title: Regulatory considerations for antiretroviral prophylaxis to prevent HIV acquisition.
abstract: 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.
authors: Forum for Collaborative HIV Research, School of Public Health, University of California, Berkeley, California, USA.
authors: V
authors: V
authors: Miller
authors: 1] Gladstone Institutes, University of California, San Francisco, California, USA [2] San Francisco AIDS Foundations, San Francisco, California, USA.
authors: R M
authors: RM
authors: Grant
mesh_terms: D000818:Animals; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D017277:Drug Approval / Q000379:methods*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006679:HIV Seropositivity / Q000188:drug therapy / Q000453:epidemiology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D014481:United States / Q000453:epidemiology
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations