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Famciclovir treatment of hepatitis B infection following liver transplantation: a long‐term, multi‐centre study
Author(s) -
Manns Michael P.,
Neuhaus Peter,
Atkinson Gillian F.,
Griffin Karen E.,
Barnass Stella,
Vollmar Jens,
Yeang Yvonne,
Young Clarence L.
Publication year - 2001
Publication title -
transplant infectious disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.69
H-Index - 67
eISSN - 1399-3062
pISSN - 1398-2273
DOI - 10.1034/j.1399-3062.2001.003001016.x
Subject(s) - medicine , famciclovir , seroconversion , gastroenterology , liver transplantation , nucleoside analogue , hepatitis b virus , hepatitis b , transplantation , immunology , virus , nucleoside , stereochemistry , chemistry
Famciclovir is a novel guanosine nucleoside analogue with activity against herpes viruses and hepatitis B virus (HBV). Several preliminary reports have described efficacy of famciclovir in patients with recurrent hepatitis B after orthotopic liver transplantation (OLT). This report describes the largest study to date of long‐term famciclovir treatment in patients with de novo or recurrent hepatitis B post‐OLT. One hundred thirty patients with detectable serum HBV DNA after OLT received oral famciclovir 500 mg tid on a compassionate‐use basis. Safety analyses included all treated patients; efficacy was assessed in all patients and a subgroup of 73 patients with complete baseline HBV DNA and alanine aminotransferase (ALT) data who had received ≥6 months of treatment. Efficacy parameters included serum levels of HBV DNA, ALT, and anti‐HBe or anti‐HBs seroconversion rates. Of the 70 patients treated for ≥6 months who could be evaluated for response/non‐response to famciclovir, 52 (74%) were responders, defined as patients who experienced a 70% decrease or more in HBV DNA levels from baseline, or who became HBV DNA‐negative, for at least two consecutive visits. In famciclovir responders, HBV DNA levels decreased by a median of 91% after 12 weeks of treatment, 95% after 6 months and >99% after 18 months of treatment. Marked differentiation between responders and non‐responders could be made soon after the onset of treatment. Among anti‐HBe positive patients with evidence of HBV replication, 12/13 were responders. Patients with high baseline ALT levels experienced more rapid suppression of HBV DNA during therapy with famciclovir. Famciclovir therapy was safe and well tolerated; serious adverse events were reported infrequently. Famciclovir treatment may be beneficial in patients with hepatitis B infection post‐OLT.