title: Pegylated interferon alpha2b plus ribavirin for the treatment of chronic hepatitis C in HIV-infected patients.
abstract: BACKGROUND
  Hepatitis C virus (HCV) and HIV coinfection constitutes an important epidemiological and clinical problem. We evaluated the safety and efficacy of Pegylated interferon alpha2b (Peg-IFN) and a fixed dose of ribavirin in the treatment of chronic hepatitis C in HIV coinfection.
  
  
  METHODS
  Open, prospective study in HCV-HIV coinfected patients with persistently elevated alanine aminotransferase (ALT) levels and a liver biopsy showing either portal or bridging fibrosis. Therapy included Peg-IFN (50 micro g weekly) with ribavirin 800 mg for 48 weeks. The primary end point was sustained virological response (SVR). Univariate and multivariate analyses were performed to determine factors associated with response.
  
  
  RESULTS
  By intent-to-treat analysis, 11 of 35 patients (31%) reached SVR. SVR was significantly better for genotypes 2/3 than for genotype 1 (54% versus 21%; P < 0.05). By multivariate logistic regression analysis, only a non-1 genotype was an independent factor for SVR [odds ratio (OR), 6; 95% confidence interval (CI), 1.1-31.7; P < 0.005]. A decrease of at least 1.5 log10 HCV RNA at week 12 of therapy was highly predictive of SVR (OR, 49.9; 95% CI, 4.9-508.2; P < 0.001). Most patients developed adverse events, although only six patients (17%) discontinued treatment due to toxicity.
  
  
  CONCLUSIONS
  The combination of low doses of Peg-IFN plus a fixed dose of ribavirin resulted in a rate of SVR similar to that obtained with higher doses of the drugs in HIV-infected patients and lower than those obtained in non-HIV patients. Response at week 12 may be useful to help guide therapy in HCV-HIV co-infected patients.
authors.affiliation: Department of Infectious Diseases, Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Leonor
authors.initials: L
authors.lastname: Moreno
authors.forename: Carmen
authors.initials: C
authors.lastname: Quereda
authors.forename: Ana
authors.initials: A
authors.lastname: Moreno
authors.forename: María J
authors.initials: MJ
authors.lastname: Perez-Elías
authors.forename: Antonio
authors.initials: A
authors.lastname: Antela
authors.forename: José L
authors.initials: JL
authors.lastname: Casado
authors.forename: Fernando
authors.initials: F
authors.lastname: Dronda
authors.forename: Maria L
authors.initials: ML
authors.lastname: Mateos
authors.forename: Rafael
authors.initials: R
authors.lastname: Bárcena
authors.forename: Santiago
authors.initials: S
authors.lastname: Moreno
mesh_terms: D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy / Q000821:virology; D015497:HIV-1; D016174:Hepacivirus / Q000235:genetics / Q000502:physiology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects; D011092:Polyethylene Glycols; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014779:Virus Replication / Q000502:physiology
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a