Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis

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 PapatheodoridisRobert Flisiak, Henry L.Y. Chan

Research output: Contribution to journalArticlepeer-review

14 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)3487-3497
Number of pages11
JournalDigestive diseases and sciences
Volume63
Issue number12
DOIs
Publication statusPublished - 2018 Dec 1

Bibliographical note

Funding Information:
Funding This study was supported by Gilead Sciences, Inc. Writing support was provided by Claire Demenis, Ph.D. (Elements Communications Ltd., Westerham, UK) and funded by Gilead Sciences, Inc.

Funding Information:
Conflict of interest These authors disclose the following: Sang Hoon Ahn: Advisor and lecturer for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, MSD, Novartis, Roche. Unrestricted research grants from Bristol-Myers Squibb, Gilead Sciences, Roche. Patrick Marcellin: Speaker and investigator for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, Roche, Tibo-tec. Florin A. Caruntu: Advisor and speaker for AbbVie, Bristol-My-ers Squibb, Gilead Sciences, GSK, Janssen, MSD, Roche. Research grants from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Roche. Magdy Elkhashab: Research support from AbbVie, Allergan, Boehringer Ingelheim, Celgene, Gilead Sciences, Janssen, Merck, Genfit, Intercept, Roche, Shire, Spring Bank. Consultant/Advisory Board/CME speaker fees from Abbvie, Gilead Sciences and Merck. Wan-Long Chuang: Member of Advisory Board and speaker for Ab-bVie, Bristol-Myers Squibb, Gilead Sciences, MSD, PharmaEssentia. Fehmi Tabak: Lecturer for AbbVie and Gilead Sciences. Jörg Petersen: Grant/research support from Bristol-Myers Squibb, Novartis, Roche. Research support from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead Sciences, Janssen, Merck, MSD, Roche, Siemens, Vertex. Consultant/Advisor for Abbott, AbbVie, Boehringer Ingel-heim, Bristol-Myers Squibb, GSK, Janssen, Kedrion, Merck, MSD, Novartis, Roche. Sponsored lectures for Abbott, Boehringer Ingel-heim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Kedrion, Merck, MSD, Novartis, Roche. William Guyer: Employee and stockholder of Gilead Sciences. Belinda Jump: Employee and stockholder of Gilead Sciences. Alain Chan: Employee and stockholder of Gilead Sciences. Mani Subramanian: Employee and stockholder of Gilead Sciences. Gerald Crans: Employee and stockholder of Gilead Sciences. Scott Fung: Speaker and advisor for AbbVie, Gilead Sciences, Merck and Lupin. Maria Buti: Gilead Sciences, MSD Novartis. Giovanni B. Gaeta: Speaker or advisor for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Merck, Roche. George Papatheodoridis: Advisor/ lecturer for Bristol-Myers Squibb, Gilead Sciences, Novartis, Roche. Research grants from Bristol-Myers Squibb, Gilead Sciences, Roche. Robert Flisiak: Research grants from Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD, Novartis, Roche. Advisory Board member for AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Gilead Sciences, Janssen, MSD, Novartis, Roche. Speaker for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD, Roche. Henry L. Y. Chan: Advisor and speaker for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Roche, MSD, Novartis. Speaker for Echosens, GSK. Unrestricted grant for HBV research from Roche. The remaining authors declare that they have no conflict of interest.

All Science Journal Classification (ASJC) codes

  • Physiology
  • Gastroenterology

Fingerprint Dive into the research topics of 'Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis'. Together they form a unique fingerprint.

Cite this