OPERA: use of pegylated interferon plus ribavirin for treating hepatitis C/HIV co-infection in interferon-naive patients.

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-naïve patients with chronic hepatitis C virus (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 co-infection. Adult subjects (n=1523) with a confirmed diagnosis of HCV and stable HIV co-infection were followed between April 2005 and March 2011; of these, 1284 were interferon-naïve 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 endpoint was sustained virological response (SVR). Secondary endpoints 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, 3 than genotype 1, 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 co-infection in interferon-naïve patients. Independent predictors of SVR include HCV genotype, undetectable baseline HIV-RNA and baseline HCV-RNA