Vaginal microbiota and cytokines in pregnant and breastfeeding women in trials of dapivirine vaginal ring and oral TDF/FTC
DVR and oral TDF/FTC did not differ in their impact on vaginal microbiota, cytokines, or vaginal infections in pregnant and breastfeeding African women.
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What the study showed
Vaginal microbiota, cytokines, and infections (bacterial vaginosis and Candida) were comparable between treatment arms during pregnancy and breastfeeding. Lactobacillus crispatus was less frequently detected postpartum and during breastfeeding than during pregnancy. BV and Candida were common in both periods, with no significant difference in rate of change between arms.
How it was done
Two parallel randomized trials (MTN-042, n=558 pregnant; MTN-043, n=197 breastfeeding) across 4 African countries. Microbiota assessed by qPCR for 12 bacterial targets; 5 cytokines and RANTES by MAGPIX; infections by Nugent score and BD Max™ panel; generalized linear mixed models with Benjamini-Hochberg adjustment.
Risk of bias
The abstract was truncated, preventing full result analysis. Absence of a PrEP-free placebo arm limits inferences about drug effects versus no intervention.
What this study does NOT prove
It cannot be concluded that neither drug alters vaginal microbiota compared to no PrEP, as no untreated control arm was included.
In clinical practice
Neither PrEP strategy showed differential measurable impact on vaginal microbiota in pregnant or breastfeeding women. Choice between DVR and oral TDF/FTC does not appear to be driven by microbiological vaginal health criteria.
Limitations
The abstract was truncated, preventing full result analysis. Absence of a PrEP-free placebo arm limits inferences about drug effects versus no intervention.
Technical appendix
Version history
- 1.0 · 2026-07-09 — Auto-generated under Evidence Standard v1.0
Paid access: structured summary from public metadata; consult the original study at the source.