Putting Prevention on the Line with New Webinar Series

AVAC is pleased to announce a series of three webinars next week, starting on Monday, March 9, that will provide advocates with the chance to hear and discuss data—released last week at the Conference on Retroviruses and Opportunistic Infections (CROI)—in dialogue with researchers and other stakeholders.

These webinars are the first in a year-long series of web-based dialogues focused on HIV prevention research and implementation. This series, HIV Prevention on the Line, will delve into issues raised in our recent AVAC Report and engage with issues and priorities that emerge over the course of the year.

We are also happy to note that this first set of webinars is being produced in partnership with IRMA and the HIV Prevention Justice Alliance. We look forward to working with IRMA and HIV PJA to bring this important information and discussions to a growing audience.

The webinar topics and times are below. Also, please note that the US will change to Daylight Savings Time on Sunday, March 8 so please double check the time in your area at www.timeanddate.com. As always each webinar will be recorded and available online at www.avac.org.

After FACTS: What’s next for HIV prevention in women?

Download slides and audio.

This webinar will feature Helen Rees, principal investigator of the FACTS 001 microbicide trial of vaginal 1% tenofovir gel. FACTS 001, which released data at CROI, found no evidence of protection overall associated with the vaginal gel. Partners Demonstration Project, which reported data at the same meeting, found that serodiscordant couples using oral PrEP and/or ART had very low levels of HIV transmission. What do these and other data mean for women, including young women and adolescent girls? Join the call to share your thoughts and learn more!

Prepare for the webinar with these talks from CROI and excerpts from AVAC Report 2014/15:

Follow the Money: Knowns and unknowns when it comes to cash transfers and financial incentives to improve health in people living with and/or at risk of HIV

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This webinar will feature Wafaa El-Sadr, principal investigator of HPTN 065 which evaluated the use of cash incentives in improving outcomes for people living with HIV in the United States, and David Wilson, the World Bank’s Global AIDS Program Director. Both speakers presented at the recent CROI conference. Cash transfers for young women and girls have also been highlighted in the recent UNAIDS “Fast Track” report and in their draft Prevention Targets released in November 2014. What do the data tell us—and what are the missing pieces? Is now the time to have a cash transfer target—as UNAIDS has proposed—or to articulate an agenda to learn more? Or to do both?

Prepare for the webinar with these talks from CROI and excerpts from AVAC Report 2014/15:

Demanding Clarity on PrEP: Understanding recent data on oral PrEP

Download slides, audio or view the Flash animation slideshow.

This webinar will feature Jean-Michel Molina of the French research agency ANRS and Sheena McCormack of the UK Medical Research Council to discuss the data from the Ipergay and PROUD studies, respectively. Both trials evaluated oral TDF/FTC (brand name Truvada) as PrEP in gay men and other men who have sex with men, and both reported at CROI, that there were high levels of protection against HIV acquisition. PROUD prescribed a daily pill regimen; IPERGAY asked trial participants to follow an “event driven” regimen that involved a sequence of doses before and after sex. IPERGAY participants took an average of four doses per week—comparable to the estimated protective dose required in trials of daily oral PrEP. So—is there now an “event-driven” regimen? How might these data affecting PrEP delivery and demand in Europe, US and beyond? Join us to explore these conversations—and more!

Prepare for the webinar with these talks from CROI and excerpts from AVAC Report 2014/15:

We look forward to welcoming you on these webinars and others as we move through the year!

Does Sex Have Impact on HIV Prevention Research?

This post was written by Morenike Folayan, Coordinator of the New HIV Vaccine and Microbicide Advocacy Society and member of the CROI Community Liaison Subcommittee.

At the CROI meeting, I seem to be getting signals that sex significantly impacts HIV research design, data interpretation and data use.

First, I learned that availability of tenofovir, the drug used for pre-exposure prophylaxis (PrEP), is 10 to 100 times lower in the vagina tissues than the rectal tissues when taken orally. This therefore implies that the results of PrEP studies conducted to assess HIV transmission through anal sex cannot be automatically translated to imply the results would be pan out the same way when considering vaginal sex. Hmmmm.

Second, I also learned, through informal conversation with those who work in the field for ARV studies, that the reasons many HIV positive men decide to commence ARV use for HIV prevention (treatment as prevention, or TasP) differ from the reasons why women do commence TasP. More men commence TasP out of a sense of protection of their sexual partner—they have a higher sense of responsibility to protect their sexual partner from getting infected. Women on the other hand, commence the use of TasP simply because they are eligible to use the product. I found that very interesting. I think there may be cultural differences in this observation. I doubt if this is the case in Africa. However, like the lessons we learn from CROI, we need evidence. I would like to see a formal study evaluate this social context of TasP use by men and women in different cultural setting.

Third, the iPrEx OLE study showed increase uptake of, and adherence to, PrEP by MSM who were at high risk for HIV infection. In the VOICE study, we see less uptake and adherence by women who were at high risk of HIV infection. Hmmm. Are we starting to see differences in cultural perception of risk or is this truly a sex difference in risk perception?

(Editor’s note: In iPrEx OLE, participants knew that they were being offered an effective prevention tool—it was an open label study; in VOICE, women were counseled that they might be receiving a placebo and that none of the strategies were proven. Understanding how context—research site, clinic, public health program or community center—affects uptake and risk perception is also key.)

Reason for more studies on sex differences in PrEP and TasP use. Maybe conducting studies with transgenders may help address this question. Maybe.

AVAC Report 2014/15: HIV Prevention on the Line

In AVAC Report 2014/15: HIV Prevention on the Line, we take on the current state of global targets for the AIDS response, looking beyond pithy slogans to explore what’s in place and what’s not in terms of targets, resources and action to begin to end the AIDS epidemic. We also provide concise updates and calls to action on key prevention interventions including AIDS vaccines, voluntary medical male circumcision, microbicides, PrEP, and hormonal contraception use and HIV risk.

Invest in an oral PrEP-driven paradigm shift

The data all point the same way: daily oral PrEP works if you take it. This excerpt from AVAC Report: HIV Prevention on the Line, provides a number of steps to scale-up PrEP rollout.

More confirmation for PrEP in gay men—now what about the ladies?

Nichole Little is the Founder and Executive Director at Sexual Health Education Research & Outreach (SHERO) and an AVAC PxROAR member. She is also part of the first cohort of the CROI Community Delegate Program, which provides an opportunity for additional community representatives to attend the meeting. She writes about how despite the new PrEP trial results, there needs to be more focus on women’s health and prevention needs.

On Tuesday, during the 2015 Conference on Retroviruses and Opportunistic Infections (CROI), findings from the iPERGAY PrEP trial were released. The results were exciting and determined that “on demand” or intermittent use of TDF/FTC (Truvada) led to an 86 percent reduction in HIV risk in the trial participants—all of whom are gay men. Absolutely awesome news.

Now… How do I go home and proudly deliver this information to a room full of women who have been waiting for the trial that tells them that their lives and sexual health matter. Us advocates, activists, educators and researchers know the nuances of who and how to fill a clinical trial. We know that women in sero-discordant relationships have done very well in PrEP studies. But, at the end of the day, good news is only good news if it directly impacts your life. These women are waiting for a piece of good news to come out of one of these conferences that will directly impact their lives. They want to hear the words, PrEP WORKS IN WOMEN, especially young women not in serodisordant couples. And since we’ve done such a good job, as community advocates in educating folks about the clinical trials process, they want us to prove women in the US will use PrEP and it will protect them.

During CROI’s opening plenary, Dr. Susan Buchbinder, UCSF, presented a talk titled HIV Prevention 2.0: What’s Next? Dr. Buchbinder discussed the challenges of incorporating the new biomedical prevention interventions with what she called “old interventions,” defined as public health campaigns, testing and condoms. She discussed the data that show post-HIV screening counseling may be a deterrent to those individuals testing negative for HIV. Is it the information we are delivering to them not effective? This concerned me because a number of the women I talk to understand the need for a female initiated HIV prevention strategy but they are no longer interested in being treated like little men or after thoughts. PrEP is indicated for men and women. But honestly, I cannot point them to the pudding where the proof is showing the type of information these iPERGAY results show.

The data around PrEP and women have not always been the most promising—think VOICE and FEM PrEP. The trials showed many women underestimated their HIV risk, which is partly the reason they didn’t use PrEP or gel. During the U.S. Women and PrEP pre-CROI conference face-to-face meeting, advocates from across the country convened to review the current biomedical prevention agenda with the goal to ensure that women are properly included in the work toward the end game. One point that threaded its way into every discussion we had during the day-long meeting was how do we determine what a high-risk woman is.

It was pointed out by Marsha Jones, from The Afiya Center, that we often don’t know that something is a risk until it is happening. The idea that the complexities of the lives of women put us in the position where it is difficult to place a target where we can then deliver effective advocacy. The idea that to identify a person as MSM is probably not offensive if you are gay or a man who has sex with other men. It makes moving into that population with a little more ease of motion because you know who you are looking for and have effective ways to reach them. With a woman, her husband may be her risk. For another woman, the stress of single-handedly having to financially provide for family may be her risk. Hell, for a great number of women… walking down the street with breasts puts us at a level of risk that men just cannot understand.

So where I am super excited that the IPERGAY results were so promising… I am challenged with how I take this information back into the community I serve. I can hear the question “What about us?” I’ve heard it year after year. All women want to know is that they are going to be able to have an HIV prevention option that is not going to interfere with the reproductive process, make them gain weight and WILL REALLY PROTECT THEM. I guess, where biomedical interventions are concerned, that is too much to ask at least at this current moment in time. But what I can tell them is that I’m a member of an army of women and men who place women in high priority. I can tell them that we are at the table and we are bringing their concerns back to the folks who control the dollars as well as those who control the science and we are letting them know that women matter.

And one day we will be sitting in a huge conference room and hear the good news that women across the globe have been waiting to hear. The kind of good news that men have been getting for the last few years. I will also reassure the women in my community that microbicides are going to change the game for us—maybe not gels but there is a lot of promise in the work that is currently being done to develop numerous other delivery methods. Now that’s AWESOME news. And until then, my sisters and I will continue to attend conferences, continue to occupy a seat at the table and continue to keep women’s health high on the list of prevention priorities.

Excitement and Disappointment at CROI as PrEP and Gel Data Break

In the moments leading up to the packed session where new PrEP and gel data were presented, longtime activist and Body editor Julie Davids tweeted that there was an “Oscar-like” atmosphere—referencing the buzz, hum and readiness of the film awards ceremony that completed on Sunday. Unlike the Oscars, which ran three hours and forty minutes, this session was brief—under two hours—and yet the news that it brought will almost certainly change the world. AVAC’s own press release is here. And below is a quick summary of this historic day.

The bottom line from Partners PrEP, PROUD and IPERGAY is that oral PrEP using TDF/FTC provides protection. We knew this already, but the new data add nuance.

  • 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 public 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.

There are a range of press statements, a statement from the US CDC and—starting on 2/25, the webcasts for the sessions will be available. You can find all of those links here.

The PrEP data are terrifically exciting findings insofar as they reinforce that this is a strategy that works when taken as prescribed. In gay men and other men who have sex with men, this means it even works when the instructions for use involve coitally-related dosing. It is really important to remember that the data so far about PrEP, protection and vaginal sex suggest that this type of strategy might not work as well for women. As we discussed in AVAC Report 2014/5, now is the time to invest in an oral PrEP-driven paradigm shift. We made this statement even before the data were out—and now we mean it more than ever.

If anything, emotions ran even higher as the FACTS 001 data were presented. Here, it was news everyone had hoped to avoid.

  • FACTS 001 was 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.

Statements and facts sheets from the FACTS consortium, other microbicide stakeholders and CONRAD are all available here.

The world has far more work to do to find additional tools, above and beyond oral PrEP—which should be rolled out to all who want and could benefit from it—to reduce rates of HIV acquisition among women worldwide.

AVAC will be working with partners to convene webinars and in-country discussions in a range of locations to talk through the implications of all of these data. We will announce the schedule in the coming weeks. If you have a specific question or would like support in organizing around these data, please contact us.

Our recently-released AVAC Report: Prevention on the Line provides background and analysis that anticipates and contextualizes these developments.

Press Release

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

Contacts

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

Kay Marshall, [email protected], +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.

Targets that Require Work: PrEP and Combination Prevention

Targets are urgently needed for daily oral PrEP and combination prevention. This graphic, from AVAC Report 2014/15: HIV Prevention on the Line, proposes goals and shows what’s in place and what is missing today.

What to Expect for PrEP in Africa in 2015

Appearing in the AVAC Report 2014/15: HIV Prevention on the Line, this graphic shows ongoing and completed PrEP trials in Africa.

Women’s Lives on the Line: AVAC’s new report takes on prevention, targets, research and results

AIDS terminology comes and goes. There are short-lived acronyms like MARP (Most-At-Risk Populations) and unpronounceable but universally recognized ones like GFATM. Right now, the way that much of the world is talking about women and girls and their risk of HIV acquisition is as treacherous a field of terms and euphemisms as advocates have seen. Women and their prevention needs are, due to fuzzy rhetoric, left hiding in plain sight.

All of this is going to matter a great deal as the world grapples with the data expected from this week’s Conference on Retroviruses and Opportunistic Infections, which will bring the release of new data on a range of HIV prevention tools including daily oral PrEP in gay men and other men who have sex with men (MSM), serodiscordant couples who were offered PrEP and also offered ART, and PrEP dosed around sex acts (different from the FDA-approved daily Truvada regimen). It will also bring the long-awaited data from the FACTS 001 microbicide trial, which tested a 1% tenofovir gel, applied before and after sex, in South African women.

We don’t know what the data are, but we do know what some of the pitfalls in discussing women’s prevention and treatment needs are. So here are a few points to keep in mind—each of which is expanded upon the recent AVAC Report: Prevention on the Line—as the week unfolds:

Daily oral PrEP is driving a paradigm shift that may mean different things for men and women. The body of evidence on daily oral PrEP shows that it works if taken correctly and consistently. Right now, there is more “real world” evidence of effectiveness in gay men and other MSM—and less is known about how PrEP could be delivered effectively in young women, particularly those who are not in stable partnerships. The data that do exist suggest that women may need to be more adherent to achieve protection against acquisition during vaginal sex, compared to anal sex. So any data on adherence and efficacy from studies in MSM needs to be contextualized—these data will apply to men whose risk is via anal sex and should not be presented as a global indication of what could work for all populations. Check out Part II in AVAC Report 2014/15 for discussion of these nuances and proposals of what global targets for daily oral PrEP could look like, including for young women and adolescent girls.

Many people aren’t saying what they mean when they say “key populations”. The term “key population” came on the scene as MARP shuffled off. It is used to mean many things, and included groups like gay men and other MSM, transgender women, people who inject drug, and sex workers. Sometimes it is used to mean under-served and over-burdened populations, and in this context that includes women and adolescents. Sometimes people say, “key populations and women”. CROI will certainly include information on prevention and treatment services for key populations. Check out our box in AVAC Report 2014/5 on what clarity should look like with this term. Watch closely as data are presented, and keep this question in mind: Where are the women?

Microbicide research is critical to the future of women’s prevention—but no single trial has all the answers. AVAC Report 2013 focused extensively on what recent trials have taught the field about women’s experiences in research. And the upcoming, highly anticipated data from FACTS 001 will provide even more information. Because women’s prevention needs are great, and the current range of available tools is small, each new finding carries enormous weight. Will an efficacy finding trigger a global change in prevention programming? No. Not right away. There are limited quantities of the gel available and much to understand about how it might work in the real world. Will a lack of efficacy signal the end of user-dependent methods? No. Not at all. Each trial has brought a trove of information about how and why women use specific products and how they relate to research, and it’s imperative to act on this information—to listen to women—whatever the outcomes.

Throughout the next few weeks, we’ll cover CROI developments and highlight relevant sections of our recent Report. Bookmark our CROI page and stay tuned!