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HIV Antiretroviral Pre‐Exposure Prophylaxis: Development Challenges and Pipeline Promise
Author(s) -
Hendrix Craig W.
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1227
Subject(s) - emtricitabine , pre exposure prophylaxis , medicine , clinical trial , men who have sex with men , serodiscordant , population , drug development , human immunodeficiency virus (hiv) , drug , pharmacology , immunology , antiretroviral therapy , viral load , environmental health , syphilis
The US Food and Drug Administration ( FDA ) approved oral daily tenofovir/emtricitabine (Truvada) for pre‐exposure prophylaxis of human immunodeficiency virus ( HIV ) infection in 2012 on the basis of two randomized controlled trials (RCTs), one in men who have sex with men ( MSM ) and another in HIV serodiscordant heterosexual couples. Subsequently, even greater efficacy has been demonstrated in MSM with rapid population‐level incidence reductions in some locations. In contrast, studies of antiretroviral pre‐exposure prophylaxis (Pr EP ) in heterosexual women showed only modest or no efficacy, largely attributed to low adherence. The mixed results of antiretroviral‐based Pr EP bear witness to unique drug development challenges at this complicated intersection of sexual behavior, public health, and drug development. Multiple innovative methods and formulation strategies followed to address unmet medical needs of persons struggling with daily oral Pr EP adherence or preference for nonsystemic Pr EP options. Clinical pharmacology plays essential roles throughout this Pr EP development process, especially in early product development and through pharmacologically informed enhancement and interpretation of clinical trials.