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PLoS One. 2010 Nov 8;5(11):e15492. doi: 10.1371/journal.pone.0015492.

S-adenosyl-methionine and betaine improve early virological response in chronic hepatitis C patients with previous nonresponse.

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  • 1Hepatology Laboratory, Department of Biomedicine, University Hospital Basel, Basel, Switzerland.

Erratum in

  • PLoS One. 2010;5(11). doi: 10.1371/annotation/14d47e6a-400a-429e-a487-6dd375e04632.

Abstract

BACKGROUND/AIMS:

Treatment of chronic hepatitis C (CHC) with pegylated interferon α (pegIFNα) and ribavirin results in a sustained response in approximately half of patients. Viral interference with IFNα signal transduction through the Jak-STAT pathway might be an important factor underlying treatment failure. S-adenosyl-L-methionine (SAMe) and betaine potentiate IFNα signaling in cultured cells that express hepatitis C virus (HCV) proteins, and enhance the inhibitory effect of IFNα on HCV replicons. We have performed a clinical study with the aim to evaluate efficacy and safety of the addition of SAMe and betaine to treatment of CHC with pegIFNα/ribavirin.

METHODS:

In this open-label pilot study, 29 patients with CHC who failed previous therapy with (peg)IFNα/ribavirin were treated with SAMe, betaine, pegIFNα2b and ribavirin. Treatment duration was 6 or 12 months, depending on genotype, and the protocol comprised a stopping rule at week 12 if early virological response (EVR) was not achieved. Virological and biochemical response and safety were assessed throughout the treatment.

RESULTS:

29 patients were enrolled and treated according to the study protocol. 79% of the patients were infected with genotype 1, 72% had advanced fibrosis, 76% had previously received pegIFNα/ribavirin, and only 14% achieved EVR to the previous treatment. When treated with the study medications, 17 patients (59%) showed an EVR, only 3 (10%) however achieved a sustained virological response (SVR). SAMe and betaine were found to be safe when used with pegIFNα/ribavirin.

CONCLUSION:

The addition of SAMe and betaine to pegIFNα/ribavirin improves early virological response in CHC.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00310336.

PMID:
21079746
[PubMed - indexed for MEDLINE]
PMCID:
PMC2975710
Free PMC Article
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