Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis
Authors
Sang Hoon Ahn ; Patrick Marcellin ; Xiaoli Ma ; Florin A. Caruntu ; Won Young Tak ; Magdy Elkhashab ; Wan-Long Chuang ; Fehmi Tabak ; Rajiv Mehta ; Jörg Petersen ; William Guyer ; Belinda Jump ; Alain Chan ; Mani Subramanian ; Gerald Crans ; Scott Fung ; Maria Buti ; Giovanni B. Gaeta ; Aric J. Hui ; George Papatheodoridis ; Robert Flisiak ; Henry L. Y. Chan
Citation
DIGESTIVE DISEASES AND SCIENCES, Vol.63(12) : 3487-3497, 2018
Chronic hepatitis B ; HBsAg loss ; HBsAg seroconversion ; Virological response
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.