IDDF2021-ABS-0080 96-week efficacy and safety of tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) switch vs. continued TDF treatment among virologically-suppressed hepatitis B patients of asian ethnicity

Sang Hoon Ahn; Jia-Horng Kao; Pietro Lampertico; Alnoor Ramji; Scott Fung; Wan-Long Chuang; Yoon Jun Kim; Chi-Yi Chen; Edward Tam; Ho Bae; Xiaoli Ma; June Sung Lee; Carol Yee Kwan Chan; Leland J Yee; Shalini Sethi; John Flaherty; Yang Zhao; Anuj Gaggar; Hie Won Hann; Young-Suk Lim; Henry Lik Yuen Chan

doi:10.1136/gutjnl-2021-IDDF.82

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IDDF2021-ABS-0080 96-week efficacy and safety of tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) switch vs. continued TDF treatment among virologically-suppressed hepatitis B patients of asian ethnicity

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IDDF2021-ABS-0080 96-week efficacy and safety of tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) switch vs. continued TDF treatment among virologically-suppressed hepatitis B patients of asian ethnicity

Sang Hoon Ahn, Jia-Horng Kao, Pietro Lampertico, Alnoor Ramji, Scott Fung, Wan-Long Chuang, Yoon Jun Kim, Chi-Yi Chen, Edward Tam, Ho Bae, …

Gut, v 70(Suppl 2), pp A77-A78

Sep 2021

DOI: https://doi.org/10.1136/gutjnl-2021-IDDF.82

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Abstract

BackgroundStudy 4018, an international Phase 3 study, previously demonstrated switching to tenofovir alafenamide (TAF) vs continued tenofovir disoproxil fumarate (TDF) in suppressed chronic hepatitis B (CHB) patients has non-inferior efficacy (TAF vs TDF) with superior bone/renal safety. We analysed the efficacy and safety of switching in Asian Ethnicity (AE) patients in Study 4018.MethodsCHB patients on TDF for ≥48 weeks with HBV DNA less than LLOQ for ≥20 IU/ml at screening were randomized to TAF 25mg QD or TDF 300mg QD, each with a matching placebo, and treated for 48 weeks in a double-blind (DB) fashion followed by all patients receiving open-label (OL) TAF 25 mg QD for an additional 48 weeks.Results400/488 (82%) were AE patients who received at least 1 dose of study drug, with 195 in the TAF-TAF arm ad 205 in the TDF-TAF arm. Virologic suppression was similarly maintained at 96-wk in both groups (95%: TAF and 94% TDF). Higher percent changes in BMD from baseline (both hip and spine) were seen among the TAF-TAF group [1.2 (3.0 SD) for hip and 2.5 (4.0) SD for spine] vs TDF-TAF group [0.12 (2.8 SD) for hip and 1.5 (3.8) SD for spine]. eGFRCG increased over years in the TAF-TAF group and from Week 48 to 96 in the TDF-TAF group. There were no study drug-related treatment-emergent grade 3 or 4 AEs or SAEs.ConclusionsFollowing TDF to TAF switch, viral suppression was maintained, with improved bone and renal safety parameters through 96 weeks in AE patients.

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Title: IDDF2021-ABS-0080 96-week efficacy and safety of tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) switch vs. continued TDF treatment among virologically-suppressed hepatitis B patients of asian ethnicity
Creators: Sang Hoon Ahn - The Chinese University of Hong Kong, Hong Kong
Jia-Horng Kao - The Chinese University of Hong Kong, Hong Kong
Pietro Lampertico - The Chinese University of Hong Kong, Hong Kong
Alnoor Ramji - The Chinese University of Hong Kong, Hong Kong
Scott Fung - The Chinese University of Hong Kong, Hong Kong
Wan-Long Chuang - The Chinese University of Hong Kong, Hong Kong
Yoon Jun Kim - The Chinese University of Hong Kong, Hong Kong
Chi-Yi Chen - The Chinese University of Hong Kong, Hong Kong
Edward Tam - The Chinese University of Hong Kong, Hong Kong
Ho Bae - The Chinese University of Hong Kong, Hong Kong
Xiaoli Ma - Chinese University of Hong Kong
June Sung Lee - The Chinese University of Hong Kong, Hong Kong
Carol Yee Kwan Chan - The Chinese University of Hong Kong, Hong Kong
Leland J Yee - The Chinese University of Hong Kong, Hong Kong
Shalini Sethi - The Chinese University of Hong Kong, Hong Kong
John Flaherty - The Chinese University of Hong Kong, Hong Kong
Yang Zhao - The Chinese University of Hong Kong, Hong Kong
Anuj Gaggar - The Chinese University of Hong Kong, Hong Kong
Hie Won Hann - The Chinese University of Hong Kong, Hong Kong
Young-Suk Lim - The Chinese University of Hong Kong, Hong Kong
Henry Lik Yuen Chan - The Chinese University of Hong Kong, Hong Kong
Publication Details: Gut, v 70(Suppl 2), pp A77-A78
Publisher: British Medical Journal (BMJ)
Resource Type: Journal article
Language: English
Academic Unit: Medicine (Graduate)
Web of Science ID: WOS:000720871000082
Other Identifier: 991019167710704721

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Web of Science research areas: Gastroenterology & Hepatology