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Original research
Self-start HIV postexposure prophylaxis (PEPSE), to reduce time to first dose and increase efficacy
  1. Julie M Fox1,2,
  2. Ming Jie Lee3,
  3. Cassandra Leach Fairhead4,
  4. Lesedi m Ledwaba-Chapman2,
  5. Achyuta V Nori1,
  6. Orla McQuillan5,
  7. Yanzhong Wang2,
  8. Amanda Clarke6,
  9. Anatole Menon-Johansson1
  1. 1Department of GUM and HIV, Guy's and St Thomas' NHS Foundation Trust, London, UK
  2. 2Department of Infectious Diseases, King's College London, London, UK
  3. 3Department of Infectious Disease, Imperial College London, London, UK
  4. 4Department of GUM and HIV, Brighton Hove and Sussex Sixth Form College, Brighton and Hove, UK
  5. 5The Northern Contraception Sexual Health Service & HIV Service, Manchester University NHS Foundation Trust, Manchester, UK
  6. 6Department of GUM and HIV, University Hospitals Sussex NHS Foundation Trust, Worthing, UK
  1. Correspondence to Dr Julie M Fox, Guy's and St Thomas' NHS Foundation Trust, London SE1 7EH, UK; julie.fox{at}kcl.ac.uk

Abstract

Background Effectiveness of HIV postexposure prophylaxis (PEPSE) correlates with speed of uptake following HIV exposure. Time to first dose has not improved in the UK for over 10 years. On-demand pre-exposure prophylaxis (PrEP) has shown that people can self-start medication for HIV prevention.

We hypothesised that advanced provision of PEPSE (HOME PEPSE) for men who have sex with men (MSM) to self- initiate would reduce time to first dose following HIV exposure.

Methods Phase IV, randomised, prospective, 48-week, open-label study was carried out. MSM at medium risk of acquiring HIV were randomised (1:1) to immediate or deferred standard of care (SOC) HOME PEPSE. Every 12 weeks, participants self-completed mental health/risk behaviour surveys and had HIV/sexually transmitted infection (STI) testing.

HOME PEPSE comprised a 5-day pack of emtricitabine/tenofovir disoproxil fumarate/maraviroc 600 mg once daily initiated following potential exposure to HIV. If taken, participants completed a risk survey; PEPSE continuation was physician directed. Primary outcome was time from potential exposure to HIV to first PEPSE dose.

Findings 139 participants randomised 1:1; 69 to immediate HOME PEPSE and 70 to deferred HOME PEPSE. Median age 30 years (IQR 26–39), 75% white, 55% UK born and 72% university educated. 31 in HOME PEPSE and 15 in SOC arm initiated PEPSE. Uptake of HOME PEPSE was appropriate in 27/31 cases (87%, 95% CI: 71% to 95%). Median time from exposure to first dose was 7.3 hours (3.0, 20.9) for HOME PEPSE and 28.5 hours (17.3, 34.0) for SOC (p<0.01). HOME PEPSE was well tolerated with no discontinuations.

No significant differences in missed opportunities for PEPSE uptake, sexual behaviour or bacterial STI infections between treatment arms.

Interpretation HOME PEPSE reduced the time from exposure to first-dose PEPSE by 21+ hours, with no impact on safety. This significantly improves the efficacy of PEPSE and provides an option for people declining PrEP.

  • HIV
  • sexual behavior
  • post-exposure prophylaxis
  • pre-exposure prophylaxis
  • preventive health services

Data availability statement

Data are available on reasonable request.

http://dx.doi.org/10.1136/sextrans-2022-055622

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • Handling editor Joseph D Tucker

    • Twitter @Jnim87, @achyutanori

    • Contributors JMF and AM-J planned the study. MJL, CLF, AC, AVN, JMF and OMcQ conducted the study. LmL-C and YW carried out statistical analysis. All authors contributed significantly to the study, analysis and write up of the manuscript. JF is the guarantor.

    • Funding This work was supported by ViiV Healthcare, grant number 200835 and Gilead Sciences, grant number IN-UK-164-1258.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.