Journal article
Predictors of response to tenofovir disoproxil fumarate plus peginterferon alfa-2a combination therapy for chronic hepatitis B
Alimentary pharmacology & therapeutics, v 44(9), pp 957-966
Nov 2016
PMID: 27629859
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
In patients with chronic hepatitis B, tenofovir disoproxil fumarate (TDF) plus pegylated interferon (PEG-IFN) for 48-weeks results in higher rates of hepatitis B surface antigen (HBsAg) loss than either monotherapy.
To identify baseline and on-treatment factors associated with HBsAg loss at Week 72 and provide a model for predicting HBsAg loss in patients receiving combination therapy for 48 weeks.
A secondary analysis of data from an open-label study where patients were randomised to TDF (300 mg/day, oral) plus PEG-IFN (PI, 180 μg/week, subcutaneous) for 48 weeks (TDF/PI-48w); TDF plus PEG-IFN for 16 weeks, TDF for 32 weeks (TDF/PI-16w+TDF-32w); TDF for 120 weeks (TDF-120w) or PEG-IFN for 48 weeks (PI-48w). Logistic regression methods were used to identify models that best predicted HBsAg loss at Week 72.
Rates of HBsAg loss at Week 72 were significantly higher in the TDF/PI-48w group (6.5%) than in the TDF/PI-16w+TDF-32w (0.5%), TDF-120w (0%) and PI-48w (2.2%) groups (P = 0.09). The only baseline factor associated with response was genotype A. HBsAg decline at Week 12 or 24 of treatment was associated with HBsAg loss at Week 72 (P < 0.001). HBsAg decline >3.5 log
IU/mL at Week 24 in the TDF/PI-48w group resulted in a positive predictive value of 85% and a negative predictive value of 99% for HBsAg loss at Week 72.
HBsAg decline at Week 24 of TDF plus PEG-IFN combination therapy may identify patients who, after completing 48 weeks of treatment, have a better chance of achieving HBsAg loss at Week 72.
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Details
- Title
- Predictors of response to tenofovir disoproxil fumarate plus peginterferon alfa-2a combination therapy for chronic hepatitis B
- Creators
- P Marcellin - Paris FranceS H Ahn - Seoul South KoreaW-L Chuang - Kaohsiung TaiwanA J Hui - Hong Kong ChinaF Tabak - Istanbul TurkeyR Mehta - Sardar Vallabhbhai National Institute of Technology SuratJ Petersen - Hamburg GermanyC-M Lee - Kaohsiung TaiwanX Ma - Philadelphia UniversityF A Caruntu - Bucharest RomaniaW Y Tak - Daegu South KoreaM Elkhashab - Toronto ON CanadaL Lin - Gilead SciencesG Wu - Gilead Sciences (United States)E B Martins - Gilead SciencesP Charuworn - Gilead SciencesL J Yee - Gilead SciencesS G Lim - SingaporeG R Foster - University of CambridgeS Fung - Toronto ON CanadaL Morano - Complejo Hospitalario de PontevedraD Samuel - Laboratoire d'études sur les monothéismesK Agarwal - University of CambridgeR Idilman - Ankara TurkeyS I Strasser - Sydney AustraliaM Buti - Barcelona SpainG B Gaeta - Italian Shipowners Research ConsortiumG Papatheodoridis - Athens GreeceR Flisiak - Bialystok PolandH L Y Chan - Hong Kong China
- Publication Details
- Alimentary pharmacology & therapeutics, v 44(9), pp 957-966
- Publisher
- Wiley
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Medicine (Graduate)
- Web of Science ID
- WOS:000387595600009
- Scopus ID
- 2-s2.0-84991099430
- Other Identifier
- 991019167658904721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Gastroenterology & Hepatology
- Pharmacology & Pharmacy