Labeling for Two HIV Drugs Updated With Safety, PK Data for Pregnant Patients

The Food and Drug Administration (FDA) has approved updates to the Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide; Gilead Sciences) and Complera (emtricitabine, rilpivirine, and tenofovir disoproxil fumarate; Gilead Sciences) labels to include safety and pharmacokinetic data in pregnant women infected with HIV-1 following revisions to the rilpivirine (Edurant) label. 

For pregnant patients who are already on Odefsey prior to pregnancy and are virologically suppressed (HIV-1 RNA <50 copies/mL), 1 tab of Odefsey taken once daily may be continued. The same recommendation has been added to the Complera label. Due to lower exposures of rilpivirine noted during pregnancy, viral load should be monitored closely. 

The “8.1 Pregnancy” and “12.3 Pharmacokinetics” sections have been updated with data showing no increase in the risk of overall major birth defects with 1st trimester exposure for rilpivirine. Findings from a clinical trial (N=19) of HIV-1 infected pregnant women showed total rilpivirine exposures were generally lower during pregnancy by 30 to 40% compared to the postpartum period. The exposure during pregnancy, however, was not significantly different from levels obtained in Phase 3 trials of rilpivirine-containing regimens. The decrease is not considered clinically relevant in patients who are virologically suppressed. 

Odefsey and Complera both consist of nucleoside analogue reverse transcriptase inhibitors and a non-nucleoside reverse transcriptase inhibitor. Odefsey is available as 200mg/25mg/25mg strength tablets in 30-count bottles and Complera is available as 200mg/300mg/25mg strength tablets in 30-count bottles. 

For more information call (800) 445-3235 or visit FDA.gov.