REYATAZ is a protease inhibitor that has been studied in both treatment-naïve and treatment-experienced HIV-1-infected patients and is administered once daily as part of combination HIV therapy.
Since its approval by the FDA in 2003, REYATAZ is classified as pregnancy category B.
The labeling update is based on data from a multicenter, open-label, prospective, single arm, pharmacokinetic study (Study 182) of 41 HIV-infected pregnant women between 12 and 32 weeks gestation (second and third trimester) with CD4 =200 cells/mm3.
Patients were treated with REYATAZ (atazanavir sulfate)/ritonavir 300/100 mg (n=20) or 400/100 mg (n=21) once daily; patients in their second trimester received REYATAZ/ritonavir 300/100 mg.
All patients received zidovudine/lamivudine 300/150 mg twice daily.
The primary objective of Study 182 was to determine the dosing of REYATAZ/ritonavir as part of a regimen that produces adequate drug exposure in pregnant women compared to historical data in HIV-infected adults.
Bristol-Myers Squibb executive director and atazanavir development lead Awny Farajallah said the labeling update is important news for both healthcare providers and HIV-positive women of child-bearing age in that it provides guidance for the use of REYATAZ, as part of combination therapy, during pregnancy and postpartum.