IDDF2020-ABS-0058 48-week safety and efficacy of switching to tenofovir alafenamide (TAF) from tenofovir disoproxil fumarate (TDF) in chronic HBV asian patients with TDF risk factors (RF). (18th November 2020)

• Record Type: Journal Article
• Authors: Ahn, Sang Hoon; Kao, Jia-Horng; Hann, Hie-Won; Scott, Fung; Trinh, Huy; Nguyen, Tuan Trong; Paik, Seung Woon; Gaggar, Anuj; Flaherty, John; Yee, Leland; Jump, Belinda; Sethi, Shalini; Wu, George; Kwan Chan, Carol Yee
• Is Part Of: Gut. Volume 69(2020)Supplement 2
• Page Start: A73
• Page End: A74
• Publication Date: 2020-11-18
• Subjects: Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2020-IDDF.141
• Languages: English
• ISSNs: 0017-5749

Abstract

Abstract : Background: In a recent Phase 3 study (Study 4018) in HBV patients suppressed on TDF treatment, switching to TAF demonstrated non-inferior efficacy to continued TDF with superior bone and renal safety at Week 48. This study is to assess the safety and efficacy of switching to TAF from TDF in patients of Asian descent with risk factors for TDF toxicity as per current EASL and AASLD guidelines. Methods: Virally suppressed patients (HBV DNA <20 IU/mL at screening) on TDF were randomized (1:1) to switch to TAF or continue TDF for 48 weeks in a double-blind fashion. Viral suppression and changes in bone (BMD by DXA) and renal (creatinine clearance [eGFRCG ]) parameters were assessed over 48 weeks. Results: Among the 400 Asian patients enrolled, 288 (72%) had at least 1 TDF RF. At Week 48, similar proportions with ≥1 RF had HBV-DNA <20IU/mL (TAF 97%; TDF 97%) and normal ALT by 2018 AASLD criteria (TAF 76%; TDF 73%). TAF subjects with ≥1 RF had increases in eGFRCG compared to decreases on TDF [median (Q1, Q3) change; TAF: +2.6 (-2.01, 7.34); TDF: -2.7 (-7.56, +15.79); p<0.0001)]. Among patients with ≥1 RF, improvements were seen in BMD for TAF vs. continued declines in TDF patients at both spine (p<0.0001) and hip (p<0.0001). Conclusions: Virally suppressed Asian patients with CHB and risk factors for TDF who switched to TAF showed improved bone and renal safety while efficacy was well-maintained.