FDA updates Prezista recommendations for pregnant women with HIV

The FDA has recently updated its testing and dosage recommendations for Prezista in pregnant women with HIV.

According to the revised recommendations, treatment-experienced patients should receive treatment history genotypic and/or phenotypic testing before starting Prezista (darunavir, Janssen Pharmaceuticals)/ritonavir therapy to determine drug susceptibility, and serum liver chemistry tests should be monitored before and during therapy.

The FDA recommends that pregnant women receive 600 mg darunavir plus 100 mg ritonavir with food twice daily. Health care providers may consider administering 800 mg darunavir plus 100 mg ritonavir once daily in virologically suppressed pregnant women who were receiving the regimen before pregnancy to avoid compromising drug tolerability and compliance.

An analysis of 34 women who received darunavir/ritonavir dosed at either 600 mg/100 mg twice daily or 800 mg/100 mg once daily in combination with a background regimen demonstrated that the regimens were well-tolerated during pregnancy and postpartum and preserved virologic responses, according to the FDA. There were no reports of mother-to-child HIV transmission among the 29 women who continued therapy through delivery.

In addition, the FDA reported no difference in annual percentage rates of birth defects in 532 infants exposed to darunavir compared with the background rate for major birth defects in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program. The prevalence of birth defects was 2.7% (95% CI, 1.2-5.1) among infants exposed to darunavir-containing regimens in the first trimester, and 1.5% (95% CI, 0.3-4.4) among exposed infants in the second or third trimester.