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

Chronic Hepatitis C Clinical Trial

— genotype  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342003
• Other study ID #: 01
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: April 25, 2011
• Start date: February 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Azienda Ospedaliera San Camillo Forlanini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• eligible subjects were naïve infected with HCV genotype 1 virus meeting the internationally recognised criteria for treatment (elevation of aminotransferases, inflammation and or fibrosis at liver biopsy).

Exclusion Criteria:

• infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)

• alcohol intake greater than 20 gr daily

• the presence of active drug abuse, chronic systemic disease, psychiatric disorders, autoimmune disease, pregnancy or lactation.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Italy	AO San Camillo Forlanini	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Camillo Forlanini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (SVR).	The primary end point was sustained undetectable serum HCVRNA 24 weeks after treatment cessation (Sustained virological response).	24 weeks after treatment cessation	Yes

External Links

•   an italian club of specialist in hepatology
•   web site of AO SCamillo Forlanini Hospital