The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection

Ann Intern Med. 2015 May 5;162(9):619-29. doi: 10.7326/M14-1313.


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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Antiviral Agents / economics*
  • Antiviral Agents / therapeutic use*
  • Cost-Benefit Analysis*
  • Disease Progression
  • Genotype
  • Hepatitis C, Chronic / complications
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / genetics
  • Humans
  • Interferon-alpha / economics
  • Interferon-alpha / therapeutic use
  • Liver Cirrhosis / drug therapy
  • Liver Cirrhosis / etiology
  • Markov Chains
  • Monte Carlo Method
  • Quality-Adjusted Life Years
  • Ribavirin / economics
  • Ribavirin / therapeutic use
  • Sofosbuvir
  • United States
  • Uridine Monophosphate / analogs & derivatives*
  • Uridine Monophosphate / economics
  • Uridine Monophosphate / therapeutic use


  • Antiviral Agents
  • Interferon-alpha
  • Ribavirin
  • Uridine Monophosphate
  • Sofosbuvir