Pretreatment evaluation of chronic hepatitis C - Risks, benefits, and costs

Context.-Chronic hepatitis C (CHC) infection affects nearly 4 million peopl e in the United States. Treatment with interferon alfa-2b has been limited by its cost and low likelihood of long-term response. Objective.-To examine the cost-effectiveness of alternative pretreatment ma nagement strategies for patients with CHC. Design.-Decision and cost-effectiveness analysis using a Markov model to ex amine prevalence of genotypes, viral load, and histological characteristics in relation to the sustained response rate with treatment. Data were based on a previously published decision model and a MEDLINE literature search f or hepatitis C, biopsy, and liver from 1966 to 1996. Patients.-A hypothetical population of patients with CHC infection and elev ated serum alanine aminotransferase level. Interventions.-Combinations of liver biopsy, genotyping, and quantitative v iral load determination prior to a single 6-month course of interferon alfa -2b; empirical interferon treatment; and conservative management. Main Outcome Measures.-Proportion of sustained responders, lifetime costs, life expectancy, and quality-adjusted life expectancy. Results.-Strategies involving hepatitis C virus (HCV) RNA testing had margi nal cost-effectiveness ratios up to $4400 per discounted quality-adjusted l ife-year gained but would miss up to 36% of sustained responders. Empirical interferon treatment had a marginal cost-effectiveness ratio of $12 400 pe r discounted quality-adjusted life-year gained and reached all potential su stained responders. Strategies involving liver biopsy were more expensive a nd would miss 6% of sustained responders and yield slightly lower life expe ctancies. Conclusions.-Routine liver biopsy before treatment with interferon increase s the cost of managing patients with CHC without improving health outcomes. Using quantitative HCV RNA testing to guide therapy misses some potential sustained responders. Empirical interferon treatment has a marginal cost-ef fectiveness ratio within the bounds of other commonly accepted therapies an d misses none of the sustained responders.