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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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