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

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• 作者：Christophe Hé ; zode¹ ; ^&lowast ; ; Helene Fontaine² ; ^&lowast ; ; Celine Dorival³ ; Fabien Zoulim⁴ ; Dominique Larrey⁵ ; Valerie Canva⁶ ; Victor De Ledinghen⁷ ; Thierry Poynard⁸ ; Didier Samuel⁹ ; Marc Bourliere¹⁰ ; Laurent Alric¹¹ ; Jean&ndash ; Jacques Raabe¹² ; Jean&ndash ; Pierre Zarski¹³ ; Patrick Marcellin¹⁴ ; Ghassan Riachi¹⁵ ; Pierre&ndash ; Henri Bernard¹⁶ ; Veronique Loustaud&ndash ; Ratti¹⁷ ; Olivier Chazouilleres¹⁸ ; Armand Abergel¹⁹ ; Dominique Guyader²⁰ ; Sophie Metivier²¹ ; Albert Tran²² ; Vincent Di Martino²³ ; Xavier Causse²⁴ ; Thong Dao²⁵ ; Damien Lucidarme²⁶ ; Isabelle Portal²⁷ ; Patrice Cacoub²⁸ ; Jerome Gournay²⁹ ; Veronique Grando&ndash ; Lemaire³⁰ ; Patrick Hillon³¹ ; Pierre Attali³² ; Thierry Fontanges³³ ; Isabelle Rosa³⁴ ; Ventzislava Petrov&ndash ; Sanchez³⁵ ; Yoann Barthe³ ; Jean&ndash ; Michel Pawlotsky³⁶ ; Stanislas Pol² ; Fabrice Carrat³ ; ³⁷ ; Jean&ndash ; Pierre Bronowicki³⁸ ; ^{jp.bronowicki@chu-nancy.fr" class="auth_mail" title="E-mail the corresponding author} ; the CUPIC Study Group
• 关键词：Chronic Hepatitis C ; CUPIC ; DAA ; Triple Therapy
• 刊名：Gastroenterology
• 出版年：2014
• 出版时间：July 2014
• 年：2014
• 卷：147
• 期：1
• 页码：132-142.e4
• 全文大小：1187 K

文摘

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.