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Journal article
Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis
Digestive diseases and sciences, v 63(12), pp 3487-3497
01 Dec 2018
PMID: 30136045
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background and AimsHepatitis B surface antigen (HBsAg) loss is the ideal clinical endpoint but is achieved rarely during oral antiviral treatment. A current unmet need in CHB management is achievement of HBsAg loss with a finite course of oral antiviral therapy, thereby allowing discontinuation of treatment. Significantly higher rates of HBsAg loss at 72weeks post-treatment have been demonstrated when tenofovir disoproxil fumarate (TDF) was combined with pegylated interferon (PEG-IFN) for 48weeks compared with either monotherapy. This analysis provides follow-up data at week 120.MethodsIn an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus PEG-IFN for 48weeks (group A), TDF plus PEG-IFN for 16weeks followed by TDF for 32weeks (group B), TDF for 120weeks (group C), or PEG-IFN for 48weeks (group D). Efficacy and safety at week 120 were assessed.ResultsRates of HBsAg loss at week 120 were significantly higher in group A (10.4%) than in group B (3.5%), group C (0%), and group D (3.5%). Rates of HBsAg loss and HBsAg seroconversion in group A were significantly higher than rates in group C (P<0.001 for both) or group D (HBsAg loss: P=0.002; HBsAg seroconversion: P<0.001).ConclusionsThe results of this analysis confirm the results from earlier time points which demonstrate the increased rate of HBsAg loss in patients treated with a finite course of PEG-IFN plus TDF compared with the rates in patients receiving either monotherapy.
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Details
- Title
- Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis
- Creators
- Sang Hoon Ahn - Yonsei UniversityPatrick Marcellin - Hôpital Beaujon, University Paris-Diderot, Clichy, FranceXiaoli Ma - Drexel UniversityFlorin A. Caruntu - National Institute for Infectious Diseases Matei Bals, Bucharest, Romania.Won Young Tak - Kyungpook National University HospitalMagdy Elkhashab - Toronto Liver CentreWan-Long Chuang - Kaohsiung Medical UniversityFehmi Tabak - Istanbul UniversityRajiv Mehta - Liver Clinic, Surat, India.Joerg Petersen - Univ Hamburg, Asklepios Klin St George, IFI Inst Interdisciplinary Med, Hamburg, GermanyWilliam Guyer - Yonsei UniversityBelinda Jump - Gilead Sciences Inc, Foster City, CA, USA.Alain Chan - Gilead Sciences Inc, Foster City, CA, USA.Mani Subramanian - Gilead Sciences Inc, Foster City, CA, USA.Gerald Crans - Gilead Sciences Inc, Foster City, CA, USA.Scott Fung - Toronto General HospitalMaria Buti - Hepatology Unit, Hospital Universitari Vall d’Hebron and CIBEREHD del Instituto Carlos III, Barcelona, SpainGiovanni B. Gaeta - University of Campania "Luigi Vanvitelli"Aric J. Hui - Alice Ho Miu Ling Nethersole HospitalGeorge Papatheodoridis - Laiko General Hospital of AthensRobert Flisiak - Medical University of BiałystokHenry L. Y. Chan - Chinese University of Hong Kong
- Publication Details
- Digestive diseases and sciences, v 63(12), pp 3487-3497
- Publisher
- Springer Nature
- Number of pages
- 11
- Grant note
- Gilead Sciences, Inc.; Gilead Sciences
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Medicine (Graduate)
- Web of Science ID
- WOS:000450660300041
- Scopus ID
- 2-s2.0-85052296425
- Other Identifier
- 991019167690704721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Gastroenterology & Hepatology