HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b (genotype)
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|ClinicalTrials.gov Identifier: NCT01342003|
Recruitment Status : Completed
First Posted : April 26, 2011
Last Update Posted : April 26, 2011
|Condition or disease|
|Chronic Hepatitis C|
Despite the challenging perspective of the new antiviral drugs directly acting on hepatitis C viral replication such as protease and polymerase inhibitors, nowadays the standard treatment in genotype 1-chronic hepatitis C (CHC) is the combination of peghylated interferon (PEG-IFN) and ribavirin for 48 weeks. It has been extensively shown that patients infected with HCV genotype 1 have a lower rate of viral response than those infected with genotype 2 and 3. In large randomized multinational trials, sustained virological response (SVR) of around 50% has been obtained with peginterferon α2a plus ribavirin in the more difficult to treat subgroup of patients infected with HCV genotype 1. Furthermore, advanced fibrosis is a predictive factor of non response to antiviral treatment in genotype 1 virus [5-7]. Very few studies have evaluated SVR difference, if any, between subtypes 1a and 1b.
We have carried out an observational study on a large cohort of HCV "naïve" patients to evaluate the influence of HCV subtypes 1 on the response to treatment with Peg-INF plus ribavirin.
|Study Type :||Observational|
|Actual Enrollment :||388 participants|
|Official Title:||HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||October 2010|
subtype 1a patients treated with peginterferon plus ribavirin
subtype 1b patients treated with peginterferon plus ribavirin
- The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (SVR). [ Time Frame: 24 weeks after treatment cessation ]The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (Sustained virological response).
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342003
|AO San Camillo Forlanini|
|Rome, Italy, 00142|
|Study Director:||Adriano M Pellicelli, MD||AO Scamilloforlanini Rome Italy|