Postpartum maternal monitoring for renal safety related to tenofovir exposure during breastfeeding in the PROMISE 1077BF randomized trial.

ABSTRACT:

Background

Tenofovir disoproxil fumarate (TDF) is frequently used in antiretroviral therapy (ART) for pregnant and breastfeeding women living with HIV. Although TDF-containing ART is known to be effective for prevention of perinatal transmission, there is limited information about renal safety of maternal TDF during the breastfeeding period.

Setting

In the postpartum component of the PROMISE trial, 2431 women living with HIV and CD4 counts ≥350 cells/mm 3 were randomized to either TDF-containing maternal ART (TDF-ART; n=1220) or infant nevirapine prophylaxis (iNVP; n=1211) for the prevention of HIV transmission through breastmilk at 14 sites in India and Africa; 400 women had additional renal evaluations in the P1084s substudy.

Methods

Calculated creatinine clearance

SUBMITTER: Baltrusaitis K 

PROVIDER: S-EPMC12758623 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature