Lamivudine

Lamivudine is a nucleoside analogue that blocks viral replication by termination of the proviral DNA chain during elongation and inhibition of the HBV polymerase. In the largest randomized controlled pediatric study of this drug to date, 191 children were treated with 3 mg/kg/d up to a maximum of 100 mg/d or placebo for one year. Twenty-three percent of treated children exhibited a virologic response (absence of HBeAg and HBV DNA in serum) at 52 weeks compared with 13% of placebo-treated patients. The higher the baseline ALT, the higher the response. Low baseline HBV DNA (< 800 mEq/mL) and a histologic activity index score > 4 were predictors of response. Nineteen percent of the lamivudine-treated patients developed drug-resistant mutations in the YMDD motif of the HBV polymerase gene. Despite development of the mutation, children exhibited median HBV DNA and ALT levels that were substantially lower at week 52 compared with baseline.

Lamivudine is indicated for children 2 years of age and older with HBeAg positivity, HBV DNA in serum, and elevated ALT. Dose reduction should be done in patients with impaired renal function, as follows (modified from recommendations for adults).

Creatinine clearance

(mL/min) Recommended dosage of lamivudine

15-29 3 mg/kg/d first dose then 0.75 mg/kg/d 5-14 1 mg/kg/d first dose then 0.45 mg/kg/d

Monitoring should be as is recommended for IFN. Rare but serious side effects observed in adults include lactic aci-dosis and severe hepatomegaly with steatosis, most frequently observed in obese women taking antiretroviral therapy, and posttreatment exacerbation of hepatitis that usually resolves but has rarely been fatal. The major deleterious side effect with lamivudine usage has been the emergence of drug-resistent mutants. In one early open-label study of children with HIV and HBV, lamivudine therapy was associated with peripheral neuropathy and neutropenia; 14 to 15% of the children developed pancreatitis.

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