Universität zu Köln

Serfaty, Lawrence, Forns, Xavier ORCID: 0000-0002-8188-1764, Goeser, Tobias, Ferenci, Peter, Nevens, Frederik, Carosi, Giampiero, Drenth, Joost P., Lonjon-Domanec, Isabelle, DeMasi, Ralph, Picchio, Gaston, Beumont, Maria and Marcellin, Patrick (2012). Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut, 61 (10). S. 1473 - 1481. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-3288

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Abstract

Objective Insulin resistance is a predictor of poor response to peginterferon/ribavirin in patients infected with the chronic hepatitis C virus (HCV). There are no data on direct-acting antivirals. This exploratory analysis assessed the effect of metabolic factors and insulin resistance, measured by homoeostatic model assessment (HOMA), on virological response to telaprevir in Study C208. Design Overall, 161 HCV genotype 1-infected, treatment-naive patients received 12 weeks of telaprevir plus peginterferon/ribavirin, then 12/36 weeks of peginterferon/ribavirin depending on on-treatment response criteria. The prognostic significance of several factors, including HOMA-insulin resistance (HOMA-IR), on virological response at weeks 4 and 12, end of treatment and 24 weeks after treatment was explored by multiple regression analysis. Results Baseline HOMA-IR data were available for 147 patients; baseline characteristics were consistent with the overall population. Baseline HOMA-IR <2, 2-4 and >4 was seen in 54%, 30% and 16% of patients, respectively. Neither response rates (any time point) nor week 4 viral load decline were significantly influenced by baseline HOMA-IR. In multivariate analyses, fibrosis stage and low-density lipoprotein cholesterol level were predictive of sustained virological response (OR 0.47 and 1.02, respectively). After the end of treatment, HOMA-IR was significantly lower in patients with sustained virological response than in those without (0.61 vs 1.34 for relapsers and 1.15 for non-responders; p<0.05). Conclusion In this study, baseline HOMA-IR was not predictive of virological response to telaprevir in HCV genotype 1-infected, treatment-naive patients, while sustained virological response was associated with improved HOMA-IR. These results suggest that metabolic factors and insulin resistance do not have a significant effect on telaprevir-based treatment efficacy.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Serfaty, Lawrence UNSPECIFIED UNSPECIFIED UNSPECIFIED Forns, Xavier UNSPECIFIED orcid.org/0000-0002-8188-1764 UNSPECIFIED Goeser, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Ferenci, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Nevens, Frederik UNSPECIFIED UNSPECIFIED UNSPECIFIED Carosi, Giampiero UNSPECIFIED UNSPECIFIED UNSPECIFIED Drenth, Joost P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lonjon-Domanec, Isabelle UNSPECIFIED UNSPECIFIED UNSPECIFIED DeMasi, Ralph UNSPECIFIED UNSPECIFIED UNSPECIFIED Picchio, Gaston UNSPECIFIED UNSPECIFIED UNSPECIFIED Beumont, Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Marcellin, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-482033
DOI:	10.1136/gutjnl-2011-300749
Journal or Publication Title:	Gut
Volume:	61
Number:	10
Page Range:	S. 1473 - 1481
Date:	2012
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1468-3288
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CHRONIC HEPATITIS-C; SUSTAINED VIROLOGICAL RESPONSE; HOMEOSTASIS MODEL ASSESSMENT; PEGYLATED INTERFERON; ANTIVIRAL TREATMENT; FIBROSIS; ASSOCIATION; SENSITIVITY; STEATOSIS; THERAPY Multiple languages Gastroenterology & Hepatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48203