One-pill HIV regimen submitted for FDA review

Gilead Sciences and Bristol-Myers Squibb on Thursday submitted for review to the Food and Drug Administration their once-daily anti-HIV pill that contains a full three-drug regimen. The tablet contains a full day’s dosing of Gilead’s drugs Viread and Emtriva—already packaged in a combination pill called Truvada—and BMS’s Sustiva. If approved by the FDA, it would be the first one-pill, once-daily complete HIV treatment available in the United States.

Gilead and BMS announced in December 2004 that they planned to collaborate on a venture to combine Gilead’s Truvada with Bristol-Myers Squibb’s Sustiva into a single pill that would be taken just once daily. The first two attempts to combine the medications were unsuccessful, as the resulting combination pill did not have the same bioequivalence of the drugs dosed separately. But the companies announced in January 2006 that using bilayering technology to incorporate the drugs into a single formulation was successful, and studies showed the combination pill had the same bioequivalence as the individual medications.

The U.S. Department of Health and Human Services lists the combination of Truvada and Sustiva as one of the preferred nonnucleoside reverse transcriptase inhibitor–based regimens for treating newly diagnosed HIV patients.

A decision by the FDA could come before the end of the year.

“The partnership between Bristol-Myers Squibb and Gilead was founded on the companies’ shared commitment to addressing the needs of people living with HIV,” said John C. Martin, Gilead president and CEO, in a statement. “Significant progress in science and medicine has been achieved since the advent of the first combination regimens 10 years ago, but more work is needed, and we view this partnership to create the first-ever once-daily single tablet regimen for HIV as an important step toward further simplifying dosing of HIV therapy for physicians and patients.” (The Advocate)

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