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      Cost-effectiveness and budgetary impact of HCV treatment with direct-acting antivirals in India including the risk of reinfection

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          Abstract

          Background

          HCV direct-acting antivirals (DAAs) are produced in India at low cost. However, concerns surrounding reinfection and budgetary impact limit treatment scale-up in India. We evaluate the cost-effectiveness and budgetary impact of HCV treatment in India, including reinfection.

          Methods

          A closed cohort Markov model of HCV disease progression, treatment, and reinfection was parameterized. We compared treatment by fibrosis stage (F2-F4 or F0-F4) to no treatment from a health care payer perspective. Costs (2017 USD$, based on India-specific data) and health utilities (in quality-adjusted life years, QALYs) were attached to each health state. We assumed DAAs with 90% sustained viral response at $900/treatment and 1%/year reinfection, varied in the sensitivity analysis from 0.1–15%. We deemed the intervention cost-effective if the incremental cost-effectiveness ratio (ICER) fell below India’s per capita GDP ($1,709). We assessed the budgetary impact of treating all diagnosed individuals.

          Results

          HCV treatment for diagnosed F2-F4 individuals was cost-saving (net costs -$2,881 and net QALYs 3.18/person treated; negative ICER) compared to no treatment. HCV treatment remained cost-saving with reinfection rates of 15%/year. Treating all diagnosed individuals was likely cost-effective compared to delay until F2 (mean ICER $1,586/QALY gained, 67% of simulations falling under the $1,709 threshold) with 1%/year reinfection. For all scenarios, annual retesting for reinfection was more cost-effective than the current policy (one-time retest). Treating all diagnosed individuals and reinfections results in net costs of $445–1,334 million over 5 years (<0.25% of total health care expenditure over 5 years), and cost-savings within 14 years.

          Conclusions

          HCV treatment was highly cost-effective in India, despite reinfection. Annual retesting for reinfection was cost-effective, supporting a policy change towards more frequent retesting. A comprehensive HCV treatment scale-up plan is warranted in India.

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          Most cited references31

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          Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence.

          In efforts to inform public health decision makers, the Global Burden of Diseases, Injuries, and Risk Factors 2010 (GBD2010) Study aims to estimate the burden of disease using available parameters. This study was conducted to collect and analyze available prevalence data to be used for estimating the hepatitis C virus (HCV) burden of disease. In this systematic review, antibody to HCV (anti-HCV) seroprevalence data from 232 articles were pooled to estimate age-specific seroprevalence curves in 1990 and 2005, and to produce age-standardized prevalence estimates for each of 21 GBD regions using a model-based meta-analysis. This review finds that globally the prevalence and number of people with anti-HCV has increased from 2.3% (95% uncertainty interval [UI]: 2.1%-2.5%) to 2.8% (95% UI: 2.6%-3.1%) and >122 million to >185 million between 1990 and 2005. Central and East Asia and North Africa/Middle East are estimated to have high prevalence (>3.5%); South and Southeast Asia, sub-Saharan Africa, Andean, Central, and Southern Latin America, Caribbean, Oceania, Australasia, and Central, Eastern, and Western Europe have moderate prevalence (1.5%-3.5%); whereas Asia Pacific, Tropical Latin America, and North America have low prevalence (<1.5%). The high prevalence of global HCV infection necessitates renewed efforts in primary prevention, including vaccine development, as well as new approaches to secondary and tertiary prevention to reduce the burden of chronic liver disease and to improve survival for those who already have evidence of liver disease. Copyright © 2012 American Association for the Study of Liver Diseases.
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            A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt.

            The hepatitis C pandemic has been systematically studied and characterized in North America and Europe, but this important public health problem has not received equivalent attention in other regions. The objective of this systematic review was to characterize hepatitis C virus (HCV) epidemiology in selected countries of Asia, Australia and Egypt, i.e. in a geographical area inhabited by over 40% of the global population. Data references were identified through indexed journals and non-indexed sources. In this work, 7770 articles were reviewed and 690 were selected based on their relevance. We estimated that 49.3-64.0 million adults in Asia, Australia and Egypt are anti-HCV positive. China alone has more HCV infections than all of Europe or the Americas. While most countries had prevalence rates from 1 to 2% we documented several with relatively high prevalence rates, including Egypt (15%), Pakistan (4.7%) and Taiwan (4.4%). Nosocomial infection, blood transfusion (before screening) and injection drug use were identified as common risk factors in the region. Genotype 1 was common in Australia, China, Taiwan and other countries in North Asia, while genotype 6 was found in Vietnam and other Southeast Asian countries. In India and Pakistan genotype 3 was predominant, while genotype 4 was found in Middle Eastern countries such as Egypt, Saudi Arabia and Syria. We recommend implementation of surveillance systems to guide effective public health policy that may lead to the eventual curtailment of the spread of this pandemic infection. © 2011 John Wiley & Sons A/S.
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              Risk of Late Relapse or Reinfection With Hepatitis C Virus After Achieving a Sustained Virological Response: A Systematic Review and Meta-analysis

              Sustained virological response is durable in patients treated for hepatitis C virus. Recurrence rates are generally low but increase in patient populations with risk factors for reinfection. The evidence supports the notion that risk of recurrence is driven by reinfection.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                6 June 2019
                2019
                : 14
                : 6
                : e0217964
                Affiliations
                [1 ] Division of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, La Jolla, California, United States of America
                [2 ] Department of Medicine, San Diego Veterans Affairs Medical Center, La Jolla, California, United States of America
                [3 ] Department of Medicine, Medical University of Graz, Graz, Austria
                [4 ] Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America
                [5 ] Population Health Sciences, University of Bristol, Bristol, United Kingdom
                Centers for Disease Control and Prevention, UNITED STATES
                Author notes

                Competing Interests: NM has received unrestricted research grants and honoraria from Gilead and Merck. PV has received unrestricted research grants from Gilead and honoraria from Gilead and Abbvie. MHo has received research grants from Gilead. MHi has received honoraria from Gilead, MSD and Abbvie. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0001-8780-3612
                http://orcid.org/0000-0001-8344-1810
                Article
                PONE-D-18-24666
                10.1371/journal.pone.0217964
                6553784
                31170246
                ae675668-2629-4a19-943d-b757142b5b8b
                © 2019 Chaillon et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 21 August 2018
                : 22 May 2019
                Page count
                Figures: 3, Tables: 3, Pages: 16
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
                Award ID: R01 DA037773
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100008673, Center for AIDS Research, University of California, San Diego;
                Award ID: P30 AI036214
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: MH113477
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
                Award ID: AI106039
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Award ID: MH100974
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
                Award ID: DA037811
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
                Award ID: AI106039
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
                Award ID: R01 DA037773
                Award Recipient :
                NKM and PV are supported by the National Institute for Drug Abuse [grant number R01 DA037773] and the University of California San Diego Center for AIDS Research (CFAR), a National Institute of Health (NIH) funded program [grant number P30 AI036214] which is supported by the following NIH Institutes and Centers: NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA NIGMS, and NIDDK. MHo reports additional support from NIMH MH113477 and NIAID AI106039, and SRM is supported by MH100974, DA037811, and AI106039. The views expressed are those of the authors and not necessarily those of the National Institutes of Health. PV and MHi acknowledge support from NIHR Health Protection Research Unit in Evaluation. NIH: https://www.nih.gov/. CFAR: https://cfar.ucsd.edu/en/. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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