An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia

Michael R. Charlton, Altaf Alam, Akash Shukla, Bekhbold Dashtseren, Cosmas Rinaldi Adithya Lesmana, Davadoorj Duger, Diana Alcantara Payawal, Do Duy Cuong, Ganbolor Jargalsaikhan, Ian Homer Yee Cua, Jose Decena Sollano, Karam Romeo Singh, Kaushal Madan, Khin Maung Win, Khin Pyone Kyi, Kyaw Soe Tun, Mohd Salih, Mukul Rastogi, Neeraj Saraf, Pham Thi Thu ThuyPham Tran Dieu Hien, Rino Alvani Gani, Rosmawati Mohamed, Tawesak Tanwandee, Teerha Piratvisuth, Wattana Sukeepaisarnjaroen, Win Naing, Zahid Yasin Hashmi

Research output: Contribution to journalReview article

1 Citation (Scopus)

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.

Original languageEnglish
JournalJournal of Gastroenterology
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • Asia
  • Hepatitis B virus
  • Nucleoside analogs
  • Tenofovir alafenamide

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    Charlton, M. R., Alam, A., Shukla, A., Dashtseren, B., Lesmana, C. R. A., Duger, D., Payawal, D. A., Duy Cuong, D., Jargalsaikhan, G., Cua, I. H. Y., Sollano, J. D., Singh, K. R., Madan, K., Win, K. M., Kyi, K. P., Tun, K. S., Salih, M., Rastogi, M., Saraf, N., ... Hashmi, Z. Y. (Accepted/In press). An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia. Journal of Gastroenterology. https://doi.org/10.1007/s00535-020-01698-4