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Licensed Unlicensed Requires Authentication Published by De Gruyter August 6, 2019

Advancing Novel PrEP Products – Alternatives to Non-Inferiority

David V Glidden

Abstract

With the scale-up of HIV pre-exposure prophylaxis (PrEP) with tenofovir (TDF) with or without emtricitabine (FTC), we have entered an era of highly effective HIV prevention with a growing pipeline of potential products to be studied. These studies are likely to be randomized trials with an oral TDF/FTC control arm. These studies require comparison of incident infections and can be time and resource intensive. Conventional approaches for design and analysis active controlled trial can lead to very large sample sizes. We demonstrate the important of assumptions about background infections for interpreting trial results and suggest alternative criteria for demonstrating the efficacy and effectiveness of potential PrEP agents.

Funding source: National Institute of Allergy and Infectious Diseases

Award Identifier / Grant number: R01AI143357

Funding statement: This work was supported by the National Institute of Allergy and Infectious Diseases (Funder Id: http://doi.org/10.13039/100000060, Grant Number: R01AI143357)

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Received: 2019-03-21
Revised: 2019-06-24
Accepted: 2019-06-27
Published Online: 2019-08-06

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