HIV treatment entered a new realm last month as a pill designed to bring four antiretrovirals together moved forward — after a clinical-trial process that included participation from one local HIV/AIDS agency.
The Food and Drug Administration Aug. 27 approved Gilead Sciences Inc.’s Stribild, a single-pill, once-daily regimen to reduce the effects and spread of the HIV infection. It is expected to hit shelves later this year.
Stribild, formerly called Quad, is designed for those infected with HIV who have never taken antiretrovirals. It contains two previously approved HIV drugs and two new ones.
Philadelphia FIGHT was among one of the agencies that Gilead enlisted to participate in clinical trials for the new drug.
Dr. Karam Mounzer, medical director of FIGHT’s Jonathan Lax Treatment Center, said FIGHT has been involved in nearly every trial that led to the approval of HIV medications in the last decade.
“We’re very interested at FIGHT to be part of the scientific effort to enhance and improve HIV care, and one aspect of that effort is drug development,” Mounzer said.
The 48-week phase-three trial, begun in early 2011, was a pivotal last round that was used to demonstrate the drug’s viability to the FDA.
The two-pronged study, 102 and 103, compared the drug with single-pill medication Atripla, a three-pill combo, and Norvir-boosted Reyataz with Truvada.
About a dozen people participated in FIGHT’s studies, with 1,400 involved across the country.
In the first study, Stribild was shown to suppress viral loads to undetectability in 88 percent of the patients, compared with 84 percent for Atripla. In the second, the new drug resulted in a 90-percent undetectable viral load, compared with 86 percent in the other regimen.
Mounzer said the local data showed that the pill has the potential to work as effectively as other regimens on the market.
“The tolerability was comparable with the gold standards available today,” he said. “This is a fixed-dose combination, so it’s one pill a day, which makes it very attractive as it’s simple to administer. The more pills we have that are simple to take and well-tolerated, the better it is for our patients.”
Mouzner said there were no “unexpected signals” during FIGHT’s studies.
However, he noted that there is still much to learn about Stribild.
“Toxicities usually manifest after two years of widespread use, so it’s hard to say how this will play out,” he said. “But right now it is a welcome addition. Every new option is exciting.”