Janssen Therapeutics announced that the Food and Drug Administration (FDA) has expanded the use of Prezista (darunavir) in pregnant women with HIV infection. The updated labeling now includes dosing recommendations and study data investigating the use of Prezista during pregnancy and the post-partum period.
The study analysis included 34 women who were given Prezista + ritonavir either 600mg/100mg twice daily or 800mg/100mg once daily in combination with a background regimen. Exposures to Prezista + ritonavir were found to be lower during pregnancy vs. the post-partum period but were well-tolerated, and virologic responses were sustained throughout the treatment period in both arms. There were no reports of mother-to-child HIV transmission among the women who continued treatment through delivery (n=29). The analysis did not report any new clinically relevant safety findings compared to the known safety profile of Prezista + ritonavir.
In addition, there was no difference in rates of overall birth defects for Prezista vs. the background rate for major birth defects in a reference population, according to prospective reports to the Antiretroviral Pregnancy Registry (APR) through July 2015.
Prezista, an HIV-1 protease inhibitor, is indicated for the treatment of HIV-1 infection in patients aged ≥3 years in combination with ritonavir and other antiretroviral agents. It is available as 75mg, 150mg, 600mg, and 800mg strength tablets and as a 100mg/mL oral suspension.
For more information call (800) 526-7736 or visit Prezista.com.