New Protease Inhibitors for the Treatment of Chronic Hepatitis C A Cost-Effectiveness Analysis

Background: Chronic hepatitis C virus is difficult to treat and affects approximately 3 million Americans. Protease inhibitors increase the effectiveness of standard therapy, but they are costly. A genetic assay may identify patients most likely to benefit from this treatment advance. Objective: To assess the cost-effectiveness of new protease inhibitors and an interleukin (IL)-28B genotyping assay for treating chronic hepatitis C virus. Design: Decision-analytic Markov model. Data Sources: Published literature and expert opinion. Target Population: Treatment-naive patients with chronic, genotype 1 hepatitis C virus monoinfection. Time Horizon: Lifetime. Perspective: Societal. Intervention: Strategies are defined by the use of IL-28B genotyping and type of treatment (standard therapy [pegylated interferon with ribavirin]; triple therapy [standard therapy and a protease inhibitor]). Interleukin-28B-guided triple therapy stratifies patients with CC genotypes to standard therapy and those with non-CC types to triple therapy. Outcome Measures: Discounted costs (in 2010 U.S. dollars) and quality-adjusted life-years (QALYs); incremental cost-effectiveness ratios. Results of Base-Case Analysis: For patients with mild and advanced fibrosis, universal triple therapy reduced the lifetime risk for hepatocellular carcinoma by 38% and 28%, respectively, and increased quality-adjusted life expectancy by 3% and 8%, respectively, compared with standard therapy. Gains from IL-28B-guided triple therapy were smaller. If the protease inhibitor costs $1100 per week, universal triple therapy costs $102 600 per QALY (mild fibrosis) or $51 500 per QALY (advanced fibrosis) compared with IL-28B-guided triple therapy and $70 100 per QALY (mild fibrosis) and $36 300 per QALY (advanced fibrosis) compared with standard therapy. Results of Sensitivity Analysis: Results were sensitive to the cost of protease inhibitors and treatment adherence rates. Limitation: Data on the long-term comparative effectiveness of the new protease inhibitors are lacking. Conclusion: Both universal triple therapy and IL-28B-guided triple therapy are cost-effective when the least-expensive protease inhibitor are used for patients with advanced fibrosis.