Tenofovir disoproxil fumarate (TDF) for the treatment of HBeAg-positive chronic Hepatitis B: Week 72 TDF data and week 24 Adefovir dipivoxil switch data (Study 103)
J Petersen, M Manns, S Mauss, T Berg, S Zeuzem, B Möller, J Sorbel, J Anderson, E Mondou, F Rousseau, J Heathcote · Zeitschrift für Gastroenterologie · 2008 · Heft 09
Bibliografische Angaben
Zusammenfassung
Aims: TDF, a nucleotide analogue and obligate chain terminator, has potent activity against hepatitis B virus (HBV). Methods: Subjects with HBeAg positive (+) chronic hepatitis B (CHB) were randomized 2:1 to double-blind TDF (N=176) or ADV (N=90) for the first 48 weeks. After 48 weeks eligible subjects with week (WK) 48 biopsy were switched to TDF for up to an additional 4 years. HBV DNA was measured using the Roche COBAS TaqMan assay. Results: Eighty-four subjects originally randomized to ADV initiated TDF at WK48. Seventy-two subjects had HBV DNA >400 c/ml just prior to switching to TDF. At WK72 after 24 weeks…