Tenofovir Alafenamide for Drug-Resistant Hepatitis B: A Randomized Trial for Switching From Tenofovir Disoproxil Fumarate.

Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association
Kwan Soo ByunYoung-Suk Lim

Abstract

It remains unknown whether tenofovir alafenamide (TAF) could replace tenofovir disoproxil fumarate (TDF) in patients with drug-resistant hepatitis B virus (HBV). In this multicenter randomized non-inferiority trial, 174 patients with HBV resistant to multiple drugs (lamivudine, entecavir, and/or adefovir) under TDF monotherapy for ≥96 weeks were randomized 1:1 to switch to TAF (n = 87) or continue TDF (n = 87) for 48 weeks. The primary endpoint was proportion of patients with HBV DNA <60 IU/mL at week 48. At baseline, 84 and 80 patients had HBV DNA <60 IU/mL in the TAF and TDF groups, respectively. At week 48, the proportion of patients with HBV DNA <60 IU/mL was 98.9% (86/87) in TAF group, showing non-inferiority to TDF group (97.7%, 85/87; difference, 1.1%; 95% confidence interval, -2.7% to 5.0%). Changes in median alanine aminotransferase at week 48 from baseline were statistically different between TAF and TDF groups (-3 IU/L vs +2 IU/L; P = .02). TAF group showed a statistically greater increase in bone mineral density at spine (+1.84% vs +0.08%; P = .01) and numerically higher increase in mean estimated glomerular filtration rate (+8.2% vs +4.5%; P = .06) compared with TDF group. Compared with TDF group, TAF group showed ...Continue Reading

References

Aug 31, 2006·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Hyung Joon YimAnna S F Lok
Nov 14, 2015·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Norah A TerraultUNKNOWN American Association for the Study of Liver Diseases
Apr 4, 2017·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Young-Suk LimSo Young Kwon
May 15, 2018·Journal of Hepatology·Kosh AgarwalUNKNOWN GS-US-320-0108 Investigators
Dec 8, 2020·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Pimsiri SripongpunPaul Y Kwo

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