FDA Updates Label for Darunavir (Prezista) in Pregnant Women With HIV

Darunavir /ritonavir combo gets dosing change

The FDA has approved an expansion to the darunavir (Prezista, Janssen Therapeutics) prescribing information to include data and results from a study investigating the use of darunavir during pregnancy and the postpartum period. A human immunodeficiency virus-1 (HIV-1) protease inhibitor, darunavir is indicated for the treatment of HIV-1 infection in adult and pediatric patients (3 years of age and older) with ritonavir (Norvir, AbbVie) in combination with other antiretroviral agents. The recent label update includes dosing recommendations for pregnant women with HIV.

Darunavir should not be used in children under 3 years of age. The medication is always taken with and at the same time as ritonavir in combination with other HIV-1 drugs for the treatment of HIV-1 infection in adults.

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 exposures to darunavir and ritonavir were lower during pregnancy compared with the postpartum period. The two medications were well tolerated, and virological responses were preserved throughout the treatment period in both dosage arms. There were no reports of mother-to-child HIV transmission among the 29 women who continued therapy through delivery, nor were there any new clinically relevant safety findings compared with the known safety profile of darunavir/ritonavir in adults with HIV-1 infection.

In addition, based on prospective reports to the Antiretroviral Pregnancy Registry (through July 2015) of 532 live births after darunavir exposure during pregnancy, there was no difference in the rates of overall birth defects for 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% among infants exposed to darunavir-containing regimens during the first trimester, and 1.5% among exposed infants exposed during the second or third trimester.

The updated label now recommends that pregnant women receive 600 mg of darunavir taken with 100 mg of ritonavir with food twice daily. Darunavir 800 mg taken with ritonavir 100 mg once daily should be considered only in certain pregnant patients who were already receiving a stable daily regimen of darunavir 800 mg with ritonavir 100 mg once daily before pregnancy; who are virologically suppressed (HIV-1 RNA less than 50 copies per mL); and for whom a change to twice-daily darunavir 600 mg with ritonavir 100 mg may compromise tolerability or compliance.

Source: PR Newswire(link is external); July 18, 2016.

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