Extended Lamivudine Treatment in Patients with HBeAg-negative Chronic Hepatitis B
In this study, the histological and clinical outcome of lamivudine (Epivir-HBV) 100 mg/day was assessed in 76 HBeAg-negative chronic hepatitis B patients previously randomized to a double-blind comparison study of lamivudine and placebo.
Paired liver biopsies were available before 1 year of randomized lamivudine treatment and after 2 years of further open-label treatment for 48 patients. Serum samples were analyzed for hepatitis B markers and ALT levels (n=74).
Results
The histological activity index improved, remained unchanged and worsened in 64, 32 and 5%, respectively, for patients without YMDD-variant HBV compared to 15, 54 and 31% with the variant.
None of the 42/48 patients without cirrhosis at baseline progressed to cirrhosis.
Of 24/48 patients without bridging fibrosis at pre-treatment, 83% (20/24) did not progress to bridging fibrosis.
Median HBV DNA remained below the lower limit of detection and ALT ≤1 times the ULN for patients without the variant whereas levels gradually increased to 11.3 Meq/ml (bDNA assay) and 2 times the upper limit of normal by month 24 for patients with variant.
Conclusions
The authors conclude, 揟he clinical benefit of lamivudine is greatest for patients without YMDD variants over 2 years of extended treatment. Additional therapies should be considered for patients with YMDD variants.?/span>
02/14/05
Reference
M Rizzetto and others. Extended lamivudine treatment in patients with HBeAg-negative chronic hepatitis B. Journal of Hepatology 42(2): 173-179. February 2005. |