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성균관대학교 의과대학, 삼성서울병원

Clin. Gastroenterol. Hepatol., Volume 20, Issue 2, February 2022, Pages 427-437.e5 | https://doi.org/10.1016/j.cgh.2021.04.045 Tenofovir Alafenamide for Drug-Resistant Hepatitis B: A Randomized Trial for Switching From Tenofovir Disoproxil Fumarate

Kwan Soo Byun^∗,a, Jonggi Choi^‡,a, Ji-Hoon Kim^∗, Yung Sang Lee^‡, Han Chu Lee^‡, Yoon Jun Kim^§, Byung Chul Yoo^‖, So Young Kwon^‖, Geum-Youn Gwak^¶, Young-Suk Lim^‡

^∗Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
^‡Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
^§Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea
^‖Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea
^¶Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

^aAuthors share co-first authorship.

Reprint requests Address requests for reprints to: Young-Suk Lim, MD, PhD, Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Republic of Korea.

Geum-Youn Gwak, MD, PhD, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-Gu, Seoul 06351, Republic of Korea.

Abstract

Background & Aims
It remains unknown whether tenofovir alafenamide (TAF) could replace tenofovir disoproxil fumarate (TDF) in patients with drug-resistant hepatitis B virus (HBV).

Methods
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.

Results
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 significantly greater increases in mean body weight (0.71 vs –0.37 kg; P = .01) and total, low-density lipoprotein, and high-density lipoprotein cholesterol levels (P < .001 for all) at week 48 from baseline.

Conclusions
TAF could be substituted for TDF in patients with multidrug-resistant HBV for improved bone and renal safety without a loss of efficacy. However, increases in body weight and cholesterol levels with TAF treatment would be a concern. ClinicalTrials.gov no.: NCT03241641.

Keywords : Hepatitis B, Resistance, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide

논문정보

형식Research article
게재일2022년 02월 (BRIC 등록일 2022-02-16)
연구진국내 연구진
분야 의약학 > 응용의학

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