Tenofovir disoproxil fumarate (TDF) versus Emtricitabine plus TDF for treatment of chronic Hepatitis B (CHB) in subjects with persistent viral replication receiving Adefovir dipiv…
T Berg, B Möller, G Gerken, MC Jung, U Spengler, H Hartmann, A Snow-Lampart, D Frederick, D Oldach, J Sorbel, K Borroto-Esoda, F Rousseau · Zeitschrift für Gastroenterologie · 2008 · Heft 09
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Zusammenfassung
Background and aims: TDF and FTC are nucleotide/side analogues, obligatory chain terminators, with potent activity against hepatitis B virus (HBV). The primary objective of this Phase 2 study was to characterize the antiviral activity of TDF 300mg QD versus the fixed-dose combination of TDF 300mg plus FTC 200mg QD in CHB subjects with incomplete virologic response while receiving ADV 10mg QD for at least 6 months. Methods: This is an ongoing, randomized, double-blind, double-dummy multinational study of monoinfected subjects with CHB randomized in a 1:1 ratio to receive TDF or TDF+FTC. Entry criteria included 18…