The averted infections ratio: a novel measure of effectiveness of experimental HIV pre-exposure prophylaxis agents.

ABSTRACT: Tenofovir disoproxil fumarate combined with emtricitabine is a highly effective oral pre-exposure prophylaxis (PrEP) agent for preventing the acquisition of HIV. This effectiveness has consequences for the design and analysis of trials assessing experimental PrEP regimens, which now generally include an active-control tenofovir disoproxil fumarate plus emtricitabine group, rather than a placebo group, as a comparator. Herein, we describe major problems in the interpretation of the primary measure of effectiveness proposed for these trials, namely the ratio of HIV incidence in the experimental agent group to that in the active-control group. We argue that valid interpretation requires an assumption about one of two parameters: either the incidence among trial participants had they not recei

SUBMITTER: Dunn DT 

PROVIDER: S-EPMC6035730 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature