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European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
Date:12/17/2007

icitabine), Viread (tenofovir disoproxil fumarate [DF]) and Truvada (emtricitabine/tenofovir DF) in the United States

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.

Emtriva, Viread, Truvada and ATRIPLA are not approved for the treatment of chronic hepatitis B virus (HBV) infection and their safety and efficacy have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Viread or Emtriva, which are components of Truvada and ATRIPLA. In some of these patients treated 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 [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, emtricitabin
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SOURCE Bristol-Myers Squibb Company
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