Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: example of injectable cabotegravir and oral PrEP in women

Counterfactual estimation of efficacy against placebo for novel PrEP agents using external trial data: example of injectable cabotegravir and oral PrEP in women

Abstract Introduction 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...

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Bibliographic Details
Main Authors: Deborah Donnell, Fei Gao, James P. Hughes, Brett Hanscom, Lawrence Corey, Myron S. Cohen, Srilatha Edupuganti, Nyaradzo Mgodi, Helen Rees, Jared M. Baeten, Glenda Gray, Linda‐Gail Bekker, Mina Hosseinipour, Sinead Delany‐Moretlwe
Format: Article
Language:English
Published: Wiley 2023-06-01
Series:Journal of the International AIDS Society
Subjects:
counterfactual placebo
cabotegravir
emtricitabine/tenofovir disoproxil fumarate
HIV
pre‐exposure prophylaxis
efficacy trial design
Online Access:https://doi.org/10.1002/jia2.26118

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