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

NCT01342003 | Completed

• 1 other identifier: 01
• Study Type: observational
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

HCV infection; genotype 1a; genotype 1 b

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Subtype 1a

subtype 1a patients treated with peginterferon plus ribavirin

subtype 1b

subtype 1b patients treated with peginterferon plus ribavirin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera San Camillo Forlanini: lead

Study Sites (1)

AO San Camillo Forlanini

Rome, Italy, 00142, Italy

Location

Related Publications (1)

• 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.

  PMID: 23157720 DERIVED

Related Links

• web site of AO SCamillo Forlanini Hospital

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.

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adriano M Pellicelli, MD

  AO Scamilloforlanini Rome Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 26, 2011
• Study Start: February 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 26, 2011

Record last verified: 2010-10

Locations

IT (1)