Janssen Therapeutics, Division of Janssen Products, LP (Janssen), on July 12 announced in Titusville, NJ, that the U.S. Food and Drug Administration (FDA) has approved an expansion to the PREZISTA (darunavir) U.S. Prescribing Information to include data and results from a study investigating the use of PREZISTA during pregnancy and the postpartum period. A human immunodeficiency virus (HIV-1) protease inhibitor, PREZISTA is indicated for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents. The recent label update includes dosing recommendations for pregnant women with HIV, and data demonstrates that PREZISTA taken with ritonavir was found to be well-tolerated during pregnancy and the postpartum period.
An analysis of 34 women who received PREZISTA/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 exposures to PREZISTAand ritonavir were lower during pregnancy compared with the postpartum period, but were well-tolerated, and virologic responses were preserved throughout the treatment period in both arms. There were no reports of mother-to-child HIV transmission among the 29 women who continued therapy through delivery.2 Nor were there any new clinically relevant safety findings compared with the known safety profile of PREZISTA/ritonavir in HIV-1 infected adults.
In addition, based on prospective reports to the Antiretroviral Pregnancy Registry (APR) (through July 2015) of 532 live births following PREZISTA exposure during pregnancy, there was no difference in rates of overall birth defects for PREZISTA 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 percent (95% CI, 1.2-5.1) among infants exposed to PREZISTA-containing regimens in the first trimester, and 1.5 percent (95% CI, 0.3-4.4) among exposed infants in the second or third trimester.
“Many HIV treatments have limited data available to support their use during pregnancy,” said Richard Nettles, Vice President, Medical Affairs, Janssen Therapeutics. “This expansion of our label is an important advancement in addressing the needs of women living with HIV, and it demonstrates that PREZISTA is a safe and effective treatment for pregnant women living with this disease. We are proud to be able to provide an option for physicians and mothers who are trying to determine the best approach for HIV treatment.”
The updated label now recommends that pregnant women receive 600 mg PREZISTA taken with 100 mg ritonavir with food twice daily. PREZISTA 800 mg taken with ritonavir 100 mg once daily should only be considered in certain pregnant patients who are already on a stable PREZISTA 800 mg with ritonavir 100 mg once daily regimen prior to pregnancy, are virologically suppressed (HIV-1 RNA less than 50 copies per mL) and in whom a change to twice daily PREZISTA 600 mg with ritonavir 100 mg may compromise tolerability or compliance. PRNewswire