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TRANSPLANT RECIPIENTS FAILING LAMIVUDINE THERAPY FOR
CHRONIC HEPATITIS B INFECTION
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German researchers and Bristol Myers reported on the use of a new drug being
developed for HBV, but reported on its use in transplant recipients.
Entecavir 1 mg QD, a potent HBV DNA polymerase inhibitor, was given
to nine liver transplant patients failing lamivudine monotherapy (one
received HBIG), with
baseline mean serum HBV bDNA 3.3 log10 pg/mL (Chiron assay), 9.1 log10
copies/mL (PCR
assay), and mean ALT 101 IU/L. Mean duration of transplant was 6.4 years;
four patients
received transplant for HBV-related end-stage liver disease and four were
infected post-transplantation.
Mean duration of entecavir treatment was 42 weeks (range 20-67). Four
recipients were HBeAg-positive and HBV DNA data were available for seven
patients treated >24
weeks.The mean decrease in HBV bDNA was 1.7,2.7,2.8 and 3.0 log10 at weeks
4,12,24 and
36, respectively. Five of seven recipients had undetectable HBV bDNA, and HBV
DNA by PCR
was reduced 4.2 log10 copies/mL at 24 weeks. Viral rebound did not occur in
any patient, and
none experienced hepatitis flare during treatment. Three patients with
baseline ALT > 140 IU/L
normalized, and four patients with ALT < 70 IU/L normalized or had continued
mild elevations by
week 24. No clinically important adverse events or discontinuations occurred.
Entecavir
monotherapy is well tolerated and highly effective in reducing HBV viral load
and biochemical
markers of disease in liver transplant recipients.
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