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

NCT ID: NCT01342003

Last Updated: 2011-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 388 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-10-31

Brief 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.

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.

Conditions

Chronic Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Subtype 1a

subtype 1a patients treated with peginterferon plus ribavirin

No interventions assigned to this group

subtype 1b

subtype 1b patients treated with peginterferon plus ribavirin

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera San Camillo Forlanini

OTHER

Sponsor Role: lead

Responsible Party

AO San Camillo Forlanini

Principal Investigators

Adriano M Pellicelli, MD

Role: STUDY_DIRECTOR

AO Scamilloforlanini Rome Italy

Locations

AO San Camillo Forlanini

Rome, Italy, Italy

Countries

Italy

References

Pellicelli AM, Romano M, Stroffolini T, Mazzoni E, Mecenate F, Monarca R, Picardi A, Bonaventura ME, Mastropietro C, Vignally P, Andreoli A, Marignani M, D'Ambrosio C, Miglioresi L, Nosotti L, Mitidieri O, Gentilucci UV, Puoti C, Barbaro G, Barlattani A, Furlan C, Barbarini G; CLEO Group. HCV genotype 1a shows a better virological response to antiviral therapy than HCV genotype 1b. BMC Gastroenterol. 2012 Nov 16;12:162. doi: 10.1186/1471-230X-12-162.

Reference Type: DERIVED

PMID: 23157720 (View on PubMed)

Related Links

http://www.scamilloforlanini.rm.it

web site of AO SCamillo Forlanini Hospital

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id