Two year safety and tolerability of tenofovir disoproxil fumarate (TDF) treatment in HBeAg negative and HBEAG positive patients with chronic hepatitis B (CHB)
P Buggisch, M Manns, S Mauss, T Berg, G Teuber, J Petersen, M Schuchmann, S Zeuzem, P Marcellin, J Heathcote, J Sorbel, F Rousseau · Zeitschrift für Gastroenterologie · 2009 · Heft 09
Bibliografische Angaben
Zusammenfassung
Introduction: Tenofovir disoproxil fumarate (TDF) has a well established long term safety profile in HIV-1 infected patients with more than 2 million patient years of exposure. TDF has activity against hepatitis B virus (HBV) and was approved in 2008 for the treatment of CHB. Goal: To evaluate the safety and tolerability of 2 years of TDF treatment in patients with CHB. Methods: In the Phase 3 studies 102 and 103, HBeAg negative or HBeAg positive CHB patients were randomized 2:1 to double-blind, once daily TDF 300mg or adefovir dipivoxil (ADV) 10mg. At Week (W) 48, patients with a W48 biopsy continued on open-la…
