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

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera San Camillo Forlanini
ClinicalTrials.gov Identifier:
NCT01342003
First received: April 25, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition
Chronic Hepatitis C

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera San Camillo Forlanini:

Primary Outcome Measures:
  • 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.


Enrollment: 388
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subtype 1a
subtype 1a patients treated with peginterferon plus ribavirin
subtype 1b
subtype 1b patients treated with peginterferon 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Three hundred and eighty-eight patients were included in the study. One hundred and sixty-five were HCV genotype 1 subtype 1a (42.5%) while two hundred twenty-three were of subtype 1b (57.5%).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342003

Locations
Italy
AO San Camillo Forlanini
Rome, Italy, 00142
Sponsors and Collaborators
Azienda Ospedaliera San Camillo Forlanini
Investigators
Study Director: Adriano M Pellicelli, MD AO Scamilloforlanini Rome Italy
  More Information

Additional Information:
an italian club of specialist in hepatology  This link exits the ClinicalTrials.gov site
web site of AO SCamillo Forlanini Hospital  This link exits the ClinicalTrials.gov site

No publications provided by Azienda Ospedaliera San Camillo Forlanini

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Adriano M Pellicelli, AO San Camillo Forlanini
ClinicalTrials.gov Identifier: NCT01342003     History of Changes
Other Study ID Numbers: 01
Study First Received: April 25, 2011
Last Updated: April 25, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera San Camillo Forlanini:
HCV infection
genotype 1a
genotype 1 b

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013