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The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 InfectionSofosbuvir-Based Regimens for Treatment of HCV Genotype 2 or 3 Infection

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; and Arthur Y. Kim, MD
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 31 March 2015.


From Boston Medical Center, Boston University School of Public Health, Harvard School of Public Health, and Massachusetts General Hospital, Boston, Massachusetts; University of Chicago, Chicago, Illinois; and Weill Cornell Medical College, New York, New York.

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.


Ann Intern Med. 2015;162(9):619-629. doi:10.7326/M14-1313
Text Size: A A A

Background: 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.

Objective: To estimate the cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the United States.

Design: Monte Carlo simulation, including deterministic and probabilistic sensitivity analyses.

Data Sources: Randomized trials, observational cohorts, and national health care spending surveys.

Target Population: 8 patient types defined by HCV genotype (2 vs. 3), treatment history (naive vs. experienced), and cirrhosis status (noncirrhotic vs. cirrhotic).

Time Horizon: Lifetime.

Perspective: Payer.

Intervention: Sofosbuvir-based therapies, pegylated interferon–ribavirin, and no therapy.

Outcome Measures: Discounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).

Results of Base-Case Analysis: 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.

Results of Sensitivity Analysis: 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.

Limitation: The analysis did not consider possible benefits of preventing HCV transmission.

Conclusion: 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.

Primary Funding Source: National Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.

Figures

Grahic Jump Location
Figure 1.

Results of 1-way sensitivity analyses of the effect of the cost of SOF on the ICER of SOF-based therapy for treatment of HCV genotype 2 infection in treatment-naive noncirrhotic patients.

The dotted area illustrates the range of costs at which SOF–RBV is cost-saving compared with PEG–RBV. The shaded area depicts the range of costs at which the ICER of SOF–RBV is <$100 000 per QALY gained compared with PEG–RBV. HCV = hepatitis C virus; ICER = incremental cost-effectiveness ratio; PEG = pegylated interferon; QALY = quality-adjusted life-year; RBV = ribavirin; SOF = sofosbuvir.

Grahic Jump Location
Grahic Jump Location
Figure 2.

Results of 1-way sensitivity analyses of the effect of the cost of SOF on the ICER of SOF-based therapy for treatment of HCV genotype 3 infection in treatment-naive noncirrhotic patients.

The dotted area illustrates the range of costs at which the ICER of SOF–RBV is <$100 000 per QALY gained compared with PEG–RBV–SOF. The shaded area depicts the range of costs at which the ICER of PEG–RBV–SOF is <$100 000 per QALY compared with PEG–RBV. HCV = hepatitis C virus; ICER = incremental cost-effectiveness ratio; PEG = pegylated interferon; QALY = quality-adjusted life-year; RBV = ribavirin; SOF = sofosbuvir.

Grahic Jump Location

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