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

Authors
  • Charlton, Michael R.1
  • Alam, Altaf2
  • Shukla, Akash3
  • Dashtseren, Bekhbold4
  • Lesmana, Cosmas Rinaldi Adithya5
  • Duger, Davadoorj6
  • Payawal, Diana Alcantara7
  • Duy Cuong, Do8
  • Jargalsaikhan, Ganbolor9, 10, 11
  • Cua, Ian Homer Yee12
  • Sollano, Jose Decena13
  • Singh, Karam Romeo14
  • Madan, Kaushal15
  • Win, Khin Maung16
  • Kyi, Khin Pyone17
  • Tun, Kyaw Soe18
  • Salih, Mohd.19
  • Rastogi, Mukul20, 20
  • Saraf, Neeraj21
  • Thuy, Pham Thi Thu22
  • And 8 more
  • 1 University of Chicago Biological Sciences,
  • 2 GI Hepatology, Lahore, Pakistan
  • 3 LTM Medical College and Sion Hospital,
  • 4 Liver Center Hospital, Ulaanbaatar, Mongolia
  • 5 Dr. Cipto Mangunkusumo Hospital, Universitas Indonesia,
  • 6 Mongolian National University of Medical Sciences,
  • 7 Department of Medicine, Cardinal Santos Medical Center, Mandaluyong, Metro, Manila, Philippines
  • 8 Bach Mai Hospital,
  • 9 Department Liver Center, Ulaanbaatar, Mongolia
  • 10 Department International Graduate Program in Medicine (IGPM) Institution, Ulaanbaatar, Mongolia
  • 11 Taipei Medical University,
  • 12 St. Luke’s Medical Center,
  • 13 University of Santo Tomas Hospital,
  • 14 Liver Clinic, Regional Institute of Sciences, Imphal, India
  • 15 Gastroenterology & Hepatology, Max Smart Super Speciality Hospital, Saket, New Delhi, India
  • 16 University of Medicine (1) YGN,
  • 17 Myanmar Liver Foundation, Liver Foundation,
  • 18 Myanmar GI and Liver Society, Yangon, Myanmar
  • 19 Department of Hepatology, Quaid e Azam International Hospital, Islamabad, Pakistan
  • 20 Fortis Hospital,
  • 21 Clinical/Transplant Hepatology Institute of Digestive and Hepatobiliary Sciences Medanta, The Medicity,
  • 22 Department of Medic Medical Center, Ho Chi Minh City, Vietnam
  • 23 Pham Ngoc Thach University of Medicine,
  • 24 Ciptomangunkusumo Hospital,
  • 25 University Malaya Medical Centre,
  • 26 Siriraj Hospital, Mahidol University,
  • 27 NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Prince of Songkla University,
  • 28 Khon Kaen University,
  • 29 Department of Hepatology, Yangon General Hospital, University of Medicine (1), Yangon, Myanmar
  • 30 PMC, Allied and DHQ Hospital,
Type
Published Article
Journal
Journal of Gastroenterology
Publisher
Springer Singapore
Publication Date
Jul 14, 2020
Volume
55
Issue
9
Pages
811–823
Identifiers
DOI: 10.1007/s00535-020-01698-4
PMID: 32666200
PMCID: PMC7452871
Source
PubMed Central
Keywords
License
Unknown

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.

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