Format

Send to

Choose Destination
Gastroenterology. 2014 Jul;147(1):132-142.e4. doi: 10.1053/j.gastro.2014.03.051. Epub 2014 Apr 3.

Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis.

Author information

1
Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, AP-HP, Université Paris-Est, INSERM U955, Créteil, France.
2
Department of Hepatology, Hôpital Cochin, AP-HP, Université Paris-René Descartes, INSERM U1016, Paris, France.
3
INSERM UMR-S 1136, Université Pierre et Marie Curie Paris 6, Paris, France.
4
Department of Hepatology, Hospices Civils de Lyon, INSERM U1052, Université de Lyon, Lyon, France.
5
Liver Unit-IRB-INSERM1040, Hôpital Saint Eloi, Montpellier, France.
6
Department of Hepatology and Gastroenterology, Centre Hospitalier Régional et Universitaire Claude Huriez, Lille, France.
7
Department of Hepatology and Gastroenterology, Hôpital Haut-Lévêque, Pessac, INSERM U1053, Université Bordeaux Segalen, Bordeaux, France.
8
Department of Hepatology and Gastroenterology, Groupe Hospitalier Pitié-Salpétrière, AP-HP, Université Pierre et Marie Curie Paris 6, INSERM UMR-S938, Paris, France.
9
Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, UMR-S785, Université Paris-Sud, INSERM U785, Villejuif, France.
10
Department of Hepatology and Gastroenterology, Hôpital Saint Joseph, Marseille, France.
11
Department of Internal Medicine and Digestive Diseases, UMR-152, Toulouse III University, Toulouse, France.
12
Department of Hepatology and Gastroenterology, Centre Hospitalier Régional, Metz, France.
13
Department of Hepatology and Gastroenterology, Centre Hospitalo-Universitaire, INSERM U823, Grenoble, France.
14
Department of Hepatology, Hôpital Beaujon, AP-HP, Université Paris-Diderot, INSERM CRB3, Clichy, France.
15
Department of Hepatology and Gastroenterology, CHU Charles Nicolle, Rouen, France.
16
Service d'Hépatologie et Gastroentérologie, Hôpital Saint-André, Bordeaux, INSERM U1053, Université Bordeaux Segalen, Bordeaux, France.
17
Department of Hepatology and Gastroenterology, CHU Dupuytren, Université de Limoges, UMR INSERM U1092, Limoges, France.
18
Department of Hepatology, Hôpital Saint-Antoine, AP-HP, Paris, France.
19
Department of Hepatology and Gastroenterology, CHU Estaing, Université d'Auvergne, UMR 6284, Clermont-Ferrand, France.
20
Service des Maladies du Foie, CHU Rennes, Université de Rennes 1, INSERM U991, Rennes, France.
21
Department of Hepatology and Gastroenterology, CHU Purpan, Toulouse, France.
22
Digestive Center, Centre Hospitalier Universitaire de Nice, INSERM U1065-8, Nice, France.
23
Service d'Hépatologie, CHU Jean Minjoz, Université de Franche Comté, Besançon, France.
24
Department of Hepatology and Gastroenterology and Digestive Oncology, CHR La Source, Orléans, France.
25
Department of Hepatology and Gastroenterology, CHU, INSERM U1075, Caen, France.
26
Department of Hepatology and Gastroenterology, Groupe Hospitalier de l'Institut Catholique Lillois, Faculté Libre de Médecine, Lille, France.
27
Department of Hepatology and Gastroenterology, Hôpital de la Conception, Marseille, France.
28
Department of Internal Medicine, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Pierre et Marie Curie Paris 6, INSERM, UMR-S959, CNRS, UMR 7211, Paris, France.
29
Department of Hepatology and Gastroenterology, Hôpital Hôtel-Dieu, Nantes, France.
30
Department of Hepatology and Gastroenterology, Hôpital Jean Verdier, AP-HP, Université Paris 13, Bondy, France.
31
Department of Hepatology and Gastroenterology, CHU de Dijon, Université de Bourgogne, Dijon, France.
32
Department of Hepatology and Gastroenterology, Hôpital de Bicêtre, AP-HP, Le Kremlin-Bicêtre, France.
33
Department of Hepatology and Gastroenterology, Hôpital P Oudot, Bourgoin-Jallieu, France.
34
Department of Hepatology and Gastroenterology, Centre Hospitalier Intercommunal, Créteil, France.
35
Unit for Basic and Clinical Research on Viral Hepatitis, French National Agency for Research on AIDS and Viral Hepatitis, Paris, France.
36
National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, AP-HP, Université Paris-Est, INSERM U955, Créteil, France.
37
INSERM UMR-S 1136, Université Pierre et Marie Curie Paris 6, Paris, France; Department of Public Health, Hôpital Saint-Antoine, AP-HP, Paris, France.
38
Department of Hepatology and Gastroenterology, Centre Hospitalier Universitaire de Nancy, Université de Lorraine, INSERM U954, Vandoeuvre-les-Nancy, France. Electronic address: jp.bronowicki@chu-nancy.fr.

Abstract

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/mm(3). 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/mm(3) 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.

KEYWORDS:

CUPIC; Chronic Hepatitis C; DAA; Triple Therapy

PMID:
24704719
DOI:
10.1053/j.gastro.2014.03.051
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science Icon for HAL archives ouvertes
Loading ...
Support Center