icon-folder.gif   Conference Reports for NATAP  
  EASL 44th Annual Meeting
April 22-26, 2009
Copenhagen, Denmark
Back grey_arrow_rt.gif
Characteristics of HBeAg-Positive Patients with HBsAg Loss/Seroconversion Following Treatment with Tenofovir Disoproxil Fumarate (TDF)
Reported by Jules Levin
EJ Heathcote1, G Germanidis2, G Dusheiko3, I Jacobson4, R deMan5, P Nikolaidis6, P Marcellin7, J Sorbel8, J Anderson8, E Mondou8, J Quinn8 and F Rousseau8 1Toronto Western Hospital, Toronto ONT, Canada; 2General Hospital of Thessaloniki, Thessaloniki, Greece; 3Roayal Free Hospital, London, UK; 4Weill Medical College of Cornell University, New York, NY; 5Erasmus MC, University Medical Center Rotterdam, The Netherlands; 6General Hospital of Thessaloniki, Thessaloniki, Greece; 7Hospital Beaujon, University of Paris, Clichy France; 8Gilead Sciences, Durham NC
6% of patients with up to 2 years of TDF treatment lost HBsAg
HBeAg-positive patients who lost HBsAg:
- were Caucasians chronically infected with genotypes A and D HBV
- had high baseline HBsAg and HBV DNA levels
In a multivariate model of baseline and on treatment factors, only the change in HBsAg levels at week 24 was significantly predictive of HBsAg loss
· Tenofovir DF (TDF) is a nucleotide analog and obligate chain terminator
· Approved for HIV-1 in 2001: over 2 million patient-years of experience
· Approved for chronic hepatitis B (CHB) in 2008
· Week 48 phase 3 data showed that TDF had superior antiviral efficacy to adefovir dipivoxil (ADV) in studies 102 (HBeAg negative patients) and 103 (HBeAg-positive patients)1:
- 93% vs. 63% (HBeAg-negative) and 76% vs. 13% (HBeAg-positive) with HBV DNA <400 copies/mL (<69 IU/mL) (ITT)
- 3% of patients treated with TDF for 48 weeks experienced HBsAg loss (vs. 0% ADV-treated patients)1
· Week 96 antiviral efficacy data demonstrates durable and potent activity in both HBeAg-negative and HBeAg-positive patients2,3:
- 91% of HBeAg-negative and 78% of HBeAg-positive patients had HBV DNA <400 copies/mL (<69 IU/mL) (ITT)
- Overall 6% of HBeAg positive patients lost HBsAg and 4.5% seroconverted to anti-HBs
To evaluate the characteristics of the HBeAg+ patients treated with TDF who achieved HBsAg loss/seroconversion within the fi rst 2 years of treatment


· HBV DNA and laboratory parameters were assessed every 4-8 weeks
· HBeAg and HBsAg assessed qualitatively every 12-16 weeks
· HBsAg measured quantitatively using the Abbott Architect Assay (sensitivity
≤ 0.05 IU/mL) every 12-16 weeks








1. Marcellin P, Heathcote J, Buti M et al Tenofovir Disoproxil Fumarate versus Adefovir Dipivoxil for Chronic Hepatitis B. NEJM 2008, Vol 359, pg 2442-2455.
2. Marcellin P, Buti M, Krastev Z et al . Two Year Tenofovir Disoproxil Fumarate (TDF) Treatment and Adefovir Dipivoxil (ADV) Switch Data in HBeAg-Negative Patients with Chronic Hepatitis B (Study 102) presented at AASLD 2008 (#146).
3. Heathcote J, Gane E, DeMan R et al. Two Year Tenofovir Disoproxil Fumarate (TDF) Treatment and Adefovir Dipivoxil (ADV) Switch Data in HBeAg-Positve Patients with Chronic Hepatitis B (Study 103) presented at AASLD 2008 (#158).