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

Journal of Viral Hepatitis, 08/15/2013

Since 2011, telaprevir (TVR)–based triple therapy is the new treatment standard for hepatitis C genotype 1 virus infection. The aim of the 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. TVR–based triple therapy exhibited a high frequency of side effects requiring multiple therapeutic interventions. Notably, in the ‘real–life’ cohort, no lethal case was observed so far.

Methods

  • In total, the authors treated 102 patients: 24 treatment–naive 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).

Results

  • 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 the interim ITT analysis encompassing up to 24 weeks of TVR–based triple therapy, the ‘real–life’ antiviral effects are comparable to the results of large multicentric clinical trials.

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