FDA Approves Bristol-Myers Squibb's Once Daily Protease Inhibitor Reyataz (atazanavir) for HIV Infection

The Food and Drug Administration (FDA) on 6/20/03 announced the approval of Reyataz (atazanavir sulfate), a protease inhibitor (PI) from Bristol-Myers Squibb that can be used in combination with other antiretroviral agents for the treatment of patients with HIV infection.

As is the case for all other FDA-approved anti-HIV medications, Reyataz does not cure HIV or stop transmission of the virus.

Approval of Reyataz will allow patients to access a PI that is dosed only once daily with food and has a low pill burden (two pills each day). It is the first once daily PI approved by the FDA.

FDA based its approval of Reyataz on data from two Phase II 48-week trials and from 24-48 week data from Phase 3 studies. Results from these trials showed a decrease in viral load (the amount of HIV-1 virus circulating in plasma) and an increase in CD4 cell counts (a measure of immune cells created by the body) in patients taking Reyataz in combination with other antiretroviral agents. These treatment benefits were observed both in patients who had not been previously treated and in patients who had previously received other anti-retroviral therapy.

The FDA submission included data from 15 clinical trials enrolling more than 2,400 people living with HIV.  An analysis of data from Phase II and III trials showed that Reyataz has a distinct resistance profile.  The data showed that the signature I50L mutation always developed if resistance to Reyataz emerged in treatment-naïve patients.  This signature mutation resulted in a decrease in susceptibility to Reyataz and an increase in viral susceptibility to other protease inhibitors.  In patients on their first regimen, the I50L amino acid substitution may help preserve the use of other protease inhibitors for future treatment.

A significant safety concern commonly observed with the use of PIs is hyperlipidemia (abnormally high levels of cholesterol and triglycerides). Reyataz appears to have minimal impact on lipid parameters such as tryiglycerides and cholesterol.

“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 Kathleen Squires, MD, Associate Professor of Medicine, Keck School of Medicine, University of Southern California.  “For HIV patients the approval of atazanavir could be a welcome addition to their drug regimen.”

The recommended dose of Reyataz is 400 mg (two 200 mg capsules) taken once a day with food in combination with other antiretroviral medications.  It will be available in 100 mg, 150 mg and 200 mg capsules.  For more information, please see full prescribing information at www.reyataz.com .

Sources
Bristol-Myers Squibb. www.bms.com; www.reyataz.com