icon-folder.gif   Conference Reports for NATAP  
  38th Annual Meeting of the European Association for the Study of the Liver
Istanbul, Turkey. March 28-April 1, 2003
Back grey_arrow_rt.gif
  F. van Bommel*, 1 T. Wunsche, 2 D. Schurmann, 2 K. Reinke, 3 B. Wiedenmann, 1 U. Hopf, 1 T. Berg, 1 *Presenting Author 1Medizinische Klinik M. S. Hepatologie Und Gastroenterologie, Charite Campus Virchow Klinikum, 2Medizinische Klinik M. S. Infektiologie, Charite Campus Virchow Klinikum, 3Medizinische Klinik M. S. Nephrologie Und Internistische Intensivmedizin, Charite Campus Virchow Klinikum, Berlin, Germany
The development of resistant mutants during the course of lamivudine-therapy is often associated with progression of chronic hepatitis B virus (HBV) infection. In a pilot-study we could demonstrate that tenofovir, an acyclic nucleotid-analogue and congender of adefovir affects lamivudine-resistent HBV replication in vivo with high efficacy. The aim of this study was to document long-term effectiveness and safety of tenofovir in different patients groups with chronic HBV-infection. 19 patients (10 HBV/HIV-coinfected, 4 patients with chronic HBV-infection after renal transplantation, and 5 with chronic hepatitis B; mean age 49 years [47-58]) who suffered viral breakthrough after 2-3 years of lamivudine-therapy were included in the study. All patients received 245 mg tenofovir daily for at least 24 weeks (mean 53, 7 weeks, range 24-72 weeks). At baseline, HBV DNA levels were > 20 x 106 copies/ml (HBV-Monitor, Roche) in all patients. Lamivudine-resistant mutations within the polymerase-gene were detected using a Line Probe Assay (INNO-LIPA HBV DR, Innogenetics).
During tenofovir treatment a mean log decline of 3.7 0.87 (range: 2.82-4.83) of HBV viremia was shown and HBV DNA became undetectable in 17/19 patients by the quantitative assay. No severe or clinically relevant side effects were observed. Viral resistance to tenofovir was not observed during the follow-up of up to 72 weeks, although the number of mutations in the YMDD motif increased in patients in whom lamivudine treatment was maintained. The results demonstrate that tenofovir has a significant suppressive effect on the replication of lamivudine-resistant HBV-mutants even in immune-suppressed patients.