New York, NY – Preliminary data were presented today at the International AIDS Conference by the US Centers for Disease Control and Prevention (CDC) from a safety and acceptability trial of daily use of oral tenofovir in HIV-negative gay men and other men who have sex with men (MSM) in the United States. These data, which do not include any evaluation of PrEP effectiveness, add to the body of information about ARV-based prevention available to researchers, policy makers, community and other stakeholders.

This trial, known as CDC 4323, is one of several trials around the world testing the use of antiretroviral drugs to prevent HIV infection, a concept known as PrEP, or pre-exposure prophylaxis.

The findings presented today showed that no serious safety concerns emerged in the initial analyses. CDC also shared early findings about risk-taking among men in the study. The trial was designed so that some men began taking the daily oral tenofovir or a placebo pill immediately, while other participants were delayed by nine months. This design allowed the research team to gather information on how pill-taking affected sexual behavior in participants who were all receiving the same standard prevention package, including counseling about safe sex, condoms and STD testing for the duration of the trial. The preliminary analyses indicate that rates of risk behaviors were comparable between the participants randomized to begin taking tenofovir or placebo pills daily immediately compared to those who began after nine months of trial participation.

Importantly, these results did not provide any information on whether PrEP reduces the risk HIV infection. This trial focused solely on safety and behavior issues and was not designed to explore possible effectiveness of PrEP. Several studies that are studying possible PrEP effectiveness are currently underway.

“The information from this trial provides important pieces of information about the possible use of PrEP if it is proven effective in other ongoing effectiveness trials around the world,” said Mitchell Warren, AVAC executive director. “It is encouraging to hear there were no serious safety concerns and that the men in the study did not appear to increase risk-taking behaviors while taking a pill.”

“But much more safety, adherence and risk data will be needed before PrEP can be implemented if it is proven effective. And, importantly, this trial does not tell us anything about whether or not PrEP will work to reduce the risk of infection,” Warren added.

“Antiretroviral-based prevention research shows great promises, especially in the light of the positive results from the CAPRISA 004 microbicide proof-of-concept study released earlier this week. Although the CDC safety study used oral tenofovir, the same antiretroviral that was formulated as a gel in the CAPRISA 004 microbicide study, it is important not to extrapolate between the two studies. There are a series of ongoing trials that still need to be completed before we know whether PrEP can be added to our list of available HIV prevention options. Each of these trials provides a piece of the puzzle of how antiretrovirals might be used by HIV-negative people to reduce their risk of acquiring HIV,” Warren said.

More information about PrEP research is available in AVAC’s publication A Cascade of Hope and Questions: Anticipating results of ARV-based HIV prevention trials, available at [email protected].

Contacts: 
Mitchell Warren, +1-914-661-1536, [email protected]

Kay Marshall, +1-347-249-6375, [email protected]

Mexico City, Mexico, August 3, 2008 — The AIDS Vaccine Advocacy Coalition (AVAC) today released a new report, Anticipating the Results of PrEP Trials, calling for increased action from governments, global health institutions, donors, researchers, and advocates to prepare for initial results — expected as early as 2009 — from the first trials of antiretroviral drugs being tested for HIV prevention, known as PrEP or pre-exposure prophylaxis. The report also provides the most up-to-date information about ongoing and planned PrEP research, and lays out an agenda for action on key issues that must be addressed as research on this promising HIV prevention intervention moves forward.

The new report is available online at http://www.avac.org/prep08.pdf.

PrEP clinical trials are currently planned or underway in countries in Africa, Asia, Latin America and North America. These studies are looking at the safety and efficacy of PrEP, an unproven strategy in which HIV negative people could take an antiretroviral drug (ARV), or combination of ARVs, on a regular basis in the hopes of reducing their risk of acquiring HIV.

The AVAC report was released today at a special session of researchers, advocates and other stakeholders, held at the XVII International Conference on AIDS in Mexico City to discuss the challenges of translating PrEP and other HIV prevention research into effective policy and practice.

“PrEP trials are taking place within a changing landscape of HIV prevention research,” said AVAC Executive Director Mitchell Warren. “Disappointing results have emerged from recent studies of vaccine and microbicide candidates, while male circumcision was found to be partially effective at preventing HIV transmission in some populations and is being rolled out in some African countries.

“Although still unproven human clinical research, PrEP is considered one of the promising clinical interventions against HIV currently in development,” Warren continued. “By mid-2009, more people will be enrolling in PrEP studies than in both HIV vaccine and microbicide efficacy trials combined. Advocates and communities affected by HIV need to understand PrEP and its implications for the AIDS advocacy and global health agendas, and government and private funders committed to global health must step forward now to ensure that PrEP research is fully funded.”

“We cannot wait for the study results to begin to prepare for the optimal use and delivery of PrEP,” said Pedro Goicochea, an investigator of the iPrEx PrEP study currently underway in Peru and Ecuador “Instead, we should look ahead to consider all of the possible outcomes of these trials and make real plans for making PrEP available to those who can benefit from it, as quickly and safely as possible if it is proven effective.”
Anticipating the Results of PrEP Trials provides an up-to-date status report on current PrEP research; addresses concerns about PrEP, including the possibilities of drug resistance, partial efficacy, and the potential for increased risk behavior and social stigma; looks at the potential impact of PrEP on future HIV prevention research; and considers what questions should we be preparing to ask now based on possible different research outcomes as PrEP studies begin reporting data in the next few years.

“This report provides an important overview of PrEP research and lays out the many difficult issues that are critical for advocates, communities and public health experts to understand as trials continue and report results,” said Warren. “We cannot shy away from discussing issues such as potential drug resistance, the difficulty of adhering to a once-a-day pill regimen for people who are not sick, or the cost of providing PrEP. This report and today’s meeting lay the groundwork for these important discussions.”

AVAC’s report identifies five priority issues that need attention now, including:
1. Ensure that current clinical trials have the best chance of providing results: Clinical trials now underway in Thailand, Africa, Latin American and the U.S. could establish the safety and effectiveness of PrEP, but only if these trials produce clear answers. Trial sponsors, regulatory agencies and the global health community must work together to ensure that these studies are supported to produce the data needed to determine next steps on the possible use of PrEP.

2. Identify and invest in additional research: A plan for launching additional studies — including studies on the safety and efficacy on intermittent PrEP dosing, bridging studies in additional populations, and safety and efficacy of other candidates — is needed now and will require additional funding.

3. Plan now for optimal use of PrEP: A plan of action for using PrEP to maximum public health impact should be developed now. This plan should address the issues set out in a Lancet paper of July 2007, which called for assessing appropriate settings and populations for PrEP use, determining what level of efficacy would warrant widespread delivery and determining where targeted vs. more generalized delivery would be more appropriate.

4. Prepare for global procurement and delivery of PrEP: Plans for PrEP delivery must include a well-planned and resourced campaign to deliver PrEP, an understanding of which global funders will pay for PrEP, plans for rollout, and guidance and support similar to that implemented for male circumcision.

5. Provide adequate financing: Underinvestment in PrEP is hampering progress and must be corrected. Government and private funders committed to global health must step forward now to ensure that PrEP research is fully funded.

AVAC’s Anticipating and Understanding Results series provides timely analysis of trials of new HIV prevention options. For other publications in the series, visit http://www.avac.org/.

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About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is an international nonprofit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV
prevention options. For more information, visit http://www.avac.org/.

 NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today released a report on issues surrounding clinical testing of the antiretroviral drug tenofovir as pre-exposure prophylaxis (PREP) – a possible once-a-day pill for prevention of HIV.

Legitimate ethical concerns raised by some advocates have led to cancellations and delays in some of the PREP trials. The AVAC report, “Will a Pill a Day Prevent HIV? Anticipating the Results of the Tenofovir “PREP” Trials,” examines the issues surrounding the tenofovir trials and makes recommendations for ensuring that trials are carried out ethically and that provisions are made for dealing with the results of the trials when they are available. The report also calls for more concerted coordination and advance planning to accelerate evaluation, licensing and access to PREP.

“The concerns raised about the trials are serious, and there is a need for thorough and unbiased investigation,” said Mitchell Warren, AVAC Executive Director. “But all of the concerns raised are solvable. AVAC calls on researchers, communities and advocates to work together to ensure that ethical concerns are addressed, solutions are found, and the trials go forward.”

The AVAC report calls for a coordinated effort from the World Health Organization, UNAIDS, the trial sponsors and other organizations to ensure that research and trials are coordinated and progress in an accelerated fashion, and that additional research is carried out in an expedited fashion, to ensure that we will know as soon as possible if tenofovir is a safe and effective biomedical prevention intervention.

Warren added, “We need as many HIV prevention tools as possible, so research on vaccines, microbicides and other potential interventions must also be accelerated whether or not tenofovir proves appropriate for PREP.” “AVAC remains committed to our mission of accelerating development of an AIDS vaccine, but we are also committed to working in partnership with other advocates and researchers to advance ethical prevention research and ensure that the benefits are shared globally.”

The report is available online at www.avac.org and in print on request from [email protected].

About AVAC
Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of vaccines against HIV/AIDS.

This special report and AVAC’s continuous policy analysis, advocacy, education and outreach work are made possible by the dedicated labor of AVAC advocates and support from the Bill & Melinda Gates Foundation, Broadway Cares/Equity Fights AIDS, the Ford Foundation, the International AIDS Vaccine Initiative, the Overbrook Foundation, Until There’s a Cure Foundation, the WHO-UNAIDS HIV Vaccine Initiative, and many generous individuals who have become AVAC Members. AVAC is an IRS-certified 501(c)3 tax exempt organization, and donations are tax deductible.

Recently clinical trials have been launched in Africa, Asia and the United States to explore the potential use of oral Tenofovir as a “once a day” pill to prevent HIV in uninfected individuals – an intervention known as pre-exposure prophylaxis (PREP). Yet concerns from a few activists opposed to these efforts have resulted in government decisions to halt the trials in Cambodia and Cameroon.

The decisions to halt the trials have generated a firestorm of controversy in the HIV/AIDS treatment, prevention, advocacy, and research communities. In both countries, the public allegations criticizing the trials were not completely evidence-based, and the media’s coverage was highly provocative. As a result, government decisions to stop the trials may have been premature.

Left unchecked, these forces threaten to undermine future trials. The cost is paid in people’s lives – the lives of those who might benefit from new technologies or treatments. This is not to say that unethical research should proceed. But derailing trials without high levels of evidence to support the claim that they are unethical, is a costly practice.

The Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition (AVAC) are international networks of advocates who have worked to forge meaningful collaborations between researchers, communities and activists. Both organizations are committed to ensuring that as science proceeds, the public interest is protected and the rights and interests of trial participants, users, and communities are fully represented and respected. Good prevention research must be accelerated, must be ethical, must involve communities and must result in products accessible and acceptable to the people who need them most.
We are convinced that the concerns raised by those who oppose the trials are solvable and need not have resulted in stopping trials. Issues can and should be addressed by researchers and sponsors working collaboratively with local communities and governments. Controversy over the ethics of research is an opportunity to engage communities in partnership. As Gregg Gonsalves of Gay Men’s Health Crisis recently noted, shutting down an HIV prevention study “is not a victory – it is a defeat. A victory would have been to be able to craft a solution to fix the local study.”

In this spirit, the Global Campaign and AVAC are planning to generate various materials that accurately reflect current events, assist all stakeholders with working though these issues and provide specific recommendations to accelerate ethical development of new technologies. Among the materials we will produce are:
�    A fact-sheet designed to correct some of the common misperceptions and errors of fact that have been made in the course of public discussion of these trials. This fact sheet will be available on our websites (http://www.global-campaign.org/ and http://www.avac.org/) in the next few weeks.
�    A background document that attempts to articulate the basics about Tenofovir, the current PREP studies and the various issues involved will be available in early March.
�    Two on-the-ground case studies to document what actually happened in Cambodia and Cameroon from each sector’s perspective, to identify lessons learned that could help prevent similar situations in the future. This project is already underway, and we hope to have these materials available in the coming three months.

The following key principles are pivotal:
1.    The HIV pandemic creates an incredibly urgent demand for additional safe and effective tools with which to treat HIV infection and stop transmission. This can only be achieved by responsible, credible scientific studies.
2.    Research to create these tools must be done in a way that protects the rights of vulnerable populations and contributes to overcoming the global imbalance in access to health care resources.
3.    Communities affected by research must be actively involved in its conceptualization and implementation.
4.    The rights of trial participants should be respected and participants should be admired for their contribution to helping others.
5.    Researchers and funding agencies must be held accountable for their studies, and advocates must demand that problems be resolved.
6.    AVAC and the Global Campaign are dedicated to developing effective collaborations among a broad range of civil society actors, researchers and sponsors.
We cannot combat AIDS effectively without research and development of new technologies. Without clinical trials, we cannot know what does and does not work – or how different drugs and interventions work in various populations and settings. This means wrestling, collectively and collaboratively, with the complexities of designing trials that are simultaneously ethical and scientifically rigorous. Simply objecting to existing trial designs and shutting down trials is not a solution. We must, instead, proceed with the much harder job of shaping a research standard we can support and then demanding that trials be designed and adequately funded to meet that standard.

For more information:
�    AIDS Vaccine Advocacy Coalition (AVAC): Mitchell Warren, Executive Director, [email protected], +1 (212) 367-1084, http://www.avac.org/

�    Global Campaign for Microbicides: Lori Heise, Executive Director, [email protected], +1 (202) 822-0033, http://www.global-campaign.org/