☆ 4.8 Article

96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection

JOURNAL OF HEPATOLOGY (2018)

期刊

JOURNAL OF HEPATOLOGY

卷 68, 期 4, 页码 672-681

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ELSEVIER

DOI: 10.1016/j.jhep.2017.11.039

关键词

Chronic hepatitis B virus; Bone safety; Renal safety

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Gastroenterology & Hepatology

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Gilead Sciences

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摘要

Background & Aims:Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF) through more efficient delivery of tenofovir to hepatocytes. In 48-week results from two ongoing, double-blind, randomized phase III trials, TAF was non-inferior to TDF in efficacy with improved renal and bone safety. We report 96-week outcomes for both trials. Methods:In two international trials, patients with chronic HBV infection were randomized 2:1 to receive 25 mg TAF or 300 mg TDF in a double-blinded fashion. One study enrolled HBeAg-positive patients and the other HBeAg-negative patients. We assessed efficacy in each study, and safety in the pooled population. Results:At week 96, the differences in the rates of viral suppression were similar in HBeAg-positive patients receiving TAF and TDF (73% vs. 75%, respectively, adjusted difference -2.2% (95% CI -8.3 to 3.9%; p = 0.47), and in HBeAg-negative patients receiving TAF and TDF (90% vs. 91%, respectively, adjusted difference -0.6% (95% CI -7.0 to 5.8%; p = 0.84). In both studies the proportions of patients with alanine aminotransferase above the upper limit of normal at baseline, who had normal alanine aminotransferase at week 96 of treatment, were significantly higher in patients receiving TAF than in those receiving TDF. In the pooled safety population, patients receiving TAF had significantly smaller decreases in bone mineral density than those receiving TDF in the hip (mean % change -0.33% vs. -2.51%; p < 0.001) and lumbar spine (mean % change -0.75% vs. -2.57%; p < 0.001), as well as a significantly smaller median change in estimated glomerular filtration rate by Cockcroft-Gault method (-1.2 vs. -4.8 mg/dl; p < 0.001). Conclusion:In patients with HBV infection, TAF remained as effective as TDF, with continued improved renal and bone safety, two years after the initiation of treatment. (C) 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights

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Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection

Man-Fung Yuen, Seng-Gee Lim, Robert Plesniak, Keiji Tsuji, Harry L. A. Janssen, Cristina Pojoga, Adrian Gadano, Corneliu P. Popescu, Tatyana Stepanova, Tarik Asselah, Gheorghe Diaconescu, Hyung Joon Yim, Jeong Heo, Ewa Janczewska, Alexander Wong, Nevin Idriz, Michio Imamura, Giuliano Rizzardini, Koichi Takaguchi, Pietro Andreone, Manuela Arbune, Jinlin Hou, Sung Jae Park, Andrei Vata, Jennifer Cremer, Robert Elston, Tamara Lukic, Geoff Quinn, Lauren Maynard, Stuart Kendrick, Helene Plein, Fiona Campbell, Melanie Paff, Dickens Theodore, B-Clear Study Grp

Summary: Bepirovirsen treatment for 24 weeks at a dose of 300 mg per week resulted in sustained loss of hepatitis B surface antigen (HBsAg) and HBV DNA in 9%-10% of patients with chronic HBV infection. Larger and longer trials are needed to assess the efficacy and safety of bepirovirsen.

NEW ENGLAND JOURNAL OF MEDICINE (2022)