Myers RP, Brogan AJ, Talbird SE, Thompson J, Marcellin P, Jacobson IM, DeMasi R, Menzie AM, Yoshida EM. Efficacy, safety, and cost-effectiveness in Canada of telaprevir combination therapy by baseline fibrosis stage in treatment-naïve patients with chronic genotype 1 hepatitis C virus infection. Presented at the 2013 Canadian Digestive Diseases Week and the Annual Winter Meeting of the Canadian Association for the Study of the Liver; March 2013.

AIMS: To assess the efficacy, safety, and cost-effectiveness in Canada of 12-weeks of telaprevir in combination with 24 or 48 weeks of peginterferon/ribavirin (T12PR) compared with 48 weeks of PR alone for treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection by baseline fibrosis score.

METHODS: A post-hoc analysis of the ADVANCE Phase 3 clinical trial (T12PR, N=363; PR, N=361) was conducted to analyze virologic responses (extended rapid virologic response [eRVR], sustained virologic response [SVR]) and safety by baseline liver fibrosis (METAVIR stages F0-F4). A lifetime, two-phase (treatment; post-treatment) decision analytic model assessed cost-effectiveness. Transition probabilities between health states and direct costs related to HCV and advanced liver disease treatment (e.g. for medications, physician visits, laboratory monitoring, adverse event [AE] management) were obtained from published sources. All outcomes were discounted at 5% per year and costs are reported in 2012 $CDN.

RESULTS: Fibrosis stage distribution was similar in T12PR [F0-F1, N=134 (37%); F2, N=156 (43%); F3, N=52 (14%); F4, N=21 (6%)] and PR [F0-F1, N=147 (41%); F2, N=141 (39%); F3, N=52 (14%); F4, N=21(6%)]. eRVR rates were 63%, 58%, and 52% (T12PR) and 7%, 11%, and 5% (PR) in patients with baseline fibrosis scores of F0-F1, F2, and F3-F4, respectively. SVR rates were 85%, 79%, 63%, and 71% (T12PR) and 48%, 49%, 35%, and 38% (PR), F0-F1, F2, F3, and F4, respectively. In both groups, AEs were more common among patients with more advanced liver disease. Rates of discontinuation from all study drugs due to an AE were 4% (F0-F1), 10% (F2), and 19% (F3-F4) for T12PR patients and 9% (F0- F1), 6% (F2), and 5% (F3-F4) for PR patients. Cost-effectiveness analyses are presented (Table).

CONCLUSIONS: Regardless of fibrosis stage, in treatment-naïve patients with chronic genotype 1 HCV infection, higher SVR and discontinuation rates were observed for T12PR than for PR. Compared with PR, T12PR was cost-effective across all fibrosis stages.