Long-term Lamivudine Monotherapy in Renal Transplant Recipients
with Hepatitis B-related Cirrhosis
Chronic
hepatitis B virus (HBV) infection is an important
cause of morbidity
and mortality in renal-transplant
recipients. The aim of the study was to assess
the efficacy and safety of long-term lamivudine (Epivir-HBV) monotherapy
in renal-transplant recipients with HBV-related
cirrhosis.
Seventeen
such patients [median age: 45 years; 7 with hepatitis
B e antigen (HBeAg)] received daily oral
doses of 75-150 mg lamivudine for a median of 48 (range
11-81) months. All patients had baseline serum levels of
HBV DNA of over 6 log10 copies per ml and of alanine
transaminase (ALT) of over 1.5 times the
upper normal limit (UNL).
Clinical
lamivudine resistance
was defined as a rebound of serum HBV DNA above 5.3 log10
copies per ml and of serum ALT of over 1.5 times the UNL
in patients who initially responded with HBV
DNA levels of less than 5.3 log10 copies
per ml and normal ALT values.
Controls
were 14 renal-transplant patients (median age 44 years;
3 with HBeAg) with HBV-related cirrhosis, naive to any anti-HBV
therapy, followed for 58 months (4-135).
Results
Thirteen (77%) treated patients had a persistent response
throughout the study period, including three (18%) who developed
genotypic resistance, compared with none of the untreated
controls (77% versus 0%, P < 0.0001).
Four (23%) developed clinical
resistance.
Two of three patients with
initially decompensated cirrhosis had a durable response
and clinical improvement compared with the transient responder,
whose liver function worsened following lamivudine resistance.
Two responders developed
chronic rejection requiring chronic hemodialysis. Overall,
one treated patient developed liver-related
complications, compared with eight untreated
controls (6% versus 57%, P < 0.01).
The
authors conclude, “Most renal-transplant patients treated
with lamivudine achieved a rapid and durable suppression
of HBV, which substantially lowered the risk of liver decompensation and
death.”
Department of Gastroenterology and Endocrinology, IRCCS
Maggiore Hospital and University of Milan, Milan, Italy.
10/14/05
Reference
M
Vigano and others. Long-term lamivudine monotherapy in renal-transplant
recipients with hepatitis-B-related cirrhosis. Antiviral
Therapy 10(6):709-713.
2005.
