New Issue of Px Wire: Action on Oral PrEP and Updates on Antibodies

The new issue of Px Wire, AVAC’s quarterly newsletter on HIV prevention research and implementation, is now available.

Click here to download.

In this issue, you’ll find:

  • Updates on how WHO is approaching broader guidance on oral PrEP—and what advocates think should happen next.
  • A closer look at passive immunization, an expanding area of research referring to the administration of laboratory-generated antibodies. Passive immunization is being explored in people living with HIV in attempts to help control viral replication and/or serve as part of a cure strategy. It is also being explored for HIV prevention.
  • And this issue’s centerspread provides a quick primer on passive immunization with HIV-specific antibodies, long-acting antiretroviral injectables, and preventive vaccines, including a new, informative table reviewing the pipelines in research and development for all three research avenues.

Pre-Exposure Prophylaxis Works—It’s Time to Deliver

A commentary from the leadership of the International AIDS Society on the urgency and relevance of implementing daily oral PrEP as an HIV prevention option for all people at risk of HIV. PrEP isn’t a magic bullet or a strategy that will be everything for everyone, but it’s a key choice to have at the right place at the right time for people in need. This new piece underscores the advocacy case laid out in AVAC’s call for increasing attention to PrEP.

Fighting to Save My Younger Brother’s Life

This article first appeared in the Huffington Post.

Matthew Rose is an HIV and public health advocate based in Washington, DC. He is an adviser at the Young Black Gay Men’s Leadership Initiative and also a member of AVAC’s PxROAR program and Vaccine Advocacy Resource Group.

His life and love are what hold us together in stories and statics. I think of him as my younger brother. Though it is not blood relation, we are related nonetheless. By something more than just the color of our skin but the attraction we feel within. The desire to press our flesh to another men’s flesh in a shared experience, to join with them in a moment of passion and pleasure. This desire marks this younger man as one like me. A younger self that walks his own path but still must navigate the barriers I could not clear away. Having to be unaware of that the map I tried to leave him, the secrets are tried to share are still out of his view.

Research tells us that current rates of HIV infection among a cohort of Black young gay men who are uninfected at age 18 will lead to, approximately 41 percent of them being HIV seropositive by age 40. We need to change that estimation. We have to find a way to stem the tide before the wave crests. Otherwise what hope do we have for generations of young men who are still waking to their sexuality and sexual orientation? Will they too be sentenced to this reality? When will we stop acting as if young people aren’t able to make decisions about what to do with their bodies and decisions about how to protect their bodies?

The breakwater starts by giving them power, choices, knowledge, and access to life changing options.

No state expressly prohibits minors’ access to PrEP or other HIV prevention methods. All jurisdictions expressly allow some minors to consent to medical care for the diagnosis or treatment of STIs, but only eight jurisdictions allow consent to preventive or prophylactic services.

In denying access to PrEP, we are taking away their ability to make choices later. By doing so, we take away an effective option at a time of great need, undercutting their ability to thrive.

On April 10 National Youth HIV Awareness Day, I want folks to remember that in U.S. there was an estimated 21 percent increase in HIV incidence in people aged 13-29 from 2006 to 2009. This increase was driven by a 34 percent increase in HIV incidence in young MSM — the only group to experience a significant increase in incidence in this age range.

We know that youth and young adults are the heart of the today’s epidemic… We also know that youth and young adults can, with the right information, make health decisions about their bodies. We’ve seen what access to contraception for young women has done in terms of engagement in health care. When systems are built to support the efforts of young people, young people use them to make a difference in their lives.

It means we need to better support these young people with options. Making sure they know how to and are able to reach their health potential. Youth and young adults are rising up all over this country to take on the fight to end to this epidemic. Part of supporting that effort means not limiting their options. We need to offer access to a full array of prevention choices and educate our younger brothers. To be empowered to make decisions that will help to end this epidemic.

Burning the Candle at Both Ends: An Advocacy Forum Discussion on “Injectable Prevention”

Ntando Yola has worked for eight years in HIV prevention research at the Desmond Tutu HIV Foundation (DTHF) in Cape Town. In his role as a Community Engagement Coordinator he has worked closely with various national and international HIV prevention Networks. His work has involved working with various community stakeholders, developing and implementing community education programmes, forming partnerships with health service providers and other community based organizations as key stakeholders HIV prevention research. He was also a 2013 AVAC Fellow.

At the 2015 AVAC Partners’ Forum, there was a lot of interest in advocates and activists about the important role scientific research has to play in addressing HIV. How important was it? So important that at a roundtable discussion that started after the day was scheduled to end, a small but dedicated group of participants spent over an hour talking about the current pipeline of “injectable prevention” which includes long acting injectable PrEP (I am currently working at DTHF in Cape Town, where an LAI PrEP trial is getting underway), vaccine trials and, someday, passive immunization (right now these antibodies can only be administered via a three-hour transfusion, as we learned at an incredibly accessible presentation by self-described “lab rat’ Penny Moore).

It was clear from this “after hours” discussion that, whilst the focus of community involvement primarily by researchers is within trial communities, there is a need for basic concepts of research and processes to be understood by these broader groups. Addressing this as a gap can go a long way into creating an even more supportive environment for trials and research. Since when civil society understands core concepts and questions related to biomedical research, they are more likely to engage, inform and participate. This would further ensure a natural progression of successful science to real life public health policy and implementation. Whilst globally, initiatives by organizations like AVAC seek to address this, strong and sustained partnerships between science and civil society with countries remain a lingering question as to how this should happen and whose responsibility it is.

I developed a slide set that summarized the pipeline we grappled with and some of the key findings and suggestions that came out of this meeting. There were more questions than answers, as you’ll see. If you want to learn more, raise new questions—or get involved in providing some answers—please be in touch!

Prevention on the Line Webinar Series

AVAC is putting together 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.

Slides, audio and animations from the first set of webinars are available below. Stay tuned to this page, or subscribe to our Advocates Network newsletter, for details on future webinars.

Vaccines in Vivo: Advances in AIDS Vaccine Research
This year brought the launch of long-awaited initiation of clinical trials building on positive results from the RV144 “Thai” trial. This effort is led by the Pox-Protein Public-Private Partnership (P5), including the the HIV Vaccine Trials Network, who joined the webinar to provide a status update of their current vaccine research and development program. We also featured Janssen, part of Johnson & Johnson, to provide an overview of the research program they are moving forward that focuses on a cross-clade vaccine product.

May 18, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

New Frontiers in HIV Prevention, Treatment and Cure: An advocate’s webinar on passive immunization
This webinar focused on “passive immunization”—a scientific term for an expanding area of research that’s highly relevant to treatment, prevention and cure work. There are trials in humans happening in many regions of the world—and data are beginning to come in that advocates need to understand, analyze and consider.

This hour-long webinar featured Dr. Sarah Schlesinger (Rockefeller University) who provided an overview of recent developments across the field including new data from Rockefeller.

April 21, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

Demanding Clarity on PrEP: Understanding recent data on oral PrEP

This webinar featured Jean-Michel Molina of the French research agency ANRS and Sheena McCormack of the UK Medical Research Council discussing 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 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.

March 12, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

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
This webinar featured 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.

March 11, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

After FACTS: What’s next for HIV prevention in women?
Helen Rees, principal investigator of the FACTS 001 microbicide trial of vaginal 1% tenofovir gel, spoke of their findings of no evidence of protection overall associated with the vaginal gel. Jared Baeten, co-chair of Partners PrEP, discussed the Partners Demonstration Project finding that serodiscordant couples using oral PrEP and/or ART had ver low levels of HIV transmission. We discussed what these and other data meant for women, including young and adolescent girls.

March 9, 2015Downloads: Slides (PDF) / Audio (MP3)

Women Deserve to Know About HIV Prevention Medication Too

This originally appeared on RH Reality Check.

In 2012, the Food and Drug Administration (FDA) approved the use of the antiretroviral medication Truvada as the first form of PrEP (pre-exposure prophylaxis), a pill to protect against getting HIV. To date, the United States is the only country to give regulatory approval to PrEP for HIV prevention. The Centers for Disease Control and Prevention (CDC) then issued clinical guidelines for prescribing PrEP to adults at risk of HIV. PrEP has been proven to reduce the risk of acquiring HIV equally well in both men and women—with a protection rate of up to 96 percent when taken daily without interruption or missed doses. Yet three years later, PrEP-centric media campaigns and clinical prescriptions continue to primarily target men who have sex with men.

We at the US Women and PrEP Working Group, a national advocacy coalition of more than 100 women’s health advocates, health-care providers, researchers, policymakers and industry partners, believe that everyone has the right to affordable access to the tools they need to implement their sexual and reproductive choices. Full PrEP availability—for both cis and trans women—is both a reproductive justice and human rights issue. March 10 is National Women and Girls HIV/AIDS Awareness Day. So it’s a good time to ask the question: Why are women being excluded from this potentially life-saving medication?

Of the six oral PrEP studies completed to date, only one took place in the United States. It only enrolled men and a few transgender women who have sex with men. Two international studies that only enrolled women did not show PrEP as successful, but researchers attributed this to the fact that most of the participants did not take the pills daily as instructed. In still other studies involving heterosexual couples, women who did take PrEP consistently achieved a high level of protection—showing that PrEP does work well across the gender spectrum.

Even so, the success of the trial involving American men, combined with the lack of positive data from the trials enrolling women, generated domestic press coverage that generally implied PrEP is “for men,” thus making women invisible as potential PrEP users.

In the United States, about one in four people living with HIV is a woman. Black women, who make up only 13 percent of the female population, comprise nearly two-thirds (64 percent) of new HIV infections among US women. Yet when sociologist Judith Auerbach conducted focus groups in six US cities among 144 women at high risk of HIV on their thoughts about PrEP, she discovered they were overwhelmingly unaware of the effectiveness of the medication for women.

Fewer than 10 percent of the women had even heard about PrEP; those who had thought it was only a tool for men, not for women. The remaining 90 percent were “upset, frustrated and even angry that they had not learned of it before.” They saw the failure of health professionals to reach out to them with information about PrEP as a “societal devaluation” of their lives.

In addition to human rights concerns, this kind of low awareness of PrEP’s availability is also highly problematic for practical reasons. Gender-based differences in social and economic power can sometimes make it difficult or impossible for many women to insist on condom use, and consistent condom use is infrequent overall. In a 2010 national probability study, only 22 percent of men and 18 percent of women reported using male condoms during the last ten times they had vaginal intercourse—and cis women are twice as likely to acquire HIV during heterosexual vaginal intercourse without condoms than are their male partners. Finally, women with HIV in the United States are more likely to be living in poverty and have less access to health care than men living with HIV. All of these factors make access to effective HIV prevention, including the option of PrEP, crucial for women.

Advocates are, however, making inroads in ensuring that PrEP becomes part of the narrative for women at risk of HIV. With funding by the CDC Foundation and its partners, the Sustainable Health Center Implementation PrEP Pilot Study (SHIPP) is under way. As the first PrEP study enrolling women in the United States, this demonstration project is designed to show how PrEP provision can be implemented sustainably. SHIPP is enrolling 1,200 volunteers at four federally qualified health centers in Illinois, Pennsylvania, New Jersey and Texas. These volunteers select PrEP as a part of their sexual health and primary care services. SHIPP’s results—including the rates of PrEP uptake, consistency of use, and protection from HIV—are expected in 2017. To date, about 40 percent of enrolled SHIPP participants are women, a victory for the Working Group and other PrEP supporters across the country.

In the meantime, family planning clinics and private OB-GYNs are well situated to educate women about PrEP, since 99 percent of American women, at some point in their lives, have used contraception. Not surprisingly, cost is a key concern among women considering PrEP use; these facilities can also help patients affordably obtain the medication. At this point, Truvada is the only pill approved as PrEP; Truvada Track, an advocates’ project monitoring PrEP access, reports that it is routinely covered by insurers and Medicaid. Gilead, the pharmaceutical company producing Truvada, also has a patient assistance program that supplies the drug to those without coverage and assists with co-pays to cover the testing and other services associated PrEP access and monitoring.

To choose whether or not to use PrEP, women need information about the medication, clinicians need to be educated about its use for women, and the drug needs to be affordable and accessible. While we are monitoring the implementation of SHIPP, we will continue to pressure policymakers, health-care professionals and the CDC to reach out to women. In addition, we will continue to mobilize women to demand more.

Everyone deserves the right to HIV prevention tools that we can use without our partner’s participation—for the sake of our safety, health and well-being. In short, we are tired of asking permission to protect our own lives.

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

Download slides, audio or view the Flash animation slideshow.

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.