On-Demand HIV Pre-Exposure Prophylaxis

According to World Health Organization statistics, 1.7 million people became newly infected with HIV in 2019. Daily PrEP (pre-exposure prophylaxis) with the combination of emtricitabine (FTC) and tenofovir (TAF) or tenofovir disoproxil fumarate (TDF) is highly effective in preventing HIV infection. However, many people can find it challenging to adhere to a daily pill schedule and thus, may not fully benefit from PrEP.

CDC researchers developed a new method with the potential to prevent HIV infection by administering a clinical drug regimen n only one or two doses prior to anticipated HIV exposure. This method includes co-administering FTC, tenofovir or a tenofovir prodrug such as TAF or TDF, the integrase inhibitor elvitegravir (EVG), and the pharmaco-enhancer cobicistat (COBI). The current method involves taking the drug combination only before anticipated exposure (on-demand PrEP or event driven PrEP (ED-PrEP)). Currently, no three- or four-drug combination have regulatory approvals to protect against HIV with only 1 or 2 dose administrations.

CDC studies thus far show that the process can protect non-human primates from infection by a simian immunodeficiency retrovirus. Initial analyses showed effectiveness when the drug combinations are administered as one to two oral doses before exposure to an immunodeficiency retrovirus. The discovery offers a new biomedical method for potential HIV prevention. Further research would be needed to determine if this single pill or two dose regimen before sex is safe and effective in humans. This public notice serves as CDC’s solicitation of interest from potential licensees or collaborators for a public-private partnership covered by appropriate agreement(s).