ORIGINAL ARTICLE HCV Treatment of hepatitis C in patients with haemophilia – the Israeli National Hemophilia Center experience Y. MAOR,* J. M. SCHAPIRO, D. BASHARI, Y. LURIE, à R. SAFADI,§ O. SEGOL, – M. PARITSKY,** Z. RACHLIS,** B. AVIDAN,* S. BAR-MEIR* and U. MARTINOWITZ *Department of Gastroenterology and Hepatology and the Israeli National Hemophilia Center (INHC), Sheba Medical Center Tel-Hashomer, Israel; àDepartment of Gastroenterology and Hepatology, Sourasky Medical Center, Tel-Aviv, Israel; §The Liver Unit, Hadassah Medical Center, Jerusalem, Israel; –Department of Gastroenterology and Hepatology, Carmel Medical Center, Haifa, Israel; and **Gastroenterology Unit, Ha-Emek Medical Center, Afula, Israel Summary. Treatment with pegylated interferon (Peg- IFN) and ribavirin, now the standard of care, has been shown to achieve sustained viral response (SVR) in up to 60% of patients with hepatitis C (HCV). Studies of response to this combination in HCV-infected haemophilia patients are scarce. The aim of the study was to report the results and safety of interferon/ribavirin treatment in HCV and HCV-/ HIV-infected patients at the Israeli National Hemo- philia Center. A retrospective observational cohort study was conducted on haemophilia patients infected with HCV or HCV/HIV. Patients received combination of Peg-IFN and ribavirin. Few were still treated with standard interferon. The primary end- point was sustained viral response (SVR). The secondary end-point was safety, with emphasis on increased bleeding episodes. Some 18/43 (42%) HCV mono-infected haemophilia patients achieved SVR. Relapse occurred in 14 (33%), while 11 patients (25%) were non-responders. SVR was achieved among 17/37 (46%) naı¨ve patients receiv- ing Peg-IFN and ribavirin. Among patients with genotype-1, SVR was achieved in 12/36 (33%) and 11/30 (37%) in the whole group and Peg-IFN treated naı¨ve patients, respectively. In HCV/HIV co-infected patients only 1 patient achieved SVR. Severe anaemia occurred in 14/50 (28%) patients, four received erythropoietin. None maintained stable haemoglobin levels. Two patients had significant bleeding epi- sodes. In our cohort of haemophilia patients, SVR was achieved in a lower than expected rates. A relatively high relapse rate in the HCV mono- infected patients and a very high non-response rate in the HCV/HIV co-infected patients were observed as anticipated. Anaemia was a major side effect and the use of growth factors seemed unrevealing. Keywords: anaemia, haemophilia, hepatitis C, pegy- lated interferon, ribavirin, viral response Introduction Patients with haemophilia and other inherited coag- ulation disorders who received non-virucidally treated clotting factor concentrates before 1987 had a high risk for infection with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) [1]. Seventy- five to 90% of patients with haemophilia are infected with HCV and up to 30% are HCV/HIV co-infected [2,3]. Liver disease is a major cause of morbidity and mortality in this patient population. Increased rates of progression to end-stage liver disease par- ticularly in HCV/HIV co-infection has been well- documented in patients with haemophilia [3–5]. Earlier, small scale studies reporting response rates to standard interferon as mono-therapy or in com- bination with ribavirin in HCV mono-infected patients with haemophilia have documented sus- tained viral response (SVR) of 22–43% [6,7]. These response rates were similar to the SVR achieved in non-haemophilia patients. Treatment with pegylated Correspondence: Yaakov Maor, MD, Department of Gastroen- terology and Hepatology, Sheba Medical Center, Tel-Hashomer 52621, Israel. Tel.: 972 3 5302906; fax: 972 3 5303160; e-mail: yaakov@sheba.health.gov.il Accepted after revision 4 December 2007 Haemophilia (2008), 14, 336–342 DOI: 10.1111/j.1365-2516.2007.01633.x Ó 2008 The Authors 336 Journal compilation Ó 2008 Blackwell Publishing Ltd