Real-world outcomes in patients with chronic hepatitis C: primary results of the PROBE study.

BackgroundThis large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.MethodsA diverse population of adults with CHC including patients with comorbid conditions, laboratory abnormalities and demographic features [comorbidities or special populations (CSP)] who were under-represented or excluded from peginterferon registration studies was treated with peginterferon -2a (40 kDa) or -2b (12 kDa) plus ribavirin at the investigator's discretion.ResultsDuring the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon -2a (n=3513, 65.1%) or peginterferon -2b (n=1886, 34.9%). The sustained virological response rate was 56.6% (3057/5399) overall, 59.7% (1716/2872) in patients without CSP and 53.1% (1341/2527) in patients with CSP. Significant predictors of sustained virological response included hepatitis C virus genotype 2 or 3 infection, absence of cirrhosis, hepatitis C virus RNA500 000 IU/ml, alanine transaminase quotient >3x the upper limit of normal, age 65 years, BMI<25 kg/m(2), at least 80% of the planned exposure to peginterferon and ribavirin and prescription of peginterferon -2a.ConclusionThe results provide detailed information on the outcome of therapy for CHC in a diverse Italian population that included a large number of patients with CSP and provides an insight into the generalizability of the results obtained in the more restricted setting of randomized registration trials.