One pill, once a day: That has been one of the “holy grails” of HIV treatment. It was about to become a reality – until a surprise announcement last week from Gilead Sciences that things were not going smoothly.
Last August, Gilead Sciences unveiled Truvada, a breakthrough treatment option combining their drugs Viread and Emtriva. Thus, two of the most effective meds in the “nuke” category could be taken as a single pill – no food requirements, few if any side effects. Combined with BMS’s “nonnuke” Sustiva, a highly desirable three-drug combination could require as little as two pills a day. HIVers were expecting that the next step would come this fall: An unprecedented drug company collaboration would join those three drugs into one pill, or fixed dose combination, taken once daily.
Then last week, Gilead dumped cold water on those anticipations: the FDC wasn’t achieving the same levels of medication in the blood as when the combined drugs were taken separately. Such “bioequivalence” is required to gain FDA approval.
Gilead/BMS still have three alternate co-formulations in the wings to try. Perhaps one of them will hit the bioequivalence target. However, the eagerly awaited single pill treatment will not come this fall. They hope to resubmit to the FDA sometime in 2006.
Making HIV treatment easier – fewer pills, fewer requirements, fewer side effects – helps patients stick with their treatment program. Adherence is required for treatment success, so this FDC will be a wonderful treatment option – eventually. It’s sorta like ketchup.
This article appears in August 19 • 2005.