FDA approves once-a-day HIV drug regimen studied by USC researchers
Keck School of Medicine physicians and their patients with HIV/AIDS have helped gain approval for a new, once-a-day therapy for a type of HIV.
The U.S. Food and Drug Administration recently granted marketing clearance for Reyataz, or atazanavir sulfate, for the treatment of HIV-1, the RNA virus responsible for AIDS. Atazanavir belongs to the family of medications called protease inhibitors, which form one component of anti-HIV therapy.
Kathleen Squires, associate professor of medicine at the Keck School, has been involved in administering clinical trials of the drug since its earliest stages. She noted that many other anti-HIV drugs require patients to stick to complicated dosing schedules, but atazanavir is the first protease inhibitor that patients only need to take once a day.
That makes it easier for patients to comply with a prescription regimen, considering that they usually must take three or more drugs every day.
The drug also might offer other benefits, namely to cardiovascular health.
“What makes atazanavir distinct is its unique lipid profile—we have not seen the increased cholesterol and triglyceride levels associated with some other protease inhibitors,” said Squires, medical director of the LAC+USC Medical Center HIV/AIDS clinic known as 5P21, one of the largest AIDS clinics in the nation.
LAC+USC Medical Center patients were among the 2,400 people from 15 clinical trial sites in the United States who participated in the phase II and III trials that made FDA approval possible. Atazanavir is a product of Bristol-Myers Squibb Co.