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Abstract
ObjectiveTo explore the expected long-term health and economic outcomes of telaprevir (TVR) plus peginterferon alfa-2a and ribavirin (PR), a regimen that demonstrated substantially increased sustained virologic response (SVR) compared with PR alone in adults with chronic genotype 1 hepatitis C virus (HCV) and compensated liver disease in the Phase III studies ADVANCE (treatment-naïve patients) and REALIZE (relapsers, partial responders, and null responders to previous PR treatment).Study DesignA decision-analytic model was developed to assess the cost-effectiveness of TVR+PR vs. PR in the United States (US).MethodsPatients first moved through the 72-week decision-tree treatment phase of the model and then entered the cyclic Markov post-treatment phase. Clinical data (patient characteristics, SVR rates, and adverse event rates and durations) were obtained from ADVANCE and REALIZE. Health-state transition probabilities, drug and other costs (in 2012/2013 US dollars), and utility values were obtained from the trials, published studies, and publicly available sources. Outcomes were discounted at 3% per year.ResultsRegardless of treatment history, patients receiving TVR+PR were projected to experience fewer liver-disease complications, more life-years, and more quality-adjusted life-years (QALYs) than patients receiving PR. In prior relapsers, TVR+PR was dominant, with lower total medical costs and more QALYs. For the other patient subgroups, incremental costs per QALY gained were between $16,778 (treatment-naïve patients) and $34,279 (prior null responders). Extensive sensitivity analyses confirmed robust model results.ConclusionsAt standard willingness-to-pay thresholds, TVR+PR represents a cost-effective treatment option compared with PR alone for patients with chronic genotype 1 HCV and compensated liver disease in the US. Future analyses are needed to compare TVR+PR with all existing HCV treatment options.
Highlights
Of the worldwide population, 2% to 3% (130–170 million people), including approximately 3.2 million in the United States (US), are chronically infected with the hepatitis C virus (HCV) [1], [2]
At standard willingness-to-pay thresholds, TVR+peginterferon and ribavirin (PR) represents a cost-effective treatment option compared with PR alone for patients with chronic genotype 1 HCV and compensated liver disease in the US
The model predicted that patients receiving TVR+PR were less likely to experience compensated cirrhosis, decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC), or liver transplant and were less likely to die from HCV-related causes than patients who received PR alone
Summary
2% to 3% (130–170 million people), including approximately 3.2 million in the United States (US), are chronically infected with the hepatitis C virus (HCV) [1], [2]. The primary goal of treatment of chronic HCV infection is sustained virologic response (SVR), defined as undetectable HCV RNA 24 weeks after completion of treatment. Among treatment-naıve patients with genotype 1 HCV infection, therapy with a 48-week course of peginterferon and ribavirin (PR) historically has yielded clinical trial SVR rates ranging from 42% to 46% [10], [11]; re-treatment with PR has been associated with lower SVR rates (16.3%) [12]
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