studies

1196A AASLD ABSTRACTS HEPATOLOGY, October, 2015
2025
Descriptive Comparison of Efficacy and Safety of Tenofovir
Disoproxil Fumarate (TDF) plus Pegylated-Interferon
α-2a (PEG) Combination in Asians and non-Asians
with Chronic Hepatitis B (CHB)
Patrick Marcellin 2 , Sang Hoon Ahn 3 , Won Young Tak 4 , Owen
Tak Yin Tsang 8 , Aric Josun Hui 5 , Xiaoli Ma 6 , Wan-Long Chuang 7 ,
Seng Gee Lim 9 , Rajiv Mehta 10 , Eduardo B. Martins 1 , Leland J.
Yee 1 , Phillip Dinh 1 , Lanjia Lin 1 , Prista Charuworn 1 , Mani Subramanian
1 , Scott Fung 11 , Magdy Elkhashab 12 , Huy N. Trinh 13 , Henry
Lik-Yuen Chan 14 ; 1 Gilead Sciences, Foster City, CA; 2 Hôpital
Beaujon, Université Paris-Diderot, Clichy, France; 3 Yonsei University
College of Medicine, Seoul, Korea (the Republic of); 4 Kyungpook
National University Hospital, Daegu, Korea (the Republic
of); 5 Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China;
6 Drexel University College of Medicine, Philadelphia, PA; 7 Kaohsiung
Medical University Chung-Ho Memorial Hospital, Kaohsiung,
Taiwan; 8 Princess Margaret Hospital, Hong Kong, China; 9 Yong
Loo Lin School of Medicine, National University of Singapore, Singapore,
Singapore; 10 Liver Clinic, Surat, India; 11 Toronto General
Hospital, Toronto, ON, Canada; 12 Toronto Liver Centre, Toronto,
ON, Canada; 13 San Jose Gastroenterology, San Jose, CA; 14 The
Chinese University of Hong Kong, Hong Kong, China
Background: Differences in viral and patient characteristics
between Asians and non-Asians may impact response to HBV
therapy. We examined differences in between Asian and
non-Asian patients enrolled in the TDF plus PEG combination
study GS-US-174-0149. Methods: 740 CHB patients without
advanced liver disease were randomized 1:1:1:1 to receive
TDF+PEG x48 weeks (Arm A); TDF+PEG x16 weeks followed
by TDF x32 weeks (Arm B); continuous TDF (Arm C); PEG x48
weeks (Arm D). Baseline characteristics, Week 72 efficacy and
overall safety were compared between Asians and non-Asians.
Primary efficacy was HBsAg loss at Week 72. Results: Of 554
Asian patients randomized, most were male and HBeAg-positive,
and predominantly genotype (Gt)-B/C; while among
186 non-Asian patients, most were male, HBeAg-negative and
predominantly Gt- A/ D (Table 1). Overall, rates of HBsAg
decline ≥ 1 log 10
IU/mL from baseline to Week 48 were lower
among non-Asians (11%) vs. Asians (26%) (p0.05 for
Asian vs non-Asian comparison within each treatment group).
Within each treatment arm, no significant differences were
observed for rates of normal ALT, HBeAg loss/seroconversion
between Asian and non-Asian patients at Week 48. Rates of
treatment-emergent AEs, discontinuations and SAEs were similar
between Asians and non-Asians. Conclusion: Although more
Asians had >1log 10
HBsAg decline from baseline, no statistically
significant differences in efficacy were observed between
Asians and non-Asians.
Table 1
*Among 497 Asian and 162 Non-Asians who reached Week
48.
N.S.=Not Significant
Disclosures:
Patrick Marcellin - Consulting: Roche, Gilead, BMS, Vertex, Novartis, Janssen,
MSD, Abbvie, Alios BioPharma, Idenix, Akron; Grant/Research Support: Roche,
Gilead, BMS, Novartis, Janssen, MSD, Alios BioPharma; Speaking and Teaching:
Roche, Gilead, BMS, Vertex, Novartis, Janssen, MSD, Boehringer, Pfizer,
Abbvie
Won Young Tak - Advisory Committees or Review Panels: Gilead Korea; Grant/
Research Support: SAMIL Pharma; Speaking and Teaching: Bayer Korea
Xiaoli Ma - Consulting: Gilead Sciemces, Inc
Wan-Long Chuang - Advisory Committees or Review Panels: Gilead, Abbvie;
Speaking and Teaching: BMS, Roche, MSD
Seng Gee Lim - Advisory Committees or Review Panels: Bristol-Myers Squibb,
Novartis Pharmaceuticals, Merck Sharp and Dohme Pharmaceuticals, Gilead
Pharmaceuticals, Roche Pharmaceuticals; Speaking and Teaching: Bristol-Myers
Squibb, Novartis Pharmaceuticals, Merck Sharp and Dohme Pharmaceuticals,
Gilead Pharmaceuticals
Eduardo B. Martins - Employment: Gilead Sciences, Inc.; Stock Shareholder:
Gilead Sciences, Inc.
Leland J. Yee - Employment: Gilead Science
Phillip Dinh - Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences
Lanjia Lin - Employment: Gilead; Stock Shareholder: Gilead
Prista Charuworn - Stock Shareholder: Gilead Sciences
Mani Subramanian - Employment: Gilead Sciences
Scott Fung - Advisory Committees or Review Panels: Gilead Sciences, Merck,
Vertex, Roche; Speaking and Teaching: BMS, Gilead, AbbVie, Janssen, Merck
Magdy Elkhashab - Advisory Committees or Review Panels: GSK, Gilead, Merk,
BMS, ABBVIE; Grant/Research Support: EISAI, GENENTECH, GSK, GILEAD,
ABBVIE, Merk, BMS
Huy N. Trinh - Advisory Committees or Review Panels: BMS, Gilead; Grant/
Research Support: BMS, Gilead; Speaking and Teaching: BMS, Gilead; Stock
Shareholder: Gilead
Henry Lik-Yuen Chan - Advisory Committees or Review Panels: Gilead, MSD,
Bristol-Myers Squibb, Roche, Novartis Pharmaceutical, Abbvie; Speaking and
Teaching: Echosens
The following authors have nothing to disclose: Sang Hoon Ahn, Owen Tak Yin
Tsang, Aric Josun Hui, Rajiv Mehta
2026
Characterization of Hepatitis B Surface Proteins in
HBeAg-positive Patients with Chronic Hepatitis B (CHB)
Treated With PegInterferon Alfa-2a (40KD)
Franziska Rinker 1,2 , Corinna M. Bremer 3,4 , Steffen B. Wiegand 1 ,
Birgit Bremer 1 , Michael P. Manns 1,2 , Heiner Wedemeyer 1,2 , Lei
Yang 5 , Vedran Pavlovic 6 , Cynthia Wat 6 , Dieter Glebe 3,4 , Anke R.
Kraft 1 , Markus Cornberg 1,2 ; 1 Gastroenterology, Hepatology and
Endocrinology, Medical School Hannover, Hannover, Germany;
2 German Center for Infection Research (DZIF), Hannover, Germany;
3 Institute of Medical Virology, National Reference Center
for Hepatitis B and D Viruses, Justus Liebig University Giessen,
Giessen, Germany; 4 German Center for Infection Research (DZIF),
Giessen, Germany; 5 Roche Products Ltd, Shanghai, China; 6 Roche
Products Ltd, Welwyn Garden City, United Kingdom
Background: HBsAg consists of three proteins called large
(L-), middle (M-) and small (S-)HBs that differ in amino-terminal
sequences and glycosylation status. Commercial HBsAg assays
only quantify the total amount of HBsAg. We have validated
an ELISA method for quantification of HBs proteins and demonstrated
that SHBs represents the commonest subtype (accounting
for 88% of total HBsAg, L- and M- HBs account for 8%
and 3%) in untreated HBeAg-positive patients. The aim of current
study was to explore HBs protein fractions kinetics during
pegylated interferon alfa-2a (PegIFNα-2a, Pegasys) therapy
and examine whether HBs fractions are more predictive of
treatment response than quantitative HBsAg (qHBsAg) levels.
Methods: Serum samples of 128 HBeAg-positive patients, from
two phase III/IV PegIFNα-2a trials were retrospectively analysed.
Patients received PegIFNα-2a ± lamivudine therapy for
48 weeks. Clinical and laboratory patient data from completed
trials was provided by Roche. HBs fractions were quantified