Efficacy and safety of telaprevir (TVR) triple therapy in a 'real-life' cohort of 102 patients with HCV genotype 1: interim analysis after 24 weeks of treatment.

Since 2011, telaprevir (TVR)-based triple therapy is the new treatment standard for hepatitis C genotype 1 virus infection. The aim of our retrospective interim analysis encompassing the first 24 weeks on TVR-based triple therapy was to assess 'real-life' antiviral efficacy and side effects in a large single-centre cohort, both in comparison with the data obtained in large prospective clinical trials. In total, we treated 102 patients: 24 treatment-naïve patients, 58 patients pretreated with PEG-IFN/RBV (thereof: 28 with nonresponse, 25 with relapse, five unknown) and 20 patients who previously had received nonpegylated interferon. 74 of 102 patients were assigned with HCV genotype 1b; 34 of 102 patients were treated in the context of liver cirrhosis. 72 of 102 patients have reached treatment week 24 (mean treatment duration 31 weeks). In the ITT analysis, overall response rates were at: week 4: 66%; week 12: 85%; and week 24: 78%. So far, 24 patients discontinued treatment prematurely, of those, 10 patients were due to virological failure. Haematological side effects were frequent (40% anaemia), as were 'flu-like' symptoms (94%), rash (65%) and pruritus (79%). According to our interim ITT analysis encompassing up to 24 weeks of TVR-based triple therapy, our 'real-life' antiviral effects are comparable to the results of large multicentric clinical trials. However, TVR-based triple therapy exhibited a high frequency of side effects requiring multiple therapeutic interventions. Notably, in our 'real-life' cohort, no lethal case was observed so far.