FDA approves expanded Prezista label for pregnant women with HIV

The FDA approved revised dosage recommendations for Prezista in pregnant women with HIV, according to a press release from the manufacturer.

The updated label recommends pregnant women receive 600 mg Prezista (darunavir, Janssen Therapeutics), an HIV-1 protease inhibitor, plus 100 mg ritonavir with food twice daily. It is also recommended that clinicians consider administering 800 mg darunavir plus 100 mg ritonavir once daily only in virologically suppressed pregnant women who were receiving the regimen before pregnancy to avoid compromising drug tolerability and compliance.

The FDA previously recommended the revised dosage for darunavir in pregnant women with HIV in June.

“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,” Richard Nettles, MD, vice president of medical affairs at Janssen Therapeutics, said in the release. “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 approval is indicative of results of 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. Results showed the regimens were well-tolerated during pregnancy and postpartum and preserved virologic responses. No reports of mother-to-child HIV transmission among the 29 women who continued therapy through delivery were reported, the release said.

The release also stated no difference was observed in the 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.

Darunavir, when used with ritonavir, may cause liver problems, according to the release. Clinicians with patients with chronic hepatitis B or C infection should check blood tests more often if on a darunavir-containing regimen, as there is an increased risk for developing liver problems.

For more information: https://www.prezista.com/sites/default/files/pdf/us_package_insert.pdf