Impact of telaprevir in HCV patients with cirrhosis and RVR: real-life data from Boceprevir or Telaprevir based "triple therapy" experience in southern Italy

2015 Reviews on recent clinical trials In press;

Background and rationale of study The real-life data of triple therapy-based treatment in patients with chronic hepatitis C were investigated in this survey of 12 clinical centers of southern Italy. This retrospective study analyzed data from 176 consecutive patients. Methods 125(70%) patients were treated with telaprevir, and 51(30%) with boceprevir. There were no differences in demographic characteristics between the groups. The degree of liver fibrosis(LF) was evaluated according to liver biopsy(LB) and/or transient elastography(TE). 53/176 patients (30%) had liver cirrhosis. Sixteen patients(9%) were treatment naive, and the remaining were not: 92 were non-responders(52,84%), 63 relapsed(35,79%), and 5 discontinued treatment (2,8%). Results Overall, the rapid virological response(RVR) rate was 67.6%. Of the 103 patients who had follow-up for at least 12 weeks after the end of treatment, 61 (59,2%) achieved a sustained virological response(SVR). According to multivariate analysis for SVR, RVR was the only independent predictive factor of SVR, irrespective of the degree of LF and the type of response to previous treatments. In telaprevir-treated patients, the rate of RVR was similar in patients with F0-F2, F3 and F4 fibrosis (85%, 84%, 78%, respectively), and the SVR rates among RVR patients was similar irrespective of LF. Conclusions Data from this real-life study confirm the efficacy reported in clinical trials, although cirrhosis appears to play a smaller role in influencing treatment efficacy. Moreover, RVR is the only independent predictive factor of response regardless of cirrhosis. Based on RVR and for patients with cirrhosis, a shorter therapy might be considered, at least with telaprevir-based therapy.

Pubmed : 26672601