FDA Updates HIV Drug Label to Include Dosing for Pregnant Patients

Today, the FDA updated the labeling for rilipivirine (Edurant) for the treatment of HIV-positive pregnant patients who were on stable treatment prior to conception and who are virologically suppressed, according to an agency update.
The label recommends that these patients take one 25-mg tablet once per day with a meal. The FDA noted that lower exposures of rilipivirine were observed during pregnancy, meaning that viral load should be monitored closely.
The update also includes clinical considerations dealing with dose adjustments that are necessary during pregnancy and post-partum.
Based on data from a clinical trial through the postpartum period of pregnant HIV patients taking a rilipivirine-based regimen, the FDA said that no dose adjustments are needed for those on an established regimen before pregnancy and who are virologically suppressed.
The FDA also updated the label to include additional clinical data for rilipivirine among pregnant patients. 
Prospective data for more than 390 exposures to rilpivirine during pregnancy resulting in live births indicated there was no difference between the risk of birth defects with rilpivirine compared with the birth defect rate of 2.7% in the general population, according to the FDA.
The rate of birth defects in live births was 1.2% and 1.4% among babies exposed to rilipivirine-containing regimens during the first and second/third trimesters.
Another clinical trial included 19 HIV-positive pregnant patients taking a rilpivirine combination during the second and third trimesters and postpartum.
The exposure of total rilpivirine was approximately 30% to 40% lower during pregnancy compared with postpartum, according to the label update; however, the results showed that protein binding of rilpivirine was similar during all 3 periods.
Among the 12 patients who were virologically suppressed at baseline, response persisted in 83.3% through the third trimester and in 75% through the postpartum period.
Of the 10 infants with test results available, all were negative for HIV-1 at the time of delivery and up to 16 weeks, according to the FDA. All infants were treated with antiretroviral prophylactic treatment during the study.
The FDA noted that rilpivirine was well-tolerated during pregnancy and postpartum, with no new safety findings emerging. 

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