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Three-Year Efficacy and Safety of Tenofovir Disoproxil Fumarate Treatment for Chronic Hepatitis B - pdf attached
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from Jules: at AASLD this week 4 year followup from phase 3 studies 102 & 103 will be presented
Gastroenterology Article In Press
E. Jenny Heathcote, Patrick Marcellin et al.
Background & Aims

Tenofovir disoproxil fumarate (TDF), a nucleotide analogue and potent inhibitor of hepatitis B virus (HBV) polymerase, showed superior efficacy to adefovir dipivoxil (ADV) in the treatment of chronic hepatitis B (CHB) through 48 weeks. We evaluated the long-term efficacy and safety of TDF monotherapy in patients with CHB that were positive or negative for HB e antigen (HBeAg+ or HBeAg-).
After 48 weeks of double-blind comparison of TDF to ADV, patients who underwent liver biopsy were eligible to continue study on open-label TDF for 7 additional years; data presented were collected up to 3 years (Week 144), from 85% of participants. The primary efficacy endpoints at week 144 included levels of HBV DNA and alanine aminotransferase (ALT), development of resistance mutations, and presence of HBeAg or HBsAg in blood samples.
At week 144, 87% of HBeAg- and 72% of HBeAg+ patients treated with TDF had levels of HBV DNA <400 copies/mL. Among patients who had previously received ADV and then received TDF, 88% of the HBeAg- and 71% of the HBeAg+ patients had levels of HBV DNA <400 copies/mL; overall, 81% and 74%, respectively, maintained normalized levels of ALT and 34% had lost HBeAg. Amino acid substitutions in HBV DNA polymerase that are associated with resistance to tenofovir were not detected in any patient. Cumulatively, 8% of HBeAg+ patients lost HBsAg. TDF maintained a favorable safety profile for up to 3 years.
TDF was safe and effective in the long-term management of HBeAg+ and HBeAg- patients with CHB. TDF continuously suppressed the virus; there was an increasing percentage of patients with loss of HBsAg up to 3 years, without development of resistance mutations in HBV polymerase.
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