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Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe
Date:12/11/2007

reated with Emtriva, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Hepatic function should be monitored closely with both clinical and laboratory follow- up for at least several months in patients who are co-infected with HIV and HBV and discontinue Truvada or 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 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 re
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SOURCE Bristol-Myers Squibb Company
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