Journal
GASTROENTEROLOGY
Volume 140, Issue 1, Pages 132-143Publisher
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2010.10.011
Keywords
Liver Disease; Virology; Drug Resistance; Viral Replication; Nucleotide
Categories
Funding
- Ortho Biotech Inc.
- Indenix
- Merck
- Novartis
- Human Genome Sciences
- Gilead Sciences
- GlaxoSmithKline
- Axcan
- Debiopharm
- Vertex
- Hoffman-La Roche
- Bristol Myers Squibb
- Tibotec
- Boehringer Ingelheim
- Hoffman LaRoche
- Schering-Plough
- Idenix-Novartis
- MSD
- Boehringer
- Pharmasset
- Crucell
- Biotest
- LaRoche
- Canadian Liver Foundation 1000
- Idenix
- Genentech
- Equity ownership Merrill Lynch
- Quintiles/Gilead Sciences
- Quintiles
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BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF), a nucleotide analogue and potent inhibitor of hepatitis B virus (HBV) polymerase, showed superior efficacy to adefovir dipivoxil in treatment of chronic hepatitis B through 48 weeks. We evaluated long-term efficacy and safety of TDF monotherapy in patients with chronic hepatitis B who were positive or negative for hepatitis B e antigen (HBeAg+ or HBeAg-). METHODS: After 48 weeks of double-blind comparison of TDF to adefovir dipivoxil, patients who underwent liver biopsy were eligible to continue the study on open-label TDF for 7 additional years; data presented were collected up to 3 years (week 144) from 85% of participants. Primary efficacy end points at week 144 included levels of HBV DNA and alanine aminotransferase, development of resistance mutations, and presence of HBeAg or hepatitis B surface antigen (HBsAg). 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 adefovir dipivoxil 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 alanine aminotransferase 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. CONCLUSIONS: TDF was safe and effective in the long-term management of HBeAg+ and HBeAg- patients with chronic hepatitis B.
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