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AVAC calls for rapid response to new ARV-based HIV prevention data presented at CROI, including expedited regulatory review, expanded rollout and updated research plans

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February 24, 2015

Contacts

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

Seattle, Washington — AVAC today called for a global action plan including targets, resources and research agendas to accelerate access to daily oral pre-exposure prophylaxis (PrEP), with a particular focus on those hardest hit and most underserved, in parallel with continued research to find new prevention options for those most at risk of HIV, especially young African women.

This call comes as new data from a range of antiretroviral (ARV)-based prevention trials provides strong new evidence for how well these prevention options can work. The studies were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“Today’s results add to a powerful body of evidence that ARV-based prevention works when it is used correctly and consistently,” said Mitchell Warren, AVAC’s executive director. “But they’re also a reminder that with nearly every prevention option available today, from condoms to PrEP to HIV treatment, correct and consistent use is both critically important and a real challenge.”

“The evidence tells us that we need a two-pronged approach. We should develop ambitious programs to roll out existing, proven options, including daily oral PrEP, around the world to those who can use them. At the same time, we must continue to develop and test newer methods that others at risk will actually want, demand and use,” Warren added.

Three oral PrEP trials presented at CROI provided additional evidence for use of the pill Truvada (TDF/FTC) for prevention. All three trials had very high rates of consistent use and very high rates of protection against HIV infection, specifically:

  • The Partners Demonstration project among discordant heterosexual couples (where one partner is HIV-positive and one is not) in Kenya and Uganda showed that a program that delivers both PrEP for HIV-negative partners and/or antiretroviral treatment (ART) for HIV-positive partners reduced the risk of HIV infection by 96 percent. These results highlight the potential impact of combining PrEP and ARV treatment to slow the HIV epidemic.
  • The PROUD Study among high risk men who have sex with men (MSM) in the UK showed that daily oral PrEP reduced the risk of HIV infection by 86 percent when delivered in existing sexual health clinics.
  • IPERGAY, a French study, was the first to examine the efficacy of “event-driven” PrEP – in this case, a three-day dosing strategy involving four pills around the time of sex – among high risk MSM who reported frequent sex. Overall, PrEP reduced the risk of HIV infection by 86 percent in the trial. Based on reported pill use by men in the trial, the regimen that most participants took amounted to at least four doses a week. Previous studies of daily oral PrEP have shown that this may be enough to be protective. However, it is not clear how well the event-driven regimen would work for men who have less frequent sex than the men in the trial.

“There’s growing demand for daily oral PrEP, and the data suggest that there might be other ways to use this strategy that can provide benefit,” Warren said. “For the sake of clarity and impact, providers, advocates and end users need to work together to develop clear, consistent messages that explain what’s known and not known about levels of protection in the context of different types of sex and different patterns of use.”

Also at CROI, researchers presented results from a trial of a tenofovir-based vaginal microbicide gel to be used before and after sex among young women in South Africa. FACTS 001 found no effect for 1% vaginal tenofovir gel overall in the trial. While it appeared that most of the participants used the product at some point, there was not enough correct and consistent use in the trial to provide significant levels of protection. There was a trend of modest protection among the small proportion of women in the trial who appeared to have used the product consistently. This was similar to trends seen in previous studies of tenofovir gel among women, but not enough to change the overall outcome of the trial.

“The women in the FACTS 001 trial, one of the youngest groups to date in an ARV-based prevention trial, have contributed so much to our understanding of the challenges and complexities of HIV prevention,” Warren said. “The data suggest that these young women did want a product they could use to reduce their risk, but that this particular product did not fit into the realities of their daily lives.”

“Researchers, product developers, advocates and donors must keep working with young women at high risk of HIV to find products that will make sense in their lives. Just as in contraception, we know that we need a range of safe and effective HIV prevention options for different people at risk to choose from at different points in their lives. It is clear that no single option can possibly for work all people all of the time.”

Prior trials have shown that older participants and those in more stable relationships may be more able to use the ARV-based products and dosing regimens that have been tested to date. The median age in the PROUD and IPERGAY studies, for example, was over 30. Couples in the Partners Demonstration project averaged over age 30 and were all in stable relationships. In addition, women who were most able to use the product in previous tenofovir gel trials were older and more likely to be in stable relationships. In contrast, the median age in the FACTS trial was 23, and most participants lived with their parents and were not married.

“Young people may need different options than older women and men, but they cannot afford to wait for products from future trials. Daily oral PrEP can work, right now, for at least some women and men of all ages, and our immediate task is to better understand how to deliver it in a way that can be easily integrated into their lives. Funders should invest now in large-scale targeted implementation of PrEP, linked to national programs, and Gilead (which makes the proven PrEP drug), national regulatory authorities and health ministries should prioritize licensure and rollout,” Warren said.

At the same time, oral PrEP is not the right option for everyone, and continued research into other options is critical. Two efficacy trials of a monthly vaginal ring with a different ARV called dapivirine; phase II trials of two different injectable ARVs, used every two or three months; a phase II daily rectal microbicide gel for MSM and transgender women; ongoing HIV vaccine trials and new passive antibody studies may eventually provide additional options for young people and others at high risk of HIV.

“All of the data presented here at CROI demand action: we need sustained efforts to deliver proven prevention tools, demonstrate and roll out daily oral PrEP and develop long-term solutions such as other microbicides, long-acting ARV and antibody-based prevention, vaccines and cure strategies. Together, we must keep focused on HIV prevention that’s effective, available and meets the varying needs of men and women throughout their lives,” Warren said.

Prevention on the Line, the annual AVAC state of the field report, released last week, outlines many of the steps needed to move this agenda forward. The report in online at www.avac.org/report2014-15.

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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.