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European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
Date:10/18/2007

r ATRIPLA. If appropriate, initiation of anti-hepatitis B treatment may be warranted.

It is important for patients to be aware that anti-HIV medicines including Truvada, Viread, Emtriva, SUSTIVA and ATRIPLA do not cure HIV infection or AIDS and do not reduce the risk of transmitting HIV to others.

Additional Important Information About ATRIPLA in the United States

ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate [DF] 300 mg) is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Coadministration of ATRIPLA with astemizole, bepridil, cisapride, midazolam, pimozide, triazolam, ergot derivatives, or voriconazole is contraindicated. Concomitant use of ATRIPLA with St. John's wort (Hypericum perforatum) or St. John's wort-containing products is not recommended.

Since ATRIPLA contains efavirenz, emtricitabine, and tenofovir DF, ATRIPLA should not be coadministered with SUSTIVA(R) (efavirenz), EMTRIVA, VIREAD, or TRUVADA(R) (emtricitabine/tenofovir DF). Due to similarities between emtricitabine and lamivudine, ATRIPLA should not be coadministered with drugs containing lamivudine, including Combivir(R) (lamivudine/zidovudine), Epivir(R) or Epivir-HBV(R) (lamivudine), Epzicom(TM) (abacavir sulfate/lamivudine), or Trizivir(R) (abacavir sulfate/lamivudine/zidovudine).

Serious psychiatric adverse experiences, including severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions (0.2%), have been reported in patients receiving efavirenz. In addition to efavirenz, factors identified in a clinical study that were associated with an increase in psychiatric symptoms included a history of injection drug use, psychiatric history, and use of psychiatric medication. There have been occasional reports of suicide, delusions, and psy
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SOURCE Bristol-Myers Squibb
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