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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

be monitored closely for didanosine-associated adverse events. See Full Prescribing Information for complete list of drug-drug interactions.

In Study 934, the most frequently reported grades 2-4 adverse events through 48 weeks in patients receiving efavirenz + emtricitabine + tenofovir DF were dizziness (8%), nausea (8%), diarrhea (7%), fatigue (7%), headache (5%), rash (5%), sinusitis (4%), depression (4%), insomnia (4%), and abnormal dreams (4%).

The dose of ATRIPLA is one tablet (containing 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir DF) once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms. ATRIPLA is not recommended for use in patients <18 years of age.

For complete U.S. prescribing information for ATRIPLA, visit http://www.atripla.com. For complete prescribing information for Sustiva, visit http://www.bms.com. For complete U.S. prescribing information for Truvada, Viread and Emtriva, visit http://www.gilead.com.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company. Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. Visit Gilead on the World Wide Web at http://www.gilead.com.

About Merck

Merck & Co. Inc., which operates in
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SOURCE Bristol-Myers Squibb
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