Benjamin P. Linas, MD, MPH; Devra M. Barter, MS; Jake R. Morgan, MS; Mai T. Pho, MD, MPH; Jared A. Leff, MS; Bruce R. Schackman, PhD; C. Robert Horsburgh, MD, MUS; Sabrina A. Assoumou, MD, MPH; Joshua A. Salomon, PhD; Milton C. Weinstein, PhD; Kenneth A. Freedberg, MD, MSc; Arthur Y. Kim, MD
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Grant Support: By the National Institute on Drug Abuse (R01DA031059 and R01DA027379) and the National Institute of Allergy and Infectious Diseases (R37AI042006).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-1313.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available for review upon discussion with the authors and as resources are available. Contact Dr. Linas (e-mail, Benjamin.Linas@bmc.org).
Requests for Single Reprints: Benjamin P. Linas, MD, MPH, Boston Medical Center, HIV Epidemiology and Outcomes Research Unit, 850 Harrison Avenue, Dowling 3N, Room 3205, Boston, MA 02118; e-mail, Benjamin.Linas@BMC.org.
Current Author Addresses: Dr. Linas: Boston Medical Center, HIV Epidemiology and Outcomes Research Unit, 850 Harrison Avenue, Dowling 3N, Room 3205, Boston, MA 02118.
Ms. Barter: Center for Disease Dynamics, Economics & Policy, 1616 P Street NW, Suite 430, Washington, DC 20036.
Mr. Morgan: Boston Medical Center, 850 Harrison Avenue, Dowling 3N, Room 3205, Boston, MA 02118.
Dr. Pho: University of Chicago, 5841 South Maryland Avenue, MC 5065, Chicago, IL 60307.
Mr. Leff and Dr. Schackman: Department of Healthcare Policy and Research, Weill Cornell Medical College, 425 East 61st Street, Suite #301, New York, NY 10065.
Dr. Horsburgh: Department of Epidemiology, Boston University, 715 Albany Street, T3E, Boston, MA 02118.
Dr. Assoumou: Section of Infectious Diseases, Boston Medical Center, 850 Harrison Avenue, Dowling 3N, Room 3110, Boston, MA 02118.
Dr. Salomon: Department of Global Health and Population, Harvard School of Public Health, 665 Huntington Avenue, Building 1, Room 1109, Boston, MA 02115.
Dr. Weinstein: Center for Health Decision Science, Harvard School of Public Health, 718 Huntington Avenue, Boston, MA 02115.
Dr. Freedberg: Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, 9th Floor, Boston, MA 02114.
Dr. Kim: Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit Street, Cox 5, Boston, MA 02114.
Author Contributions: Conception and design: B.P. Linas, D.M. Barter, C.R. Horsburgh, M.C. Weinstein, A.Y. Kim.
Analysis and interpretation of the data: B.P. Linas, D.M. Barter, J.R. Morgan, J.A. Leff, B.R. Schackman, C.R. Horsburgh, S.A. Assoumou, J.A. Salomon, M.C. Weinstein, K.A. Freedberg, A.Y. Kim.
Drafting of the article: B.P. Linas, D.M. Barter, J.R. Morgan, M.T. Pho, S.A. Assoumou, A.Y. Kim.
Critical revision of the article for important intellectual content: B.P. Linas, J.R. Morgan, M.T. Pho, J.A. Leff, B.R. Schackman, J.A. Salomon, M.C. Weinstein, K.A. Freedberg, A.Y. Kim.
Final approval of the article: B.P. Linas, D.M. Barter, J.R. Morgan, M.T. Pho, J.A. Leff, B.R. Schackman, C.R. Horsburgh, S.A. Assoumou, J.A. Salomon, M.C. Weinstein, K.A. Freedberg, A.Y. Kim.
Provision of study materials or patients: B.P. Linas, D.M. Barter.
Statistical expertise: B.P. Linas, J.R. Morgan, J.A. Salomon, M.C. Weinstein.
Obtaining of funding: B.P. Linas.
Administrative, technical, or logistic support: B.P. Linas, D.M. Barter, J.R. Morgan, J.A. Leff.
Collection and assembly of data: B.P. Linas, D.M. Barter, J.R. Morgan.
Chronic infection with hepatitis C virus (HCV) genotype 2 or 3 can be treated with sofosbuvir without interferon. Because sofosbuvir is costly, its benefits should be compared with the additional resources used.
To estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States.
Monte Carlo simulation, including deterministic and probabilistic sensitivity analyses.
Randomized trials, observational cohorts, and national health care spending surveys.
8 patient types defined by HCV genotype (2 vs. 3), treatment history (naive vs. experienced), and cirrhosis status (noncirrhotic vs. cirrhotic).
Sofosbuvir-based therapies, pegylated interferon–ribavirin, and no therapy.
Discounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).
The ICER of sofosbuvir-based treatment was less than $100 000 per QALY in cirrhotic patients (genotype 2 or 3 and treatment-naive or treatment-experienced) and in treatment-experienced noncirrhotic patients but was greater than $200 000 per QALY in treatment-naive noncirrhotic patients.
The ICER of sofosbuvir-based therapy for treatment-naive noncirrhotic patients with genotype 2 or 3 infection was less than $100 000 per QALY when the cost of sofosbuvir was reduced by approximately 40% and 60%, respectively. In probabilistic sensitivity analyses, cost-effectiveness conclusions were robust to uncertainty in treatment efficacy.
The analysis did not consider possible benefits of preventing HCV transmission.
Sofosbuvir provides good value for money for treatment-experienced patients with HCV genotype 2 or 3 infection and those with cirrhosis. At their current cost, sofosbuvir-based regimens for treatment-naive noncirrhotic patients exceed willingness-to-pay thresholds commonly cited in the United States.
National Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.
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Linas BP, Barter DM, Morgan JR, Pho MT, Leff JA, Schackman BR, et al. The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection. Ann Intern Med. 2015;162:619-629. doi: 10.7326/M14-1313
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Published: Ann Intern Med. 2015;162(9):619-629.
Gastroenterology/Hepatology, Healthcare Delivery and Policy, Infectious Disease, Viral Hepatitis.
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