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Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
Date:10/17/2007

rug regimen in a single once-daily pill."

ATRIPLA was developed through a joint venture partnership between Bristol-Myers Squibb Company and Gilead Sciences. The product was approved by the U.S. Food and Drug Administration in July 2006 and has since become the most-prescribed treatment regimen for patients starting HIV therapy in the United States. In Canada, approximately 60,000 people are living with HIV, and around 2,500 new HIV diagnoses are reported each year.

Clinical data support the use of the three-drug regimen contained in ATRIPLA in HIV treatment-naive patients. A randomized, open label, active-controlled, multicenter, non-inferiority study, Study 934, compared a once-daily regimen of Viread, Emtriva and SUSTIVA, the components of ATRIPLA, with twice-daily Combivir(R) (lamivudine/zidovudine) and once-daily SUSTIVA in treatment-naive patients with HIV. Through 48 weeks, 84 percent of patients in the Viread/Emtriva/SUSTIVA group (n=244) compared to 73 percent of patients in the Combivir/SUSTIVA group (n=243) achieved and maintained a viral load of less than 400 copies/mL. This difference largely results from the higher number of discontinuations in the Combivir/SUSTIVA group due to adverse events (9 percent vs. 4 percent in the Viread/Emtriva/SUSTIVA group) and other reasons including loss to follow-up, patient withdrawal, non-compliance and protocol violation (14 percent vs. 10 percent in the Viread/Emtriva/SUSTIVA group).

In addition, 80 percent and 70 percent of patients in the Viread/Emtriva/SUSTIVA group and the Combivir/SUSTIVA group, respectively, achieved and maintained a viral load less than 50 copies/mL through 48 weeks. Selected treatment-emergent adverse events (Grades 2-4) reported in greater than or equal to 5 percent of patients in the Viread/Emtriva/SUSTIVA group through 48 weeks included dizziness, nausea, diarrhea, fatigue, headache and rash.

Important Product Safety Information About ATRIPLA (efavirenz 600 mg/emtr
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SOURCE Bristol-Myers Squibb Company
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