Tenofovir disoproxil fumarate (TDF), emtricitabine ... - Semantic Scholar

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emtricitabine (FTC)/TDF (fixed-dose combination; n 5 45), or entecavir (ETV; n 5 ... Chang Gung University College of Medicine, Taipei, Taiwan; 2Department of ...
Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/ TDF, and Entecavir in Patients with Decompensated Chronic Hepatitis B Liver Disease Yun-Fan Liaw,1 I-Shyan Sheen,1 Chuan-Mo Lee,2 Ulus Salih Akarca,3 George V. Papatheodoridis,4 Florence Suet-Hing Wong,5 Ting-Tsung Chang,6 Andrzej Horban,7 Chia Wang,8 Peter Kwan,9 Maria Buti,10 Martin Prieto,11 Thomas Berg,12 Kathryn Kitrinos,13 Ken Peschell,13 Elsa Mondou,13 David Frederick,13 Franck Rousseau,13 and Eugene R. Schiff14 Data are limited on the safety and effectiveness of oral antivirals other than lamivudine and adefovir dipivoxil for treatment of chronic hepatitis B (CHB) in patients with decompensated liver disease. This Phase 2, double-blind study randomized 112 patients with CHB and decompensated liver disease to receive either tenofovir disoproxil fumarate (TDF; n 5 45), emtricitabine (FTC)/TDF (fixed-dose combination; n 5 45), or entecavir (ETV; n 5 22). The primary endpoint was safety; more specifically, tolerability failure (adverse events resulting in permanent treatment discontinuation) and confirmed serum creatinine increase 0.5 mg/dL from baseline or confirmed serum phosphorus