFL
| | - Hyun Jin Song
- Pharmaceutical Outcomes and PolicyCollege of PharmacyUniversity of FloridaGainesvilleFL
| | - Vincent Lo Re
- Division of Infectious DiseasesDepartment of Medicine and Center for Clinical Epidemiology and BiostatisticsDepartment of Biostatistics, Epidemiology, and InformaticsPerelman School of MedicineUniversity of PennsylvaniaPhiladelphiaPA
| | - Lindsey M Childs-Kean
- Pharmacotherapy and Translational ResearchCollege of PharmacyUniversity of FloridaGainesvilleFL
| | - Wei-Hsuan Lo-Ciganic
- Pharmaceutical Outcomes and PolicyCollege of PharmacyUniversity of FloridaGainesvilleFL
| | - Robert L Cook
- Department of MedicineUniversity of FloridaGainesvilleFL
| | - David R Nelson
- Department of MedicineUniversity of FloridaGainesvilleFL
| |
Collapse
|
|
14
|
Torre P, Aglitti A, Masarone M, Persico M. Viral hepatitis: Milestones, unresolved issues, and future goals. World J Gastroenterol 2021; 27:4603-4638. [PMID: 34366625 PMCID: PMC8326259 DOI: 10.3748/wjg.v27.i28.4603] [Citation(s) in RCA: 23] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/27/2021] [Revised: 04/11/2021] [Accepted: 06/16/2021] [Indexed: 02/06/2023] Open
Abstract
In this review the current overall knowledge on hepatitis A, B, C, D, and E will be discussed. These diseases are all characterized by liver inflammation but have significant differences in distribution, transmission routes, and outcomes. Hepatitis B virus and hepatitis C virus are transmitted by exposure to infected blood, and in addition to acute infection, they can cause chronic hepatitis, which in turn can evolve into cirrhosis. It is estimated that more than 300 million people suffer from chronic hepatitis B or C worldwide. Hepatitis D virus, which is also transmitted by blood, only affects hepatitis B virus infected people, and this dual infection results in worse liver-related outcomes. Hepatitis A and E spread via the fecal-oral route, which corresponds mainly to the ingestion of food or water contaminated with infected stools. However, in developed countries hepatitis E is predominantly a zoonosis. Although hepatitis A virus and hepatitis E virus are usually responsible for a self-limiting hepatitis, a serious, rarely fatal illness is also possible, and in immunosuppressed patients, such as organ transplant recipients, hepatitis E virus infection can become chronic. The description of goals achieved, unresolved issues, and the latest research on this topic may make it possible to speculate on future scenarios in the world of viral hepatitis.
Collapse
Affiliation(s)
- Pietro Torre
- Internal Medicine and Hepatology Unit, Department of Medicine, Surgery and Dentistry, “Scuola Medica Salernitana,” University of Salerno, Salerno 84081, Italy
| | - Andrea Aglitti
- Internal Medicine and Hepatology Unit, Department of Medicine, Surgery and Dentistry, “Scuola Medica Salernitana,” University of Salerno, Salerno 84081, Italy
| | - Mario Masarone
- Internal Medicine and Hepatology Unit, Department of Medicine, Surgery and Dentistry, “Scuola Medica Salernitana,” University of Salerno, Salerno 84081, Italy
| | - Marcello Persico
- Internal Medicine and Hepatology Unit, Department of Medicine, Surgery and Dentistry, “Scuola Medica Salernitana,” University of Salerno, Salerno 84081, Italy
| |
Collapse
|
|
15
|
Yang X, Tang Y, Xu D, Zhang G, Xu P, Tang H, Pang L. Efficacy and safety of ledipasvir/sofosbuvir for hepatitis C among drug users: a systematic review and meta-analysis. Virol J 2021; 18:156. [PMID: 34315488 PMCID: PMC8314543 DOI: 10.1186/s12985-021-01625-w] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/12/2021] [Accepted: 07/12/2021] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND AND AIMS Limited data is available on the efficacy of direct acting anti-viral drugs on hepatitis C in drug users. The aim of this meta-analysis was to comprehensively analyze the efficacy and safety of LDV/SOF in drug users infected with the hepatitis C virus (HCV). METHODS The PubMed, Cochrane library, Embase and Web of Science databases were searched for articles published till April 2021 on HCV-positive drug users who were treated with ledipasvir/sofosbuvir (LDV/SOF). The primary endpoint was pooled sustained virological response at 12 weeks (SVR12) with 95% confidence interval (95% CI). Funnel plots and Egger's test were used to assess the publication bias. RESULTS A total of 12 studies and 711 subjects treated with LDV/SOF-based regimen for HCV were included, and the pooled SVR12 rate was 89.8% (95% CI 85.9-92.7). The pooled SVR12 rate of genotype 1 drug users was 92.4% (95% CI 88.6-95.0). Subgroup analysis showed that pooled SVR12 rates of patients treated with LDV/SOF and LDV/SOF ± RBV were 89.2% (95% CI 83.4-93.1), 90.4% (95% CI 83.6-94.5) respectively. In addition, the SVR12 rates were 88% (95% CI 70.7-95.7) for 8 weeks, 89.9% (95% CI 81.0-94.9) for 12 weeks and 82.2% (95% CI 24.9-98.5) for 24 weeks of treatment. CONCLUSION LDV/SOF is a safe and relatively effective treatment for hepatitis C in drug users.
Collapse
Affiliation(s)
- Xue Yang
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Yang Tang
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Di Xu
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Guang Zhang
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Peng Xu
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| | - Houlin Tang
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
| | - Lin Pang
- National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
| |
Collapse
|
|
16
|
Oru E, Trickey A, Shirali R, Kanters S, Easterbrook P. Decentralisation, integration, and task-shifting in hepatitis C virus infection testing and treatment: a global systematic review and meta-analysis. Lancet Glob Health 2021; 9:e431-e445. [PMID: 33639097 PMCID: PMC7966682 DOI: 10.1016/s2214-109x(20)30505-2] [Citation(s) in RCA: 127] [Impact Index Per Article: 31.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2020] [Revised: 09/17/2020] [Accepted: 11/09/2020] [Indexed: 12/11/2022]
Abstract
BACKGROUND Increasing access to hepatitis C virus (HCV) care and treatment will require simplified service delivery models. We aimed to evaluate the effects of decentralisation and integration of testing, care, and treatment with harm-reduction and other services, and task-shifting to non-specialists on outcomes across the HCV care continuum. METHODS For this systematic review and meta-analysis, we searched PubMed, Embase, WHO Global Index Medicus, and conference abstracts for studies published between Jan 1, 2008, and Feb 20, 2018, that evaluated uptake of HCV testing, linkage to care, treatment, cure assessment, and sustained virological response at 12 weeks (SVR12) in people who inject drugs, people in prisons, people living with HIV, and the general population. Randomised controlled trials, non-randomised studies, and observational studies were eligible for inclusion. Studies with a sample size of ten or less for the largest denominator were excluded. Studies were categorised according to the level of decentralisation: full (testing and treatment at same site), partial (testing at decentralised site and referral elsewhere for treatment), or none. Task-shifting was categorised as treatment by specialists or non-specialists. Data on outcomes across the HCV care continuum (linkage to care, treatment uptake, and SVR12) were pooled using random-effects meta-analysis. FINDINGS Our search identified 8050 reports, of which 132 met the eligibility criteria, and an additional ten reports were identified from reference citations and grey literature. Therefore, the final synthesis included 142 studies from 34 countries (20 [14%] studies from low-income and middle-income countries) and a total of 489 996 patients (239 446 [49%] from low-income and middle-income countries). Rates of linkage to care were higher with full decentralisation compared with partial or no decentralisation among people who inject drugs (full 72% [95% CI 57-85] vs partial 53% [38-67] vs none 47% [11-84]) and among people in prisons (full 94% [79-100] vs partial 50% [29-71]), although the CIs overlap for people who inject drugs. Similarly, treatment uptake was higher with full decentralisation compared with partial or no decentralisation (people who inject drugs: full 73% [65-80] vs partial 66% [55-77] vs none 35% [23-48]; people in prisons: full 72% [48-91] vs partial 39% [17-63]), although CIs overlap for full versus partial decentralisation. The results in the general population studies were more heterogeneous. SVR12 rates were high (≥90%) across different levels of decentralisation in all populations. Task-shifting of care and treatment to a non-specialist was associated with similar SVR12 rates to treatment delivered by specialists. There was a severe or critical risk of bias for 46% of studies, and heterogeneity across studies tended to be very high (I2>90%). INTERPRETATION Decentralisation and integration of HCV care to harm-reduction sites or primary care showed some evidence of improved access to testing, linkage to care, and treatment, and task-shifting of care and treatment to non-specialists was associated with similarly high cure rates to care delivered by specialists, across a range of populations and settings. These findings provide support for the adoption of decentralisation and task-shifting to non-specialists in national HCV programmes. FUNDING Unitaid.
Collapse
Affiliation(s)
- Ena Oru
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland
| | - Adam Trickey
- Population Health Sciences, University of Bristol, Bristol, UK
| | | | - Steve Kanters
- School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada
| | - Philippa Easterbrook
- Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, Geneva, Switzerland.
| |
Collapse
|
|
17
|
Graf C, Mücke MM, Dultz G, Peiffer KH, Kubesch A, Ingiliz P, Zeuzem S, Herrmann E, Vermehren J. Efficacy of Direct-acting Antivirals for Chronic Hepatitis C Virus Infection in People Who Inject Drugs or Receive Opioid Substitution Therapy: A Systematic Review and Meta-analysis. Clin Infect Dis 2021; 70:2355-2365. [PMID: 31513710 DOI: 10.1093/cid/ciz696] [Citation(s) in RCA: 56] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2019] [Accepted: 07/23/2019] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Treatment uptake for hepatitis C virus (HCV) infection in people who inject drugs (PWID) and patients on opioid substitution therapy (OST) is still low despite treatment guidelines that advocate the use of direct-acting antivirals (DAAs) in all patients. Our aim in this review was to investigate treatment outcomes among PWID and patients on OST in comparison to control cohorts. METHODS A search of Embase, Medline, PubMed, and Web of Science (from October 2010 to March 2018) was conducted to assess sustained virologic response (SVR), discontinuation rates, adherence, and HCV reinfection in PWID and patients on OST. RESULTS We identified 11 primary articles and 12 conference abstracts comprising 1702 patients on OST, 538 PWID, and 19 723 patients who served as controls. Among patients on OST, the pooled SVR was 90% (95% confidence interval [CI], 87% to 93%) and pooled treatment discontinuation rate was 7% (95% CI, 4% to 11%). Similarly, the pooled SVR was 88% (95% CI, 80% to 93%) in PWID and the pooled treatment discontinuation rate was 9% (95% CI, 5% to 15%). There was no significant difference regarding pooled rates of SVR, adherence, and discontinuation between patients on OST and controls as well as between PWID and controls. HCV reinfection rates among patients on OST ranged from 0.0 to 12.5 per 100 person-years. CONCLUSIONS HCV treatment outcomes in PWID and patients on OST are similar to those in patients without a history of injecting drugs, supporting current guideline recommendations to treat HCV in these patient populations.
Collapse
Affiliation(s)
- Christiana Graf
- Department of Internal Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany
| | - Marcus M Mücke
- Department of Internal Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany
| | - Georg Dultz
- Department of Internal Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany
| | - Kai-Henrik Peiffer
- Department of Internal Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany
| | - Alica Kubesch
- Department of Internal Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany
| | | | - Stefan Zeuzem
- Department of Internal Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany
| | - Eva Herrmann
- Institute of Biostatistics and Mathematical Modeling, Goethe University Frankfurt, Frankfurt am Main, Germany
| | - Johannes Vermehren
- Department of Internal Medicine, University Hospital Frankfurt, Frankfurt am Main, Germany
| |
Collapse
|
|
18
|
Liou JW, Mani H, Yen JH, Hsu HJ, Chang CC. Hepatitis C virus core protein: Not just a nucleocapsid building block, but an immunity and inflammation modulator. Tzu Chi Med J 2021; 34:139-147. [PMID: 35465281 PMCID: PMC9020238 DOI: 10.4103/tcmj.tcmj_97_21] [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: 04/13/2021] [Revised: 03/12/2021] [Accepted: 06/02/2021] [Indexed: 11/13/2022] Open
Abstract
Coevolution occurs between viruses and their hosts. The hosts need to evolve means to eliminate pathogenic virus infections, and the viruses, for their own survival and multiplication, have to develop mechanisms to escape clearance by hosts. Hepatitis C virus (HCV) of Flaviviridae is a pathogen which infects human liver and causes hepatitis, a condition of liver inflammation. Unlike most of the other flaviviruses, HCV has an excellent ability to evade host immunity to establish chronic infection. The persistent liver infection leads to chronic hepatitis, liver cirrhosis, hepatocellular carcinoma (HCC), as well as extrahepatic HCV-related diseases. HCV genomic RNA only expresses 10 proteins, many of which bear functions, in addition to those involved in HCV life cycle, for assisting the virus to develop its persistency. HCV core protein is a structural protein which encapsulates HCV genomic RNA and assembles into nucleocapsids. The core protein is also found to exert functions to affect host inflammation and immune responses by altering a variety of host pathways. This paper reviews the studies regarding the HCV core protein-induced alterations of host immunity and inflammatory responses, as well as the involvements of the HCV core protein in pro- and anti-inflammatory cytokine stimulations, host cellular transcription, lipid metabolism, cell apoptosis, cell proliferations, immune cell differentiations, oxidative stress, and hepatocyte steatosis, which leads to liver fibrosis, cirrhosis, and HCC. Implications of roles played by the HCV core protein in therapeutic resistance are also discussed.
Collapse
|
|
19
|
Pawlotsky JM, Negro F, Aghemo A, Berenguer M, Dalgard O, Dusheiko G, Marra F, Puoti M, Wedemeyer H. EASL recommendations on treatment of hepatitis C: Final update of the series ☆. J Hepatol 2020; 73:1170-1218. [PMID: 32956768 DOI: 10.1016/j.jhep.2020.08.018] [Citation(s) in RCA: 758] [Impact Index Per Article: 151.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2020] [Accepted: 08/18/2020] [Indexed: 02/08/2023]
Abstract
Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Clinical care for patients with HCV-related liver disease has advanced considerably thanks to an enhanced understanding of the pathophysiology of the disease, as well as developments in diagnostic procedures and improvements in therapy and prevention. These therapies make it possible to eliminate hepatitis C as a major public health threat, as per the World Health Organization target, although the timeline and feasibility vary from region to region. These European Association for the Study of the Liver recommendations on treatment of hepatitis C describe the optimal management of patients with recently acquired and chronic HCV infections in 2020 and onwards.
Collapse
|
|
20
|
Min JE, Pearce LA, Janjua NZ, Ti L, Nosyk B. The Causal Effect of Opioid Agonist Treatment on Adherence to Direct-Acting Antiviral Treatment for Hepatitis C Virus. Open Forum Infect Dis 2020. [DOI: 10.1093/ofid/ofaa418] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/14/2022] Open
Abstract
Abstract
Background
Opioid agonist treatment (OAT) supports adherence in medication regimens for other concurrent conditions. However, sparse evidence is available on its effect on promoting retention to direct-acting antivirals (DAAs) for people with opioid use disorder (PWOUD) with concurrent hepatitis C virus (HCV). Our objective was to determine the causal impact of OAT exposure on DAA adherence among HCV-positive PWOUD.
Methods
We executed a retrospective study using linked population-level data for British Columbia, Canada (January 1996–September 2018). We estimated the effect of OAT on DAA adherence using generalized estimating equations (GEEs) and marginal structural modeling (MSM) for time-varying confounding. The primary outcome was 85% DAA adherence (minimum 6 of 7 days).
Results
We included 2820 HCV-positive PWOUD who initiated a DAA regimen (32.6% female, 83.9% previously accessing OAT), with 2410 (95% among uncensored episodes) completing the regimen. The GEE-adjusted odds ratio of DAA adherence after OAT exposure was 1.05 (0.89–1.23), whereas the MSM-adjusted odds ratio was 0.97 (0.78–1.22).
Conclusions
In a setting with universal healthcare and widespread access to OAT and DAA treatment, DAA regimen completion rates were high regardless of OAT, and engagement in OAT did not increase DAA adherence. Nonengagement in OAT should not preclude DAA treatment for PWOUD.
Collapse
Affiliation(s)
- Jeong E Min
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
| | - Lindsay A Pearce
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
- University of Melbourne, School of Population and Global Health, Victoria, Melbourne, Australia
| | - Naveed Z Janjua
- British Columbia Centre for Disease Control, Vancouver, Canada
- School of Population and Public Health, University of British Columbia, Vancouver, Canada
| | - Lianping Ti
- School of Population and Public Health, University of British Columbia, Vancouver, Canada
- British Columbia Centre on Substance Use, Vancouver, Canada
| | - Bohdan Nosyk
- British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada
- Faculty of Health Sciences, Simon Fraser University, Burnaby, Canada
| |
Collapse
|
|
21
|
Hong J, Wright RC, Partovi N, Yoshida EM, Hussaini T. Review of Clinically Relevant Drug Interactions with Next Generation Hepatitis C Direct-acting Antiviral Agents. J Clin Transl Hepatol 2020; 8:322-335. [PMID: 33083256 PMCID: PMC7562806 DOI: 10.14218/jcth.2020.00034] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/19/2020] [Revised: 06/28/2020] [Accepted: 06/30/2020] [Indexed: 12/12/2022] Open
Abstract
In this review, we examine the pharmacokinetics and clinically relevant drug interactions of the newer generation direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C, specifically sofosbuvir/velpatasvir (Epclusa®), sofosbuvir/velpatasvir/voxilaprevir (Vosevi®), glecaprevir/pibrentasvir (Maviret®), and elbasvir/grazoprevir (Zepatier®). We searched MEDLINE (1948-January 2020), Embase (1964-January 2020), Google, and GoogleScholar using the terms pharmacokinetics, drug interaction, drug metabolism, sofosbuvir, velpatasvir, Epclusa, voxilaprevir, Vosevi, glecaprevir, pibrentasvir, Maviret, elbasvir, grazoprevir, and Zepatier, from inception to January 13, 2020. The search was limited to randomized controlled trials, in vitro studies, prospective and retrospective human studies, drug monographs, abstracts, and conference proceedings. All relevant published literature on pharmacokinetic and pharmacodynamic interactions involving DAAs were reviewed and the data extracted. Numerous clinically relevant drug-drug interactions (DDIs) were identified with the newer generation DAAs and commonly prescribed drugs. NS3/4A protease inhibitors are more likely to be involved in DDIs, followed by NS5A inhibitors and NS5B polymerase inhibitor. The majority of clinically relevant DDIs are predictable, according to known pharmacokinetic, pharmacodynamics, and physicochemical properties of DAAs; however, in select cases, unpredictable DDIs do occur. As expected, many drug interactions exist between newer generation DAAs and commonly prescribed medications. While the majority of clinically relevant interactions are predictable, many require therapeutic dose adjustment or careful selection of non-interacting drugs. In select cases, severe and unpredictable drug interactions can occur. Clinicians should consult hepatitis C virus pharmacotherapy experts and tertiary drug interaction resources when initiating DAA therapy in patients taking other medications.
Collapse
Affiliation(s)
- Jenny Hong
- Pharmaceutical Sciences, Vancouver General Hospital, Vancouver, BC, Canada
| | - Robert C. Wright
- Pharmaceutical Sciences, Vancouver General Hospital, Vancouver, BC, Canada
| | - Nilu Partovi
- Pharmaceutical Sciences, Vancouver General Hospital, Vancouver, BC, Canada
- Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada
| | - Eric M. Yoshida
- Liver Transplant Program, Vancouver General Hospital, Vancouver, BC, Canada
- Division of Gastroenterology, Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
| | - Trana Hussaini
- Pharmaceutical Sciences, Vancouver General Hospital, Vancouver, BC, Canada
- Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada
- Liver Transplant Program, Vancouver General Hospital, Vancouver, BC, Canada
| |
Collapse
|
|
22
|
Schulte B, Schmidt CS, Manthey J, Strada L, Christensen S, Cimander K, Görne H, Khaykin P, Scherbaum N, Walcher S, Mauss S, Schäfer I, Verthein U, Rehm J, Reimer J. Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study. Open Forum Infect Dis 2020; 7:ofaa317. [PMID: 32875003 PMCID: PMC7452367 DOI: 10.1093/ofid/ofaa317] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2020] [Accepted: 08/07/2020] [Indexed: 12/15/2022] Open
Abstract
Background Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs. Methods HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs). Results We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients. Conclusions This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.
Collapse
Affiliation(s)
- Bernd Schulte
- Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany
| | - Christiane S Schmidt
- Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany
| | - Jakob Manthey
- Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany.,Institute of Clinical Psychology and Psychotherapy & Center of Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany
| | - Lisa Strada
- Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany
| | - Stefan Christensen
- Center for Interdisciplinary Medicine Infectious Diseases, Muenster, Germany.,Department of Gastroenterology and Hepatology, Muenster University Hospital, Muenster, Germany
| | - Konrad Cimander
- Kompetenzzentrum Suchtmedizin, Infektiologie und Cannabis-Therapie, Hannover, Germany
| | - Herbert Görne
- MediZentrum Hamburg, Praxis für Suchtmedizin, Hamburg, Germany
| | | | - Norbert Scherbaum
- LVR-Hospital Essen, Department of Addictive Behaviour and Addiction Medicine, Medical Faculty, University of Duisburg-Essen, Essen, Germany
| | | | - Stefan Mauss
- Center for HIV and Hepatogastroenterology, Düsseldorf, Germany
| | - Ingo Schäfer
- Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany
| | - Uwe Verthein
- Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany
| | - Jürgen Rehm
- Institute of Clinical Psychology and Psychotherapy & Center of Clinical Epidemiology and Longitudinal Studies, Technische Universität Dresden, Dresden, Germany.,Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.,Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.,Faculty of Medicine, Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.,Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.,Department of International Health Projects, Institute for Leadership and Health Management, I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation
| | - Jens Reimer
- Centre for Interdisciplinary Addiction Research, Department of Psychiatry, Medical Centre Hamburg-Eppendorf, Hamburg, Germany.,Gesundheit Nord, Bremen, Germany
| |
Collapse
|
|
23
|
Li YP, Yang Y, Wang MQ, Zhang X, Wang WJ, Li M, Wu FP, Dang SS. Facial and bilateral lower extremity edema due to drug-drug interactions in a patient with hepatitis C virus infection and benign prostate hypertrophy: A case report. World J Clin Cases 2020; 8:3372-3376. [PMID: 32874995 PMCID: PMC7441249 DOI: 10.12998/wjcc.v8.i15.3372] [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: 03/18/2020] [Revised: 06/07/2020] [Accepted: 07/16/2020] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND New direct-acting antivirals (DAAs)-based anti-hepatitis C virus (HCV) therapies are highly effective in patients with HCV infection. However, safety data are lacking regarding HCV treatment with DAAs and drugs for comorbidities. CASE SUMMARY Herein, we reported a case of HCV-infection in a 46-year-old man with benign prostatic hypertrophy. The patient received sofosbuvir/velpatasvir as well as methadone maintenance therapy for drug abuse. The viral load became negative at week 1 post treatment. He developed facial and bilateral lower extremity edema 48 h after starting receiving tamsulosin. Edema disappeared 10 d after treatment with oral furosemide and spironolactone. CONCLUSION In conclusion, this is the first case of an acute edema in the course of treatment with new DAAs, methadone and tamsulosin. These agents are useful in clinical management of patients with HCV infection, particularly in men with benign prostatic hypertrophy. Clinicians should be aware of potential drug-drug interactions in this subset of patients.
Collapse
Affiliation(s)
- Ya-Ping Li
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| | - Ying Yang
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| | - Mu-Qi Wang
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| | - Xin Zhang
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| | - Wen-Jun Wang
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| | - Mei Li
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| | - Feng-Ping Wu
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| | - Shuang-Suo Dang
- Department of Infectious Diseases, Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an 710004, Shaanxi Province, China
| |
Collapse
|
|
24
|
Yu ML, Chen PJ, Dai CY, Hu TH, Huang CF, Huang YH, Hung CH, Lin CY, Liu CH, Liu CJ, Peng CY, Lin HC, Kao JH, Chuang WL. 2020 Taiwan consensus statement on the management of hepatitis C: Part (II) special populations. J Formos Med Assoc 2020; 119:1135-1157. [PMID: 32354689 DOI: 10.1016/j.jfma.2020.04.002] [Citation(s) in RCA: 59] [Impact Index Per Article: 11.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2020] [Accepted: 04/05/2020] [Indexed: 12/13/2022] Open
Abstract
Hepatitis C virus (HCV) infection is a silent killer that leads to rapid progression of liver cirrhosis and hepatocellular carcinoma (HCC). High prevalence of HCV infection has been reported in Taiwan, especially in high-risk populations including people who inject drugs (PWID) and patients requiring dialysis. Besides, certain populations merit special considerations due to suboptimal outcome, potential drug-drug interaction, or possible side effect. Therefore, in the second part of this 2-part consensus, the Taiwan Association for the Study of the Liver (TASL) proposes the treatment recommendations for the special population in order to serve as guidance to optimizing the outcome in the direct-acting antiviral (DAA) era. Special populations include patients with acute or recent HCV infection, previous DAA failure, chronic kidney disease, decompensated cirrhosis, HCC, liver and other solid organ transplantations, receiving an HCV viremic organ, hepatitis B virus (HBV) and HCV dual infection, HCV and human immunodeficiency virus (HIV) coinfection, active tuberculosis infection, PWID, bleeding disorders and hemoglobinopathies, children and adolescents, and pregnancy. Moreover, future perspectives regarding the management of hepatitis C are also discussed and summarized in this consensus statement.
Collapse
Affiliation(s)
- Ming-Lung Yu
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; School of Medicine and Hepatitis Research Center, College of Medicine, Center for Cancer Research and Center for Liquid Biopsy, Kaohsiung Medical University, Kaohsiung, Taiwan.
| | - Pei-Jer Chen
- Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
| | - Chia-Yen Dai
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; School of Medicine and Hepatitis Research Center, College of Medicine, Center for Cancer Research and Center for Liquid Biopsy, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Tsung-Hui Hu
- Division of Hepato-Gastroenterology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan
| | - Chung-Feng Huang
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; School of Medicine and Hepatitis Research Center, College of Medicine, Center for Cancer Research and Center for Liquid Biopsy, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Yi-Hsiang Huang
- Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Clinical Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan
| | - Chao-Hung Hung
- Division of Hepato-Gastroenterology, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan
| | - Chun-Yen Lin
- Department of Gastroenterology and Hepatology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; School of Medicine, Chang Gung University, Taoyuan, Taiwan
| | - Chen-Hua Liu
- Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
| | - Chun-Jen Liu
- Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
| | - Cheng-Yuan Peng
- Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung, Taiwan
| | - Han-Chieh Lin
- Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
| | - Jia-Horng Kao
- Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
| | - Wan-Long Chuang
- Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; School of Medicine and Hepatitis Research Center, College of Medicine, Center for Cancer Research and Center for Liquid Biopsy, Kaohsiung Medical University, Kaohsiung, Taiwan
| |
Collapse
|
|
25
|
Monte-Boquet E, Verdugo RM, Navarro H, Quer JC, Ventayol P. Importance of adherence to treatment with direct-acting antivirals in hepatitis C. GASTROENTEROLOGIA Y HEPATOLOGIA 2020; 42 Suppl 1:14-19. [PMID: 32560768 DOI: 10.1016/s0210-5705(20)30183-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
Abstract
The introduction of direct-acting antivirals (DAA) and the implementation of the National Strategic Plan has extended the spectrum of patients suitable for treatment to include practically all affected individuals. There has been a change in patient profile. Most patients are previously untreated, with lesser awareness of the disease, and taking polymedication, and are often under treatment with opioid replacement therapy, are active drug users or have psychiatric comorbidities. This article reviews the most important factors determining the degree of treatment adherence, in particular, drug therapy complexity, the adverse effects of DAA, demographic factors (age, ethnic group, sex, educational level, marital status) and psychosocial factors (beliefs, motivation to take therapy and negative attitude to therapy), as well as the doctor-patient relationship, knowledge/awareness of the disease, and finally comorbidities and drug abuse or abuse of other substances such as alcohol. Supplement information: This article is part of a supplement entitled "The value of simplicity in hepatitis C treatment", which is sponsored by Gilead. © 2019 Elsevier España, S.L.U. All rights reserved.
Collapse
Affiliation(s)
- Emilio Monte-Boquet
- Unidad de Atención Farmacéutica a Pacientes Externos, Servicio de Farmacia, Hospital Universitari i Politècnic La Fe, Valencia, España.
| | - Ramón Morillo Verdugo
- Servicio de Farmacia Hospitalaria, Hospital Nuestra Señora de Valme, Sevilla, España
| | - Herminia Navarro
- Servicio de Farmacia Hospitalaria, Hospital Universitario Miguel Servet, Zaragoza, España
| | - Joan Carles Quer
- Servicio de Digestivo, Hospital Universitari Joan XXIII, Tarragona, España
| | - Pere Ventayol
- Servicio de Farmacia Hospitalaria, Hospital Universitari Son Espases, Palma de Mallorca, España
| |
Collapse
|
|
26
|
Biondi MJ, Feld JJ. Hepatitis C models of care: approaches to elimination. CANADIAN LIVER JOURNAL 2020; 3:165-176. [PMID: 35991853 PMCID: PMC9202783 DOI: 10.3138/canlivj.2019-0002] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2019] [Accepted: 01/27/2019] [Indexed: 07/29/2023]
Abstract
Hepatitis C direct-acting antivirals (DAAs) have an efficacy of 95% or greater, with pangenotypic options. Many regions in Canada have recently abolished the need to demonstrate fibrosis before treatment with DAAs, and several combination therapies are available under public and private insurance coverage. As a result, efforts to increase treatment are largely focused on engaging specific populations and providers. With minimal side effects and decreased need for monitoring, hepatitis C screening, linkage, and treatment can largely be done in a single setting. In this article, we highlight both Canadian and international examples of the specialist's ongoing role and discuss the task shifting of hepatitis C treatment to primary care; specialized community clinics; and mental health, corrections, addictions, and opioid substitution therapy settings. Although specialists continue to support most models of care described in the literature, we highlight the potential for non-specialist care in working toward the elimination of hepatitis C in Canada.
Collapse
Affiliation(s)
- Mia J Biondi
- Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario
- Arthur Labatt Family School of Nursing, Western University, London, Ontario
| | - Jordan J Feld
- Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario
- Institute of Medical Sciences, University of Toronto, Toronto, Ontario
| |
Collapse
|
|
27
|
Biondi MJ, Feld JJ. Hepatitis C models of care: approaches to elimination. CANADIAN LIVER JOURNAL 2020. [DOI: 10.3138/canlivj-2019-0002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
Hepatitis C direct-acting antivirals (DAAs) have an efficacy of 95% or greater, with pangenotypic options. Many regions in Canada have recently abolished the need to demonstrate fibrosis before treatment with DAAs, and several combination therapies are available under public and private insurance coverage. As a result, efforts to increase treatment are largely focused on engaging specific populations and providers. With minimal side effects and decreased need for monitoring, hepatitis C screening, linkage, and treatment can largely be done in a single setting. In this article, we highlight both Canadian and international examples of the specialist’s ongoing role and discuss the task shifting of hepatitis C treatment to primary care; specialized community clinics; and mental health, corrections, addictions, and opioid substitution therapy settings. Although specialists continue to support most models of care described in the literature, we highlight the potential for non-specialist care in working toward the elimination of hepatitis C in Canada.
Collapse
Affiliation(s)
- Mia J Biondi
- Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario
- Arthur Labatt Family School of Nursing, Western University, London, Ontario
| | - Jordan J Feld
- Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Ontario
- Institute of Medical Sciences, University of Toronto, Toronto, Ontario
| |
Collapse
|
|
28
|
Serper M, Evon DM, Stewart PW, Lok AS, Amador J, Reeve BB, Golin CE, Fried MW, Reddy KR, Sterling RK, Sarkar S, Di Bisceglie AM, Lim JK, Nelson DR, Reau N. Medication Non-adherence in a Prospective, Multi-center Cohort Treated with Hepatitis C Direct-Acting Antivirals. J Gen Intern Med 2020; 35:1011-1020. [PMID: 31659661 PMCID: PMC7174473 DOI: 10.1007/s11606-019-05394-9] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/15/2019] [Revised: 07/15/2019] [Accepted: 08/23/2019] [Indexed: 12/18/2022]
Abstract
BACKGROUND The prevalence and risk factors for non-adherence to direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) in clinical practice settings are under-studied. OBJECTIVES (1) To quantify DAA non-adherence in the total cohort and among subgroups with and without mental health conditions, alcohol use, and substance use, and (2) to investigate patient- and treatment-level risk factor non-adherence. DESIGN Prospective, observational cohort study. PARTICIPANTS A total of 1562 patients receiving DAAs between January 2016 and October 2017 at 11 US medical centers including academic and community practices. MAIN MEASURES Self-reported medication non-adherence, defined as any missed doses in the past 7 days, surveyed early (T2: at 4 ± 2 weeks) and late in treatment (T3: 2-3 weeks prior to end of treatment). Non-adherence to post-treatment follow-up visits was defined as absence of lab results after DAA therapy completion. KEY RESULTS Of 1447 patients, 162 (11%) reported non-adherence at T2 or T3. Medical records indicated 262 (17%) of the 1562 participants had not returned for post-treatment visits. At baseline, 37% of patients reported mental health conditions, 15% reported alcohol use, and 23% reported using substances in the previous year. Baseline characteristics associated with DAA non-adherence included alcohol use (OR 1.96), younger age (< 35 years vs. > 55 years: OR 3.40), non-white race (OR > 2.26), and DAA treatment cohort, but not substance use or mental health condition. Non-adherence to follow-up exhibited association with younger age and a higher baseline overall symptom burden. Among 1287 patients with evaluable sustained virologic response (SVR) data, 53 patients (4%) did not achieve SVR. The bivariate correlation between adherence and SVR was negligible (r = 0.01). CONCLUSIONS DAA non-adherence was low and SVR rates were high. Mental health conditions, substance use, and alcohol use should not disqualify patients from DAA therapy. Patients with alcohol use disorder before DAA therapy initiation may benefit from targeted on-treatment support.
Collapse
Affiliation(s)
- Marina Serper
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Donna M Evon
- Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC, 27599, USA.
| | - Paul W Stewart
- Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA
| | - Anna S Lok
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA
| | - Jipcy Amador
- Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA
| | - Bryce B Reeve
- Department of Population Health Sciences, Duke University, Durham, NC, USA
| | - Carol E Golin
- Division of General Medicine and Clinical Epidemiology, Department of Medicine, Department of Health Behaviors, University of North Carolina, Chapel Hill, NC, USA
| | - Michael W Fried
- Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, NC, 27599, USA
| | - K Rajender Reddy
- Division of Gastroenterology and Hepatology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA
| | - Richard K Sterling
- Division of Gastroenterology, Hepatology & Nutrition, Department of Internal Medicine, Virginia Commonwealth University, Richmond, VA, USA
| | - Souvik Sarkar
- Division of Gastroenterology and Hepatology, Department of Medicine, University of California at Davis, Davis, CA, USA
| | - Adrian M Di Bisceglie
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Saint Louis University, St. Louis, MO, USA
| | - Joseph K Lim
- Yale Liver Center and Section of Digestive Diseases, Yale University, New Haven, CT, USA
| | - David R Nelson
- Division of Gastroenterology, Hepatology & Nutrition, Department of Medicine, University of Florida, Gainesville, FL, USA
| | - Nancy Reau
- Department of Internal Medicine, Section of Hepatology, Rush University, Chicago, IL, USA
| |
Collapse
|
|
29
|
Dalgard O. Hepatitis C virus and injecting drug use: what are the challenges? CLINICAL DILEMMAS IN VIRAL LIVER DISEASE 2020:78-81. [DOI: 10.1002/9781119533481.ch13] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
|
|
30
|
Ing Lorenzini K, Girardin F. Direct-acting antiviral interactions with opioids, alcohol or illicit drugs of abuse in HCV-infected patients. Liver Int 2020; 40:32-44. [PMID: 31654604 DOI: 10.1111/liv.14283] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/28/2019] [Revised: 09/17/2019] [Accepted: 10/15/2019] [Indexed: 02/13/2023]
Abstract
The hepatitis C virus (HCV) prevalence is extremely high in patients who consume and inject illicit drugs. Concerns about poor adherence and fear of interaction with drugs of abuse could constitute further disincentive for treatment initiation in these patients. We discussed the pharmacokinetics (PKs) and pharmacodynamics (PD) of currently prescribed direct antiviral agents (NSA5 inhibitors: daclatasvir, elbasvir, ledipasvir, pibrentasvir, velpatasvir; NS5B inhibitor: sofosbuvir; NS3/4A protease inhibitors: glecaprevir, grazoprevir, voxilaprevir) and most common substances of abuse (opioids: buprenorphine, fentanyl, heroin, methadone, morphine, oxycodone; stimulants: amphetamines, cathinones, cocaine; cannabinoids; ethanol). Overall, most direct-acting antivirals (DAAs) are substrates and inhibitors of the transmembrane transporter P-glycoprotein (P-gp), and several of them are metabolized by cytochrome P450 enzymes. Clinically relevant interactions are associated with P-gp and CYP3A modulators. Most substances of abuse are eliminated by Phase I and Phase II metabolizing enzymes, but none of them are either major inhibitors or inducers. PK studies did not show any relevant interactions between DAA and methadone or buprenorphine. Based on pharmacological considerations, neither efficacy loss nor adverse drug event associated with detrimental interaction are expected with opioids, stimulants, cannabinoids and ethanol. In summary, our literature review shows that the interaction potential of DAA with most opioids and illicit drugs is limited and should not be a hurdle to the initiate DAA.
Collapse
Affiliation(s)
- Kuntheavy Ing Lorenzini
- Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva, Geneva, Switzerland
| | - François Girardin
- Division of Clinical Pharmacology and Toxicology, University Hospitals of Geneva, Geneva, Switzerland
| |
Collapse
|
|
31
|
Determinants of Hepatitis C Treatment Adherence and Treatment Completion Among Veterans in the Direct Acting Antiviral Era. Dig Dis Sci 2019; 64:3001-3012. [PMID: 30903364 DOI: 10.1007/s10620-019-05590-x] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/17/2018] [Accepted: 03/12/2019] [Indexed: 02/06/2023]
Abstract
BACKGROUND Despite the availability of direct acting antiviral medications (DAAs), there are ongoing concerns about adherence to hepatitis C virus (HCV) treatment. We sought to understand the barriers to and facilitators of DAA adherence in the Veteran population. METHODS Patients completed semi-structured interviews focused on barriers to and facilitators of HCV treatment adherence both pre- and post-DAA treatment. Adherence was assessed via provider pill count and self-report. Thematic analyses were conducted in the qualitative software program Atlas.ti in order to understand anticipated barriers to and facilitators of treatment adherence and completion. Charts were reviewed for clinical data and sustained virologic response (SVR12). RESULTS Of 40 patients, 15 had cirrhosis and 10 had prior interferon-based treatment. Pre-treatment interviews revealed anticipated barriers to adherence such as side effects (n = 21) and forgetting pills (n = 11). Most patients (n = 27) reported following provider advice, and others had unique reasons not to (e.g., feeling like a "guinea pig"). Post-treatment interviews uncovered facilitators of treatment including wanting to cure HCV (n = 17), positive results (n = 18), and minimal side effects (n = 15). Three patients (8%) did not complete therapy (whom we further elaborate on) and 6 (15%) missed doses but completed treatment. SVR12 was achieved by all participants who completed therapy (93%). Patients who did not complete therapy or missed doses were all treatment naïve, mostly non-cirrhotic (8 of 9), and often anticipated concerns with forgetting their medications. CONCLUSIONS This qualitative study uncovered several unanticipated determinants of HCV treatment completion and provides rationale for several targeted interventions such as incorporating structured positive reinforcement.
Collapse
|
|
32
|
Childs-Kean LM, Brumwell NA, Lodl EF. Profile of sofosbuvir/velpatasvir/voxilaprevir in the treatment of hepatitis C. Infect Drug Resist 2019; 12:2259-2268. [PMID: 31413603 PMCID: PMC6662169 DOI: 10.2147/idr.s171338] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/10/2019] [Accepted: 06/23/2019] [Indexed: 12/20/2022] Open
Abstract
The treatment of chronic hepatitis C has been revolutionized with the introduction of direct-acting antivirals (DAAs). However, some patients are not cured with first-line treatment. Sofosbuvir/velpatasvir/voxilaprevir is a fixed-dose combination of a polymerase inhibitor, an NS5A inhibitor, and a protease inhibitor with activity against strains of the hepatitis C virus that show resistance to other first-line antiviral regimens. Sofosbuvir/velpatasvir/voxilaprevir has been studied in four Phase III randomized trials: POLARIS-1, −2, −3, and −4, which enrolled both treatment naïve and experienced patients with and without compensated cirrhosis. In these trials, at least 95% of patients treated with sofosbuvir/velpatasvir/voxilaprevir achieved sustained virological response (SVR). This includes favorable treatment outcomes in patients who had previously failed a regimen containing sofosbuvir or an NS5A inhibitor. Patient-reported outcomes also improved during and after treatment with sofosbuvir/velpatasvir/voxilaprevir. Treatment with sofosbuvir/velpatasvir/voxilaprevir is well tolerated, with the most commonly reported adverse events being headache, fatigue, diarrhea, and nausea. The approval of sofosbuvir/velpatasvir/voxilaprevir allows a treatment option for patients who have failed treatment with certain DAA regimens.
Collapse
Affiliation(s)
- Lindsey M Childs-Kean
- Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA
| | - Natalie A Brumwell
- Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA
| | - Emma F Lodl
- Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA
| |
Collapse
|
|
33
|
Schaefer EA, Anderson MA, Kim AY, Sfeir MM. Case 15-2019: A 55-Year-Old Man with Jaundice. N Engl J Med 2019; 380:1955-1963. [PMID: 31091378 DOI: 10.1056/nejmcpc1900592] [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] [Indexed: 11/19/2022]
Affiliation(s)
- Esperance A Schaefer
- From the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Massachusetts General Hospital, and the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Harvard Medical School - both in Boston
| | - Mark A Anderson
- From the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Massachusetts General Hospital, and the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Harvard Medical School - both in Boston
| | - Arthur Y Kim
- From the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Massachusetts General Hospital, and the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Harvard Medical School - both in Boston
| | - Maroun M Sfeir
- From the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Massachusetts General Hospital, and the Departments of Medicine (E.A.S., A.Y.K.), Radiology (M.A.A.), and Pathology (M.M.S.), Harvard Medical School - both in Boston
| |
Collapse
|
|
34
|
Hepatitis C continuum of care and utilization of healthcare and harm reduction services among persons who inject drugs in Seattle. Drug Alcohol Depend 2019; 195:114-120. [PMID: 30611979 PMCID: PMC6440747 DOI: 10.1016/j.drugalcdep.2018.11.026] [Citation(s) in RCA: 35] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2018] [Revised: 11/20/2018] [Accepted: 11/23/2018] [Indexed: 12/21/2022]
Abstract
BACKGROUND To describe the "continuum of care" for hepatitis C virus (HCV) and related health service utilization among persons who inject drugs (PWID) in the Seattle metropolitan area. METHODS The study analyzed data from the 2015 National HIV Behavioral Surveillance system focused on PWID, which included local questions on HCV treatment and testing. We calculated respondent driven sampling (RDS)-adjusted percentages of participants who had completed each step of the care continuum and compared healthcare harm reduction services among participants who were HCV + vs. HCV- using bivariate analyses. RESULTS 513 PWID were screened for HCV antibodies (Ab). Of those, 59.7% were HCV Ab+. Among those HCV Ab+, 86.4% had been tested for HCV at least once; 69.9% reported a previous diagnosis. Of those diagnosed, 55.9% had received a confirmatory test, 17.2% had ever received any medications for HCV, and 7.2% had completed treatment. The majority of HCV Ab + participants had seen a health care provider in the past 12 months (85.6%). CONCLUSIONS There is a large gap between HCV screening and treatment among Seattle area PWID.
Collapse
|
|
35
|
Kåberg M, Navér G, Hammarberg A, Weiland O. Incidence and spontaneous clearance of hepatitis C virus (HCV) in people who inject drugs at the Stockholm Needle Exchange-Importance for HCV elimination. J Viral Hepat 2018; 25:1452-1461. [PMID: 29998522 DOI: 10.1111/jvh.12969] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/11/2018] [Revised: 06/14/2018] [Accepted: 06/15/2018] [Indexed: 12/11/2022]
Abstract
The major transmission route for hepatitis C virus (HCV) is through sharing of unsterile injection equipment among people who inject drugs (PWID). The WHO strategy for HCV elimination by 2030 proposes increased efforts to treat PWID populations that drive the HCV epidemic. Among participants in the Stockholm needle exchange programme (NEP), the HCV prevalence is 60%. We aimed to study HCV incidence, spontaneous HCV clearance rate, and predictors associated with new HCV infections and reinfections in NEP participants. All 2320 patients enrolled in the programme between 8 April 2013 and 23 September 2016 were tested for HCV at baseline, and responded to a questionnaire regarding sociodemographic data and injection risk behaviour. Tests for HCV were repeated at an interval of 3-6 months. The anti-HCV prevalence in the NEP participants at baseline was 77%, and the prevalence of HCV RNA was 57%. 24% of the anti-HCV positive were HCV RNA negative with a spontaneously cleared HCV infection. The overall HCV incidence rate was 22/100 PY. The HCV incidence rate in the HCV naive group was 26/100 PY, and in the spontaneously cleared group 19/100. Although there were no significant differences in becoming HCV infected between the two groups (31% vs 29%), the rate of spontaneous HCV clearance was significantly lower in the HCV naive group, 20% vs 44%, (P < 0.05). A high HCV incidence rate was noted among the PWID indicating that treatment needs to be scaled up in conjunction with harm reduction measures to achieve HCV elimination goals set by WHO. This includes high coverage needle exchange programmes and effective addiction treatment for substance users, including opiate substitution treatment.
Collapse
Affiliation(s)
- Martin Kåberg
- Department of Medicine Huddinge, Division of Infectious Diseases, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.,Capio Maria, Addiction Centre, Stockholm, Sweden.,Stockholm Needle Exchange, Stockholm Centre for Dependency Disorders, Stockholm, Sweden
| | - Georg Navér
- Stockholm Needle Exchange, Stockholm Centre for Dependency Disorders, Stockholm, Sweden.,Study Program of Medicine, Karolinska Institutet, Stockholm, Sweden
| | - Anders Hammarberg
- Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.,Stockholm Centre for Dependency Disorders, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden
| | - Ola Weiland
- Department of Medicine Huddinge, Division of Infectious Diseases, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden
| |
Collapse
|
|
36
|
Zignego AL, Monti M, Gragnani L. Sofosbuvir/Velpatasvir for the treatment of Hepatitis C Virus infection. ACTA BIO-MEDICA : ATENEI PARMENSIS 2018; 89:321-331. [PMID: 30333452 PMCID: PMC6502110 DOI: 10.23750/abm.v89i3.7718] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 10/01/2018] [Indexed: 12/11/2022]
Abstract
Hepatitis C Virus (HCV) infection is major health problem worldwide, with 150 million infected people according to recent epidemiologic estimations. The introduction of direct-acting antivirals made a revolutionary change in the management of HCV infected patients with surprisingly high rates of antiviral response, improved tolerability and reduced time of treatment. Sofosbuvir, in combination with different partner drugs, has been the molecule that led this incredible change. The last generation of SOF-based regimens, namely Sofosbuvir/Velpatasvir, represents a single tablet, once a day, pangenotypic and pan-fibrotic combination, demonstrated to be safe and effective in almost all type of HCV infected individuals. This review overviews the main clinical data of SOF/VEL registration trials, underlying the key features of this combination in terms of efficacy, safety and Patients Reported Outcomes obtained in more than 1800 HCV chronically infected subjects. (www.actabiomedica.it)
Collapse
|