July 11, 2010

Meta-Analysis Shows Extended Therapy Improves Response of Patients with Chronic Hepatitis C Virus Genotype 1 Infection

Harald Farnik, Christian M. Lange, Christoph Sarrazin, Bernd Kronenberger, Stefan Zeuzem, Eva Herrmann

Received 17 February 2010; received in revised form 17 June 2010; accepted 18 June 2010. published online 30 June 2010.

Accepted Manuscript

Abstract

Background & Aims:
Clinical trials have provided conflicting results about whether extended duration of treatment with pegylated interferon-alfa (pegIFN-alfa) and ribavirin (more than 48 weeks) improves rates of sustained virologic response (SVR) in patients infected with hepatitis C virus (HCV) genotype 1 that have a slow virologic response. We performed a meta-analysis to determine the overall impact of extended treatment, compared to standard treatment, on virologic response rates in these patients.

Methods:
We performed a literature search to identify randomized controlled trials (RCT) that included mono-infected, treatment-naive patients infected with HCV genotype 1; data were compared between slow responding patients treated with pegIFN-alfa-2a/b plus ribavirin for 48 weeks and those that received extended treatment (as much as 72 weeks). Endpoints included SVR rates, end-of-treatment response and relapse rates; they were calculated as meta-analysis of data with binary outcome according to the DerSimonian-Laird estimate.

Results:
Six randomized controlled trials assessed the benefits of extended treatment with pegIFN-alfa-2a/b and ribavirin in treatment-naive patients with HCV genotype 1 that were slow responders (n=669). The extended treatment significantly improved SVR rates in slow responders, compared to the standard of care (14.7% increase in overall SVR, 95% confidence interval: 4%–25.5%, P =0.0072). Rates of viral relapse were significantly reduced by extended treatment but end-of-treatment response rates were similar. The frequency of voluntary treatment discontinuation, but not of serious adverse events, was significantly increased by extended therapy.

Conclusions:
Extending the duration of treatment with pegIFN-alfa-2a/b and ribavirin in patients with HCV genotype 1 and a slow response to therapy improves the rate of SVR.

Keywords: antiviral therapy, individualized treatment, treatment duration, EOT

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