NCT01342003

HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 388 (actual)
• Sponsor: Azienda Ospedaliera San Camillo Forlanini · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Hepatitis C

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-07-01
• Completion: 2010-10-01
• First posted: 2011-04-26
• Last updated: 2011-04-26

Locations

1 site across 1 country: Italy