Gilead Sciences ($GILD) has unveiled important details from a pivotal study for its Quad pill for HIV, showing the industry that the four-drug combo was as effective as its approved Atripla med without bringing on some of that treatment's side effects. The details come amid the big biotech's hunt for FDA approval of Quad, a cornerstone to the future of its multibillion-dollar franchise for HIV drugs.
Foster City, CA-based Gilead announced that the trial was a success last year, yet the new details show evidence of why doctors might opt to put patients on Quad over Atripla if U.S. regulators approve it. The study showed that 88% of patients who took Quad had target levels of HIV virus compared with 84% of patients on Atripla after 48 weeks of treatment, Reuters reported. On the safety front, Atripla patients had more frequent spells of dizziness, weird dreams and insomnia. Quad was linked with higher rates of nausea than Atripla in the study.
There has been lots of buzz around Gilead's expensive foray into the blockbuster hepatitis C arena, yet the company will bankroll that effort with revenue from its bread-and-butter HIV business. Atripla brought in the bulk of Gilead's $8.1 billion in revenue last year, Reuters reported. Yet Gilead has to share revenue from sales of Atripla--which combines the company's two-med pill Truvada with Bristol-Myers Squibb's ($BMY) Sustiva--with BMS. With Quad, Gilead owns all four components, Bloomberg reported.
U.S. regulators are expected to decide whether to green-light Quad by Aug. 27. This week, however, plenty of physicians will decide for themselves whether they like the data Gilead is presenting on the drug during the Conference on Retroviruses and Opportunistic Infections in Seattle.
Dr. Paul Sax, a physician at Brigham and Women's Hospital in Boston and lead investigator on the Quad study, said, as quoted by Reuters, that the evidence from the trial tells him that "it looks like a switch would be virologically safe and maybe associated with fewer central nervous system side effects."
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