Famciclovir treatment of hepatitis B infection following liver transplantation: a long-term, multi-centre study.
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 > or =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 > or =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.
Manns
M P
MP
Department of Gastroenterology and Hepatology, Center for Internal Medicine, Medical School of Hannover, Hannover, Germany. manns.michael@mh-hannover.de
Neuhaus
P
P
Atkinson
G F
GF
Griffin
K E
KE
Barnass
S
S
Vollmar
J
J
Yeang
Y
Y
Young
C L
CL
D015075:2-Aminopurine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D000077595:Famciclovir; D005260:Female; D006509:Hepatitis B / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D015075:2-Aminopurine; D000410:Alanine Transaminase; D000077595:Famciclovir