TFV quantification from rectal sponges is predictive of plasma TFV exposure during rectal dosing.

<p>Plasma TFV exposure is correlated linearly with rectal sponge TFV exposure. (p<0.001, robust RSE  = 0.38) The linear correlation is the same regardless of number of rectal doses. Shaded regions are the 10–90% confidence intervals of the mean predictions from robust linear regression model.</p

Demographics.

<p>Demographics.</p

Study Design.

<p>Study Design.</p

Rectal tissue exposure to TFV and TFVdp (median ± IQR) is higher during rectal dosing with multiple rectal dosing, resulting in accumulation of TFVdp.

<p>Each set of figures documents the 30 min drug quantification in the left-side graph and the 24 hr in the right side graph in rectal tissue biopsy homogenate (5A, 5B) and isolated mucosal mononuclear immune cells (MMC) (5C). Comparisons performed with paired Wilcoxon signed-rank test; only a subset of patients gave both C_{30 min} and C_{24 h} samples. Figure S5A  =  TFV_Tissue; Figure S5B  =  TFVdp_Tissue; Figure S5C  =  TFVdp_MMC. There is accumulation of TFV and TFVdp from multiple rectal dosing. Critical p for significance was 0.025 after Bonferroni correction.</p

Sample Collection.

<p>All 18 trial participants received a single oral dose of 300 mg TDF followed by intensive 24 h PK. After ∼2 week resting period, 12 subjects were randomized to receive a single rectal gel dose of 1% TFV gel with intensive 24 h PK followed, after ∼2 week resting period, by 6 sequential, daily, self-administered rectal 1% TFV gel doses with the 7th dose administered in-clinic with subsequent 24 h intensive PK.</p

Distribution of components of the couples’ HIV-1 empiric risk score.

<p>Distribution of components of the couples’ HIV-1 empiric risk score.</p