Steatosis is an independent predictor of relapse following rapid virologic response in patients with HCV genotype 3.

Abstract

BACKGROUND & AIMS:

It is recommended that patients with chronic hepatitis C virus (HCV) genotype 3 infections receive 24 weeks of treatment. A rapid virologic response (RVR; at week 4) predicts a sustained virologic response (SVR), although not all patients with an RVR achieve an SVR. We explored the relationships among hepatic steatosis, level of HCV RNA, relapse, and RVR in a phase 3 randomized controlled trial of 932 patients infected with HCV genotype 2 (n = 427) or 3 (n = 505) who received 24 weeks of therapy with interferon-α.

METHODS:

In patients with an RVR (HCV RNA <43 IU/mL), the presence of an SVR was modeled using multivariate logistic regression as a function of age, sex, weight, body mass index, insulin resistance, steatosis, and levels of γ-glutamyl transpeptidase, alanine aminotransferase, liver fibrosis, and baseline HCV RNA.

RESULTS:

RVR, SVR, and relapse rates among patients with HCV genotype 3 were 79.6%, 79.2%, and 15.6%, respectively; corresponding rates among patients with HCV genotype 2 were 86.7%, 84.3%, and 10.1%. An RVR had high predictive value for an SVR in patients with HCV genotypes 2 (88.9%) and 3 (88.1%). The strongest independent predictors of relapse in patients with genotype 3 and an RVR were steatosis (odds ratio 3.0; P = .003) and HCV RNA ≥400,000 IU/mL (odds ratio 2.5; P = .04). Relapse rates in patients with steatosis were 17.4% and 20.9% for low and high baseline levels of HCV RNA, respectively; corresponding rates in those without steatosis were 2.5% and 8.8%.

CONCLUSIONS:

Steatosis was associated with significantly higher rates of relapse, irrespective of viral load, in patients infected with HCV genotype 3 who had an RVR. Further studies are needed to determine if longer treatment durations are effective in patients with an RVR and these risk factors.

• Authors: Samir R Shah, Keyur Patel, Patrick Marcellin, Graham R Foster, Michael Manns, Shyam Kottilil, Letha Healey, Erik Pulkstenis, G Mani Subramanian, John G McHutchison, Mark S Sulkowski, Stefan Zeuzem, David R Nelson
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 9 Issue 8 Pg. 688-93 (Aug 2011) ISSN: 1542-7714 [Electronic] United States
• PMID: 21640198 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antiviral Agents
• Interferon-alpha
• RNA, Viral
• gamma-Glutamyltransferase
• Alanine Transaminase

Topics

• Adult
• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage)
• Fatty Liver (diagnosis)
• Female
• Genotype
• Hepacivirus (classification, genetics)
• Hepatitis C, Chronic (complications, drug therapy, virology)
• Humans
• Interferon-alpha (administration & dosage)
• Liver Cirrhosis (pathology)
• Male
• Middle Aged
• Prognosis
• RNA, Viral (blood)
• Recurrence
• Treatment Failure
• Viral Load
• gamma-Glutamyltransferase (blood)