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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

European Journal of Gastroenterology & Hepatology: April 2014 - Volume 26 - Issue 4 - p 388–395
doi: 10.1097/MEG.0000000000000039
Original Articles: Hepatitis

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.

aDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, University of Palermo, Palermo

bDepartment of Public Medicine, Section of Infectious Diseases, Second University of Naples, Naples

cDepartment of Gastroenterology and Hepatology, University of Torino, Torino

dSPARC Consulting, Milan

eRoche SpA, Monza

fDepartment of Medicine, Centre for Liver Disease, Fatebenefratelli Hospital, Napoli, Italy

Correspondence to Antonio Craxì, MD, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Di.Bi.M.I.S., University of Palermo, Piazza delle Cliniche 2, 90127 Palermo, Italy Tel: +39 091 6553248; fax: +39 091 6552156; e-mail: antonio.craxi@unipa.it

Received October 11, 2013

Accepted December 9, 2013

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins