FDA updates rilpivirine label for use during pregnancy

13 November 2018. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 31 October 2018, the US FDA approved changes to the label for fixed dose combinations (FDC) containing rilpivirine: Odefsey (RPV/FTC/TAF) and Eviplera/Complera (RPV/FTC/TDF).

For pregnant patients who are already on an RPV-based FDC prior to pregnancy and are virologically suppressed (HIV-1 RNA less than 50 copies/mL), one tablet, once daily may be continued.

Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.

A similar recommendation was recently made for rilpivirine (RPV) (trade name Edurant) as a single ARV.

Source:

FDA list serve update (31 October 2018)

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