Regulatory Considerations for Antiretroviral Prophylaxis to Prevent HIV Acquisition. Antiretrovirals (ARVs) decrease the infectiousness of treated HIV-infected persons and can reduce the acquisition of HIV infection when taken by uninfected persons. Coformulated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is approved in the United States for the preexposure prophylaxis (PrEP) indication, changing the regulatory landscape for new prophylactic agents. We describe the challenge of conducting rigorous clinical end-point trials for prophylactic agents and point to alternatives that leverage new information about correlates of HIV risk and protection.
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