Year: 2025
Type: article
Study design: Observational Study
Abstract: Synopsis Background Rilpivirine, a NNRTI for preventing mother-to-child HIV transmission, may have reduced plasma exposure in the second and third trimesters due to increased metabolism/elimination in pregnant women, potentially compromising its efficacy. The study aimed to evaluate maternal rilpivirine plasma concentrations during pregnancy and postpartum. Material and methods A multicenter, cross-sectional, cohort was conducted from 2020 to 2023. Pregnant women living with HIV-1 receiving rilpivirine 25mg once-daily containing regimen were enrolled. Plasma concentrations of rilpivirine were determined throughout pregnancy and postpartum. A population pharmacokinetic approach was performed to analyze the plasma concentrations. Rilpivirine trough plasma concentrations (C 24h ) were estimated using individual parameters and interpreted using an efficacy threshold of 48 ng/mL (# 4-fold protein adjusted EC 50 ). Results Seventy-two (97% sub-Saharan African) pregnant women were enrolled: median age 34 years old (IQR25-75% 28-38). All were receiving a triple therapy including FTC/TFV (as TDF or TAF) associated NRTIs. Overall, 222 plasma concentrations were determined. There was no effect of gestational age or trimester on pharmacokinetic parameters to improve the between-occasion variabilities. Median rilpivirine estimated C 24h were 79 ng/mL (IQR25-75% 55-105). Among the 72 women, 14% of them presented C 24h <48 ng/mL. Only one woman presented >200 copies/mL viral load during her pregnancy. Conclusions In our study, no significant effect of pregnancy on rilpivirine pharmacokinetic parameters was reported. No dose adjustment for orally administered rilpivirine should be recommended in this setting.
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,900
OpenAlex ID: W4415315482