HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b (genotype)
Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This observational study was carried out on a large group of "naïve" HCV patients to evaluate difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment with peginterferon (Peg-IFN) plus ribavirin.
Chronic Hepatitis C
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b|
- The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (SVR). [ Time Frame: 24 weeks after treatment cessation ] [ Designated as safety issue: Yes ]The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (Sustained virological response).
Biospecimen Retention: Samples With DNA
HCVRNA determination was performed quantitatively before the treatment (TaqMan Roche Diagnostics). The TaqMan value utilized to determine the response was 15 IU/ml. TaqMan method was a standardized method utilized from December 2007 in all the center of the CLEO group. HCVRNA value was expressed as log10 IU/ml.
|Study Start Date:||February 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
subtype 1a patients treated with peginterferon plus ribavirin
subtype 1b patients treated with peginterferon plus ribavirin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342003
|AO San Camillo Forlanini|
|Rome, Italy, 00142|
|Study Director:||Adriano M Pellicelli, MD||AO Scamilloforlanini Rome Italy|