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European Journal of Gastroenterology & Hepatology:
doi: 10.1097/MEG.0000000000000039
Original Articles: Hepatitis

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

Craxì, Antonioa; Piccinino, Feliceb; Ciancio, Alessiac; Iannacone, Claudiod; Deodato, Barbarae; Golotta, Caterinae; Ascione, Antoniof

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Background: This large prospective multicentre cohort study aimed to improve knowledge of therapy for chronic hepatitis C (CHC) in real clinical practice.

Methods: A 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 α-2a (40 kDa) or α-2b (12 kDa) plus ribavirin at the investigator’s discretion.

Results: During the study, 5399 treatment-naive patients [2527 (46.8%) with CSP] received peginterferon α-2a (n=3513, 65.1%) or peginterferon α-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 RNA≤500 000 IU/ml, alanine transaminase quotient >3× the upper limit of normal, age ≤65 years, BMI<25 kg/m2, at least 80% of the planned exposure to peginterferon and ribavirin and prescription of peginterferon α-2a.

Conclusion: The 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.

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins


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