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Statistical approaches to accelerate the development of long-acting antiretrovirals for HIV pre-exposure prophylaxis

Statistical approaches to accelerate the development of long-acting antiretrovirals for HIV... Downloaded from http://journals.lww.com/co-hivandaids by BhDMf5ePHKbH4TTImqenVA5KvPVPZ0P5BEgU+IUTEfzO/GUWifn2IfwcEVVH9SSn on 06/02/2020 REVIEW URRENT Statistical approaches to accelerate the PINION development of long-acting antiretrovirals for HIV pre-exposure prophylaxis David V. Glidden Purpose of review This review considers statistical issues in the design and analysis of the studies used to develop long-acting formulations of antiretrovirals for pre-exposure prophylaxis (PrEP). Recent finding An abundant pipeline of products is maturing. Accelerating their evaluation as clinical products requires abandonment of noninferiority standards. Randomized trials should be based on the comparison of principled but innovative estimates of background HIV risk and enrich enrollment for those who do not desire current PrEP products. At every stage of testing, innovative analyses can be applied to help inform and accelerate later studies. Summary The development of new long-acting PrEP regimens can be accelerated by innovations in design, ingenuity in synthesizing data sources, and application of causal inference methods. Keywords HIV prevention, implant, long-acting injectable, noninferiority, pre-exposure prophylaxis INTRODUCTION Formative data for phase III trials While the present technologies to control the HIV Animal studies have been used in the proof of epidemic are promising, the prevention movement concept for the effectiveness of potential PrEP is falling far short of its goal. In http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Current Opinion in HIV & AIDS Wolters Kluwer Health

Statistical approaches to accelerate the development of long-acting antiretrovirals for HIV pre-exposure prophylaxis

Current Opinion in HIV & AIDS , Volume 15 (1) – Jan 1, 2020

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References (33)

Publisher
Wolters Kluwer Health
ISSN
1746-630X
eISSN
1746-6318
DOI
10.1097/COH.0000000000000589
Publisher site
See Article on Publisher Site

Abstract

Downloaded from http://journals.lww.com/co-hivandaids by BhDMf5ePHKbH4TTImqenVA5KvPVPZ0P5BEgU+IUTEfzO/GUWifn2IfwcEVVH9SSn on 06/02/2020 REVIEW URRENT Statistical approaches to accelerate the PINION development of long-acting antiretrovirals for HIV pre-exposure prophylaxis David V. Glidden Purpose of review This review considers statistical issues in the design and analysis of the studies used to develop long-acting formulations of antiretrovirals for pre-exposure prophylaxis (PrEP). Recent finding An abundant pipeline of products is maturing. Accelerating their evaluation as clinical products requires abandonment of noninferiority standards. Randomized trials should be based on the comparison of principled but innovative estimates of background HIV risk and enrich enrollment for those who do not desire current PrEP products. At every stage of testing, innovative analyses can be applied to help inform and accelerate later studies. Summary The development of new long-acting PrEP regimens can be accelerated by innovations in design, ingenuity in synthesizing data sources, and application of causal inference methods. Keywords HIV prevention, implant, long-acting injectable, noninferiority, pre-exposure prophylaxis INTRODUCTION Formative data for phase III trials While the present technologies to control the HIV Animal studies have been used in the proof of epidemic are promising, the prevention movement concept for the effectiveness of potential PrEP is falling far short of its goal. In

Journal

Current Opinion in HIV & AIDSWolters Kluwer Health

Published: Jan 1, 2020

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