Three-Year Efficacy and Safety of Tenofovir Disoproxil Fumarate Treatment for Chronic Hepatitis B


Heathcote E. J., Marcellin P., Buti M., Gane E., De Man R. A., Krastev Z., ...Daha Fazla

GASTROENTEROLOGY, cilt.140, sa.1, ss.132-143, 2011 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 140 Sayı: 1
  • Basım Tarihi: 2011
  • Doi Numarası: 10.1053/j.gastro.2010.10.011
  • Dergi Adı: GASTROENTEROLOGY
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.132-143
  • Anahtar Kelimeler: Liver Disease, Virology, Drug Resistance, Viral Replication, Nucleotide, HBEAG-POSITIVE PATIENTS, TERM-FOLLOW-UP, SERUM HBSAG, PEGINTERFERON ALPHA-2A, ADEFOVIR DIPIVOXIL, SUSTAINED RESPONSE, NEGATIVE PATIENTS, NATURAL-HISTORY, VIRUS-INFECTION, DNA LEVEL
  • Bursa Uludağ Üniversitesi Adresli: Evet

Özet

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.