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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Hepatitis C

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subtype 1a<br>subtype 1a patients treated with peginterferon plus ribavirin | |
| subtype 1b<br>subtype 1b patients treated with peginterferon plus ribavirin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV infection, genotype 1a, genotype 1 b