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Lam L, Carrieri P, Hejblum G, Bellet J, Bourlière M, Carrat F. Real-world economic burden of hepatitis C and impact of direct-acting antivirals in France: A nationwide claims data analysis. Liver Int 2024; 44:1233-1242. [PMID: 38375961 DOI: 10.1111/liv.15872] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2023] [Revised: 01/04/2024] [Accepted: 02/08/2024] [Indexed: 02/21/2024]
Abstract
BACKGROUND AND AIMS The economic impact of managing patients with hepatitis C virus (HCV) infection remains unknown. This study aimed to assess the economic burden of chronic HCV infection from a national health insurance perspective and the impact of direct-acting antivirals (DAAs) using nationwide real-world data. METHODS Patients with chronic HCV infection were identified from the French Health Insurance Claims Databases (SNDS) and matched for age and sex to the general population. Health resource utilization and reimbursements were summarized according to healthcare expenditure items from 2012 to 2021. The economic burden attributable to chronic HCV infection was evaluated over a 10-year period. Finally, the impact of DAAs was estimated using economic data derived from the SNDS. RESULTS A total of 145 187 patients with chronic HCV infection were identified. Among the patients eligible for DAA therapy, 81.5% had received DAA by the end of 2021. Over a 10-year period, managing patients with chronic HCV infection resulted in an additional cost of €9.71 billion (95% confidence interval [CI]: €9.66-€9.78 billion) or €9191 (95% CI: €9134-€9252) per patient per year compared to the general population. After DAA therapy, patients with chronic HCV infection had a higher economic burden than the general population, with an additional cost of €5781 (95% CI: €5540-€6028) per patient at the fifth-year post-DAA therapy. CONCLUSIONS A significant economic burden persists among patients with HCV infection after DAA treatment. The high proportion of patients not treated with DAA therapy supports reinforcing policies for universal access.
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Affiliation(s)
- Laurent Lam
- INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, IPLESP, Sorbonne Université, Paris, France
| | - Patrizia Carrieri
- INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Aix Marseille Univ, Marseille, France
| | - Gilles Hejblum
- INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, IPLESP, Sorbonne Université, Paris, France
| | - Jonathan Bellet
- INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, IPLESP, Sorbonne Université, Paris, France
| | - Marc Bourlière
- Department of Hepatology and Gastroenterology, Hôpital Saint Joseph, Marseille, France
- INSERM, UMR 1252 IRD SESSTIM, Aix Marseille Université, Marseille, France
| | - Fabrice Carrat
- INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, IPLESP, Sorbonne Université, Paris, France
- Department of Public Health, Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Antoine, Sorbonne Université, Paris, France
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Zhang W, Zhang J, Tang S, Liu Y, Du X, Qiu L, Liu M, Yu H, Pan CQ. Efficacy and Safety of Sofosbuvir-based Regimens in Hepatitis C Patients With Decompensated Cirrhosis: A Systematic Review and Meta-analysis. J Clin Transl Hepatol 2023; 11:144-155. [PMID: 36406321 PMCID: PMC9647115 DOI: 10.14218/jcth.2022.00006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/04/2022] [Revised: 05/04/2022] [Accepted: 05/13/2022] [Indexed: 12/04/2022] Open
Abstract
BACKGROUND AND AIMS Decompensated cirrhotic patients with hepatitis C (HCV) are often under-represented in clinical trials. We aimed to evaluate pooled data on the efficacy and safety of sofosbuvir (SOF)-based regimens in these patients. METHODS We conducted a systemic review and meta-analysis by searching multiple databases for studies published from October 2010 to October 2020. Outcomes of interest were sustained virologic response (SVR) and safety of SOF-based regimens in decompensated HCV patients. Two reviewers independently performed the study selection and data extraction. RESULTS We included 33 studies that enrolled 5,302 HCV patients. The pooled SVR rate in decompensated patients with SOF-based regimens was 85.1% (95% CI: 82.8-87.3). Patients on SOF/velpatasvir±ribavirin achieved a significantly higher SVR (91.0%, 95% CI: 87.7-93.9) than that of SOF/ledipasvir±ribavirin [(86.3%, 95% CI: 84.6-87.8); p=0.004)], or on SOF/daclatasvir±ribavirin (82.4%, 95% CI: 78.2-86.2%; p<0.001). Adding ribavirin to SOF-based regimens (pooled SVR 84.9%, 95% CI: 81.7-87.9) did not significantly increase the SVR [(83.8% (95% CI: 76.8-89.8%; p=0.76)] in decompensated patients, which was also true in subgroup analyses for each regimen within the same treatment duration. However, adding ribavirin significantly increased the frequency of adverse events from 52.9% (95% CI: 28.0-77.1) to 89.2% (95% CI: 68.1-99.9) and frequency of severe events. The pooled incidence of hepatocellular carcinoma and case-fatality of decompensated patients were 3.1% (95% CI: 1.5-5.0) and 4.6% (95% CI: 3.1-6.3), respectively. The overall heterogeneity was high. There was no publication bias. CONCLUSIONS The analysis found that 12 weeks of SOF/velpatasvir without ribavirin is the preferred therapy, with a significantly higher SVR compared with other SOF-based regimens in decompensated HCV patients.
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Affiliation(s)
- Wenyan Zhang
- Beijing Youan Hospital, Capital Medical University, Beijing, China
| | - Jing Zhang
- Beijing Youan Hospital, Capital Medical University, Beijing, China
| | - Shan Tang
- Beijing Youan Hospital, Capital Medical University, Beijing, China
| | - Yali Liu
- Beijing Youan Hospital, Capital Medical University, Beijing, China
| | - Xiaofei Du
- Beijing Youan Hospital, Capital Medical University, Beijing, China
| | - Lixia Qiu
- Beijing Youan Hospital, Capital Medical University, Beijing, China
| | - Menglu Liu
- Beijing Youan Hospital, Capital Medical University, Beijing, China
| | - Haibin Yu
- Beijing Youan Hospital, Capital Medical University, Beijing, China
- Correspondence to: Haibin Yu, The Third Unit, Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China. ORCID: https://orcid.org/0000-0002-2123-7790. Tel: +86-13811669802, Fax: +86-10-63056962, E-mail: ; Calvin Q Pan, Tisch Hospital of NYU Langone Health, NYU School of Medicine, NY, USA. ORCID: https://orcid.org/0000-0002-3723-6688. Tel: +1-7188887728, Fax: +1-7183536901, E-mail:
| | - Calvin Q. Pan
- Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Health, NYU Grossman School of Medicine, New York, USA
- Correspondence to: Haibin Yu, The Third Unit, Department of Hepatology, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China. ORCID: https://orcid.org/0000-0002-2123-7790. Tel: +86-13811669802, Fax: +86-10-63056962, E-mail: ; Calvin Q Pan, Tisch Hospital of NYU Langone Health, NYU School of Medicine, NY, USA. ORCID: https://orcid.org/0000-0002-3723-6688. Tel: +1-7188887728, Fax: +1-7183536901, E-mail:
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Giannini A. Who gets the last bed? Ethics criteria for scarce resource allocation in the era of COVID-19. Minerva Anestesiol 2020; 87:267-271. [PMID: 33319957 DOI: 10.23736/s0375-9393.20.15345-8] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Affiliation(s)
- Alberto Giannini
- Unit of Pediatric Anesthesia and Intensive Care, Children's Hospital, ASST Spedali Civili, Brescia, Italy -
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Mathur P, Kottilil S. Hepatitis C Core Antigen Testing: Still an Effective Diagnostic Method for Global Elimination of Hepatitis C. Clin Infect Dis 2020; 70:674-675. [PMID: 30943285 DOI: 10.1093/cid/ciz273] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/17/2019] [Accepted: 03/28/2019] [Indexed: 12/20/2022] Open
Affiliation(s)
- Poonam Mathur
- Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore
| | - Shyam Kottilil
- Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore
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Duchesne L, Hejblum G, Njouom R, Touré Kane C, Toni TD, Moh R, Sylla B, Rouveau N, Attia A, Lacombe K. Model-based cost-effectiveness estimates of testing strategies for diagnosing hepatitis C virus infection in Central and Western Africa. PLoS One 2020; 15:e0238035. [PMID: 32833976 PMCID: PMC7446873 DOI: 10.1371/journal.pone.0238035] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/18/2020] [Accepted: 08/07/2020] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Whereas 72% of hepatitis C virus (HCV)-infected people worldwide live in low- and middle-income countries (LMICs), only 6% of them have been diagnosed. Innovative technologies for HCV diagnosis provide opportunities for developing testing strategies more adapted to resource-constrained settings. However, studies about their economic feasibility in LMICs are lacking. METHODS Adopting a health sector perspective in Cameroon, Cote-d'Ivoire, and Senegal, a decision tree model was developed to compare 12 testing strategies with the following characteristics: a one-step or two-step testing sequence, HCV-RNA or HCV core antigen as confirmative biomarker, laboratory or point-of-care (POC) tests, and venous blood samples or dried blood spots (DBS). Outcomes measures were the number of true positives (TPs), cost per screened individual, incremental cost-effectiveness ratios, and nationwide budget. Corresponding time horizon was immediate, and outcomes were accordingly not discounted. Detailed sensitivity analyses were conducted. FINDINGS In the base-case, a two-step POC-based strategy including anti-HCV antibody (HCV-Ab) and HCV-RNA testing had the lowest cost, €8.18 per screened individual. Assuming a lost-to-follow-up rate after screening > 1.9%, a DBS-based laboratory HCV-RNA after HCV-Ab POC testing was the single un-dominated strategy, requiring an additional cost of €3653.56 per additional TP detected. Both strategies would require 8-25% of the annual public health expenditure of the study countries for diagnosing 30% of HCV-infected individuals. Assuming a seroprevalence > 46.9% or a cost of POC HCV-RNA < €7.32, a one-step strategy based on POC HCV-RNA dominated the two-step POC-based strategy but resulted in many more false-positive cases. CONCLUSIONS POC HCV-Ab followed by either POC- or DBS-based HCV-RNA testing would be the most cost-effective strategies in the study countries. Without a substantial increase in funding for health or a dramatic decrease in assay prices, HCV testing would constitute an economic barrier to the implementation of HCV elimination programs in LMICs.
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Affiliation(s)
- Léa Duchesne
- Institut Pierre Louis d’Épidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France
| | - Gilles Hejblum
- Institut Pierre Louis d’Épidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France
| | - Richard Njouom
- Virology Department, Pasteur Centre of Cameroon, Yaoundé, Cameroon
| | - Coumba Touré Kane
- Laboratoire de Bactériologie Virologie, Centre Hospitalier Universitaire Aristide Le Dantec/ Université Cheikh Anta Diop de Dakar, Dakar, Senegal
| | - Thomas d’Aquin Toni
- Centre de Diagnostic et de Recherches sur le SIDA (CeDReS), Centre Hospitalier Universitaire de Treichville, Abidjan, Côte d’Ivoire
| | - Raoul Moh
- Programme PAC-CI, Abidjan, Côte d’Ivoire
- Unité de formation et de recherche de Sciences Médicales, Unité Pédagogique de Dermatologie et Infectiologie, Université Félix Houphouët Boigny, Abidjan
| | - Babacar Sylla
- Institut de Médecine et d'Epidémiologie Appliquée (IMEA), Paris, France
| | - Nicolas Rouveau
- International Research and Collaboration unit, Agence Nationale de Recherche sur le Sida et les hépatites virales (ANRS), Paris, France
| | - Alain Attia
- Service d’Hépatologie, Centre Hospitalier Universitaire de Yopougon, Abidjan, Côte d’Ivoire
| | - Karine Lacombe
- Institut Pierre Louis d’Epidémiologie et de Santé Publique, Sorbonne Université, INSERM, AP-HP, Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, Paris, France
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Godman B, McCabe H, D Leong T. Fixed dose drug combinations - are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries. Expert Rev Pharmacoecon Outcomes Res 2020; 20:1-26. [PMID: 32237953 DOI: 10.1080/14737167.2020.1734456] [Citation(s) in RCA: 43] [Impact Index Per Article: 8.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
Introduction: There are positive aspects regarding the prescribing of fixed dose combinations (FDCs) versus prescribing the medicines separately. However, these have to be balanced against concerns including increased costs and their irrationality in some cases. Consequently, there is a need to review their value among lower- and middle-income countries (LMICs) which have the greatest prevalence of both infectious and noninfectious diseases and issues of affordability.Areas covered: Review of potential advantages, disadvantages, cost-effectiveness, and availability of FDCs in high priority disease areas in LMICs and possible initiatives to enhance the prescribing of valued FDCs and limit their use where there are concerns with their value.Expert commentary: FDCs are valued across LMICs. Advantages include potentially improved response rates, reduced adverse reactions, increased adherence rates, and reduced costs. Concerns include increased chances of drug:drug interactions, reduced effectiveness, potential for imprecise diagnoses and higher unjustified prices. Overall certain FDCs including those for malaria, tuberculosis, and hypertension are valued and listed in the country's essential medicine lists, with initiatives needed to enhance their prescribing where currently low prescribing rates. Proposed initiatives include robust clinical and economic data to address the current paucity of pharmacoeconomic data. Irrational FDCs persists in some countries which are being addressed.
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Affiliation(s)
- Brian Godman
- Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.,Division of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa.,Division of Clinical Pharmacology, Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden
| | - Holly McCabe
- Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
| | - Trudy D Leong
- Division of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa
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Bardach A, Hernández-Vásquez A, Palacios A, Calderón M, Soto N, Balan D, Augustovski F. Epidemiología, consumo de recursos y costos del manejo médico de la Hepatitis C en Argentina, Colombia, Uruguay y Venezuela. Value Health Reg Issues 2019; 20:180-190. [PMID: 31654963 DOI: 10.1016/j.vhri.2019.06.004] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/12/2018] [Revised: 05/15/2019] [Accepted: 06/11/2019] [Indexed: 02/07/2023]
Abstract
OBJECTIVE To describe the epidemiology, the consumption of resources and the relevant costs in the management of hepatitis C in four Latin American countries: Argentina, Colombia, Uruguay and Venezuela. STUDY DESIGN Bibliographic review, study of costs and elicitation by experts METHODS: A literature search was carried out to collect epidemiological and cost data for the management of the disease. Information was additionally elicited with hepatologists from each country using the modified Delphi Panel technique. For the estimation of costs, the perspective of the health system was adopted. The direct medical costs of the different stages associated with the natural history of the disease were considered through micro-costing. RESULTS Extensive epidemiological and economic information is provided for the four countries under study. The age range between 40 and 60 years was the most affected. The frequency of genotypes showed a predominance of genotype 1 (68 to 88%), genotype 1b having been reported as the most prevalent in Argentina and Colombia and 1a in Uruguay and Venezuela. The costs of drug regimens, associated health events and adverse events present important differences in the four selected countries of Latin America. CONCLUSION Hepatitis C presents a high burden of disease in the countries under study, and its management imposes significant costs on health systems.
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Affiliation(s)
- Ariel Bardach
- IECS Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina; CIESP Centro de Investigaciones en Epidemiología y Salud Pública, Instituto para la Efectividad Clínica y Sanitaria, Buenos Aires, Argentina.
| | | | - Alfredo Palacios
- IECS Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina
| | - María Calderón
- IECS Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina
| | - Natalie Soto
- IECS Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina
| | - Dario Balan
- IECS Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina
| | - Federico Augustovski
- IECS Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina; CIESP Centro de Investigaciones en Epidemiología y Salud Pública, Instituto para la Efectividad Clínica y Sanitaria, Buenos Aires, Argentina
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Bayatpoor ME, Khosravi MH, Sharafi H, Rezaee-Zavareh MS, Behnava B, Alavian SM. Sofosbuvir and Ribavirin with or Without Pegylated-Interferon in Hepatitis C Virus Genotype-2 or -3 Infections: A Systematic Review and Meta-Analysis. ARCHIVES OF CLINICAL INFECTIOUS DISEASES 2019; In Press. [DOI: 10.5812/archcid.79465] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/03/2023]
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James SL, Abate D, Abate KH, Abay SM, Abbafati C, Abbasi N, Abbastabar H, Abd-Allah F, Abdela J, Abdelalim A, Abdollahpour I, Abdulkader RS, Abebe Z, Abera SF, Abil OZ, Abraha HN, Abu-Raddad LJ, Abu-Rmeileh NME, Accrombessi MMK, Acharya D, Acharya P, Ackerman IN, Adamu AA, Adebayo OM, Adekanmbi V, Adetokunboh OO, Adib MG, Adsuar JC, Afanvi KA, Afarideh M, Afshin A, Agarwal G, Agesa KM, Aggarwal R, Aghayan SA, Agrawal S, Ahmadi A, Ahmadi M, Ahmadieh H, Ahmed MB, Aichour AN, Aichour I, Aichour MTE, Akinyemiju T, Akseer N, Al-Aly Z, Al-Eyadhy A, Al-Mekhlafi HM, Al-Raddadi RM, Alahdab F, Alam K, Alam T, Alashi A, Alavian SM, Alene KA, Alijanzadeh M, Alizadeh-Navaei R, Aljunid SM, Alkerwi A, Alla F, Allebeck P, Alouani MML, Altirkawi K, Alvis-Guzman N, Amare AT, Aminde LN, Ammar W, Amoako YA, Anber NH, Andrei CL, Androudi S, Animut MD, Anjomshoa M, Ansha MG, Antonio CAT, Anwari P, Arabloo J, Arauz A, Aremu O, Ariani F, Armoon B, Ärnlöv J, Arora A, Artaman A, Aryal KK, Asayesh H, Asghar RJ, Ataro Z, Atre SR, Ausloos M, Avila-Burgos L, Avokpaho EFGA, Awasthi A, Ayala Quintanilla BP, Ayer R, Azzopardi PS, Babazadeh A, Badali H, Badawi A, Bali AG, et alJames SL, Abate D, Abate KH, Abay SM, Abbafati C, Abbasi N, Abbastabar H, Abd-Allah F, Abdela J, Abdelalim A, Abdollahpour I, Abdulkader RS, Abebe Z, Abera SF, Abil OZ, Abraha HN, Abu-Raddad LJ, Abu-Rmeileh NME, Accrombessi MMK, Acharya D, Acharya P, Ackerman IN, Adamu AA, Adebayo OM, Adekanmbi V, Adetokunboh OO, Adib MG, Adsuar JC, Afanvi KA, Afarideh M, Afshin A, Agarwal G, Agesa KM, Aggarwal R, Aghayan SA, Agrawal S, Ahmadi A, Ahmadi M, Ahmadieh H, Ahmed MB, Aichour AN, Aichour I, Aichour MTE, Akinyemiju T, Akseer N, Al-Aly Z, Al-Eyadhy A, Al-Mekhlafi HM, Al-Raddadi RM, Alahdab F, Alam K, Alam T, Alashi A, Alavian SM, Alene KA, Alijanzadeh M, Alizadeh-Navaei R, Aljunid SM, Alkerwi A, Alla F, Allebeck P, Alouani MML, Altirkawi K, Alvis-Guzman N, Amare AT, Aminde LN, Ammar W, Amoako YA, Anber NH, Andrei CL, Androudi S, Animut MD, Anjomshoa M, Ansha MG, Antonio CAT, Anwari P, Arabloo J, Arauz A, Aremu O, Ariani F, Armoon B, Ärnlöv J, Arora A, Artaman A, Aryal KK, Asayesh H, Asghar RJ, Ataro Z, Atre SR, Ausloos M, Avila-Burgos L, Avokpaho EFGA, Awasthi A, Ayala Quintanilla BP, Ayer R, Azzopardi PS, Babazadeh A, Badali H, Badawi A, Bali AG, Ballesteros KE, Ballew SH, Banach M, Banoub JAM, Banstola A, Barac A, Barboza MA, Barker-Collo SL, Bärnighausen TW, Barrero LH, Baune BT, Bazargan-Hejazi S, Bedi N, Beghi E, Behzadifar M, Behzadifar M, Béjot Y, Belachew AB, Belay YA, Bell ML, Bello AK, Bensenor IM, Bernabe E, Bernstein RS, Beuran M, Beyranvand T, Bhala N, Bhattarai S, Bhaumik S, Bhutta ZA, Biadgo B, Bijani A, Bikbov B, Bilano V, Bililign N, Bin Sayeed MS, Bisanzio D, Blacker BF, Blyth FM, Bou-Orm IR, Boufous S, Bourne R, Brady OJ, Brainin M, Brant LC, Brazinova A, Breitborde NJK, Brenner H, Briant PS, Briggs AM, Briko AN, Britton G, Brugha T, Buchbinder R, Busse R, Butt ZA, Cahuana-Hurtado L, Cano J, Cárdenas R, Carrero JJ, Carter A, Carvalho F, Castañeda-Orjuela CA, Castillo Rivas J, Castro F, Catalá-López F, Cercy KM, Cerin E, Chaiah Y, Chang AR, Chang HY, Chang JC, Charlson FJ, Chattopadhyay A, Chattu VK, Chaturvedi P, Chiang PPC, Chin KL, Chitheer A, Choi JYJ, Chowdhury R, Christensen H, Christopher DJ, Cicuttini FM, Ciobanu LG, Cirillo M, Claro RM, Collado-Mateo D, Cooper C, Coresh J, Cortesi PA, Cortinovis M, Costa M, Cousin E, Criqui MH, Cromwell EA, Cross M, Crump JA, Dadi AF, Dandona L, Dandona R, Dargan PI, Daryani A, Das Gupta R, Das Neves J, Dasa TT, Davey G, Davis AC, Davitoiu DV, De Courten B, De La Hoz FP, De Leo D, De Neve JW, Degefa MG, Degenhardt L, Deiparine S, Dellavalle RP, Demoz GT, Deribe K, Dervenis N, Des Jarlais DC, Dessie GA, Dey S, Dharmaratne SD, Dinberu MT, Dirac MA, Djalalinia S, Doan L, Dokova K, Doku DT, Dorsey ER, Doyle KE, Driscoll TR, Dubey M, Dubljanin E, Duken EE, Duncan BB, Duraes AR, Ebrahimi H, Ebrahimpour S, Echko MM, Edvardsson D, Effiong A, Ehrlich JR, El Bcheraoui C, El Sayed Zaki M, El-Khatib Z, Elkout H, Elyazar IRF, Enayati A, Endries AY, Er B, Erskine HE, Eshrati B, Eskandarieh S, Esteghamati A, Esteghamati S, Fakhim H, Fallah Omrani V, Faramarzi M, Fareed M, Farhadi F, Farid TA, Farinha CSES, Farioli A, Faro A, Farvid MS, Farzadfar F, Feigin VL, Fentahun N, Fereshtehnejad SM, Fernandes E, Fernandes JC, Ferrari AJ, Feyissa GT, Filip I, Fischer F, Fitzmaurice C, Foigt NA, Foreman KJ, Fox J, Frank TD, Fukumoto T, Fullman N, Fürst T, Furtado JM, Futran ND, Gall S, Ganji M, Gankpe FG, Garcia-Basteiro AL, Gardner WM, Gebre AK, Gebremedhin AT, Gebremichael TG, Gelano TF, Geleijnse JM, Genova-Maleras R, Geramo YCD, Gething PW, Gezae KE, Ghadiri K, Ghasemi Falavarjani K, Ghasemi-Kasman M, Ghimire M, Ghosh R, Ghoshal AG, Giampaoli S, Gill PS, Gill TK, Ginawi IA, Giussani G, Gnedovskaya EV, Goldberg EM, Goli S, Gómez-Dantés H, Gona PN, Gopalani SV, Gorman TM, Goulart AC, Goulart BNG, Grada A, Grams ME, Grosso G, Gugnani HC, Guo Y, Gupta PC, Gupta R, Gupta R, Gupta T, Gyawali B, Haagsma JA, Hachinski V, Hafezi-Nejad N, Haghparast Bidgoli H, Hagos TB, Hailu GB, Haj-Mirzaian A, Haj-Mirzaian A, Hamadeh RR, Hamidi S, Handal AJ, Hankey GJ, Hao Y, Harb HL, Harikrishnan S, Haro JM, Hasan M, Hassankhani H, Hassen HY, Havmoeller R, Hawley CN, Hay RJ, Hay SI, Hedayatizadeh-Omran A, Heibati B, Hendrie D, Henok A, Herteliu C, Heydarpour S, Hibstu DT, Hoang HT, Hoek HW, Hoffman HJ, Hole MK, Homaie Rad E, Hoogar P, Hosgood HD, Hosseini SM, Hosseinzadeh M, Hostiuc M, Hostiuc S, Hotez PJ, Hoy DG, Hsairi M, Htet AS, Hu G, Huang JJ, Huynh CK, Iburg KM, Ikeda CT, Ileanu B, Ilesanmi OS, Iqbal U, Irvani SSN, Irvine CMS, Islam SMS, Islami F, Jacobsen KH, Jahangiry L, Jahanmehr N, Jain SK, Jakovljevic M, Javanbakht M, Jayatilleke AU, Jeemon P, Jha RP, Jha V, Ji JS, Johnson CO, Jonas JB, Jozwiak JJ, Jungari SB, Jürisson M, Kabir Z, Kadel R, Kahsay A, Kalani R, Kanchan T, Karami M, Karami Matin B, Karch A, Karema C, Karimi N, Karimi SM, Kasaeian A, Kassa DH, Kassa GM, Kassa TD, Kassebaum NJ, Katikireddi SV, Kawakami N, Karyani AK, Keighobadi MM, Keiyoro PN, Kemmer L, Kemp GR, Kengne AP, Keren A, Khader YS, Khafaei B, Khafaie MA, Khajavi A, Khalil IA, Khan EA, Khan MS, Khan MA, Khang YH, Khazaei M, Khoja AT, Khosravi A, Khosravi MH, Kiadaliri AA, Kiirithio DN, Kim CI, Kim D, Kim P, Kim YE, Kim YJ, Kimokoti RW, Kinfu Y, Kisa A, Kissimova-Skarbek K, Kivimäki M, Knudsen AKS, Kocarnik JM, Kochhar S, Kokubo Y, Kolola T, Kopec JA, Kosen S, Kotsakis GA, Koul PA, Koyanagi A, Kravchenko MA, Krishan K, Krohn KJ, Kuate Defo B, Kucuk Bicer B, Kumar GA, Kumar M, Kyu HH, Lad DP, Lad SD, Lafranconi A, Lalloo R, Lallukka T, Lami FH, Lansingh VC, Latifi A, Lau KMM, Lazarus JV, Leasher JL, Ledesma JR, Lee PH, Leigh J, Leung J, Levi M, Lewycka S, Li S, Li Y, Liao Y, Liben ML, Lim LL, Lim SS, Liu S, Lodha R, Looker KJ, Lopez AD, Lorkowski S, Lotufo PA, Low N, Lozano R, Lucas TCD, Lucchesi LR, Lunevicius R, Lyons RA, Ma S, 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Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018; 392:1789-1858. [PMID: 30496104 PMCID: PMC6227754 DOI: 10.1016/s0140-6736(18)32279-7] [Show More Authors] [Citation(s) in RCA: 8390] [Impact Index Per Article: 1198.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/09/2018] [Revised: 08/30/2018] [Accepted: 09/12/2018] [Indexed: 02/06/2023]
Abstract
BACKGROUND The Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017) includes a comprehensive assessment of incidence, prevalence, and years lived with disability (YLDs) for 354 causes in 195 countries and territories from 1990 to 2017. Previous GBD studies have shown how the decline of mortality rates from 1990 to 2016 has led to an increase in life expectancy, an ageing global population, and an expansion of the non-fatal burden of disease and injury. These studies have also shown how a substantial portion of the world's population experiences non-fatal health loss with considerable heterogeneity among different causes, locations, ages, and sexes. Ongoing objectives of the GBD study include increasing the level of estimation detail, improving analytical strategies, and increasing the amount of high-quality data. METHODS We estimated incidence and prevalence for 354 diseases and injuries and 3484 sequelae. We used an updated and extensive body of literature studies, survey data, surveillance data, inpatient admission records, outpatient visit records, and health insurance claims, and additionally used results from cause of death models to inform estimates using a total of 68 781 data sources. Newly available clinical data from India, Iran, Japan, Jordan, Nepal, China, Brazil, Norway, and Italy were incorporated, as well as updated claims data from the USA and new claims data from Taiwan (province of China) and Singapore. We used DisMod-MR 2.1, a Bayesian meta-regression tool, as the main method of estimation, ensuring consistency between rates of incidence, prevalence, remission, and cause of death for each condition. YLDs were estimated as the product of a prevalence estimate and a disability weight for health states of each mutually exclusive sequela, adjusted for comorbidity. We updated the Socio-demographic Index (SDI), a summary development indicator of income per capita, years of schooling, and total fertility rate. Additionally, we calculated differences between male and female YLDs to identify divergent trends across sexes. GBD 2017 complies with the Guidelines for Accurate and Transparent Health Estimates Reporting. FINDINGS Globally, for females, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and haemoglobinopathies and haemolytic anaemias in both 1990 and 2017. For males, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and tuberculosis including latent tuberculosis infection in both 1990 and 2017. In terms of YLDs, low back pain, headache disorders, and dietary iron deficiency were the leading Level 3 causes of YLD counts in 1990, whereas low back pain, headache disorders, and depressive disorders were the leading causes in 2017 for both sexes combined. All-cause age-standardised YLD rates decreased by 3·9% (95% uncertainty interval [UI] 3·1-4·6) from 1990 to 2017; however, the all-age YLD rate increased by 7·2% (6·0-8·4) while the total sum of global YLDs increased from 562 million (421-723) to 853 million (642-1100). The increases for males and females were similar, with increases in all-age YLD rates of 7·9% (6·6-9·2) for males and 6·5% (5·4-7·7) for females. We found significant differences between males and females in terms of age-standardised prevalence estimates for multiple causes. The causes with the greatest relative differences between sexes in 2017 included substance use disorders (3018 cases [95% UI 2782-3252] per 100 000 in males vs s1400 [1279-1524] per 100 000 in females), transport injuries (3322 [3082-3583] vs 2336 [2154-2535]), and self-harm and interpersonal violence (3265 [2943-3630] vs 5643 [5057-6302]). INTERPRETATION Global all-cause age-standardised YLD rates have improved only slightly over a period spanning nearly three decades. However, the magnitude of the non-fatal disease burden has expanded globally, with increasing numbers of people who have a wide spectrum of conditions. A subset of conditions has remained globally pervasive since 1990, whereas other conditions have displayed more dynamic trends, with different ages, sexes, and geographies across the globe experiencing varying burdens and trends of health loss. This study emphasises how global improvements in premature mortality for select conditions have led to older populations with complex and potentially expensive diseases, yet also highlights global achievements in certain domains of disease and injury. FUNDING Bill & Melinda Gates Foundation.
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James SL, Abate D, Abate KH, Abay SM, Abbafati C, Abbasi N, Abbastabar H, Abd-Allah F, Abdela J, Abdelalim A, Abdollahpour I, Abdulkader RS, Abebe Z, Abera SF, Abil OZ, Abraha HN, Abu-Raddad LJ, Abu-Rmeileh NME, Accrombessi MMK, Acharya D, Acharya P, Ackerman IN, Adamu AA, Adebayo OM, Adekanmbi V, Adetokunboh OO, Adib MG, Adsuar JC, Afanvi KA, Afarideh M, Afshin A, Agarwal G, Agesa KM, Aggarwal R, Aghayan SA, Agrawal S, Ahmadi A, Ahmadi M, Ahmadieh H, Ahmed MB, Aichour AN, Aichour I, Aichour MTE, Akinyemiju T, Akseer N, Al-Aly Z, Al-Eyadhy A, Al-Mekhlafi HM, Al-Raddadi RM, Alahdab F, Alam K, Alam T, Alashi A, Alavian SM, Alene KA, Alijanzadeh M, Alizadeh-Navaei R, Aljunid SM, Alkerwi A, Alla F, Allebeck P, Alouani MML, Altirkawi K, Alvis-Guzman N, Amare AT, Aminde LN, Ammar W, Amoako YA, Anber NH, Andrei CL, Androudi S, Animut MD, Anjomshoa M, Ansha MG, Antonio CAT, Anwari P, Arabloo J, Arauz A, Aremu O, Ariani F, Armoon B, Ärnlöv J, Arora A, Artaman A, Aryal KK, Asayesh H, Asghar RJ, 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Guo Y, Gupta PC, Gupta R, Gupta R, Gupta T, Gyawali B, Haagsma JA, Hachinski V, Hafezi-Nejad N, Haghparast Bidgoli H, Hagos TB, Hailu GB, Haj-Mirzaian A, Haj-Mirzaian A, Hamadeh RR, Hamidi S, Handal AJ, Hankey GJ, Hao Y, Harb HL, Harikrishnan S, Haro JM, Hasan M, Hassankhani H, Hassen HY, Havmoeller R, Hawley CN, Hay RJ, Hay SI, Hedayatizadeh-Omran A, Heibati B, Hendrie D, Henok A, Herteliu C, Heydarpour S, Hibstu DT, Hoang HT, Hoek HW, Hoffman HJ, Hole MK, Homaie Rad E, Hoogar P, Hosgood HD, Hosseini SM, Hosseinzadeh M, Hostiuc M, Hostiuc S, Hotez PJ, Hoy DG, Hsairi M, Htet AS, Hu G, Huang JJ, Huynh CK, Iburg KM, Ikeda CT, Ileanu B, Ilesanmi OS, Iqbal U, Irvani SSN, Irvine CMS, Islam SMS, Islami F, Jacobsen KH, Jahangiry L, Jahanmehr N, Jain SK, Jakovljevic M, Javanbakht M, Jayatilleke AU, Jeemon P, Jha RP, Jha V, Ji JS, Johnson CO, Jonas JB, Jozwiak JJ, Jungari SB, Jürisson M, Kabir Z, Kadel R, Kahsay A, Kalani R, Kanchan T, Karami M, Karami Matin B, Karch A, Karema C, Karimi N, Karimi SM, Kasaeian A, Kassa DH, Kassa GM, Kassa TD, Kassebaum NJ, Katikireddi SV, Kawakami N, Karyani AK, Keighobadi MM, Keiyoro PN, Kemmer L, Kemp GR, Kengne AP, Keren A, Khader YS, Khafaei B, Khafaie MA, Khajavi A, Khalil IA, Khan EA, Khan MS, Khan MA, Khang YH, Khazaei M, Khoja AT, Khosravi A, Khosravi MH, Kiadaliri AA, Kiirithio DN, Kim CI, Kim D, Kim P, Kim YE, Kim YJ, Kimokoti RW, Kinfu Y, Kisa A, Kissimova-Skarbek K, Kivimäki M, Knudsen AKS, Kocarnik JM, Kochhar S, Kokubo Y, Kolola T, Kopec JA, Kosen S, Kotsakis GA, Koul PA, Koyanagi A, Kravchenko MA, Krishan K, Krohn KJ, Kuate Defo B, Kucuk Bicer B, Kumar GA, Kumar M, Kyu HH, Lad DP, Lad SD, Lafranconi A, Lalloo R, Lallukka T, Lami FH, Lansingh VC, Latifi A, Lau KMM, Lazarus JV, Leasher JL, Ledesma JR, Lee PH, Leigh J, Leung J, Levi M, Lewycka S, Li S, Li Y, Liao Y, Liben ML, Lim LL, Lim SS, Liu S, Lodha R, Looker KJ, Lopez AD, Lorkowski S, Lotufo PA, Low N, Lozano R, Lucas TCD, Lucchesi LR, Lunevicius R, Lyons RA, Ma S, Macarayan ERK, Mackay MT, Madotto F, Magdy Abd El Razek H, Magdy Abd El Razek M, Maghavani DP, Mahotra NB, Mai HT, Majdan M, Majdzadeh R, Majeed A, Malekzadeh R, Malta DC, Mamun AA, Manda AL, Manguerra H, Manhertz T, Mansournia MA, Mantovani LG, Mapoma CC, Maravilla JC, Marcenes W, Marks A, Martins-Melo FR, Martopullo I, März W, Marzan MB, Mashamba-Thompson TP, Massenburg BB, Mathur MR, Matsushita K, Maulik PK, Mazidi M, McAlinden C, McGrath JJ, McKee M, Mehndiratta MM, Mehrotra R, Mehta KM, Mehta V, Mejia-Rodriguez F, Mekonen T, Melese A, Melku M, Meltzer M, Memiah PTN, Memish ZA, Mendoza W, Mengistu DT, Mengistu G, Mensah GA, Mereta ST, Meretoja A, Meretoja TJ, Mestrovic T, Mezerji NMG, Miazgowski B, Miazgowski T, Millear AI, Miller TR, Miltz B, Mini GK, Mirarefin M, Mirrakhimov EM, Misganaw AT, Mitchell PB, Mitiku H, Moazen B, Mohajer B, Mohammad KA, Mohammadifard N, Mohammadnia-Afrouzi M, Mohammed MA, Mohammed S, Mohebi F, Moitra M, Mokdad AH, Molokhia M, Monasta L, Moodley Y, Moosazadeh M, Moradi G, Moradi-Lakeh M, Moradinazar M, Moraga P, Morawska L, Moreno Velásquez I, Morgado-Da-Costa J, Morrison SD, Moschos MM, Mountjoy-Venning WC, Mousavi SM, Mruts KB, Muche AA, Muchie KF, Mueller UO, Muhammed OS, Mukhopadhyay S, Muller K, Mumford JE, Murhekar M, Musa J, Musa KI, Mustafa G, Nabhan AF, Nagata C, Naghavi M, Naheed A, Nahvijou A, Naik G, Naik N, Najafi F, Naldi L, Nam HS, Nangia V, Nansseu JR, Nascimento BR, Natarajan G, Neamati N, Negoi I, Negoi RI, Neupane S, Newton CRJ, Ngunjiri JW, Nguyen AQ, Nguyen HT, Nguyen HLT, Nguyen HT, Nguyen LH, Nguyen M, Nguyen NB, Nguyen SH, Nichols E, Ningrum DNA, Nixon MR, Nolutshungu N, Nomura S, Norheim OF, Noroozi M, Norrving B, Noubiap JJ, Nouri HR, Nourollahpour Shiadeh M, Nowroozi MR, Nsoesie EO, Nyasulu PS, Odell CM, Ofori-Asenso R, Ogbo FA, Oh IH, Oladimeji O, Olagunju AT, Olagunju TO, Olivares PR, Olsen HE, Olusanya BO, Ong KL, Ong SK, Oren E, Ortiz A, Ota E, Otstavnov SS, Øverland S, Owolabi MO, P A M, Pacella R, Pakpour AH, Pana A, Panda-Jonas S, Parisi A, Park EK, Parry CDH, Patel S, Pati S, Patil ST, Patle A, Patton GC, Paturi VR, Paulson KR, Pearce N, Pereira DM, Perico N, Pesudovs K, Pham HQ, Phillips MR, Pigott DM, Pillay JD, Piradov MA, Pirsaheb M, Pishgar F, Plana-Ripoll O, Plass D, Polinder S, Popova S, Postma MJ, Pourshams A, Poustchi H, Prabhakaran D, Prakash S, Prakash V, Purcell CA, Purwar MB, Qorbani M, Quistberg DA, Radfar A, Rafay A, Rafiei A, Rahim F, Rahimi K, Rahimi-Movaghar A, Rahimi-Movaghar V, Rahman M, Rahman MHU, Rahman MA, Rahman SU, Rai RK, Rajati F, Ram U, Ranjan P, Ranta A, Rao PC, Rawaf DL, Rawaf S, Reddy KS, Reiner RC, Reinig N, Reitsma MB, Remuzzi G, Renzaho AMN, Resnikoff S, Rezaei S, Rezai MS, Ribeiro ALP, Roberts NLS, Robinson SR, Roever L, Ronfani L, Roshandel G, Rostami A, Roth GA, Roy A, Rubagotti E, Sachdev PS, Sadat N, Saddik B, Sadeghi E, Saeedi Moghaddam S, Safari H, Safari Y, Safari-Faramani R, Safdarian M, Safi S, Safiri S, Sagar R, Sahebkar A, Sahraian MA, Sajadi HS, Salam N, Salama JS, Salamati P, Saleem K, Saleem Z, Salimi Y, Salomon JA, Salvi SS, Salz I, Samy AM, Sanabria J, Sang Y, Santomauro DF, Santos IS, Santos JV, Santric Milicevic MM, Sao Jose BP, Sardana M, Sarker AR, Sarrafzadegan N, Sartorius B, Sarvi S, Sathian B, Satpathy M, Sawant AR, Sawhney M, Saxena S, Saylan M, Schaeffner E, Schmidt MI, Schneider IJC, Schöttker B, Schwebel DC, Schwendicke F, Scott JG, Sekerija M, Sepanlou SG, Serván-Mori E, Seyedmousavi S, Shabaninejad H, Shafieesabet A, Shahbazi M, Shaheen AA, Shaikh MA, Shams-Beyranvand M, Shamsi M, Shamsizadeh M, Sharafi H, Sharafi K, Sharif M, Sharif-Alhoseini M, Sharma M, Sharma R, She J, Sheikh A, Shi P, Shibuya K, Shigematsu M, Shiri R, Shirkoohi R, Shishani K, Shiue I, Shokraneh F, Shoman H, Shrime MG, Si S, Siabani S, Siddiqi TJ, Sigfusdottir ID, Sigurvinsdottir R, Silva JP, Silveira DGA, Singam NSV, Singh JA, Singh NP, Singh V, Sinha DN, Skiadaresi E, Slepak ELN, Sliwa K, Smith DL, Smith M, Soares Filho AM, Sobaih BH, Sobhani S, Sobngwi E, Soneji SS, Soofi M, Soosaraei M, Sorensen RJD, Soriano JB, Soyiri IN, Sposato LA, Sreeramareddy CT, Srinivasan V, Stanaway JD, Stein DJ, Steiner C, Steiner TJ, Stokes MA, Stovner LJ, Subart ML, Sudaryanto A, Sufiyan MB, Sunguya BF, Sur PJ, Sutradhar I, Sykes BL, Sylte DO, Tabarés-Seisdedos R, Tadakamadla SK, Tadesse BT, Tandon N, Tassew SG, Tavakkoli M, Taveira N, Taylor HR, Tehrani-Banihashemi A, Tekalign TG, Tekelemedhin SW, Tekle MG, Temesgen H, Temsah MH, Temsah O, Terkawi AS, Teweldemedhin M, Thankappan KR, Thomas N, Tilahun B, To QG, Tonelli M, Topor-Madry R, Topouzis F, Torre AE, Tortajada-Girbés M, Touvier M, Tovani-Palone MR, Towbin JA, Tran BX, Tran KB, Troeger CE, Truelsen TC, Tsilimbaris MK, Tsoi D, Tudor Car L, Tuzcu EM, Ukwaja KN, Ullah I, Undurraga EA, Unutzer J, Updike RL, Usman MS, Uthman OA, Vaduganathan M, Vaezi A, Valdez PR, Varughese S, Vasankari TJ, Venketasubramanian N, Villafaina S, Violante FS, Vladimirov SK, Vlassov V, Vollset SE, Vosoughi K, Vujcic IS, Wagnew FS, Waheed Y, Waller SG, Wang Y, Wang YP, Weiderpass E, Weintraub RG, Weiss DJ, Weldegebreal F, Weldegwergs KG, Werdecker A, West TE, Whiteford HA, Widecka J, Wijeratne T, Wilner LB, Wilson S, Winkler AS, Wiyeh AB, Wiysonge CS, Wolfe CDA, Woolf AD, Wu S, Wu YC, Wyper GMA, Xavier D, Xu G, Yadgir S, Yadollahpour A, Yahyazadeh Jabbari SH, Yamada T, Yan LL, Yano Y, Yaseri M, Yasin YJ, Yeshaneh A, Yimer EM, Yip P, Yisma E, Yonemoto N, Yoon SJ, Yotebieng M, Younis MZ, Yousefifard M, Yu C, Zadnik V, Zaidi Z, Zaman SB, Zamani M, Zare Z, Zeleke AJ, Zenebe ZM, Zhang K, Zhao Z, Zhou M, Zodpey S, Zucker I, Vos T, Murray CJL. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018; 392:1789-1858. [PMID: 30496104 PMCID: PMC6227754 DOI: 10.1016/s0140-6736(18)32279-7#] [Show More Authors] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/09/2018] [Revised: 08/30/2018] [Accepted: 09/12/2018] [Indexed: 08/12/2023]
Abstract
BACKGROUND The Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017) includes a comprehensive assessment of incidence, prevalence, and years lived with disability (YLDs) for 354 causes in 195 countries and territories from 1990 to 2017. Previous GBD studies have shown how the decline of mortality rates from 1990 to 2016 has led to an increase in life expectancy, an ageing global population, and an expansion of the non-fatal burden of disease and injury. These studies have also shown how a substantial portion of the world's population experiences non-fatal health loss with considerable heterogeneity among different causes, locations, ages, and sexes. Ongoing objectives of the GBD study include increasing the level of estimation detail, improving analytical strategies, and increasing the amount of high-quality data. METHODS We estimated incidence and prevalence for 354 diseases and injuries and 3484 sequelae. We used an updated and extensive body of literature studies, survey data, surveillance data, inpatient admission records, outpatient visit records, and health insurance claims, and additionally used results from cause of death models to inform estimates using a total of 68 781 data sources. Newly available clinical data from India, Iran, Japan, Jordan, Nepal, China, Brazil, Norway, and Italy were incorporated, as well as updated claims data from the USA and new claims data from Taiwan (province of China) and Singapore. We used DisMod-MR 2.1, a Bayesian meta-regression tool, as the main method of estimation, ensuring consistency between rates of incidence, prevalence, remission, and cause of death for each condition. YLDs were estimated as the product of a prevalence estimate and a disability weight for health states of each mutually exclusive sequela, adjusted for comorbidity. We updated the Socio-demographic Index (SDI), a summary development indicator of income per capita, years of schooling, and total fertility rate. Additionally, we calculated differences between male and female YLDs to identify divergent trends across sexes. GBD 2017 complies with the Guidelines for Accurate and Transparent Health Estimates Reporting. FINDINGS Globally, for females, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and haemoglobinopathies and haemolytic anaemias in both 1990 and 2017. For males, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and tuberculosis including latent tuberculosis infection in both 1990 and 2017. In terms of YLDs, low back pain, headache disorders, and dietary iron deficiency were the leading Level 3 causes of YLD counts in 1990, whereas low back pain, headache disorders, and depressive disorders were the leading causes in 2017 for both sexes combined. All-cause age-standardised YLD rates decreased by 3·9% (95% uncertainty interval [UI] 3·1-4·6) from 1990 to 2017; however, the all-age YLD rate increased by 7·2% (6·0-8·4) while the total sum of global YLDs increased from 562 million (421-723) to 853 million (642-1100). The increases for males and females were similar, with increases in all-age YLD rates of 7·9% (6·6-9·2) for males and 6·5% (5·4-7·7) for females. We found significant differences between males and females in terms of age-standardised prevalence estimates for multiple causes. The causes with the greatest relative differences between sexes in 2017 included substance use disorders (3018 cases [95% UI 2782-3252] per 100 000 in males vs s1400 [1279-1524] per 100 000 in females), transport injuries (3322 [3082-3583] vs 2336 [2154-2535]), and self-harm and interpersonal violence (3265 [2943-3630] vs 5643 [5057-6302]). INTERPRETATION Global all-cause age-standardised YLD rates have improved only slightly over a period spanning nearly three decades. However, the magnitude of the non-fatal disease burden has expanded globally, with increasing numbers of people who have a wide spectrum of conditions. A subset of conditions has remained globally pervasive since 1990, whereas other conditions have displayed more dynamic trends, with different ages, sexes, and geographies across the globe experiencing varying burdens and trends of health loss. This study emphasises how global improvements in premature mortality for select conditions have led to older populations with complex and potentially expensive diseases, yet also highlights global achievements in certain domains of disease and injury. FUNDING Bill & Melinda Gates Foundation.
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Abutaleb A, Kottilil S, Wilson E. Glecaprevir/pibrentasvir expands reach while reducing cost and duration of hepatitis C virus therapy. Hepatol Int 2018; 12:214-222. [PMID: 29845496 PMCID: PMC6436099 DOI: 10.1007/s12072-018-9873-y] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/13/2018] [Accepted: 05/18/2018] [Indexed: 01/15/2023]
Abstract
Hepatitis C virus (HCV) treatments have dramatically progressed from poorly tolerated, moderately successful interferon-based therapies to highly effective all-oral interferon-free regimens. While sustained virologic responses have significantly improved with fixed-dose combinations (FDC) of these direct-acting antivirals (DAA), cost remains high and certain populations of patients remain difficult to treat. Glecaprevir (GLE, an NS3/4A protease inhibitor) and pibrentasvir (PIB, NS5A inhibitor) were recently approved as a FDC therapy for HCV, and have expanded reach, reduced cost, and in certain populations, reduced HCV treatment duration. GLE/PIB is effective across all genotypes, and has been shown to be effective in HIV-infected patients, patients with chronic kidney disease, and Child-Pugh A-compensated cirrhosis. GLE/PIB is also effective for a shortened duration of 8 weeks in treatment-naive non-cirrhotic patients.
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Affiliation(s)
- Ameer Abutaleb
- Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA
- Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, Baltimore, MD, USA
| | - Shyam Kottilil
- Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA
| | - Eleanor Wilson
- Division of Clinical Care and Research, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA
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Muzembo BA, Mbendi NC, Nakayama SF. Systematic review with meta-analysis: performance of dried blood spots for hepatitis C antibodies detection. Public Health 2017; 153:128-136. [PMID: 29035801 DOI: 10.1016/j.puhe.2017.08.008] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/10/2017] [Revised: 07/10/2017] [Accepted: 08/21/2017] [Indexed: 12/30/2022]
Abstract
OBJECTIVES Dried blood spots (DBS) specimens can be used for hepatitis C virus (HCV) infection screening in cases where serum specimens are difficult to obtain. However, uncertainties surround the sensitivity and specificity of DBS for HCV antibodies (anti-HCV) serology testing. We aimed to evaluate the accuracy of DBS use to screen for HCV infection. STUDY DESIGN We carried out a systematic review and meta-analysis. METHODS Medline and EMBASE databases were searched for articles published between 1989 and November 2016. We included studies comparing DBS to plasma/serum specimens to detect anti-HCV in adults. Two authors extracted data and assessed the quality of the studies using an adapted standards for reporting diagnostic accuracy studies (STARD) and independently checked the data for accuracy. Meta-analysis was computed with the bivariate and the hierarchical summary receiver-operating characteristic models. RESULTS Twelve studies (3307 specimens) were analyzed, where 11 of them evaluated the anti-HCV using enzyme immunoassays (EIAs), and the remaining one used rapid diagnostic tests. The studies were mostly case-controls (83.3%) and from developed countries (66.7%). The overall pooled sensitivity (95% confidence interval; CI) and specificity (95% CI) of DBS to detect anti-HCV was 98.1% (96.1-99.1%) and 99.7% (98.9-99.9%), respectively. In studies using EIAs, the pooled sensitivity and specificity were 97.3% (94.3-98.8%) and 99.6% (98.5-99.9%), respectively. Considering only studies using EIAs, sensitivity analysis excluding one study carried out in people who inject drugs showed the pooled sensitivity of 97.8% (96.2-98.8%) and specificity of 99.5% (98.5-99.9%). CONCLUSIONS In testing for anti-HCV by means of EIAs, the efficacy of DBS is found to be similar or slightly lower than that of serum specimens. However, the risk of finding negative and positive results that are both false when using DBS remains present. Therefore, further work including optimal storage and processing methodologies are recommended. This is to help establish consensus guidelines for use of DBS specimens for anti-HCV screening.
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Affiliation(s)
- B A Muzembo
- Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba, Japan.
| | - N C Mbendi
- Gastroenterology Department, Kinshasa University, Kinshasa, DR Congo
| | - S F Nakayama
- Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba, Japan
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Mathur P, Comstock E, McSweegan E, Mercer N, Kumar NS, Kottilil S. A pilot study to expand treatment of chronic hepatitis C in resource-limited settings. Antiviral Res 2017; 146:184-190. [PMID: 28927676 DOI: 10.1016/j.antiviral.2017.09.007] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2017] [Revised: 07/11/2017] [Accepted: 09/13/2017] [Indexed: 01/06/2023]
Abstract
The past five years have seen a revolution in the treatment of chronic hepatitis C, as short duration oral regimens of direct-acting antiviral drugs (DAAs), with nearly 100% cure rates for all genotypes, have replaced longer courses of ribavirin and injected interferon. Although initially very expensive, these DAAs are now becoming available in generic equivalents in countries with large numbers of chronically infected people, such as India. However, a number of obstacles may hinder the delivery of these drugs in resource-limited settings, including lack of access to diagnostic testing and the restriction of treatment to a small number of medical specialists. New approaches are therefore needed to make DAAs available to the estimated 71 million infected people, many of whom disproportionately live in low- or middle-income countries. A recent pilot study (ASCEND) of hepatitis C management in a low-income population in Washington, D.C., demonstrated that trained nurse practitioners, primary care physicians and hepatologists were equally successful in diagnosing and treating patients, indicating that such an approach might be successful in resource-limited regions of the world. Members of the Global Virus Network have received funding to carry out a similar training project in a region of India with a high prevalence of hepatitis C. This paper reviews the challenges of delivering DAA therapy in low- and middle-income countries, describes plans for performing and evaluating the effectiveness of a training program in India, and discusses future needs for the eventual elimination of hepatitis C.
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Affiliation(s)
- Poonam Mathur
- Division of Clinical Care and Research at the Institute of Human Virology (IHV), University of Maryland, School of Medicine, Baltimore, MD, USA
| | - Emily Comstock
- Division of Clinical Care and Research at the Institute of Human Virology (IHV), University of Maryland, School of Medicine, Baltimore, MD, USA
| | | | | | | | - Shyamasundaran Kottilil
- Division of Clinical Care and Research at the Institute of Human Virology (IHV), University of Maryland, School of Medicine, Baltimore, MD, USA; Global Virus Network, Baltimore, MD, USA.
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Khalil AT, Ali M, Tanveer F, Ovais M, Idrees M, Shinwari ZK, Hollenbeck JE. Emerging Viral Infections in Pakistan: Issues, Concerns, and Future Prospects. Health Secur 2017. [DOI: 10.1089/hs.2016.0072] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023] Open
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Olmstead AD, Lee TD, Chow R, Gunadasa K, Auk B, Krajden M, Jassem AN. Development and validation of a real-time, reverse transcription PCR assay for rapid and low-cost genotyping of hepatitis C virus genotypes 1a, 1b, 2, and 3a. J Virol Methods 2017; 244:17-22. [PMID: 28219761 DOI: 10.1016/j.jviromet.2017.02.009] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2016] [Revised: 02/10/2017] [Accepted: 02/10/2017] [Indexed: 12/17/2022]
Abstract
Hepatitis C virus (HCV) infection affects millions of people and leads to liver fibrosis, cirrhosis, and hepatocellular carcinoma. Treatment regimen selection requires HCV genotype (Gt) and Gt 1 subtype determination. Use of a laboratory developed, reverse transcription (RT)-PCR assay was explored as a low-cost, high-throughput screening approach for the major HCV genotypes and subtypes in North America. A commercial line probe assay (LiPA) was used for comparison. Sequencing and/or an alternative PCR assay were used for discordant analyses. Testing of 155 clinical samples revealed that a paired, duplex real-time RT-PCR assay that targets Gts 1a and 3a in one reaction and Gts 1b and 2 in another had 95% overall sensitivity and individual Gt sensitivity and specificity of 98-100% and 85-98%, respectively. The RT-PCR assay detected mixed HCV Gts in clinical and spiked samples and no false-positive reactions occurred with rare Gts 3b, 4, 5, or 6. Implementation of the RT-PCR assay, with some reflex LiPA testing, would cost only a small portion of the cost of using LiPA alone, and can also save 1.5h of hands-on time. The use of a laboratory developed RT-PCR assay for HCV genotyping has the potential to reduce cost and labour burdens in high-volume testing settings.
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Affiliation(s)
- Andrea D Olmstead
- University of British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada
| | - Tracy D Lee
- British Columbia Centre for Disease Control Public Health Laboratory, Provincial Health Services Authority, Vancouver, British Columbia, Canada
| | - Ron Chow
- British Columbia Centre for Disease Control Public Health Laboratory, Provincial Health Services Authority, Vancouver, British Columbia, Canada
| | - Kingsley Gunadasa
- British Columbia Centre for Disease Control Public Health Laboratory, Provincial Health Services Authority, Vancouver, British Columbia, Canada
| | - Brian Auk
- British Columbia Centre for Disease Control Public Health Laboratory, Provincial Health Services Authority, Vancouver, British Columbia, Canada
| | - Mel Krajden
- British Columbia Centre for Disease Control Public Health Laboratory, Provincial Health Services Authority, Vancouver, British Columbia, Canada; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada
| | - Agatha N Jassem
- British Columbia Centre for Disease Control Public Health Laboratory, Provincial Health Services Authority, Vancouver, British Columbia, Canada; Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
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Ravinetto R, De Weggheleire A, Dorlo TP, Francque S, Sokkab A, Pouget C, Meessen B, Tabernero P, Newton PN, Lynen L. Predictable threats to public health through delaying universal access to innovative medicines for hepatitis C: a pharmaceutical standpoint. Trop Med Int Health 2016; 21:1490-1495. [PMID: 27671365 PMCID: PMC5244681 DOI: 10.1111/tmi.12784] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Affiliation(s)
- Raffaella Ravinetto
- Clinical Sciences DepartmentInstitute of Tropical MedicineAntwerpBelgium
- Clinical Pharmacology and PharmacotherapyKU LeuvenLeuvenBelgium
| | | | - Thomas P.C. Dorlo
- Department Pharmaceutical BiosciencesUppsala UniversityUppsalaSweden
- Division of Pharmacoepidemiology & Clinical PharmacologyUtrecht UniversityUtrechtThe Netherlands
| | | | - An Sokkab
- Sihanouk Hospital Centre of HopePhnom PenhCambodia
| | | | - Bruno Meessen
- Public Health DepartmentInstitute of Tropical MedicineAntwerpBelgium
| | | | - Paul N. Newton
- Lao‐Oxford‐Mahosot Hospital‐Wellcome Trust Research UnitMahosot HospitalVientianeLao PDR
- Centre for Tropical Medicine & Global HealthNuffield Department of MedicineOxford UniversityOxfordUK
- Worldwide Antimalarial Resistance NetworkChurchill HospitalOxford UniversityOxfordUK
- London School of Hygiene and Tropical MedicineLondonUK
| | - Lut Lynen
- Clinical Sciences DepartmentInstitute of Tropical MedicineAntwerpBelgium
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Gentile I, Maraolo AE, Niola M, Graziano V, Borgia G, Paternoster M. Limiting the access to direct-acting antivirals against HCV: an ethical dilemma. Expert Rev Gastroenterol Hepatol 2016; 10:1227-1234. [PMID: 27607920 DOI: 10.1080/17474124.2016.1234375] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Hepatitis C virus (HCV) infection affects about 200 million people worldwide and represents a leading cause of liver-related mortality. Eradication of HCV infection, achieved mainly through direct-acting antivirals (DAA), results in a decrease of mortality and an improvement of quality of life. These drugs have a maximal efficacy and an optimal tolerability. However, their high cost precludes a universal access even in wealthy countries. Areas covered: This article deals with the policies adopted for the use of the new anti-HCV drugs, especially in Europe and most of all in Italy, supposedly the developed country with the highest HCV prevalence. The literature search was performed using Pubmed and Web of Science. Moreover, national regulatory institutional websites were consulted. Expert commentary: The current policy of limitation to the access of the DAA presents a series of ethical issues that makes it non-applicable. A 'treat-all' strategy should resolve all ethical dilemmas, by virtue of the wide benefits of anti-HCV treatment not only for the advanced stage of infection, but also for the initial stages. A reduction in price of the drugs is the actual condition to achieve such a change.
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Affiliation(s)
- Ivan Gentile
- a Department of Clinical Medicine and Surgery , University of Naples Federico II , Naples , Italy
| | - Alberto E Maraolo
- a Department of Clinical Medicine and Surgery , University of Naples Federico II , Naples , Italy
| | - Massimo Niola
- b Department of Advanced Biomedical Sciences , University of Naples Federico II , Naples , Italy
| | - Vincenzo Graziano
- b Department of Advanced Biomedical Sciences , University of Naples Federico II , Naples , Italy
| | - Guglielmo Borgia
- a Department of Clinical Medicine and Surgery , University of Naples Federico II , Naples , Italy
| | - Mariano Paternoster
- b Department of Advanced Biomedical Sciences , University of Naples Federico II , Naples , Italy
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Habib S, Malik S, Fu B, Chang J, Nalesnik M, Humar A, Shaikh OS. Hepatitis C in Liver Allograft Recipients: Utility of One-Year Post-Transplantation Biopsy as an Indicator of Antiviral Therapy. Gastroenterology Res 2016; 8:281-290. [PMID: 27785310 PMCID: PMC5051027 DOI: 10.14740/gr694w] [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] [Accepted: 12/15/2015] [Indexed: 12/02/2022] Open
Abstract
Background All-oral interferon-free regimens for hepatitis C viral (HCV) infection are highly efficacious; however, high cost is a barrier to applicability. Liver allograft recipients are particularly likely to benefit from therapy as HCV often leads to graft dysfunction and loss. In this study, we aimed to establish the utility of allograft biopsy at 1 year post-transplant as an indicator of treatment. Methods and Results Among 252 liver recipients enrolled, 136 (54%) developed severe disease (fibrosing cholestatic hepatitis (FCH) or fibrosis stage ≥ 2 at 1 year post-transplant). Multivariable analysis revealed younger recipient age and female gender, older donor age and T cell depletive therapy to be independent predictors of severe disease. Recipients with severe disease had higher rate of further graft loss compared to those with mild disease. Patients with mild disease and sustained virologic response (SVR) had the best survival rate, whereas those with severe disease and viremia had the worst survival (96% versus 63% at 5 years). Conclusion In conclusion, allograft biopsy at 1 year helps identify recipients at high risk of further graft dysfunction and loss. In view of high cost of therapy, treatment should be preferably directed to high-risk patients including those with FCH or fibrosis stage ≥ 2 by 1 year post-transplant.
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Affiliation(s)
- Shahid Habib
- Division of Gastroenterology & Hepatology, Liver Research Institute, University of Arizona, Tucson, AZ, USA
| | - Shahid Malik
- Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
| | - Bo Fu
- Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA
| | - Joyce Chang
- Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
| | - Michael Nalesnik
- Division of Transplantation Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
| | - Abhinav Humar
- Division of Transplantation Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
| | - Obaid S Shaikh
- Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
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Alavian SM, Rezaee-Zavareh MS. Daclatasvir-based Treatment Regimens for Hepatitis C Virus Infection: A Systematic Review and Meta-Analysis. HEPATITIS MONTHLY 2016; 16:e41077. [PMID: 27826322 PMCID: PMC5097339 DOI: 10.5812/hepatmon.41077] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 08/02/2016] [Revised: 08/07/2016] [Accepted: 08/14/2016] [Indexed: 12/11/2022]
Abstract
CONTEXT Direct acting antivirals (DAAs) have recently emerged as a promising therapeutic regimen for the treatment of hepatitis C virus (HCV) infection, which is a major public health problem. Among the known DAAs, daclatasvir (DCV), an inhibitor of the non-structural 5A protein, has been used in combination with several drugs for treatment of infection with HCV of different genotypes under different conditions. We conducted a systematic review and meta-analysis of combination therapy with DCV. EVIDENCE ACQUISITION We performed a systematic search in PubMed, Scopus, Science Direct and Web of Science with appropriate keywords for DCV. Studies that evaluated any regimen containing DCV and reported the sustained virological response (SVR) 12 weeks after therapy based on the HCV genotype, treatment duration and use of ribavirin (RBV) were included. The selected studies were considered for meta-analysis using STATA 11.0. RESULTS We found six different regimens containing DCV: DCV/asunaprevir (ASV), DCV/ASV/beclubavir, DCV/pegylated interferon lambda or alpha/RBV with or without ASV, DCV/simeprevir, DCV/VX-135 and DCV/sofosbuvir (SOF). Most of these regimens were used for the treatment of HCV genotype 1 infections, and in most cases, treatment failure was noted in subtype 1a infections. Among all these regimens, DCV/SOF with or without RBV for 12 or 24 weeks was found to be an efficacious approach for treatment of different types of patients with infections with different HCV genotypes. CONCLUSIONS Among the treatment regimens containing DCV, DCV/SOF has the highest SVR rate for the treatment of infection with different HCV genotypes in different patient contexts; thus, this regimen shows promise for the treatment of HCV infections.
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Affiliation(s)
- Seyed Moayed Alavian
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
- Middle East Liver Diseases (MELD) Center, Tehran, IR Iran
- Meta-analysis Study Group for Treatment of Hepatitis C, Iran Hepatitis Network, Tehran, IR Iran
| | - Mohammad Saeid Rezaee-Zavareh
- Middle East Liver Diseases (MELD) Center, Tehran, IR Iran
- Meta-analysis Study Group for Treatment of Hepatitis C, Iran Hepatitis Network, Tehran, IR Iran
- Students’ Research Committee, Baqiyatallah University of Medical Sciences, Tehran, IR Iran
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20
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Vernaz N, Girardin F, Goossens N, Brügger U, Riguzzi M, Perrier A, Negro F. Drug Pricing Evolution in Hepatitis C. PLoS One 2016; 11:e0157098. [PMID: 27310294 PMCID: PMC4911078 DOI: 10.1371/journal.pone.0157098] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2016] [Accepted: 05/24/2016] [Indexed: 01/27/2023] Open
Abstract
Objective We aimed to determine the association between the stepwise increase in the sustained viral response (SVR) and Swiss and United States (US) market prices of drug regimens for treatment-naive, genotype 1 chronic hepatitis C virus (HCV) infection in the last 25 years. We identified the following five steps in the development of HCV treatment regimens: 1) interferon (IFN)-α monotherapy in the early '90s, 2) IFN-α in combination with ribavirin (RBV), 3) pegylated (peg) IFN-α in combination with RBV, 4) the first direct acting antivirals (DAAs) (telaprevir and boceprevir) in combination with pegIFN-α and RBV, and 5) newer DAA-based regimens, such as sofosbuvir (which is or is not combined with ledipasvir) and fixed-dose combination of ritonavir-boosted paritaprevir and ombitasvir in combination with dasabuvir. Design We performed a linear regression and mean cost analysis to test for an association between SVRs and HCV regimen prices. We conducted a sensitivity analysis using US prices at the time of US drug licensing. We selected randomized clinical trials of drugs approved for use in Switzerland from 1997 to July 2015 including treatment-naïve patients with HCV genotype 1 infection. Results We identified a statistically significant positive relationship between the proportion of patients achieving SVRs and the costs of HCV regimens in Switzerland (with a bivariate ordinary least square regression yielding an R2 measure of 0.96) and the US (R2 = 0.95). The incremental cost per additional percentage of SVR was 597.14 USD in Switzerland and 1,063.81 USD in the US. Conclusion The pricing of drugs for HCV regimens follows a value-based model, which has a stable ratio of costs per achieved SVR over 25 years. Health care systems are struggling with the high resource use of these new agents despite their obvious long-term advantages for the overall health of the population. Therefore, the pharmaceutical industry, health care payers and other stakeholders are challenged with finding new drug pricing schemes to treat the entire population infected with HCV.
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Affiliation(s)
- Nathalie Vernaz
- Medical Direction, Geneva University Hospitals, University of Geneva, Geneva, Switzerland
- Finance Direction, Geneva University Hospitals, Geneva, Switzerland
- * E-mail:
| | - François Girardin
- Medical Direction, Geneva University Hospitals, University of Geneva, Geneva, Switzerland
- Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals, University of Geneva, Geneva, Switzerland
| | - Nicolas Goossens
- Divisions of Gastroenterology and Hepatology, Geneva University Hospitals, University of Geneva, Geneva, Switzerland
| | - Urs Brügger
- Winterthur Institute of Health Economics, Zurich University of Applied Sciences, Winterthur, Switzerland
| | - Marco Riguzzi
- Winterthur Institute of Health Economics, Zurich University of Applied Sciences, Winterthur, Switzerland
| | - Arnaud Perrier
- Medical Direction, Geneva University Hospitals, University of Geneva, Geneva, Switzerland
- Division of General Internal Medicine, Geneva University Hospitals, University of Geneva, Geneva, Switzerland
| | - Francesco Negro
- Divisions of Gastroenterology and Hepatology and of Clinical Pathology, Geneva University Hospitals, Geneva, Switzerland
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21
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Rosenthal ES, Graham CS. Price and affordability of direct-acting antiviral regimens for hepatitis C virus in the United States. Infect Agent Cancer 2016; 11:24. [PMID: 27186235 PMCID: PMC4867525 DOI: 10.1186/s13027-016-0071-z] [Citation(s) in RCA: 97] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2015] [Accepted: 03/30/2016] [Indexed: 02/06/2023] Open
Abstract
Hepatitis C virus is a serious infection causing cirrhosis, liver cancer, and death. The recent development of direct-acting antivirals has dramatically improved tolerability of treatment and rates of cure. However, the high price of these medications has often limited access to care and resulted in rationing of medications in the United States to those with advanced liver disease, access to specialist care, and without active substance use. This review assesses the way pharmaceutical prices are established and how pricing of directly acting antiviral regimens in the United States has impacted access to treatment for hepatitis C virus.
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Affiliation(s)
- Elana S. Rosenthal
- />Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD USA
| | - Camilla S. Graham
- />Division of Infectious Diseases, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA USA
- />Trek Therapeutics, PBC, Cambridge, MA USA
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22
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Rizk HH, Hamdy NM, Al-Ansari NL, El-Mesallamy HO. Pretreatment Predictors of Response to PegIFN-RBV Therapy in Egyptian Patients with HCV Genotype 4. PLoS One 2016; 11:e0153895. [PMID: 27100663 PMCID: PMC4839712 DOI: 10.1371/journal.pone.0153895] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/18/2015] [Accepted: 04/05/2016] [Indexed: 12/21/2022] Open
Abstract
BACKGROUND Egypt has the highest prevalence of a difficult to treat chronic hepatitis C virus (HCV), genotype 4. Pretreatment factors could guide individualization of therapy which aids in treatment optimization and interleukin IL28B gene polymorphism has been shown to closely relate to HCV treatment response. Polymorphisms in genes encoding inhibitors of T-cell response, which have role in disease progression as Programmed Cell Death 1 (PD-1), and Cytotoxic T-Lymphocytes Antigen-4 (CTLA-4), could be candidate markers predicting treatment response. METHODS This cohort study consisted of 200 chronic HCV genotype 4 infected patients treated with PegIFN α-2a and RBV in 2 hepatology centers. Genotyping of the polymorphisms in the IL28B gene region (rs12979860), PD1.3 (rs11568821) and CTLA-4 (rs231775) was performed on DNA collected from each patient using TaqMan® genotyping assay. Groups were classified according to response into sustained virological responders (SVR), or non-responders (NR). A multivariate logistic regression analysis was used to identify potential markers, host pretreatment clinical and viral predictive factors including viral load, insulin resistance, and alpha fetoprotein (AFP) related to treatment response. RESULTS Our results showed that in a multivariate analyses IL28B C/C genotype was the most significant predictor for SVR (OR = 10.86; p<0.0001) followed by AFP (OR = 0.915; p = 0.001) then CTLA-4/G genotypes (OR = 1.948; p = 0.022). However, PD-1.3/A genotypes and platelets count were significantly related to response in univariate analysis only (OR = 1.973; p = 0.023; OR = 1.007; p = 0.009 respectively). CONCLUSION IL28B SNP, AFP level, and CTLA-4 SNP could be used in conjunction to predict treatment response in HCV genotype 4 infected Egyptian patients.
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Affiliation(s)
- Hanan H. Rizk
- Biochemistry Department, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt
| | - Nadia M. Hamdy
- Biochemistry Department, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt
| | - Nadia L. Al-Ansari
- Endemic Medicine Department & Hepatology Unit, Faculty of Medicine, Ain-Shams University, Cairo, Egypt
| | - Hala O. El-Mesallamy
- Biochemistry Department, Faculty of Pharmacy, Ain-Shams University, Cairo, Egypt
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Gul A, Zahid N, Ahmed J, Zahir F, Khan IA, Ali I. Molecular characterization of Hepatitis C virus 3a in Peshawar. BMC Infect Dis 2016; 16:163. [PMID: 27090517 PMCID: PMC4836082 DOI: 10.1186/s12879-016-1488-0] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2015] [Accepted: 03/29/2016] [Indexed: 01/17/2023] Open
Abstract
Background The purpose of this study was to explore molecular epidemiology of HCV genotype 3a in Peshawar based on sequencing and phylogenetic analysis of Core region of HCV genome. Methods Chronically infected Hepatitis C virus infected patients enrolled under the Prime Minister Hepatitis C control program at three Tertiary care units of Peshawar [Khyber Teaching Hospital Peshawar, Lady Reading Hospital Peshawar, Hayat Abad Medical Complex Peshawar] were included in this cross sectional observational study. Qualitative detection of HCV and HCV genotyping was carried out by a modified reverse transcription-polymerase chain reaction (RT-PCR) and type specific genotyping assay. The Core gene of HCV genotype 3a was amplified, cloned and sequenced. The sequences obtained were used for phylogenetic analysis using MEGA 6 software. Results Among the 422 (82.75 %) PCR positive samples, 192 (45.5 %) were identified as having HCV genotype 3a infection. HCV Core gene sequencing was carried out randomly for the characterization of HCV 3a. Nucleotide sequence analysis of the obtained viral genomic sequences based on partial HCV 3a Core gene sequences with reference sequences from different countries showed that our sequences clustered with some local and regional sequences with high bootstrap values. Conclusion HCV 3a is highly prevalent in Peshawar, Pakistan and its phylogenetics based on Core gene sequences indicate the prevalence of different lineages of HCV 3a in Peshawar which may have consequences for disease management strategies causing more economic pressure on the impoverished population due to possible antiviral resistance.
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Affiliation(s)
- Amina Gul
- Institute of Basic Medical Sciences, Khyber Medical University Peshawar, Peshawar, Pakistan.,Department of Biosciences, COMSATS Institute of Information Technology Islamabad, Islamabad, Pakistan
| | - Nabeela Zahid
- IBGE, The University of Agriculture Peshawar, Peshawar, Pakistan
| | - Jawad Ahmed
- Institute of Basic Medical Sciences, Khyber Medical University Peshawar, Peshawar, Pakistan
| | - Fazli Zahir
- IBGE, The University of Agriculture Peshawar, Peshawar, Pakistan
| | - Imtiaz Ali Khan
- Department of Entomology, The University of Agriculture Peshawar, Peshawar, Pakistan
| | - Ijaz Ali
- Department of Biosciences, COMSATS Institute of Information Technology Islamabad, Islamabad, Pakistan.
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Hesamizadeh K, Sharafi H, Rezaee-Zavareh MS, Behnava B, Alavian SM. Next Steps Toward Eradication of Hepatitis C in the Era of Direct Acting Antivirals. HEPATITIS MONTHLY 2016; 16:e37089. [PMID: 27275164 PMCID: PMC4893415 DOI: 10.5812/hepatmon.37089] [Citation(s) in RCA: 61] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 02/12/2016] [Accepted: 02/21/2016] [Indexed: 12/11/2022]
Abstract
CONTEXT After the introduction of safe and highly effective hepatitis C virus (HCV) treatments, eradication of HCV in the next 20 years is the ultimate goal. Since 2011, the advent of first generation direct acting antivirals (DAAs) were started and followed by the introduction of a new wave of DAAs in 2013 which exhibit outstanding efficacy. It is obvious that the eradication of hepatitis C is not restricted to development of DAAs. EVIDENCE ACQUISITION An electronic search of available literature published was conducted in all peer-reviewed journal indexed in PubMed, Scopus and Google scholar. The literature search was done among articles related treatment of hepatitis C with DAAs in different patient groups with mass screening of the patients and cost benefit of new treatments as main key words. RESULTS There are major steps that should be taken to eradicate HCV, including (1) the development of screening strategies, particularly for groups such as intravenous drug users and recipients of blood or blood products before the introduction of HCV screening in donors; (2) the development of strategies to overcome issues with the high cost of recently introduced treatments; (3) special attention to special patient groups, such as HIV/HCV co-infection, hemophilia, thalassemia, hemodialysis, and liver-transplant patients; and (4) development of preventive strategies, such as the development of an efficient HCV vaccine, special attention to harm reduction in high-risk groups, and promotion of mass awareness of HCV. CONCLUSIONS The eradication of HCV will require significant governmental financial investment for screening, prevention, and treatment of infected patients. Although, we have a long way to eradication of HCV, the next steps could be including proper planning to patient finding, availability of new treatments to all patients and development of HCV prevention strategies such as vaccines.
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Affiliation(s)
- Khashayar Hesamizadeh
- Middle East Liver Disease (MELD) Center, Tehran, IR Iran
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
| | - Heidar Sharafi
- Middle East Liver Disease (MELD) Center, Tehran, IR Iran
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
| | - Mohammad Saeid Rezaee-Zavareh
- Middle East Liver Disease (MELD) Center, Tehran, IR Iran
- Students’ Research Committee, Baqiyatallah University of Medical Sciences, Tehran, IR Iran
| | - Bita Behnava
- Middle East Liver Disease (MELD) Center, Tehran, IR Iran
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
| | - Seyed Moayed Alavian
- Middle East Liver Disease (MELD) Center, Tehran, IR Iran
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases (BRCGL), Baqiyatallah University of Medical Sciences, Tehran, IR Iran
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25
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Denkinger CM, Kessel M. Diagnostics for hepatitis C: an urgent need for action. LANCET GLOBAL HEALTH 2016; 3:e195. [PMID: 25794673 DOI: 10.1016/s2214-109x(15)70092-6] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
Affiliation(s)
- Claudia M Denkinger
- FIND, 1211 Geneva 20, Switzerland; Division of Infectious Disease, Beth Israel Deaconess Medical Center, Boston, MA, USA.
| | - Mark Kessel
- FIND, 1211 Geneva 20, Switzerland; Shearman & Sterling, London, UK; Symphony Capital LLC, New York, NY, USA
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26
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Waheed Y. Hepatitis C eradication: A long way to go. World J Gastroenterol 2015; 21:12510-12512. [PMID: 26604658 PMCID: PMC4649134 DOI: 10.3748/wjg.v21.i43.12510] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/04/2015] [Revised: 07/28/2015] [Accepted: 09/15/2015] [Indexed: 02/06/2023] Open
Abstract
Hepatitis C virus (HCV) is a major global health problem with high morbidity and mortality. About 185 million people are living with HCV, of which 80% are living in low and middle income countries. With the development of new highly effective treatments for HCV, it is considered that the eradication of HCV may only be one step away. The major problem with new treatment options is its high price. The price of sofosbuvir-based treatment for one patient in the United States is US$85000-110000, while the actual production cost of a 12 wk direct-acting antiviral regimen is less than US$250. Another major hindrance in HCV eradication is the lack of quality management of blood transfusion screens. Due to the lack of HCV screening, 75% of people in the United States with HCV infection are unaware of their positive HCV status. The control of massive HCV pandemic will require a significant financial investment, political will, and support from medical, pharmaceutical, and civil organizations around the globe.
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Muir AJ, Naggie S. Hepatitis C Virus Treatment: Is It Possible To Cure All Hepatitis C Virus Patients? Clin Gastroenterol Hepatol 2015; 13:2166-72. [PMID: 26192145 PMCID: PMC4892426 DOI: 10.1016/j.cgh.2015.07.015] [Citation(s) in RCA: 36] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/07/2015] [Revised: 07/12/2015] [Accepted: 07/13/2015] [Indexed: 02/07/2023]
Abstract
The recent advances in hepatitis C virus (HCV) therapeutics have brought combinations of direct acting antiviral medications that offer interferon-free, well-tolerated regimens with sustained virologic response rates greater than 90% in clinical trials for many patient groups. The successes have prompted discussions regarding cure for all patients. These regimens have already demonstrated the ability to cure previously challenging patient groups, including human immunodeficiency virus-HCV coinfection, decompensated cirrhosis, and post-liver transplantation. Limitations exist in the current portfolio of agents, with suboptimal outcomes for genotype 3 and limited data in genotypes 5 and 6. More data are urgently needed in patients with chronic kidney disease and in children. With ongoing developments, highly effective regimens for all these patient groups are within reach. To deliver HCV treatment throughout the world and particularly in low- and middle-income countries, regimens need to be affordable but also pan-genotypic, well-tolerated, and delivered once daily for 4-8 weeks. With such a regimen, cure for all patients would then hinge on the ability to identify patients with HCV infection and deliver treatment within their communities. This review will discuss the strategies that will be necessary to realize this opportunity to cure all persons with HCV infection.
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Affiliation(s)
- Andrew J. Muir
- Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina,Division of Gastroenterology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina
| | - Susanna Naggie
- Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina,Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine, Durham, North Carolina
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Craxì L, Cammà C, Craxì A. HCV: the best cure possible or the best possible cure? J Viral Hepat 2015; 22:627-9. [PMID: 26135025 DOI: 10.1111/jvh.12411] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/14/2015] [Accepted: 03/14/2015] [Indexed: 12/09/2022]
Abstract
Progress in medicine goes along with an exponential growth of the cost of drugs and devices. While any person has the right to obtain the best possible benefit from medical care, a state needs to strike a balance between granting the optimal personal benefit to each individual and the needs of the society as a whole. Health systems in all countries therefore are facing a huge problem of distributive justice, as while they should guarantee individual rights, among which the right to health in its broader sense, including physical, psychological and social well-being (therefore not limited to healing, but extending to compliance and quality of life), they must also grant equal access to the healthcare resources and keep the distribution system sustainable.
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Affiliation(s)
- L Craxì
- Institute of Bioethics, 'A. Gemelli' School of Medicine, Università Cattolica del Sacro Cuore, Rome, Italy
| | - C Cammà
- Sezione di Gastroenterologia & Epatologia, Di.Bi.M.I.S., University of Palermo, Palermo, Italy
| | - A Craxì
- Sezione di Gastroenterologia & Epatologia, Di.Bi.M.I.S., University of Palermo, Palermo, Italy
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29
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Hepatitis C virus and HIV infections among people who inject drugs in the Middle East and North Africa: a neglected public health burden? J Int AIDS Soc 2015. [PMID: 26221872 PMCID: PMC4518656 DOI: 10.7448/ias.18.1.20582] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
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