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

Journal: The lancet. Gastroenterology & hepatology
PMID: 28404092

Abstract

BACKGROUND: The novel prodrug tenofovir alafenamide delivers the nucleotide reverse transcriptase inhibitor tenofovir to target cells more efficiently at a lower dose than tenofovir disoproxil fumarate, thereby reducing systemic exposure. We compared the efficacy and safety of the two drugs in patients with HBeAg-negative chronic hepatitis B virus (HBV) infection in a non-inferiority study.

Authors

  • Maria Buti
    Liver Unit, Department of Medicine, Hospital General Universitari Vall d'Hebron and Ciberehd del Instituto Carlos III, Barcelona, Spain. Electronic address: mbuti@vhebron.net.
  • Edward Gane
    New Zealand Liver Transplant Unit, University of Auckland, Auckland, New Zealand.
  • Wai Kay Seto
    Department of Medicine, Queen Mary Hospital, Hong Kong.
  • 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.
  • Wan-Long Chuang
    Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Tatjana Stepanova
    Modern Medicine Clinic, Moscow, Russian Federation.
  • Aric-Josun Hui
    Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong.
  • Young-Suk Lim
    Department of Gastroenterology, Asan Medical Center, Seoul, South Korea.
  • Rajiv Mehta
    Department of GI Endoscopy, Surat Institute of Medical Sciences (SIDS), Surat, Gujarat, India.
  • Harry L A Janssen
    Toronto Centre for Liver Disease, Toronto, ON, Canada.
  • Subrat K Acharya
    All India Institute of Medical Sciences, New Delhi, Delhi, India.
  • John F Flaherty
    Gilead Sciences, Foster City, CA, USA.
  • Benedetta Massetto
    Gilead Sciences, Foster City, CA, USA.
  • Andrea L Cathcart
    Gilead Sciences, Foster City, CA, USA.
  • Kyungpil Kim
    Gilead Sciences, Foster City, CA, USA.
  • Anuj Gaggar
    Gilead Sciences, Foster City, CA, USA.
  • G Mani Subramanian
    Gilead Sciences, Foster City, CA, USA.
  • John G McHutchison
    Gilead Sciences, Foster City, CA, USA.
  • Calvin Q Pan
    Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Medical Center, NYU School of Medicine, New York, NY, USA.
  • Maurizia Brunetto
    Hepatology Unit, University Hospital of Pisa, Pisa, Italy.
  • Namiki Izumi
    Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.
  • Patrick Marcellin
    Service d'Hépatologie, Hôpital Beaujon, Clichy, France.

Keywords

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