FDA Updates Atripla Package Insert
NEW YORK, July 1, 2008--In June 2008, the U.S. FDA updated the ATRIPLA package insert (PI) with additional safety and efficacy data, showing ATRIPLA's durability of response over three years.
The updated ATRIPLA PI is based on 144-week data from the ongoing study 934 comparing a once-daily regimen of ATRIPLA with a twice-daily CombivirR/once-daily SUSTIVAR regimen, which demonstrate the safety and efficacy profile of the components of ATRIPLA long-term.
These data show that:
-----71 percent of ATRIPLA patients compared to 58 percent of Combivir/SUSTIVA patients achieved and maintained viral load less than 400 copies/mL
-----64 percent of patients in the ATRIPLA arm compared to 56 percent of patients in the Combivir/SUSTIVA arm achieved and maintained viral load less than 50 copies/mL
-----The mean increase from baseline in CD4 cell counts were 312 and 271 cells/mm in the ATRIPLA and Combivir/SUSTIVA arms, respectively
These data are significant because measuring viral load and CD4 count are two key predictors of disease progression and death in HIV patients. As the treatment landscape for HIV improves and patients live longer, the importance of a proven, potent and durable first-line regimen with simple dosing is critical.
Additionally, these data add to the growing body of evidence for ATRIPLA as an important option in the HIV HAART regimen arsenal.
About ATRIPLA: ATRIPLA is the first and only once-daily single tablet regimen for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. This product is a combination of three HIV medicines: SUSTIVAR, the cornerstone of HIV treatment (efavirenz), EMTRIVAR (emtricitabine) and VIREADR (tenofovir disoproxil fumarate). ATRIPLA 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. ATRIPLA has been approved for marketing in the United States, Canada and Europe. ATRIPLA is developed through a U.S. joint venture between Bristol-Myers Squibb and Gilead Sciences.
Stacey Isaacs, working with Ruder Finn
732-656-0277
stacey@staceyisaacs.com
