Self-start HIV postexposure prophylaxis (PEPSE), to reduce time to first dose and increase efficacy

Area of Science:

• Public Health
• Infectious Diseases
• Clinical Trials

Background:

• HIV postexposure prophylaxis (PEPSE) effectiveness is time-dependent, with no improvement in uptake speed in the UK for over a decade.
• Self-initiation of on-demand pre-exposure prophylaxis (PrEP) demonstrates patient capacity for self-managed HIV prevention medication.
• The study investigated advanced provision of PEPSE (HOME PEPSE) for self-initiation among men who have sex with men (MSM) to reduce time to first dose.

Purpose of the Study:

• To evaluate the effectiveness of self-initiated HOME PEPSE in reducing the time to the first dose of PEPSE after potential HIV exposure.
• To assess the safety and tolerability of the HOME PEPSE intervention.
• To compare sexual behavior and sexually transmitted infection (STI) rates between immediate and deferred HOME PEPSE groups.

Main Methods:

• A Phase IV, randomized, prospective, open-label study involving MSM at medium risk for HIV acquisition.
• Participants were randomized (1:1) to immediate or deferred standard of care (SOC) HOME PEPSE.
• HOME PEPSE involved a 5-day pack of emtricitabine/tenofovir disoproxil fumarate/maraviroc for self-initiation upon potential HIV exposure, with physician-directed continuation.

Main Results:

• 139 MSM were randomized; 31 initiated HOME PEPSE. Uptake was appropriate in 87% of initiations.
• Median time from exposure to first dose was significantly reduced with HOME PEPSE (7.3 hours) compared to SOC (28.5 hours) (p<0.01).
• HOME PEPSE was well-tolerated, with no discontinuations and no significant differences in sexual behavior or bacterial STIs between arms.

Conclusions:

• Self-initiated HOME PEPSE significantly reduces the time to first-dose PEPSE by over 21 hours, enhancing its efficacy.
• The intervention is safe and well-tolerated, offering a viable option for individuals who decline PrEP.
• HOME PEPSE represents a promising strategy to improve timely HIV prevention following exposure.