FDA Clears Darunavir (Prezista) for Pregnant Women With HIV

Megan Brooks

Disclosures

July 20, 2016

The US Food and Drug Administration has expanded the use of the protease inhibitor darunavir (Prezista, Janssen Therapeutics) to pregnant women with HIV infection, the company announced.

Darunavir is already indicated for treatment of HIV-1 infection in adults and children aged 3 years or older, in combination with ritonavir with other antiretroviral agents.

Darunavir plus ritonavir was found to be well tolerated during pregnancy and the postpartum period, the company said.

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

An analysis of 34 women treated with darunavir plus ritonavir at either dosing schedule in combination with a background regimen found that exposures to darunavir/ritonavir were lower during pregnancy versus the postpartum period, but were well tolerated, and virologic responses were preserved throughout the treatment period.

There were no reports of mother-to-child HIV transmission in the 29 women who continued therapy through delivery or any new clinically relevant safety findings compared with the known safety profile of darunavir/ritonavir in HIV-1– infected adults, the company said.

In addition, based on prospective reports to the Antiretroviral Pregnancy Registry (through July 2015) of 532 live births following darunavir exposure during pregnancy, there was no difference in rates of overall birth defects for darunavir relative to background rates in a reference population of the Metropolitan Atlanta Congenital Defects Program. The prevalence of birth defects was 2.7% among infants exposed to darunavir-containing regimens in the first trimester, and 1.5% among infants exposed in the second or third trimester.

"Many HIV treatments have limited data available to support their use during pregnancy," Richard Nettles, Janssen Therapeutics vice president of medical affairs, said in a news release. "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."

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