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Completed

NCT Number: NCT01342003

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Camillo Forlanini

Other

Registry information

Acronym: genotype

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2011
Registry last updated
Apr 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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