title: OPERA: responses to peginterferon and ribavirin therapy in a subgroup of interferon-naïve patients with HIV/HCV genotype 2/3 co-infection in Italy.
abstract: OBJECTIVE
  Hepatitis C virus (HCV) genotype 3 (G3) is common among HIV/HCV co-infected individuals and associated with moderate sustained virological response (SVR) rates with pegylated interferon (PEG-IFN) plus ribavirin (RBV) therapy, while G2 is less frequent and associated with higher SVR. To determine SVR and other response rates, identify SVR predictors and analyse differences between G2 and G3 with PEG-IFN/RBV in a large HIV/HCV G2/3 patient population.
  
  
  METHODS
  This subgroup analysis of the prospective, observational OPERA (Optimized Pegylated interferon Efficacy and anti-Retroviral Approach) study was conducted between 2005 and 2011 in Italy in PEG-IFN/RBV-naïve HIV/HCV patients. The primary efficacy endpoint was SVR rate (HCV RNA <50 IU/ml or undetectable 24 weeks after end-of-treatment).
  
  
  RESULTS
  Five hundred and fifty-six HCV G2/3 patients (G2 n = 60; G3 n = 496) were treated with PEG-IFN alfa-2a 180 μg/week or PEG-IFN alfa-2b 1.5 μg/kg, + RBV 13.6 ± 2.3 (mean ± SD) mg/kg/day for median 47 (26-54) weeks. SVR rates were 57.7%, 68.3% and 56.5% for G2/3, G2 and G3 respectively) and RVR rates were 53.2%, 57.1% and 45.8% respectively. Independent SVR predictors were undetectable baseline HIV RNA [adjusted odds ratio (AOR), 2.64; 95% CI: 1.523-4.565, P = 0.0005], age (AOR 0.95 per year; 95% CI: 0.908-0.994, P = 0.0258) and anti-HCV treatment duration (AOR 1.034 per week; 95% CI: 1.013-1.057, P = 0.0019).
  
  
  CONCLUSIONS
  Undetectable HIV RNA, longer anti-HCV treatment adherence and younger age were independent SVR predictors in treatment-naïve HIV/HCV G2/3 patients receiving PEG-IFN/RBV. Suppressing HIV RNA replication before anti-HCV therapy and increasing adherence to PEG-IFN/RBV treatment SVR rates may improve SVR.
authors.affiliation: Department of Infectious Diseases, Hepatology Outpatients Unit University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Bruno
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cariti
authors.forename: Paola
authors.initials: P
authors.lastname: Nasta
authors.forename: Amedeo
authors.initials: A
authors.lastname: Capetti
authors.forename: Veronica
authors.initials: V
authors.lastname: Ravasio
authors.forename: Massimo
authors.initials: M
authors.lastname: Galli
authors.forename: Enzo
authors.initials: E
authors.lastname: Raise
authors.forename: Giulio
authors.initials: G
authors.lastname: Palmieri
authors.forename: Claudio
authors.initials: C
authors.lastname: Iannacone
authors.forename: Massimo
authors.initials: M
authors.lastname: Puoti
mesh_terms: D060085:Coinfection / Q000188:drug therapy*; D004359:Drug Therapy, Combination / Q000379:methods; D005838:Genotype; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000150:complications / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007558:Italy; D016017:Odds Ratio; 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*
chemical_list: D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
keywords: HIV infections; hepatitis C; peginterferon alfa-2a; ribavirin