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Limitations of populations studied safety and efficacy of epivir-hbv have not been established in patients with decompensated liver disease or organ transplants; pediatric patients 2 years of age; patients dually infected with hbv and hcv, hepatitis delta, or hiv; or other populations not included in the principal phase iii controlled studies.

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adverse reactions in clinical trials of adults with chronic hepatitis b virus infection clinical adverse reactions regardless of investigator s causality assessment reported in greater or equal to 10 of subjects who received epivir-hbv and reported at a rate greater than placebo are listed in table 2.

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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 treatment see warnings and precautions .

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epivir-hbv tablets and epivir-hbv oral solution contain a lower dose of the same drug lamivudine as epivir tablets, epivir oral solution, combivir tablets, and trizivir tablets; therefore, epivir-hbv should not be taken together with epivir, combivir, or trizivir.

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epivir-hbv is indicated for the treatment of chronic hepatitis b virus hbv infection associated with evidence of hepatitis b viral replication and active liver inflammation see clinical studies 14.

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