FDA approve a labelling update for Reyataz (BMS) for HIV-infected pregnant women

The FDA has approved an update to the labeling for Reyataz (atazanavir sulfate), from BMS, to include dose recommendations in HIV-infected pregnant women. In HIV combination therapy, treatment with the recommended adult dose of Reyataz 300 mg, boosted with 100 mg of ritonavir, achieved minimum plasma concentrations (24 hours post-dose) during the third trimester of pregnancy comparable to that observed historically in HIV-infected adults. During the postpartum period, atazanavir concentrations may be increased; therefore, while no dose adjustment is necessary, patients should be monitored for adverse events for two months after delivery. The update is based on data from a multicenter 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/mm. Pregnant women do not require a dose adjustment for Reyataz/ritonavir except in the case of treatment-experienced pregnant women during the second or third trimester when Reyataz is co-administered with either tenofovir or an H2-receptor antagonist (H2RA). In that case, Reyataz 400 mg plus ritonavir 100 mg once daily is recommended.