P70 Telaprevir in combination with peginterferon and ribavirin in genotype 1 HCV Treatment-Naïve patients: final results of phase 3 ADVANCE Study

AimThe ADVANCE study is a 3-arm double-blind, randomised, placebo-controlled Phase 3 study assessing efficacy and safety of two telaprevir (TVR, T)-based response-guided regimens compared with peginterferon alfa-2a 180 _g/week and ribavirin 1000–1200 mg/day (PR) in treatment-naive patients with chronic genotype 1 HCV infection.MethodTreatment arms were (a) T 750 mg q8 h in combination with PR for 8 weeks, followed by additional weeks of PR; (b) T 750 mg q8 h in combination with PR for 12 weeks, followed by additional weeks of PR; (c) PR for 48 weeks (control arm). Patients in T arms achieving an extended rapid viral response (eRVR, undetectable HCV RNA at weeks 4 and 12) received a total of 24 weeks of therapy while those who did not received a total of 48 weeks of therapy. Randomisation was 1:1:1 and patients were stratified by HCV RNA (25%) AEs in the T arms were fatigue, pruritus, nausea, headache, anaemia, rash, influenza-like illness, insomnia, fever, and diarrhoea. Discontinuation of treatment due to AEs occurred in 8% in T8PR, 7% in T12PR and 4% in PR48; due to rash occurred in 0.5%, 1.4% and 0.0% and due to anaemia occurred in 3.3%, 0.8% and 0.6% in T8PR, T12PR and control arms, respectively.ConclusionA significantly greater proportion of patients achieved SVR with 12-week and 8-week telaprevir-based combination regimens (75% and 69%, respectively), compared with PR48 control arm (44%, p