1. An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia.
- Author
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Charlton MR, Alam A, Shukla A, Dashtseren B, Lesmana CRA, Duger D, Payawal DA, Duy Cuong D, Jargalsaikhan G, Cua IHY, Sollano JD, Singh KR, Madan K, Win KM, Kyi KP, Tun KS, Salih M, Rastogi M, Saraf N, Thuy PTT, Hien PTD, Gani RA, Mohamed R, Tanwandee T, Piratvisuth T, Sukeepaisarnjaroen W, Naing W, and Hashmi ZY
- Subjects
- Alanine adverse effects, Alanine pharmacology, Antiviral Agents adverse effects, Antiviral Agents pharmacology, Asia, Drug Resistance, Viral, Hepatitis B, Chronic virology, Humans, Randomized Controlled Trials as Topic, Tenofovir administration & dosage, Tenofovir adverse effects, Tenofovir pharmacology, Alanine administration & dosage, Antiviral Agents administration & dosage, Hepatitis B, Chronic drug therapy, Tenofovir analogs & derivatives
- Abstract
Asia has intermediate-to-high prevalence and high morbidity of hepatitis B virus (HBV) infection. The use of guideline-recommended nucleos(t)ide analogs with high barrier to resistance, such as entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), is one of the key interventions for curbing HBV infection and associated morbidity in Asia. However, there are some challenges to the use of ETV and TDF; while ETV is associated with high resistance in lamivudine (LAM)-exposed (especially LAM-refractory) patients; bone and renal safety issues are a major concern with TDF. Hence, a panel of twenty-eight expert hepatologists from Asia convened, reviewed the literature, and developed the current expert opinion-based review article for the use of TAF in the resource-constrained settings in Asia. This article provides a comprehensive review of two large, phase 3, double-blind, randomized controlled trials of TAF versus TDF in HBeAg-negative (study 0108) and HBeAg-positive (study 0110) chronic HBV patients (> 70% Asians). These studies revealed as follows: (1) non-inferiority for the proportion of patients who had HBV DNA < 29 IU/mL; (2) significantly high rate of normalization of alanine aminotransferase levels; (3) no incidence of resistance; and (4) significantly better bone and renal safety, with TAF vs. TDF up to 144 weeks. Considering the benefits of TAF, the expert panel proposed recommendations for optimizing the use of TAF in Asia, along with guidance on specific patient groups at risk of renal or bone disease suitable for TAF therapy. The guidance provided in this article may help clinicians optimize the use of TAF in Asia.
- Published
- 2020
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