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Asians have Different Hepatitis B Surface Antigen (HBsAg) Kinetics than Non-Asians while Undergoing Treatment with Tenofovir Disoproxil Fumarate (TDF) or Adefovir (ADV) Followed by TDF up to 192 Weeks
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Reported by Jules Levin
22nd Conference of the Asian Pacific Association for the Study of the Liver (APASL)
February 16-19, 2012 Taipei, Taiwan
S Fung1, E Gane2, IM Jacobson3, P Dinh4, R Ebrahimi4, LJ Yee4, EB Martins4, P Charuworn4, K Kitrinos4, G Dusheiko5, H Trinh6, S Gordon7, R Flisiak8, EJ Heathcote1 and P Marcellin9
1University of Toronto, Toronto, ON, Canada; 2Auckland City Hospital, Auckland, New Zealand; 3Weill Medical College of Cornell University, New York, NY, USA; 4Gilead Sciences, Foster City, CA, USA; 5Royal Free Hospital, London, UK; 6San Jose Gastroenterology, San Jose, CA, USA; 7Henry Ford Medical Center, Detroit, MI, USA; 8Medical University of Bialystok, Bialystok, Poland; 9Hopital Beaujon, University of Paris, Clichy, France
Introduction
· In registration studies of tenofovir disoproxil fumarate (TDF), HBsAg loss has been described in 11% of patients over 5 years 1,2
- Clinical characteristics such as ALT elevations and HBeAg loss have also been described in some patients with HBsAg loss [see Marcellin et al.
Poster: PP09-042]
- In these studies, HBsAg loss has not been observed in Asians
· Little is known about individuals who have significant HBsAg declines in the absence of HBsAg loss
· Also, it is unknown whether Asians and non-Asians have different HBsAg kinetics during treatment with TDF
Objective
· To evaluate the kinetics of HBsAg decline between Asian and non-Asian patients treated with TDF or adefovir dipivoxil (ADV) followed by TDF
Methods
· Data analyzed from two pivotal TDF studies1
- GS-US-174-0102
· HBeAg-negative patients
· 375 patients enrolled
- GS-US-174-0103
· HBeAg-positive patients
· 266 patients enrolled
· Study design (Figure 1)
- TDF or ADV for 48 weeks, followed by TDF for another 192 weeks
- The present analyses are based on data through year 4
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