CLINICAL STUDIES Comparing the safety, tolerability and quality of life in patients with chronic hepatitis B vs chronic hepatitis C treated with peginterferon alpha-2a Patrick Marcellin 1 , George K. K. Lau 2 , Stefan Zeuzem 3 , E. Jenny Heathcote 4 , Paul J. Pockros 5 , K. Rajender Reddy 6 , Teerha Piratvisuth 7 , Patrizia Farci 8 , Wan-Cheng Chow 9 , Ji-Dong Jia 10 , Woon Paik 11 , Neil Wintfeld 12 and Nigel Pluck 13 1 Service d’H ´ epatologie & INSERM CRB3, University of Paris, Ho ˆ pital Beaujon, Clichy, France 2 Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, China 3 Department of Medicine I, J.W. Goethe University Hospital, Frankfurt, Germany 4 Toronto Western Hospital, University Health Network, Toronto, ON, Canada 5 Division of Gastroenterology/Hepatology, SC Liver Research Consortium, Scripps Clinic, La Jolla, CA, USA 6 Gastroenterology Division, Hospital of the University of Pennsylvania, Philadelphia, PA, USA 7 Department of Internal Medicine, Songklanakarin Hospital, NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University, Hat Yai, Thailand 8 Dipartimento di Scienze Mediche, Universita ` di Cagliari, Cagliari, Italy 9 Department of Gastroenterology, Singapore General Hospital, Singapore, Singapore 10 Liver Research Centre, Beijing Friendship Hospital, Capital University of Medical Sciences, Beijing, China 11 Samsung Medical Center, Division of Gastroenterology, Sungkyunkwan University School of Medicine, Seoul, South Korea 12 Hoffmann-La Roche Inc. Nutley, NJ, USA 13 Roche Products Ltd, Welwyn Garden City, Hertfordshire, UK Keywords chronic hepatitis B – chronic hepatitis C – health-related quality of life – hepatitis B virus – hepatitis C virus – pegylated interferon Abbreviations ALT, alanine aminotransferase; CHB, chronic hepatitis B; CHC, chronic hepatitis C; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B s antigen; HBV, hepatitis B virus;HCV, hepatitis C virus; HRQL, health-related quality of life; MCS, mental component summary; PCS, physical component summary; ULN, upper limit of normal Correspondence Prof. P. Marcellin, Service d’H´ epatologie and INSERM CRB3, University of Paris, Ho ˆ pital Beaujon, Pavillon Abrami, 100 Boulevard G´ en ´ eral Leclerc, 92110 Clichy, France Tel: 133 1 40 87 53 38 Fax: 133 1 47 30 94 40 e-mail: patrick.marcellin@bjn.ap-hop-paris.fr Received 20 December 2007 Accepted 25 December 2007 DOI:10.1111/j.1478-3231.2008.01696.x Abstract Background/Aims: Hepatitis B and C viruses (HBV and HCV) are two clinically distinct but related diseases. Pooled data from five studies of peginterferon alpha- 2a in patients with chronic HCV infection (CHC) were compared with two studies of the drug in patients with chronic HBV infection (CHB). Method: The HBV studies included both hepatitis B e antigen (HBeAg)-positive (n = 271) and HBeAg-negative (n = 177) patients; 791 patients took part in the HCV trials. In all studies, patients were treated with 180 mg peginterferon alpha-2a monotherapy once weekly for 48 weeks. The number of adverse events (AEs), discontinuations and dose modifications were documented. Health-related quality of life (HRQL) was assessed using the Short-Form 36 questionnaire. Safety was assessed through- out the treatment period. A 24-week treatment-free follow-up period was also included. Results: Differences (HBV vs HCV) were observed in the incidence of AEs (88–89 vs 96–100%), serious AEs (4–5 vs 7–16%) and treatment withdrawals (6–8 vs 17–33%). The frequency of depression-related events was lower in CHB patients (4 vs 22%, P o 0.001), as was the impact of treatment on HRQL. Conclusions: The safety and tolerability of peginterferon alpha-2a in patients with CHB compares favourably with that observed in CHC patients, with a lower incidence of common interferon-related AEs and a significantly lower incidence of depression. Liver International (2008) c  2008 The Authors. Journal compilation c  2008 Blackwell Munksgaard 477 Liver International ISSN 1478-3223