Δημοσίευση

Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B.

ΤίτλοςThree-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B.
Publication TypeJournal Article
Year of Publication2011
AuthorsE Heathcote, J., Marcellin P., Buti M., Gane E., De Man R. A., Krastev Z., Germanidis G., Lee S. S., Flisiak R., Kaita K., Manns M., Kotzev I., Tchernev K., Buggisch P., Weilert F., Kurdas O. Ovunc, Shiffman M. L., Trinh H., Gurel S., Snow-Lampart A., Borroto-Esoda K., Mondou E., Anderson J., Sorbel J., & Rousseau F.
JournalGastroenterology
Volume140
Issue1
Pagination132-43
Date Published2011 Jan
ISSN1528-0012
Λέξεις κλειδιάAdenine, Adolescent, Adult, Alanine Transaminase, Antiviral Agents, Biopsy, DNA, Viral, Drug Resistance, Viral, Female, Follow-Up Studies, Hepatitis B e Antigens, Hepatitis B virus, Hepatitis B, Chronic, Humans, Male, Middle Aged, Organophosphonates, Randomized Controlled Trials as Topic, Treatment Outcome, Virus Replication, Young Adult
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 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.

DOI10.1053/j.gastro.2010.10.011
Alternate JournalGastroenterology
PubMed ID20955704

Επικοινωνία

Γραμματεία Τμήματος Ιατρικής T.K. 54124 Θεσσαλονίκη
 

Συνδεθείτε

Το τμήμα Ιατρικής στα social networks.
Ακολουθήστε μας ή συνδεθείτε μαζί μας.