title: Safety and efficacy of treatment with pegylated interferon alpha-2a with ribavirin in chronic hepatitis C genotype 4.
abstract: The hepatitis C virus (HCV) genotype is an important predictive outcome parameter for pegylated interferon  plus ribavirin therapy. Most published therapeutic trials to date have enrolled mainly patients with HCV genotypes 1, 2 and 3. Limited studies have focused on genotype 4 patients, who have had a poor representation in pivotal trials. Our aim was to evaluate the efficacy and safety of treatment with standard dose pegylated interferon alfa-2a in combination with weight-based ribavirin in patients with chronic hepatitis C genotype 4. In this prospective observational study, 198 patients with HCV-4 were included in this study from February 2004 to August 2005,188 patients who received at least 1 dose of drugs were included in the ITT analysis and they were treated with pegylated interferon alfa-2a and ribavirin for 48 weeks. Baseline and demographic characteristics, response to treatment at weeks 12, 48 and 72, and the nature and frequency of adverse effects were analyzed. Virological response at week 12 was achieved in 144 patients (76.6%). Virological response at the end of treatment was present in 110 patients (58.5%). At week 72, 99 patients presented SVR (52.7%). The reported adverse events were similar to those found in the literature for treatments of similar dose and duration. In conclusion, combined treatment with pegylated interferon alfa-2a and ribavirin was well tolerated and effective in chronic hepatitis C genotype 4, yielding response rates between those reported for genotype 1 and those of genotypes 2-3.
authors.affiliation: Consorcio Hospital General Universitario de Valencia, Spain.
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Urquijo
authors.forename: Moisés
authors.initials: M
authors.lastname: Diago
authors.forename: Jaume
authors.initials: J
authors.lastname: Boadas
authors.forename: Ramón
authors.initials: R
authors.lastname: Planas
authors.forename: Ricard
authors.initials: R
authors.lastname: Solá
authors.forename: Juan Angel
authors.initials: JA
authors.lastname: Del Olmo
authors.forename: Javier
authors.initials: J
authors.lastname: Crespo
authors.forename: José Carlos
authors.initials: JC
authors.lastname: Erdozaín
authors.forename: María Dolores
authors.initials: MD
authors.lastname: Antón
authors.forename: Carlos
authors.initials: C
authors.lastname: Arocena
authors.forename: Dolores
authors.initials: D
authors.lastname: Suarez
authors.forename: Josep
authors.initials: J
authors.lastname: Giné
authors.forename: Josep M
authors.initials: JM
authors.lastname: Barrera
authors.forename: Javier
authors.initials: J
authors.lastname: Gracia-Samaniego
authors.forename: Ricardo
authors.initials: R
authors.lastname: Perez
authors.forename: Blai
authors.initials: B
authors.lastname: Dalmau
authors.forename: Miguel
authors.initials: M
authors.lastname: Montoro
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a