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Abstract Details
Combination of Tenofovir Disoproxil Fumarate and Peginterferon alfa-2a Increases Loss of Hepatitis B Surface Antigen in Patients with Chronic Hepatitis B
Author information
1Service d'Hépatologie, Hôpital Beaujon, University Paris-Diderot, INSERM CRI, Clichy, France. Electronic address: patrick.marcellin@bjn.aphp.fr.
2Division of Gastroenterology, Yonsei University College of Medicine, Seoul, South Korea.
3Drexel University College of Medicine, Philadelphia, PA, USA.
4National Institute for Infectious Diseases, 'Matei Bals', Bucharest, Romania.
5Kyungpook National University Hospital, Daegu, South Korea.
6Toronto Liver Center, Toronto, Canada.
7Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
8Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
9University of Istanbul, Cerrahpasa Medical Faculty, Istanbul, Turkey.
10Liver Clinic, Surat, India.
11IFI Institute for Interdisciplinary Medicine at the Asklepios Klinik St. George, University of Hamburg, Hamburg, Germany.
12Queen Mary University of London, London, UK.
13Nexus Development, Palo Alto, CA, USA.
14Gilead Sciences Inc., Foster City, CA, USA.
15Academic Medical Center, Amsterdam, The Netherlands.
16University of Toronto, Department of Medicine, Toronto General Hospital, Toronto, Canada.
17AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.
18San Jose Gastroenterology, San Jose, California, USA.
19Hepatology Unit, Hospital Universitari Vall d'Hebron and CIBER-EHD del Instituto Carlos III, Barcelona, Spain.
20Viral Hepatitis Unit, Department of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy.
21The Chinese University of Hong Kong, Hong Kong; Alice Ho Miu Ling Nethersole Hospital, Hong Kong.
22Athens University Medical School, "Laiko" General Hospital of Athens, Athens, Greece.
23Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
24Department of Medicine and Therapeutics and Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong. Electronic address: hlychan@cuhk.edu.hk.
Abstract
BACKGROUND AND AIMS:
Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in patients receiving the combination of tenofovir disoproxil fumarate (TDF) and peginterferon alfa-2a (peginterferon), for a finite duration, in a randomized trial METHODS: In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus peginterferon for 48 weeks (group A), TDF plus peginterferon for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or peginterferon for 48 weeks (group D). The primary endpoint was the proportion of patients with serum HBsAg loss at week 72.
RESULTS:
At week 72, 9.1% of subjects in group A had HBsAg loss, compared with 2.8% of subjects in group B, none of the subjects in group C, and 2.8% of subjects in group D. A significantly higher proportion of subjects in group A had HBsAg loss than in group C (P<.001) or group D (P=.003). However, the proportions of subjects with HBsAg loss did not differ significantly between group B and group C (P=.466) or group D (P=.883). HBsAg loss in group A occurred in hepatitis B e antigen-positive and -negative patients with all major viral genotypes. The incidence of common adverse events (including headache, alopecia, and pyrexia) and treatment discontinuation due to adverse events was similar among groups.
CONCLUSION:
A significantly greater proportion of patients receiving TDF plus peginterferon for 48 weeks had HBsAg loss than those receiving TDF or peginterferon alone. ClinicalTrials.gov no: NCT01277601.