Tenofovir Spray Drying Sachet Enema Powder Formulation for HIV prevention

Case ID:
C17178

#C17178


Unmet Need

Worldwide, nearly 2 million people are infected with HIV each year (see UptoDate). In the US specifically, 36,801 people were newly diagnosed with HIV in 2019 (see CDC). Since there is no cure for HIV infection, current best practice involves prevention of infection through pre-exposure prophylaxis (PreP), which can reduce the risk by 99% when taken as directed (see CDC). Despite the known benefit of taking PreP, only 25% of people for whom it was recommended took PrEP in the US in 2020 (see CDC). Even for those who do take PreP, adherence is often suboptimal, and it’s thought that expanding the number of options for PreP usage could increase both population uptake and adherence (see Beymer and Garrison). As such, there remains a need for development of new, innovative PreP therapeutics that are more likely to be used by high-risk individuals.


Technology Overview

Researchers at Johns Hopkins and the University of Pittsburgh have developed a new form of HIV PreP consisting of an enema powder that contains antiretroviral drug. The powder can be simply dissolved in water by the end-user to create an enema, which could then be self-administered before receptive anal intercourse to give higher local concentrations of antiretroviral drug than currently approved PreP modalities. Because douching is performed before anal intercourse by the majority of high-risk individuals, the developed technology presents a behaviorally congruent method for PreP administration that could greatly increase population uptake and adherence.


Stage of Development

The innovative PreP formulation has been fully developed and tested in Phase I clinical trials. Since results indicated end-user feasibility, the product is now planned for use in Phase II trials for safety and preference.


Publication

N/A

 

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For Information, Contact:
Vera Sampels
vsampel2@jhu.edu
410-614-0300
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