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Information about Epivir-HBV.

You should not take Epivir-HBVfor treating hepatitis Bif you also take other medicine that contains Epivir HBV or emtricitabinewhich includes:

This is not a complete list of possible side effectsIf you notice other effects not listed abovecontact your doctor or pharmacist.

HIV counseling and testing should be offered to all patients before beginning treatment with Epivir-HBV and periodically during treatment because of the risk of emergence of resistant-HIV-1 and limitation of treatment options if Epivir-HBV is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatmentsee Warnings and Precautions5.3

There appears to be a significant risk of pancreatitis in pediatric patients treated with lamivudineIn pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitislamivudine should be used with extreme caution and only if there is no satisfactory alternativeTreatment with lamivudine should be stopped immediately if clinical signssymptomsor laboratory abnormalities suggestive of pancreatitis occurThe scored tablet is the preferred dosage formulation in children and adolescents able to take a solid dosage form due to lower virologic suppression rates and increased risk of viral resistance with the oral solutionAdditionallythe tablet formulation is preferred when possible to avoid an interaction between lamivudine oral solution and sorbitol-containing medicationsConsider increased monitoring of viral load when using the oral solution in all pediatric patientsincluding infants and neonates.

Patients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis BDuring treatmentcombinations of events such as return of persistently elevated ALTincreasing levels of HBV DNA over time after an initial decline below assay limitprogression of clinical signs or symptoms of hepatic diseaseand/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic responseSuch observations should be taken into consideration when determining the advisability of continuing therapy with Epivir-HBV.

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as in the adult controlled trials, most subjects treated with epivir-hbv had decreases in hbv dna below the assay limit early in treatment, but about one-third of subjects with this initial response had reappearance of assay-detectable hbv dna during treatment.

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