Details

Autor(en) / Beteiligte

• Hézode, Christophe
• Fontaine, Helene
• Dorival, Celine
• Zoulim, Fabien
• Larrey, Dominique
• Canva, Valerie
• De Ledinghen, Victor
• Poynard, Thierry
• Samuel, Didier
• Bourliere, Marc
• Alric, Laurent
• Raabe, Jean–Jacques
• Zarski, Jean–Pierre
• Marcellin, Patrick
• Riachi, Ghassan
• Bernard, Pierre–Henri
• Loustaud–Ratti, Veronique
• Chazouilleres, Olivier
• Abergel, Armand
• Guyader, Dominique
• Metivier, Sophie
• Tran, Albert
• Di Martino, Vincent
• Causse, Xavier
• Dao, Thong
• Lucidarme, Damien
• Portal, Isabelle
• Cacoub, Patrice
• Gournay, Jerome
• Grando–Lemaire, Veronique
• Hillon, Patrick
• Attali, Pierre
• Fontanges, Thierry
• Rosa, Isabelle
• Petrov–Sanchez, Ventzislava
• Barthe, Yoann
• Pawlotsky, Jean–Michel
• Pol, Stanislas
• Carrat, Fabrice
• Bronowicki, Jean–Pierre

Titel

Effectiveness of Telaprevir or Boceprevir in Treatment-Experienced Patients With HCV Genotype 1 Infection and Cirrhosis

Ist Teil von

• Gastroenterology (New York, N.Y. 1943), 2014-07, Vol.147 (1), p.132-142.e4

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2014

Quelle

MEDLINE

Beschreibungen/Notizen

• Background & Aims We investigated the effectiveness of the protease inhibitors peginterferon and ribavirin in treatment-experienced patients with hepatitis C virus (HCV) genotype 1 infection and cirrhosis. Methods In the Compassionate Use of Protease Inhibitors in Viral C Cirrhosis study, 511 patients with HCV genotype 1 infection and compensated cirrhosis who did not respond to a prior course of peginterferon and ribavirin (44.3% relapsers or patients with viral breakthrough, 44.8% partial responders, and 8.0% null responders) were given either telaprevir (n = 299) or boceprevir (n = 212) for 48 weeks. We assessed percentages of patients with sustained viral responses 12 weeks after therapy and safety. This observational study did not allow for direct comparison of the 2 regimens. Results Among patients given telaprevir, 74.2% of relapsers, 40.0% of partial responders, and 19.4% of null responders achieved SVR12. Among those given boceprevir, 53.9% of relapsers, 38.3% of partial responders, and none of the null responders achieved SVR12. In multivariate analysis, factors associated with SVR12 included prior response to treatment response, no lead-in phase, HCV subtype 1b (vs 1a), and baseline platelet count greater than 100,000/mm3 . Severe adverse events occurred in 49.9% of cases, including liver decompensation, severe infections in 10.4%, and death in 2.2%. In multivariate analysis, baseline serum albumin level less than 35 g/L and baseline platelet counts of 100,000/mm3 or less predicted severe side effects or death. Conclusions Relatively high percentages of real-life, treatment-experienced patients with HCV genotype 1 infection and cirrhosis respond to the combination of peginterferon and ribavirin with telaprevir or boceprevir. However, side effects are frequent and often severe. Baseline levels of albumin and platelet counts can be used to guide treatment decisions. ClinicalTrials.gov number: NCT01514890.