What question did this study set out to answer?

To compare the safety, acceptability, pharmacokinetic, and pharmacodynamic profiles of reduced-glycerin 1% tenofovir rectal gel versus daily oral emtricitabine/tenofovir disoproxil fumarate.

September 20, 2021AIDS Research and Human RetrovirusesOpen Access

An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate

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To compare the safety, acceptability, pharmacokinetic, and pharmacodynamic profiles of reduced-glycerin 1% tenofovir rectal gel versus daily oral emtricitabine/tenofovir disoproxil fumarate.
Conducted a Phase 2, open-label, three-period randomized sequence crossover trial (NCT01687218) in 195 HIV-1-uninfected men who have sex with men and transgender women, including 37 in a mucosal substudy across sites in the United States and Thailand.
Participants completed three 8-week periods evaluating daily rectal 1% tenofovir gel, intercourse-associated rectal tenofovir gel (or at least twice weekly), and daily oral emtricitabine/tenofovir disoproxil fumarate.
Evaluated systemic and mucosal drug pharmacokinetics and tested protective efficacy using ex vivo HIV-1 biopsy challenge of rectal tissue.
Systemic tenofovir concentrations were significantly higher following daily oral exposure and daily rectal gel application compared to intercourse-associated rectal use (p < .001).
All three PrEP delivery approaches significantly inhibited ex vivo HIV-1 explant infection (p < .05).
A significant inverse correlation was observed between explant HIV-1 p24 expression and mucosal tissue concentrations of tenofovir and emtricitabine (p < .0001).

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Implication

Randomized crossover trial demonstrates ex vivo HIV protection across rectal tenofovir gel and oral regimens in MSM and transgender women, supporting flexible prevention strategies.

Cite This Study

McGowan et al. (2021) studied this question.

synapsesocial.com/papers/6a9fd8396e77178a3bd55b5f https://doi.org/10.1089/aid.2021.0115

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Implication

Randomized crossover trial demonstrates ex vivo HIV protection across rectal tenofovir gel and oral regimens in MSM and transgender women, supporting flexible prevention strategies.

An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate

Key Points

Discussion

Implication

Cite This Study

An Open-Label Pharmacokinetic and Pharmacodynamic Assessment of Tenofovir Gel and Oral Emtricitabine/Tenofovir Disoproxil Fumarate

Key Points

Discussion

Implication

Cite This Study

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