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Three Years of Tenofovir Disoproxil Fumarate (TDF) Treatment in HBeAg-Positive Patients (HBeAg+) With Chronic Hepatitis B (Study 103)
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Reported by Jules Levin
60th Annual Meeting of the American Association
for the Study of Liver Diseases
October 30 - November 3, 2009
Boston, Massachusetts, USA
E J Heathcote1, E Gane2, R deMan3, S S Lee4, R Flisiak5, M Manns6, K Tchernev7, O Kurdas8, M Shiffman9, P Marcellin10, J Sorbel11, J Anderson11, E Mondou11, and F Rousseau11
1University of Toronto, Ontario Canada; 2Middlemore Hospital, Auckland New Zealand; 3Erasmus MC, University Medical Center Rotterdam, The Netherlands; 4University of Calgary, Calgary AB Canada; 5Medical University of
Bialystok, Bialystok Poland; 6Medical School of Hannover (MHH), Hannover, Germany; 7Medical University, Sofi a Bulgaria; 8Haydarpapa Nu
BACKGROUND
Tenofovir DF (TDF) was approved for HIV-1 in 2001 and chronic hepatitis B (CHB) in 2008: ∼ 2.4 million patient-years of experience
Week 48 Phase 3 data showed TDF superior to adefovir dipivoxil (ADV): 76% of HBeAg-positive TDF-treated patients (versus 13% ADV-treated patients) had HBV DNA <400 copies/mL
TDF treatment in HBeAg-positive patients beyond Week 48 showed:
- Both stable and viremic patients on ADV can effectively switch to TDF and achieve or maintain viral suppression (HBV DNA < 400 copies/mL), normal ALT and increasing HBeAg and HBsAg loss at Week 96
- TDF patients treated for 96 weeks maintained HBV DNA < 400 copies/mL, normal ALT levels and experienced increasing HBeAg and HBsAg loss
OBJECTIVE
Evaluate the safety and effi cacy of up to 3 years of TDF therapy
*Patients had the option to add FTC 200 mg at the discretion of the investigator if confirmedHBV DNA ≥400 copies/ml at week 72 or beyond
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