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:


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:
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 April 17, 2014