Introduction Current standard of care (SOC) for treatment of HCV Genotype 1 (G1) naive patients comprises of pegylated interferon (P) plus ribavirin (R) for 48 weeks resulting in a sustained viral response (SVR) of 42 to 46% in treated patients. Telaprevir (TVR) is a novel selective inhibitor of the HCV NS3-4A protease. We report here results from phase II program.
Method PROVE 1 (n=263) and PROVE 2 (n=334) were randomised controlled phase IIb comparisons of 12 weeks TVR plus PR up to 48 weeks vs PR alone in G1 treatment-naïve patients. In the same population, the C208 study (n=161) compared TVR dosed every 8 h or every 12 h in combination with P2a or P2b with a response guided therapy design. In treatment experienced patients, the PROVE 3 trial (n=453) compared different TVR-based regimens to PR.
Results Higher SVRs compared to SOC in treatment-naive subjects were observed in the TVR groups (61–69%) in the PROVE 1 and 2 studies as well as the C208 study (81–85%). In PROVE 3, 51% (vs. 14% in control) of previous non-responders achieved SVR. The most common AEs through week 48 included; pruritus, rash, anemia, fatigue, weakness and headaches. Overall discontinuation of all drugs due to rash was observed in 4–7% of the subjects.
Conclusion TVR-based triple therapy significantly improves SVR rates in comparison to SOC in G1 HCV infected patients. It offers the potential to reduce treatment duration by half in the majority of treatment-naive patients. Phase III studies of TVR-based regimen are currently underway.