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The Food and Drug Administration (FDA) has approved labeling updates for Prezcobix (darunavir, cobicistat; Janssen) regarding its use in pregnant women.
The labeling now states that Prezcobix is not recommended for use in pregnant women due to substantially lower exposures of the active ingredients, darunavir and cobicistat, during pregnancy. Treatment should not be initiated in pregnant women, and an alternative regimen should be recommended for women who become pregnant during Prezcobix therapy.
The use of Prezcobix with a background regimen was evaluated in a trial (N=7) of pregnant women taking Prezcobix prior to study enrollment. The study observed women in their 2nd and 3rd trimesters, and through 12 weeks postpartum. The study found exposure to darunavir and cobicistat as part of an antiretroviral regimen was substantially lower during the 2nd and 3rd trimesters vs the postpartum period.
Specifically, total darunavir AUC24h was 56% lower and Cmin was 92% lower in the 2nd trimester vs postpartum; total cobicistat AUC24h and Cmin were 63% and 83% lower, respectively, compared with postpartum. In the 3rd trimester, the total darunavir AUC24h and Cmin were 50% and 89% lower, respectively, compared with postpartum; total cobicistat AUC24h and Cmin were 49% and 83% lower, respectively, compared with postpartum.
Of the 6 women who completed the trial, 1 had virologic failure (HIV-1 RNA level >1000 copies/mL) from the 3rd trimester through the postpartum period. Five patients maintained virologic response (HIV-1 RNA level <50 copies/mL) throughout the study. No data on virologic response is available when Prezcobix is started during pregnancy.
Prezcobix is currently approved to treat HIV-1 infection in adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M T74P, L76V, I84V, L89V), in combination with other antiretrovirals. Prezcobix includes darunavir, a HIV-1 protease inhibitor, and cobicistat, a CYP3A inhibitor. It is available as 800mg/150mg tablets in 30-count bottles.
For more information call (800) 526-7736 or visit Prezcobix.com.
