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

Charlton MR 1 , Alam A 2 , Shukla A 3 , Dashtseren B 4 , Lesmana CRA 5 , Duger D 6 Show all authors , Payawal DA 7 , Duy Cuong D 8 , Jargalsaikhan G 9 , Cua IHY 10 , Sollano JD 11 , Singh KR 12 , Madan K 13 , Win KM 14 , Kyi KP 15 , Tun KS 16 , Salih M 17 , Rastogi M 18 , Saraf N 19 , Thuy PTT 20 , Hien PTD 21 , Gani RA 22 , Mohamed R 23 , Tanwandee T 24 , Piratvisuth T 25 , Sukeepaisarnjaroen W 26 , Naing W 27 , Hashmi ZY 28

Affiliations 

  • 1 Transplant Institute, Center for Liver Diseases, University of Chicago Biological Sciences, 5841 South Maryland Avenue, Chicago, Illinois, USA. mcharlton@medicine.bsd.uchicago.edu
  • 2 GI Hepatology, Lahore, Pakistan
  • 3 Department of Gastroenterology, LTM Medical College and Sion Hospital, Maharashtra, Mumbai, India
  • 4 Liver Center Hospital, Ulaanbaatar, Mongolia
  • 5 Department of Internal Medicine, Hepatobiliary Division, Dr. Cipto Mangunkusumo Hospital, Universitas Indonesia, Jakarta, Indonesia
  • 6 Mongolian National University of Medical Sciences, Ulaanbaatar, Mongolia
  • 7 Department of Medicine, Cardinal Santos Medical Center, Mandaluyong, Metro, Manila, Philippines
  • 8 Department of Infectious Diseases and HIV Outpatient Clinic, Bach Mai Hospital, Hanoi, Vietnam
  • 9 Department Liver Center, Ulaanbaatar, Mongolia
  • 10 Research Committee and Social Committee, Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Taguig, Philippines
  • 11 Department of Medicine, University of Santo Tomas Hospital, Manila, Philippines
  • 12 Liver Clinic, Regional Institute of Sciences, Imphal, India
  • 13 Gastroenterology & Hepatology, Max Smart Super Speciality Hospital, Saket, New Delhi, India
  • 14 University of Medicine (1) YGN, Yangon, Myanmar
  • 15 Myanmar Liver Foundation, Liver Foundation, Yangon, Myanmar
  • 16 Myanmar GI and Liver Society, Yangon, Myanmar
  • 17 Department of Hepatology, Quaid e Azam International Hospital, Islamabad, Pakistan
  • 18 Department of Hepatology and Gastroenterology, Fortis Hospital, Noida, India
  • 19 Clinical/Transplant Hepatology Institute of Digestive and Hepatobiliary Sciences Medanta, The Medicity, Gurgaon, New Delhi, India
  • 20 Department of Medic Medical Center, Ho Chi Minh City, Vietnam
  • 21 Department of Infectious Disease, Pham Ngoc Thach University of Medicine, Ho Chi Minh, Vietnam
  • 22 Liver Transplantation team, Ciptomangunkusumo Hospital, Jakarta, Indonesia
  • 23 Department of Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 24 Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • 25 Department of Medicine, NKC Institute of Gastroenterology and Hepatology, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand
  • 26 Gastroenterology Unit, Department of Medicine, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
  • 27 Department of Hepatology, Yangon General Hospital, University of Medicine (1), Yangon, Myanmar
  • 28 PMC, Allied and DHQ Hospital, Faisalabad, Pakistan
J Gastroenterol, 2020 Sep;55(9):811-823.
PMID: 32666200 DOI: 10.1007/s00535-020-01698-4

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 

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