Overview
Publication
J Int AIDS Soc. 2023 Jun; 26(6):e26118.
PubMed ID: 37363917
Title
Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: Example of injectable cabotegravir and oral PrEP in women
Authors
Donnell D, Gao F, Hughes JP, Hanscom B, Corey L, Cohen MS, Edupuganti S, Mgodi N, Rees H,Baeten JM, Gray G, Bekker LG, Hosseinipour M, Delany-Moretlwe S
Abstract
Multiple antiretroviral agents have demonstrated efficacy for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). As a result, clinical trials of novel agents have transitioned from placebo- to active-controlled designs; however, active-controlled trials do not provide an estimate of efficacy versus no use of PrEP. Counterfactual placebo comparisons using other data sources could be employed to provide this information.
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