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43rd Annual Meeting of the European Association For The Study Of The Liver
Milan, Italy
April 23-27, 2008
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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)
  Reported by Jules Levin
43rd Annual Meeting of the European Association for the Study of the Liver
April 23-27, 2008
Milan, Italy
J Heathcote,1 J George,2 S Gordon,3 J-P Bronowicki,4 J Sperl,5 R Williams,6 P Martin,7 M Beniowski,8 J Sorbel,9 J Anderson,9 E Mondou,9 A Snow-Lampart9 and F Rousseau9
1University of Toronto, Toronto Canada; 2 Westmead Hospital, Westmean Australia; 3Henry Ford Hospital, Detroit, MI USA; 4Hospital de Brabois, Vandoeuvre les Nancy, France; 5Institute of Clinical & Experimental Medicine, Praha, Czech Republic; 6University College London Hospital, London UK; 7Mount Sinai School of Medicine, New York, NY USA; 8Oddzial Kliniczny Chorob Zakaznych, Chorzow Poland; 9Gilead Sciences, Inc., Durham, NC USA
Author Conclusions for HBeAg Positive Study (Week 72)
· Week 72 results (79% <400 c/ml) confirm and reinforce the continuing favourable safety and efficacy of TDF for treatment of CHB
· Progressive increase in HBsAg loss (5% by Week 64)
· A Week 24 HBV DNA predictive rule is not useful for TDF
· ADV patients can safely and effectively switch to TDF
· Study 103 is continuing through Year 8
· Tenofovir DF (TDF) is a nucleotide analogue that is an obligate HBV DNA chain terminator
· TDF in combination therapy is approved for HIV-1
· Recent favourable EMEA opinion for the treatment of CHB (EU Aprroved TDF during EASL meeting)
Key eligibility criteria:
- HBeAg+
- Treatment naive
- 18-69 years of age
- Compensated liver disease
- HBV DNA >106 copies/mL
- ALT > 2x and < 10xULN
- Knodell Necroinflammatory score ≥ 3
- HIV, HDV, HCV negative
88% of patients still on study at week 72
· HBV DNA and laboratory analyses every 4 weeks during Year 1 and every 8 weeks during Year 2
· HBeAg and HBsAg every 12 weeks during Year 1 and every 16 weeks during Year 2
· HBV DNA measured using Roche COBAS TaqMan assay (Virologic response 69 IU/mL or 400 c/mL)
· Resistance surveillance







Resistance Surveillance
· No mutations associated with TDF resistance detected at week 48
· No TDF-treated patient had a loss of viral response (≥400 copies/mL after being <400 copies/mL) between Weeks 48 and 72