Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial.

Journal: The lancet. Gastroenterology & hepatology
PMID: 28404091

Abstract

BACKGROUND: Tenofovir alafenamide is a novel prodrug formulated to deliver the active metabolite to target cells more efficiently than tenofovir disoproxil fumarate at a lower dose, thereby reducing systemic exposure. In patients with HIV, tenofovir alafenamide was as efficacious as tenofovir disoproxil fumarate, with reduced bone and renal toxic effects. We compared the efficacy and safety of the two drugs in patients with HBeAg-positive chronic hepatitis B virus (HBV) infection in a non-inferiority study.

Authors

  • Henry L Y Chan
    Department of Medicine and Therapeutics, Institute of Digestive Disease and State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.
  • Scott Fung
    Toronto General Hospital, Toronto, ON, Canada.
  • Wai Kay Seto
    Department of Medicine, Queen Mary Hospital, Hong Kong.
  • Wan-Long Chuang
    Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Chi-Yi Chen
    Chiayi Christian Hospital, Chiayi, Taiwan.
  • Hyung Joon Kim
    Department of Urology, Konyang University, College of Medicine, Daejeon, Korea.
  • Aric Josun Hui
    Alice Ho Miu Ling Nethersole Hospital, Hong Kong.
  • Harry L A Janssen
    Toronto Centre for Liver Disease, Toronto, ON, Canada.
  • Abhijit Chowdhury
    Institute of Post Graduate Medical Education and Research, Kolkata, India.
  • Tak Yin Owen Tsang
    Princess Margaret Hospital, Hong Kong.
  • Rajiv Mehta
    Department of GI Endoscopy, Surat Institute of Medical Sciences (SIDS), Surat, Gujarat, India.
  • Edward Gane
    New Zealand Liver Transplant Unit, University of Auckland, Auckland, New Zealand.
  • John F Flaherty
    Gilead Sciences, Foster City, CA, USA.
  • Benedetta Massetto
    Gilead Sciences, Foster City, CA, USA.
  • Anuj Gaggar
    Gilead Sciences, Foster City, CA, USA.
  • Kathryn M Kitrinos
    Gilead Sciences, Foster City, CA, USA.
  • Lanjia Lin
    Gilead Sciences, Foster City, CA, USA.
  • G Mani Subramanian
    Gilead Sciences, Foster City, CA, USA.
  • John G McHutchison
    Gilead Sciences, Foster City, CA, USA.
  • Young-Suk Lim
    Department of Gastroenterology, Asan Medical Center, Seoul, South Korea.
  • Subrat K Acharya
    All India Institute of Medical Sciences, New Delhi, Delhi, India.
  • Kosh Agarwal
    Kings College Hospital, London, UK.

Keywords

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