D Shoeb1, J Dearden1, A Weatherall1, C Bargery1, S Moreea2, S Alam2, E White3, X Vila4, D Freshwater5, S Ryder6, P R Mills7, G J Alexander8, D Forton9, G R Foster10. 1. Queen Marys University of London, The Liver Unit, Blizard Institute, United Kingdom. 2. Bradford Teaching Hospitals Foundation Trust, Bradford, United Kingdom. 3. Barts Health, Clinical Transplantation Laboratory, London, United Kingdom. 4. North Manchester General Hospital, Manchester, United Kingdom. 5. University Hospitals, Birmingham NHS Foundation Trust, Birmingham, United Kingdom. 6. Queens Medical Centre, Nottingham, United Kingdom. 7. Gartnavel General Hospital, Glasgow, United Kingdom. 8. Addenbrooke's Hospital, Cambridge, United Kingdom. 9. St George's University of London, London, United Kingdom. 10. Queen Marys University of London, The Liver Unit, Blizard Institute, United Kingdom. Electronic address: g.r.foster@qmul.ac.uk.
Abstract
BACKGROUND & AIMS:Patients with genotype 3 hepatitis C virus (HCV) infection and cirrhosis have poor response rates after 24 weeks treatment with pegylated interferon and ribavirin. Treatment for 48 weeks is therefore recommended, although the benefits of this are untested. We examined extended therapy in patients with genotype 3 HCV and advanced fibrosis. METHODS: Multicentre, open labelled randomized trial comparing therapy with 24 weeks pegylated interferon and ribavirin to 48 weeks of the same therapy. RESULTS:136 patients completed the study. 67 received 24 weeks therapy and the SVR rate (48%) did not differ from that seen in the 69 patients who received 48 weeks therapy (42%). The response rates in patients with biopsy proven cirrhosis (13 patients treated for 24 weeks, 18 patients treated for 48 weeks) or cirrhosis proven on imaging (28 patients treated for 24 weeks and 25 patients treated for 48 weeks) were 46% in those treated for 24 weeks and 40% in those treated for 48 weeks. The differences were not significantly different. Treatment failure was due to relapse in the majority of patients. CONCLUSIONS:Patients with genotype 3 HCV and advanced fibrosis do not benefit from extended therapy with pegylated interferon and ribavirin.
RCT Entities:
BACKGROUND & AIMS:Patients with genotype 3 hepatitis C virus (HCV) infection and cirrhosis have poor response rates after 24 weeks treatment with pegylated interferon and ribavirin. Treatment for 48 weeks is therefore recommended, although the benefits of this are untested. We examined extended therapy in patients with genotype 3 HCV and advanced fibrosis. METHODS: Multicentre, open labelled randomized trial comparing therapy with 24 weeks pegylated interferon and ribavirin to 48 weeks of the same therapy. RESULTS: 136 patients completed the study. 67 received 24 weeks therapy and the SVR rate (48%) did not differ from that seen in the 69 patients who received 48 weeks therapy (42%). The response rates in patients with biopsy proven cirrhosis (13 patients treated for 24 weeks, 18 patients treated for 48 weeks) or cirrhosis proven on imaging (28 patients treated for 24 weeks and 25 patients treated for 48 weeks) were 46% in those treated for 24 weeks and 40% in those treated for 48 weeks. The differences were not significantly different. Treatment failure was due to relapse in the majority of patients. CONCLUSIONS:Patients with genotype 3 HCV and advanced fibrosis do not benefit from extended therapy with pegylated interferon and ribavirin.