FDA Approves Three-Drug Combination Tablet for HIV-1

ROCKVILLE, Maryland—The FDA has approved Atripla, a fixed-dose combination of three previously approved antiretroviral drugs that is taken once a day in tablet form to treat HIV-1 infection. Atripla consists of Sustiva (efavirenz, Bristol-Myers Squibb), approved in 1998; Emtriva (emtricitabine, Gilead Sciences), approved in 2003; and Viread (tenofovir disoproxil fumarate, Gilead) approved in 2001. A joint venture by Bristol-Myers Squibb and Gilead, the first if its kind in the area of HIV treatment, will market Atripla in the United States. Merck controls the rights to Sustiva in several parts of the world, and the three companies will cooperate in ensuring the medication is available to physicians and patients, the FDA said.

The trial submitted to support Atripla involved 244 adults infected with HIV-1, who received the three drugs contained in the new fixed-dose combination medication. At the end of the 48-week study, 80% of the participants achieved a marked reduction in their HIV count and a substantial increase in the number of healthy CD4 immune-system cells.