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.
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.