Tuesday, June 25, 2013

Telaprevir Activity in Treatment-Naïve Genotype 4 Hepatitis C-Infected Patients: A Randomized Trial

Telaprevir Activity in Treatment-Naïve Genotype 4 Hepatitis C-Infected Patients: A Randomized Trial

Yves Benhamou1, Joseph Moussalli1, Vlad Ratziu1,2, Pascal Lebray1, Katrien De Backer3, Sandra De Meyer3, Anne Ghys3, Donghan Luo4, Gaston Picchio4 and Maria Beumont3

+ Author Affiliations
1Service d'Hépato-Gasteroentérologie, Hôpital Pitié-Salpêtrière, Paris, France
2Université Pierre et Marie Curie, Paris VI, Paris, France
3Janssen Infectious Diseases BVBA, Beerse, Belgium
4Janssen Research and Development, Titusville, NJ, USA
Correspondence: Dr Yves Benhamou, Hôpital Pitié-Salpêtrière, 47–83 Boulevard de l'Hôpital, Paris, France (ybenhamou@teaser.fr)

The partially-blinded, randomized, phase IIa C210 study evaluated the antiviral activity of telaprevir-based regimens in treatment-naïve, genotype 4 chronic hepatitis C virus (HCV)-infected patients.

Patients (n=24) received 15 days of telaprevir 750 mg every 8 hours (T; n=8), telaprevir in combination with peginterferon alfa-2a and ribavirin (Peg-IFN/RBV; TPR; n=8), or Peg-IFN/RBV plus placebo (PR; n = 8), followed by Peg-IFN/RBV for 46 or 48 weeks. The primary objective was to assess the effect of telaprevir on HCV RNA levels.

HCV RNA levels decreased slightly with T and PR; TPR produced substantial, rapid declines. At Day 15, median HCV RNA reductions from baseline were -0.77, -4.32, and -1.58 log10 IU/mL for T, TPR and PR, respectively, and 0 (T), 1 (TPR), and 0 (PR) patients had undetectable HCV RNA. Five/eight patients who received telaprevir monotherapy had viral breakthrough within 15 days of treatment. Adverse event incidence was similar across treatments and comparable with previous clinical trials. One patient (T group) had a serious adverse event (considered unrelated to telaprevir) that led to treatment discontinuation.

Telaprevir with Peg-IFN/RBV had greater activity against HCV genotype 4 than Peg-IFN/RBV or telaprevir monotherapy. Telaprevir was generally safe and well tolerated. Further investigation of telaprevir combination therapy in genotype 4 patients is warranted.


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