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Three-Year Efficacy and Safety of Tenofovir Disoproxil Fumarate Treatment for Chronic Hepatitis B - pdf attached
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Download the PDF
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.
Abstract
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-).
Methods:
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.
Results:
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.
Conclusion:
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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