title: OPERA: use of pegylated interferon plus ribavirin for treating HCV-HIV coinfection in interferon-naive patients.
abstract: BACKGROUND
  The Optimized Pegylated interferons Efficacy and anti-Retroviral Approach (OPERA) study aimed to assess the efficacy and safety profile of treatment with pegylated interferons (PEG-IFNs) in interferon-naive patients with chronic HCV and HIV infection in routine clinical practice.
  
  
  METHODS
  This was a multicentre, prospective observational cohort study conducted at 98 Italian referral centres for the treatment of chronic HCV and HIV coinfection. Adult subjects (n=1,523) with a confirmed diagnosis of HCV and stable HIV coinfection were followed between April 2005 and March 2011; of these, 1,284 were interferon-naive and were the focus of this analysis. Patients received PEG-IFN-α2a or -α2b plus ribavirin combination therapy. The choice of treatment and dose was at the investigator's discretion, according to the summary of product characteristics and current guidelines. The primary efficacy end point was sustained virological response (SVR). Secondary end points included rates of rapid viral response, early viral response and response at end of treatment.
  
  
  RESULTS
  SVR was achieved by 40.0% of patients; the highest SVR rate was observed in patients with HCV genotypes 2 and 3. More genotype 2 and 3 than genotype 1 and 4 patients achieved rapid and early viral responses, and end of treatment responses. Higher SVR rates were also associated with ≥80% anti-HCV treatment compliance and lower baseline HCV levels.
  
  
  CONCLUSIONS
  The OPERA study results show that PEG-IFN plus ribavirin is an effective treatment for HCV-HIV coinfection in interferon-naive patients. Independent predictors of SVR include HCV genotype, undetectable baseline HIV RNA and baseline HCV RNA<500,000 IU/ml.
authors.affiliation: Institute of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Carosi
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: Roberto
authors.initials: R
authors.lastname: Gulminetti
authors.forename: Massimo
authors.initials: M
authors.lastname: Galli
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Angarano
authors.forename: Gabriella
authors.initials: G
authors.lastname: Verucchi
authors.forename: Emanuele
authors.initials: E
authors.lastname: Pontali
authors.forename: Amedeo
authors.initials: A
authors.lastname: Capetti
authors.forename: Enzo
authors.initials: E
authors.lastname: Raise
authors.forename: Veronica
authors.initials: V
authors.lastname: Ravasio
authors.forename: Ivana
authors.initials: I
authors.lastname: Maida
authors.forename: Claudio
authors.initials: C
authors.lastname: Iannacone
authors.forename: Antonietta
authors.initials: A
authors.lastname: Caputo
authors.forename: Massimo
authors.initials: M
authors.lastname: Puoti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D060085:Coinfection; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology / Q000821:virology; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology / Q000821:virology; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a