Gastroenterology 2014;146:980–988

Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B Scott Fung,1 Peter Kwan,2 Milotka Fabri,3 Andrzej Horban,4 Mijomir Pelemis,5 Hie-Won Hann,6 Selim Gurel,7 Florin A. Caruntu,8 John F. Flaherty,9 Benedetta Massetto,9 Phillip Dinh,9 Amoreena Corsa,9 G. Mani Subramanian,9 John G. McHutchison,9 Petr Husa,10 and Edward Gane11 CLINICAL LIVER

1 Department of Medicine, University of Toronto, Toronto, Ontario, Canada; 2University of British Columbia, Vancouver, British Columbia, Canada; 3Clinic for Infectious Diseases, Medical University of Novi Sad, Serbia; 4Medical University of Warsaw, Warsaw, Poland; 5Clinic for Infectious and Tropical Diseases, Clinical Center of Serbia, Belgrade Medical Faculty, Belgrade, Serbia; 6Thomas Jefferson University, Philadelphia, Pennsylvania; 7Uludag Universitesi Tip Fakultesi, Bursa, Gorukle, Turkey; 8 National Institute for Infectious Diseases, “Prof Dr Matei Bals,” Bucharest, Romania; 9Gilead Sciences, Inc, Foster City, California; 10 University Hospital Brno and Faculty of Medicine, Masaryk University Brno, Brno, Czech Republic; and 11Auckland City Hospital, Auckland, New Zealand

BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited. METHODS: In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n ¼ 141) or a combination of emtricitabine (FTC, 200 mg; n ¼ 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg)positive or HBeAg-negative, with levels of HBV DNA 3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V  rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA

Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B.

Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficac...
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