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PrEP: Roadmap to the Real World

Establishing the Real-World Effectiveness of PrEP Through Demonstration Projects

August 2011

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Table of Contents


Introduction

Thirty years into the HIV epidemic in the United States, we are at an important crossroads. Exciting new data have emerged in the last year from several clinical trials demonstrating that pre-exposure prophylaxis (PrEP) -- whereby HIV-negative individuals take antiretroviral (ARV) drugs to protect themselves from infection -- can significantly reduce the chance of HIV acquisition when offered as part of a comprehensive prevention package (including condoms, risk-reduction counseling, and screening and management of other sexually transmitted infections).

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However, worrisome statistics from the U.S. Centers for Disease Control and Prevention (CDC) were also recently reported, showing sharp increases in new HIV infections in African American gay men and other men who have sex with men (G/MSM).1 These data highlight the urgency of knowing whether and how the efficacy of PrEP in the trials reported so far translates into effectiveness -- that is, the ability to reduce new HIV infections in the real world.

Proving real-world effectiveness will require leadership, resources, and the engagement of multiple stakeholders: three key ingredients that have yet to be fully realized. As such, we -- the AIDS Foundation of Chicago, AVAC, the Black AIDS Institute, National Minority AIDS Council, Project Inform, and San Francisco AIDS Foundation -- are calling on the Department of Health and Human Services (DHHS) to lead an expedited process to clearly outline and commit to a comprehensive plan for implementing PrEP demonstration projects focused on G/MSM. The data suggest that PrEP can be an important HIV prevention strategy for G/MSM and transgender women, who continue to bear the brunt of the HIV epidemic in the United States. We look forward to the further analysis of existing PrEP efficacy data in other populations and to the results ongoing trials, yet we feel it is critical to move now to address how to successfully deliver PrEP to G/MSM and transgender women while we await those additional analyses and results.

We urge the DHHS to develop a plan addressing:

  • the number and geographic location of projects that will be needed to assess the relevance, feasibility, and potential efficacy of PrEP for different communities of G/MSM and transgender women;
  • the questions to be addressed through these projects; and
  • the human and financial resources (both governmental and non-governmental) necessary to implement the projects.

At least two demonstration projects targeting G/MSM have been proposed and are under discussion among researchers, program implementers, and funders, but these two projects will not be sufficient to determine how to implement PrEP in diverse communities of G/MSM. Moreover, robust funding of a suite of projects, a critical next step, remains uncertain. It is time for the DHHS and its partner agencies to put into effect a thorough, integrated, and strategic plan for demonstration projects that are fully funded, complementary rather than duplicative, and able to answer critical questions related to the feasibility, desirability, and potential impact of PrEP programs in G/MSM communities across the country.

This document offers a roadmap to stakeholders for critical questions that we feel must be addressed by demonstration projects and the overarching structure and focus of these projects. The report is intended to start a dialogue that must involve all stakeholders -- government agencies, pharmaceutical manufacturers, researchers, and especially the community of people living with and affected by HIV.


PrEP's Promise: What the Data Show

Fortunately, most individuals do not become infected with HIV, even in the groups and regions in the United States with the highest HIV prevalence and incidence. Moreover, some existing behavioral interventions are relatively effective at reducing risk behaviors in those who have found it challenging to consistently use condoms. However, the recent CDC data highlight that these existing interventions are not reaching those most in need and creating sustained behavior change.

The iPrEx PrEP study found that daily oral tenofovir (TDF) plus emtricitabine (FTC), combined with standard prevention practices, reduced the risk of infection by 42% overall in G/MSM and the small number of transgender women also enrolled in the trial in several countries. The trial ran to its expected completion date and data were reported in November 2010.2

Additional data from more recent clinical trials with heterosexual men and women are also quite encouraging. In the Partners PrEP study -- reported in July 2011 at the IAS Conference in Rome -- the HIV-negative partner in serodiscordant heterosexual couples in Kenya and Uganda received either oral TDF alone, oral TDF/FTC, or a placebo pill, along with the standard prevention package.3 Researchers with the Partners PrEP study reported that, due to significant evidence of benefit, the study's Data Safety Monitoring Board (DSMB) recommended that the placebo arm of the study be discontinued and that placebo participants be offered the chance to enroll in one of the active arms of the study. Both TDF and TDF/FTC (along with standard prevention practices) were able to decrease risk of infection in the HIV-negative partners: TDF reduced risk of infection by approximately 62% overall and TDF/FTC reduced risk of infection by approximately 73% overall.

A second PrEP study reported positive results in July 2011. TDF2, conducted among young heterosexual men and women in Botswana, compared TDF/FTC with a placebo tablet; both study arms also received the standard prevention package. In that study, PrEP reduced the risk of infection by approximately 63% overall.4

On the other hand, a third study with heterosexual women in several African countries, called FEM-PrEP, was not able to show an effect PrEP versus a placebo, and is being stopped early due to "futility."5 Analyses of the data are ongoing to help understand this anomalous outcome.

Another study among heterosexual women, called VOICE, is ongoing and is studying oral TDF, oral TDF/FTC, and topical tenofovir gel. There is an also an ongoing study of oral TDF among intravenous drug users in Bangkok, Thailand. Both of these studies are expected to conclude in 2012.

Thus far, all of the reported studies have found TDF and TDF/FTC to be well tolerated and relatively safe under the study conditions and for the time period in which the drugs were administered. The studies have also shown that, in the context of a clinical trial, PrEP use has not had a significant adverse effect on safe sex practices and may have helped to improve them. Drug resistance has been an issue only for those few trial participants who initiated PrEP use while already infected with HIV.

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This article was provided by Project Inform. Visit Project Inform's website to find out more about their activities, publications and services.
 
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