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Digestive Diseases and Sciences
December 2018, Volume 63, Issue 12, pp 3487–3497 | Cite as
Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis
Authors
Authors and affiliations
Sang Hoon AhnPatrick MarcellinEmail authorXiaoli MaFlorin A. CaruntuWon Young TakMagdy ElkhashabWan-Long ChuangFehmi TabakRajiv MehtaJörg PetersenWilliam GuyerBelinda JumpAlain ChanMani SubramanianGerald Crans
Sang Hoon Ahn
1
Patrick Marcellin
2Email author
Xiaoli Ma
3
Florin A. Caruntu
4
Won Young Tak
5
Magdy Elkhashab
6
Wan-Long Chuang
7
Fehmi Tabak
8
Rajiv Mehta
9
Jörg Petersen
10
William Guyer
1
Belinda Jump
11
Alain Chan
11
Mani Subramanian
11
Gerald Crans
11
Scott Fung
12
Maria Buti
13
Giovanni B. Gaeta
14
Aric J. Hui
1516
George Papatheodoridis
17
Robert Flisiak
18
Henry L. Y. Chan
19Email author
1.Department of Internal Medicine, Yonsei University College of MedicineBrain Korea 21 Plus Project for Medical ScienceSeoulRepublic of Korea
2.Hôpital BeaujonUniversity Paris-DiderotClichyFrance
3.Drexel University College of MedicinePhiladelphiaUSA
4.National Institute for Infectious Diseases “Matei Bals”BucharestRomania
5.Kyungpook National University HospitalDaeguSouth Korea
6.Toronto Liver CentreTorontoCanada
7.Kaohsiung Medical University HospitalKaohsiung Medical UniversityKaohsiungTaiwan
8.Cerrahpasa Medical FacultyUniversity of IstanbulIstanbulTurkey
9.Liver ClinicSuratIndia
10.IFI Institute for Interdisciplinary Medicine, Asklepios Klinik St. GeorgeUniversity of HamburgHamburgGermany
11.Gilead Sciences IncFoster CityUSA
12.Toronto General HospitalTorontoCanada
13.Hepatology UnitHospital Universitari Vall d’Hebron and CIBEREHD del Instituto Carlos IIIBarcelonaSpain
14.Infectious Diseases and Viral Hepatitis UnitUniversity of Campania “Luigi Vanvitelli”NaplesItaly
15.The Chinese University of Hong KongHong KongChina
16.Alice Ho Miu Ling Nethersole HospitalHong KongChina
17.Medical School of National and Kapodistrian University of AthensGeneral Hospital of Athens “Laiko”AthensGreece
18.Department of Infectious Diseases and HepatologyMedical University of BialystokBiałystokPoland
19.Department of Medicine and Therapeutics and Institute of Digestive DiseaseThe Chinese University of Hong KongHong KongChina
Open Access
Original Article
First Online: 22 August 2018
398 Downloads
Abstract
Background and Aims
Hepatitis 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 72 weeks post-treatment have been demonstrated when tenofovir disoproxil fumarate (TDF) was combined with pegylated interferon (PEG-IFN) for 48 weeks compared with either monotherapy. This analysis provides follow-up data at week 120.
Methods
In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus PEG-IFN for 48 weeks (group A), TDF plus PEG-IFN for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or PEG-IFN for 48 weeks (group D). Efficacy and safety at week 120 were assessed.
Results
Rates 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).
Conclusions
The 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.
Keywords
Chronic hepatitis B HBsAg seroconversion HBsAg loss Virological response |
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发表于 2018-11-24 18:55