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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-Negative Chronic Hepatitis B: Week 72 TDF Data and Week 24 Adefovir Dipivoxil Switch Data (Study 102)
  Reported by Jules Levin
43rd Annual Meeting of the European Association for the Study of the Liver
April 23-27, 2008
Milan, Italy
P Marcellin,1 I Jacobson,2 F Habersetzer,3 H Senturk,4 P Andreone,5 C Moyes,6 A Horban,7 G Teuber,8 J Sorbel,9 J Anderson,9 E Mondou,9 J Quinn,9 and F Rousseau9
1University of Paris, Clichy France; 2Weill Medical College of Cornell University, New York, NY, USA; 3Hopital Civil de Strasbourg, Strasbourg France; 4Istanbul University, Istanbul, Turkey; 5University of Bologna, Bologna, Italy; 6The Hepatitis Foundation of New Zealand, Whakatane, New Zealand; 7Hospital of Infectious Diseases, Warsaw, Poland; 8Johann-Wolfgang Goethe University, Frankfurt, Germany; 9Gilead Sciences, Inc., Durham NC USA
Author Conclusions for HBeAg Negative Study (Week 72)
· Week 72 results confirm and reinforce the favourable safety and efficacy of TDF for treatment of CHB
· No resistance identified through 72 weeks of therapy
· A Week 24 predictive rule is not useful for TDF
· ADV patients can safely and effectively switch to TDF
· Study 102 is continuing through Year 8
· Tenofovir DF (TDF) is a nucleotide analogue that inhibits viral replication by direct binding to HBV RT resulting in chain termination after being incorporated into HBV DNA
· TDF in combination therapy is approved for the treatment of HIV-1
· Recent favourable EMEA opinion for the treatment of CHB (TDF was approved in Europe during EASL)


Key eligibility criteria
· HBeAg- subjects
· Age 18-69 years
· Compensated liver disease
· Lamivudine experienced or naive
· HBV DNA > 105 c/mL
· ALT ≥ ULN and <10xULN
· Knodell Necroinflammatory score ≥ 3
· HIV, HDV, HCV negative
· 90 % of enrolled patients were still on study at week 72
· HBV DNA and laboratory analyses every 4 weeks during Year 1 and every 8 weeks during Year 2
· HBsAg every 12 weeks during Year 1 and every 16 weeks during Year 2
· HBV DNA measured using Roche COBAS TaqMan assay (response <69 IU/mL or 400 c/mL)
· Resistance surveillance





Resistance Surveillance
· Two patients (originally randomized to TDF) had a loss of viral response (≥400 copies/mL after being <400 copies/mL) between Weeks 48 and 72
· Non-adherence documented for both patients
· Neither patient developed mutations associated with TDF resistance