Comparative Effectiveness Review Number 76 Treatment for Hepatitis C Virus Infection in Adults Comparative Effectiveness Review Number 76 Treatment for Hepatitis C Virus Infection in Adults Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-2007-10057-I Prepared by: Oregon Evidence-based Practice Center Oregon Health & Science University Portland, OR Investigators: Roger Chou, M.D. Daniel Hartung, Pharm.D., M.P.H. Basmah Rahman, M.P.H. Ngoc Wasson, M.P.H. Erika Cottrell, Ph.D. Rongwei Fu, Ph.D. AHRQ Publication No. 12(13)-EHC113-EF November 2012 This report is based on research conducted by the Oregon Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10057-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products or actions may not be stated or implied. This document is in the public domain and may be used and reprinted without special permission, except those copyrighted materials that are clearly noted in the document. Further reproduction of those copyrighted materials is prohibited without the specific permission of copyright holders. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. Suggested citation: Chou R, Hartung D, Rahman B, Wasson N, Cottrell E, Fu R. Treatment for Hepatitis C Virus Infection in Adults. Comparative Effectiveness Review No. 76. (Prepared by Oregon Evidence-based Practice Center under Contract No. 290-2007-10057-I.) AHRQ Publication No. 12(13)-EHC113-EF. Rockville, MD: Agency for Healthcare Research and Quality. November 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm. ii Preface The Agency for Healthcare Research and Quality (AHRQ) conducts the Effective Health Care Program as part of its mission to organize knowledge and make it available to inform decisions about health care. As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Congress directed AHRQ to conduct and support research on the comparative outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services to meet the needs of Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). AHRQ has an established network of Evidence-based Practice Centers (EPCs) that produce Evidence Reports/Technology Assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care. The EPCs now lend their expertise to the Effective Health Care Program by conducting comparative effectiveness reviews (CERs) of medications, devices, and other relevant interventions, including strategies for how these items and services can best be organized, managed, and delivered. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. In the context of developing recommendations for practice, systematic reviews are useful because they define the strengths and limits of the evidence, clarifying whether assertions about the value of the intervention are based on strong evidence from clinical studies. For more information about systematic reviews, see www.effectivehealthcare.ahrq.gov/reference/purpose.cfm. AHRQ expects that CERs will be helpful to health plans, providers, purchasers, government programs, and the health care system as a whole. In addition, AHRQ is committed to presenting information in different formats so that consumers who make decisions about their own and their family’s health can benefit from the evidence. Transparency and stakeholder input from are essential to the Effective Health Care Program. Please visit the Web site (www.effectivehealthcare.ahrq.gov) to see draft research questions and reports or to join an email list to learn about new program products and opportunities for input. Comparative Effectiveness Reviews will be updated regularly. We welcome comments on this CER. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to [email protected]. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Stephanie Chang, M.D., M.P.H. Christine Chang M.D., M.P.H. Director Task Order Officer Evidence-based Practice Program Center for Outcomes and Evidence Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments We thank our colleagues at the Oregon Evidence-based Practice Center, Robin Paynter, M.L.I.S., and Rose Campbell, M.L.I.S., for conducting the literature searches, and Leah Williams, B.S., Ed Reid, M.A., and Elaine Graham, M.L.S. for editorial support. We appreciate and acknowledge the contributions of AHRQ Task Order Officer Christine Chang, M.D., M.P.H.; USPSTF Medical Officer Iris Mabry-Hernandez, M.D., M.P.H.; and Evidence-based Practice Center Program Associate Editor Kathleen N. Lohr, Ph.D. We also thank the Key Informants, members of the Technical Expert Panel, and Peer Reviewers. Key Informants Miriam Alter, Ph.D., M.P.H. John Ward, M.D., M.P.H. Professor, Infectious Disease Epidemiology Director, Viral Hepatitis Division Department of Internal Medicine Centers for Disease Control and Prevention Division of Infectious Disease Atlanta, GA University of Texas Austin, TX Barbara Yawn, M.D., M.Sc., F.A.A.C.P. Director of Research, Olmstead Medical Michael Ninburg, M.P.A. Center Executive Director University of Minnesota Hepatitis Education Project Minneapolis, MN Seattle, WA Janet Patin, M.D. Oregon Rural Practice-based Research Network (ORPRN) Dunes Family Clinic Reedsport, OR iv Technical Expert Panel Miriam Alter, Ph.D., M.P.H. Bruce A. Runyon, M.D. Professor, Infectious Disease Epidemiology Chief, Liver Service Department of Internal Medicine Professor of Medicine Division of Infectious Disease Loma Linda University Medical Center University of Texas Loma Linda, CA Austin, TX Bryce Smith, Ph.D. Kirsten Bibbins-Domingo, Ph.D., M.D. Viral Hepatitis Division Associate Professor of Medicine and Centers for Disease Control and Prevention Epidemiology & Biostatistics Atlanta, GA University of California, San Francisco San Francisco, CA Donna E. Sweet, M.D., M.A.C.P. American College of Physicians Robert Gish, M.D. Professor of Medicine Co-director, Chief of Clinical Hepatology University of Kansas School of Medicine Professor of Clinical Medicine Wichita, KS University of California, San Diego San Diego, CA Timothy Wilt, M.D., M.P.H. Professor, Department of Medicine, Stephen E. Livingston, M.D. Minneapolis VA Medical Center Alaska Native Tribal Health Consortium University of Minnesota Liver Disease and Hepatitis Program Minneapolis, MN Anchorage, AK Peer Reviewers Robert Gish, M.D. Averell Sherker, M.D. School of Medicine National Institutes of Health, NIDDK University of California, San Diego Bethesda, MD San Diego, CA Donna Sweet, M.D., M.A.C.P. Adelita Gonzales Cantu, Ph.D., R.N. Via Christi Regional Medical Center-St. School of Nursing Francis Campus University of Texas Health Science Center Wichita, KS at San Antonio San Antonio, TX Fasiha Kanwal, M.D. Saint Louis University School of Medicine St. Louis, MO v Treatment for Hepatitis C Virus Infection in Adults Structured Abstract Objectives. This report systematically reviews the comparative benefits and harms of current antiviral treatment regimens for chronic hepatitis C virus (HCV) infection in treatment-naïve adults. Data sources. MEDLINE® (1947 to August 2012), the Cochrane Central Register of Controlled Trials (through 3rd quarter 2012), clinical trial registries, and reference lists. Review methods. We used predefined criteria to determine study eligibility. We selected randomized trials of dual therapy with pegylated interferon