April 29, 2005

One-a-Day Med Too Good To Be True?

When HIVers heard the word this week that the first-ever one-pill-once-a-day regimen from Gilead Sciences and Bristol-Myers Squibb wasn’t developing according to plan, there wasn’t exactly panic in the streets. But longtime survivors may have wondered if the prospect of a one-a-day—which made the early years of combo therapy’s routine fistful of pills three times daily seem like ancient history—was just one more dashed treatment dream. Was there more to Gilead’s official explanation than met the eye? Had the partnership between competitors Gilead and BMS—unprecedented in the high-stakes, cut-throat HIV drug industry—hit the rocks?

No way, say our top treatment activists. “This isn’t a pharma problem, for a change,” Project Inform’s Marty Delaney said. “It’s a pharmacokinetic problem.”

In other words, it was the combination—BMS’ non-nuke Sustiva teamed up with Gilead’s nukes Emtriva and Viread—that went wrong, not the two companies’ teamwork. In fact, as Delaney pointed out, “Dr. John Martin, the president of Gilead, used to work at BMS, where he helped develop early HIV compounds, so they know what they’re doing.”   

Bob Huff, editor of Gay Men’s Health Crisis’ Treatment News, agreed: “Gilead’s explanation rings true: The formulation wasn’t bio-available. But the pill is still on track.” In a new formulation for new tests, Sustiva, when taken bundled with Emtriva and Viread in one pill, was less effective—inadequate levels of the drug were sustained in the bloodstream—than when taken as a separate pill. But that does not mean that the old formulation is not safe and effective in a regimen with Emtriva and Viread. These two nukes, of course, work well as one, and are already available as Truvada.

Stay tuned for a second try, says Gilead rep James Loduca, confirming that everything else—from the stability (shelf life) of the drug to that of the partnership—tested just fine, thank you. “If everything goes well, we’ll file for drug approval by the end of the year.”

Delaney even sees a critical upside in this developmental downer. “It’s good they figured this technical problem out before it was on the market,” he said. “We have seen similar problems on the international market with the pre-approved combos made by generic companies, but only after they were already in people’s bodies.”