TY - JOUR
T1 - An expert review on the use of tenofovir alafenamide for the treatment of chronic hepatitis B virus infection in Asia
AU - Charlton, Michael R.
AU - Alam, Altaf
AU - Shukla, Akash
AU - Dashtseren, Bekhbold
AU - Lesmana, Cosmas Rinaldi Adithya
AU - Duger, Davadoorj
AU - Payawal, Diana Alcantara
AU - Duy Cuong, Do
AU - Jargalsaikhan, Ganbolor
AU - Cua, Ian Homer Yee
AU - Sollano, Jose Decena
AU - Singh, Karam Romeo
AU - Madan, Kaushal
AU - Win, Khin Maung
AU - Kyi, Khin Pyone
AU - Tun, Kyaw Soe
AU - Salih, Mohd
AU - Rastogi, Mukul
AU - Saraf, Neeraj
AU - Thuy, Pham Thi Thu
AU - Hien, Pham Tran Dieu
AU - Gani, Rino Alvani
AU - Mohamed, Rosmawati
AU - Tanwandee, Tawesak
AU - Piratvisuth, Teerha
AU - Sukeepaisarnjaroen, Wattana
AU - Naing, Win
AU - Hashmi, Zahid Yasin
N1 - Funding Information:
The authors would like to thank Mylan Pharmaceuticals Ltd. for financial support in execution of this project. They would also like to thank BioQuest Solutions Ltd. for providing writing assistance
Funding Information:
The authors would like to thank Mylan Pharmaceuticals Ltd. for financial support in execution of this project. They would also like to thank BioQuest Solutions Ltd. for providing writing assistance
Funding Information:
The project is supported by Mylan Pharmaceuticals Ltd. However, Mylan was not involved in the discussion during the expert consensus meeting or in the process of development of this manuscript. Acknowledgements
Funding Information:
Author Michael Charlton: Consulting and research support for Gilead Sciences, Merck, AbbVie, Novartis and Only consulting support for Mylan. Author Teerha Piratvisuth received commercial research and funding from Gilead Sciences, Roche Diagnostic, Janssen, Fibrogen, VIR and received honoraria from Bristol-Meyers Squibb, Gilead Sciences, Bayer, Abbott, Esai, Mylan Ferring and MSD.
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
KW - Asia
KW - Hepatitis B virus
KW - Nucleoside analogs
KW - Tenofovir alafenamide
UR - http://www.scopus.com/inward/record.url?scp=85087857583&partnerID=8YFLogxK
U2 - 10.1007/s00535-020-01698-4
DO - 10.1007/s00535-020-01698-4
M3 - Review article
AN - SCOPUS:85087857583
SN - 0944-1174
VL - 55
SP - 811
EP - 823
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
IS - 9
ER -
