Improved simian HIV (SHIV) prevention in non-human primate models with chemoprophylaxis combination that can be taken in one or two oral doses before or after exposure


HIV and AIDS remain persistent problems for the United States and countries around the world. In 2015, nearly 40,000 people were diagnosed with HIV in the US alone. Pre-exposure prophylaxis (PrEP) can help prevent HIV infections in people who are not infected with HIV but are at high risk of becoming infected with HIV. PrEP involves taking daily medications and is the most effective when medications are taken consistently. However, many people find it challenging to adhere to a daily pill schedule and cannot fully benefit from PrEP. CDC researchers have developed a medication dosing regimen with a combination consisting of a pharmacokinetic enhancer, integrase inhibitor, and nucleoside reverse transcriptase inhibitors that can be effective in primates against simian HIV if taken in one or two pill doses either immediately before or after SHIV exposure to prevent infection. Initial research has likely shown success in protecting against simian HIV infection in primates who received a combination of emtricitabine, tenofovir alafenamide, elvitegravir, and cobicistat (referred to as FTC/TAF/EVG/COBI). Further research would be needed to determine if this limited dosing regimen could prevent HIV (for humans), increase medication adherence, lower costs, and reduce potentially harmful side effects of daily chemoprophylaxis.

Potential Commercial Applications: Competitive Advantages:
  • Initial prevention of simian HIV; potential prevention of HIV in persons at high risk of infection
  • A “before sex” or “after sex” pill dosing regimen that can prevent infection with HIV
 
  • Doesn't require daily medications and can enhance medication adherence
  • New drug combination with 1 or 2 pill doses before or after simian HIV exposure shown to be effective in first primate study
  • On-demand dosing regimen can be more cost effective than daily medications
  • Limited dosing regimen can reduce potentially harmful side effects of daily chemoprophylaxis


Related Invention(s):
E-195-2013-0


Inventors:

Walid Heneine (CDC)  ➽ more inventions...

Jose Garcia Lerma (CDC)  ➽ more inventions...

Ivana Massud (CDC)  ➽ more inventions...


Intellectual Property:
US Application No. 62/473,799
PCT Application No. PCT/US2018/023152

Publications:
Garcia Lerma, JG, et al.
Massud, I, et al.
Massud, I, et al.

Collaboration Opportunity:

The CDC is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize improved HIV chemoprophylaxis with reverse transcriptase and integrase inhibitors . For collaboration opportunities, please contact CDC Technology Transfer Office at tto@cdc.gov or 1-404-639-1330.


Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-037-2017-0
Updated: Mar 20, 2018