FIG. 4.

Changes in ex vivo infectibility by HIV_BaL 10⁴ TCID₅₀ of rectal biopsies following TVF exposure. Graphs document the changes in cumulative p24 from ex vivo tissue infectibility at V2 (all baseline; no product exposure) compared to the same subject's tissue samples collected/exposed ex vivo following product exposure. (A and B) Show changes following single-oral exposure. As there was no placebo group during the oral-exposure stage, results from 30 minutes (A) and 24 hours (B) post-exposure are shown to demonstrate absence of delayed suppressive effects due to a systemically-delivered oral drug (B). (C and D) Show results at baseline (each graph: left side) and 30 minutes after (each graph: right side) single topical exposure to TFV gel (C) compared to HEC placebo (D). (E and F) Show the same arrangement 30 minutes following 7-days topical exposure. The points for the same individual are linked by a solid line. The p-value of a paired test (Wilcoxon for A,B; t-test for C–F) is displayed within each plot; effect sizes are displayed under each plot and ANCOVAs, showing differences between TFV-exposed and placebo groups, after adjusting for baseline measurements, are placed between respective graphs.