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Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs.

May be administered with or without foodFood decreases the ratebut not the extentof oral absorptionThe scored tablet is the preferred dosage formulation in pediatric patients able to take a solid dosage form due to lower virologic suppression rates and increased risk of viral resistance with the oral solution as a result of an interaction with sorbitol-containing medicinesConsider increased monitoring of viral load when using the oral solution.

Lamivudine is an antiviral agent with activity against HBVsee Microbiology12.4

In controlled clinical trialsYMDD-mutant HBV was detected in subjects with on-Epivir-HBV re-appearance of HBV DNA after an initial decline below the solution-hybridization assay limitsee Microbiology12.4Subjects treated with Epivir-HBVadults and childrenwith YMDD-mutant HBV at 52 weeks showed diminished treatment responses in comparison with subjects treated with Epivir-HBV without evidence of YMDD substitutionsincluding the followinglower rates of HBeAg seroconversion and HBeAg lossno greater than placebo recipientsmore frequent return of positive HBV DNAand more frequent ALT elevationsIn the controlled trialswhen subjects developed YMDD-mutant HBVthey had a rise in HBV DNA and ALT from their own previous on-treatment levelsProgression of hepatitis Bincluding deathhas been reported in some subjects with YMDD-mutant HBVincluding subjects from the liver transplant setting and from other clinical trialsIn clinical practicemonitoring of ALT and HBV DNA levels during treatment with Epivir-HBV may aid in treatment decisions if emergence of viral mutants is suspected.

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each 20-ml dose 100 mg of epivir-hbv oral solution contains 4 grams of sucrose.