PxROAR “Raves” in Europe and the United States

AVAC hosted a two-day training “Rave” at its New York office in April. This annual workshop brings together US-based advocates from AVAC’s PxROAR (Prevention Research Outreach Advocacy and Representation) program for an intensive update on the latest in the field of biomedical HIV prevention research and implementation, and provides a space for advocacy strategizing. This year’s focus was on treatment as prevention and pre-exposure prophylaxis (PrEP).

The recently expanded US ROAR team hails mainly from the 12 US municipalities bearing the highest AIDS burden in the country, as identified by the US Health and Human Services National HIV/AIDS Strategy Operational Plan. ROAR members are already active on the frontlines of the AIDS response in these areas and will be expanding or strengthening their work on treatment as prevention and PrEP. In one initiative discussed at the April meeting, PxROAR members decided to examine available data on rates of uptake of HIV testing, linkage to care, initiation of and long-term adherence to ART. They hope to use information on these “treatment cascades” to guide advocacy at the state and city level. They also plan to work with PrEP demonstration projects and research sites to spread the word about this prevention strategy. For more detail about US ROAR’s pursuits, read the PxROAR Advocacy Guide for US ARV-based Prevention Campaign.

AVAC also hosted a “Rave” for its European partners. This month’s Brussels meeting brought together advocates from Belgium, France, Germany, Italy, Netherlands, Spain and the United Kingdom. Participants discussed soliciting new European ROAR members and strategized around securing and sustaining European funding for research and implementation of ARV-based prevention. Jean-Daniel Lelièvre’s from France’s INSERM provided an update on European research towards a cure. His presentation underscored the need for advocacy directed at national governments and the European Commission to maintain funding for research even during difficult economic times.

Also in Europe, AVAC is collaborating with UK-based NAM/AIDSMAP on a series of webinars for HIV prevention advocates in Europe. On Tuesday, June 11 we will be holding a webinar on HIV cure research. Sign up for our Advocates’ Network newsletter to be notified when more information is available.

Partner Voices: What the Heck is PrEP?

PxROAR member Nichole Little talks about her recent work with PxROAR colleague Robert Newells.

For years here in Oakland, CA, community health advocates have tried everything to get ahead of the curve on HIV transmission. When presented with a new tool, pre-exposure prophylaxis (PrEP), my fellow PxROAR member Robert Newells and I were eager to take advantage. To better understand how our community could implement PrEP we planned a series of local meetings on the subject.

The first of three community meetings took place late last month. Speakers at What the Heck Is PrEP: Biomedical Interventions for an AIDS-Free Generation included Ruben Gamundi from Gilead Sciences, HVTN 2013 Ramp Scholar Angela Scott and Yamini Oseguera-Bhatnagar and Ifeoma Udoh of the Oakland Downtown Youth Center. The presentations were designed as an introduction to PrEP and the clinical trial results of PrEP safety and effectiveness data. Participants included a number of Oakland HIV/AIDS service organizations who discussed the potential benefits of PrEP but expressed concern over the issue of access in a community where many already struggle to receive basic medical care.

The next two meetings in the series will focus on coordinating a response among the larger Oakland HIV prevention community. Later this month we’ll meet with local AIDS service organizations to encourage collaboration in an effort to reach a greater number of people with uniform and accurate information. We’re working to ensure these organizations are familiar with HIV prevention intervention basics and know how to best give this information to their clients and patients.

Our goal is to be sure everyone thoroughly understands the subject matter. It will be at these local organizations that discussions about whether PrEP could work in their community or not. The hope is that the advocates and activists can have informed conversations with clients and other at-risk community members. Robert and I are excited to be able to share this very important and exciting information with our community partners. Oakland is alive and ready to mobilize!

PrEP Trial Design and Ethical Considerations

In January AVAC collaborated with the French AIDS organization Sidaction to host a meeting, Challenges of clinical trial design, degree of evidence and recommendations in the era of PrEP. The meeting provided a forum for local French researchers and advocates to discuss IPERGAY, the intermittent PrEP study currently underway with men who have sex with men in France. A number of international researchers, advocates and normative agencies were also on hand to broaden the discussion. Advocates on both sides of the Atlantic have questioned the use of a placebo arm in IPERGAY since the US FDA approved daily TDF/FTC (Truvada) for prevention last July. French and other European regulators, however, have yet to approve the use of Truvada as PrEP, therefore it is not currently available for prevention, only treatment.

The daylong gathering brought key stakeholders together to discuss the difficult questions of trial design and ethics—issues relevant not only to IPERGAY but to other current and future biomedical prevention trials. Presentations from the meeting are available at www.prepwatch.com/#sidaction.

While participants in the meeting highlighted the various perspectives on the actual IPERGAY trial design, there was general agreement on the important role of the trial in answering questions around intermittent PrEP, whether TDF/FTC could be taken “on demand”, meaning at the time of sex, and still reduce the risk of HIV transmission.

At the meeting the French organization AIDES called on the French regulatory agency (the National Security Agency of Medicines and Health Products, or MSNA) to approve Truvada via a compassionate use authorization for HIV prevention among most at-risk groups. For a copy of the press release, click here.

Continue following developments at www.prepwatch.org/#sidaction.

ARV-Based Prevention Research and Development Product Pipeline

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Press Release

VOICE trial results underscore need to accelerate development of additional HIV prevention options for women; PrEP strategies remain valuable prevention tool

New York, NY – Results from a large-scale HIV prevention trial among African women known as VOICE (Vaginal and Oral Interventions to Control the Epidemic) provide an urgent reminder that products must meet the needs of the people using them. While disappointing, the results lend new urgency and direction to the search for additional safe and effective HIV prevention options for women, AVAC said today.

Researchers announced today that none of three pre-exposure prophylaxis (PrEP) and microbicide interventions tested in VOICE—daily oral tenofovir, daily oral TDF/FTC (Truvada), and daily 1% vaginal tenofovir gel—provided additional protection against HIV in the study, likely because few of the women in the trial used the products as directed. This low adherence explains the lack of benefit and is consistent with data from other antiretroviral (ARV)-based prevention trials that found a correlation between higher levels of adherence and protection from HIV. The new results were presented in Atlanta at the 20th Conference on Retroviruses and Opportunistic Infections (CROI).

“The VOICE results reinforce what we already know from previous trials—these interventions work when they are used, and they don’t work when they are not used,” said Mitchell Warren, AVAC Executive Director. “PrEP is still a valuable option for many women, and men, who recognize their risk and can take PrEP consistently. Now we have a dual responsibility to understand who might benefit from daily PrEP and ensure that they can access it, and to accelerate the development of additional options that can meet the urgent needs of others.”

A range of trials has shown varying levels of effectiveness of tenofovir-based prevention for heterosexual men and women, and for men and transgender women who have sex with men. The VOICE data do not invalidate the prior trial results, including the finding that daily oral tenofovir-based PrEP provided high levels of protection for women in stable relationships where one partner was HIV-positive, and that 1% vaginal tenofovir gel was modestly effective on a different dosing schedule.

“Previous trials of tenofovir-based gel and pills have shown that biologically this approach can work, but only if the product is used. HIV prevention is never just biomedical—behavior is key. What we’ve learned from VOICE and other trials is that adherence to the prescribed dose—the behavioral component—is the variable that determines effectiveness,” Warren added.

“Biomedical tools do not work in a vacuum but rather in the complex realities of women’s and girls’ lives. The women of VOICE and other prevention trials have much to tell us. Now we need to listen to what they are saying and design prevention options based on a better understanding of their reproductive and sexual health needs and desires, their perceptions of personal risk for HIV infection, and their interest in and ability to use the products offered in those trials,” Warren said.

VOICE showed a very high incidence of HIV in the trial—5.7 percent among all the women in the trial and 8.8 percent among unmarried women under the age of 25 in South Africa.

“The high rates of new HIV infections among women, especially young women, are the most shocking and disturbing data from this trial. They are a sobering reminder of how desperately women need new prevention options that they can and will use to protect themselves from HIV,” said Elizabeth Bukusi, Deputy Director (Research and Training) of the Kenya Medical Research Institute (KEMRI) and an AVAC Board Member. “The VOICE results teach us again that an urgent need for new prevention options does not mean women will automatically demand or use those products.”

Following the 2012 US Food and Drug Administration (FDA) approval of Truvada as PrEP for adults at risk of HIV, AVAC called for a comprehensive package of PrEP demonstration projects for all populations—including young women—that could benefit from the proven option of daily oral TDF/FTC. Demonstration projects and other studies in which participants know that they are taking an intervention that has been proven to work will provide important information about how adherence can be supported in real-world situations. AVAC is also working with advocacy partners in the US and internationally to push national health agencies to systematically determine how PrEP can be delivered to the women and men who will benefit from it. This includes a statement released today from a coalition of HIV and women’s health advocates calling on US agencies to coordinate a PrEP agenda to quickly and accurately answer questions about how PrEP can be made available to women in the US.

At the same time, AVAC calls for accelerated research and development of additional HIV prevention options that are less dependent on adherence and may be easier and more desirable for women to use. These include different delivery mechanisms, such as long-acting rings and injections, and less-than-daily dosing schedules, such as that being tested in the FACTS 001 trial, which is looking at 1% tenofovir vaginal gel used around the time of sex. Renewed commitment and resources are also urgently needed for research to develop HIV vaccines, which would overcome many of the issues around adherence, and combined contraceptive and HIV prevention methods, which would address many women’s needs more comprehensively.

“The data presented today are only the beginning of what we will learn from VOICE. We need to make sure that we get all of the information we can from the VOICE participants to help us understand why women were dedicated to the trial and yet were not willing or able to use the products consistently. These women are at such high risk for HIV, we owe it to them to work with them to find the options that they can and will use to protect themselves,” Warren said.

For more information about the VOICE results and ARV-based prevention visit www.avac.org/prep and www.avac.org/microbicides. The Working Group on US Women and PrEP Statement is online at www.prepwatch.org/#women.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

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