FDA approves three-in-one antiretroviral pill

The Food and Drug Administration on Wednesday approved Bristol-Myers Squibb and Gilead Sciences' three-in-one HIV treatment that’s taken just once daily. Called Atripla, the pill contains 600 milligrams of BMS’s nonnucleoside reverse transcriptase inhibitor Sustiva, 200 milligrams of Gilead’s nucleoside reverse transcriptase inhibitor Emtriva, and 300 milligrams of Gilead’s nucleotide reverse transcriptase inhibitor Viread. Atripla is the first-ever one-pill, once-daily full antiretroviral regimen approved for use in the United States.

“The availability of Atripla marks the culmination of 10 years of efforts to simplify dosing while helping to achieve and maintain effective viral suppression for adults infected with HIV,” said John G. Bartlett of Johns Hopkins University in a press statement.

Gilead and BMS officials say Atripla will be on the market by the end of next week. Industry experts say the price of Atripla will likely be the same as its component drugs, about $1,200 per month. The pill also is expected to be available through not-for-profit agreements with developing nations for about $600 per person per year.

A study earlier this year in The New England Journal of Medicine showed that Atripla is more effective at controlling HIV in treatment-naive patients than even the current gold standard of nonnucleoside reverse transcriptase inhibitor–based therapy. Led by researchers at Johns Hopkins University, the study showed that the Sustiva-Viread-Emtriva combination did a better job of reducing HIV viral levels and increasing CD4-cell counts after one year of treatment that the gold-standard combination of Sustiva plus Retrovir and Epivir. Also, fewer individuals on the one-pill regimen dropped out of the study due to adverse events.

Atripla's Sustiva-Emtriva-Viread combination is currently recommended by the Department of Health and Human Services for the treatment of HIV-positive adults just beginning antiretroviral therapy.

The collaboration between BMS and Gilead is the first of its kind in the 25-year history of the AIDS epidemic. In December 2004 the companies established a U.S. joint venture to develop and commercialize the single-pill regimen. The first two attempts to mix the drugs failed, with the combinations not achieving the same bioequivalence as the three component drugs dosed individually. But a new layering technology permitted researchers to successfully stack the component medications into a single pill on the companies' third try, and the resulting medication was submitted to the FDA for review in April.

“We appreciate the recognition by the FDA of this important therapeutic advance, and with their approval of Atripla in just over two months, patients will now have rapid access to the first once-daily single tablet regimen for the treatment of HIV infection in adults,” John C. Martin, president and CEO of Gilead Sciences, said in a press statement.

“With the approval of Atripla, Bristol-Myers Squibb continues two decades of progress in the development and commercialization of medications to treat HIV,” said BMS president of U.S. pharmaceuticals Anthony C. Hopper in a press statement. “Atripla is an important step forward as we continue our focus on discovering, developing, and providing innovative treatments for serious diseases.” (The Advocate)