Money, Drugs and Labor: Economist Jeffrey Sachs’ solution to ending the HIV/AIDS crisis

“President Clinton should lay the foundation for ending the HIV/AIDS crisis by 2030,” says Jeffrey Sachs, expert on global economic development and provocateur. “Tell her to knock down drug prices in the US… raise a miniscule US$10 billion a year needed to double the global number of people on treatment… and support a systemized cadre of community health workers.”

These were his instructions on how to reach the UNAIDS 90-90-90 targets. The intimate audience of high-level influencers at the annual meeting of the International Association of Providers of AIDS Care (IAPAC), dubbed Controlling the HIV Epidemic with Antiretrovirals, responded with emphatic applause. Except, of course, the one Gilead pharmaceutical representative at the back of the room.

Sachs puts forth compelling arguments. His economic take on how to finally put AIDS to rest seems sensible enough and straightforward. But how to apply his broad-stoke remedy to real life and the diversity of micro-epidemics is a lot less clear. Below is a more granular description of his approach along with its challenges.

Money: Ending AIDS is merely a rounding error

Last time I saw Jeffrey Sachs speak was in Durban, South Africa, in 2000, where he argued the case for what turned out to be the Global Fund. He was not yet director of the Earth Institute at Columbia University, but he was perhaps trying to soften his image. (His leadership role imposing shock privatization policies in several European countries in the post-Soviet era wrought brutal consequences and were still fresh in the mind of the public.) The younger Sachs had said 16 years ago, “AIDS control is hampered by a shocking extent of underfunding and the lack of scientific scrutiny in donor funded-projects.” He went on to call for a UNAIDS global fund of some US$4 billion per year.

It was the first time I heard the “billion” dollar figure as a necessary AIDS response. I remember thinking that’s a lot. A lot of money. But the fact was that by 2001 there were 20 million cases of HIV globally and, according to Sachs, not one person on the African continent was on donor-supported ARV treatment.

The next decade of North-South activism brought about bilateral and multilateral commitments from high-income countries. Donors began to substantially fund antiretroviral treatment (ART) in 2002 and 2003. Today there are 17 million people on ART worldwide and unrivaled scientific breakthroughs in prevention. As a result, according to Sachs, HIV is currently in the control phase, heading toward its end. (Sachs categorizes the epidemic into four phases—the first two are silence and awareness, and the final one would be “end of epidemic”.)

This month, in the IAPAC meeting room in Geneva there was serious talk of how to end HIV/AIDS as a public health crisis by 2030. However, Sachs is still calling current spending on the AIDS response a sub-therapeutic dose—in 2015, US$19 billion was invested in low- and middle-income countries. He appeals for an additional US$10 billion per year for the Global Fund and PEPFAR. This is a mere rounding error, Sachs says, when you look at the world’s combined high-income economies hovering at around US$50 trillion per year. He points out that an extra US$10 billion for AIDS equals 0.02 percent of annual income of these countries. Underscoring this embarrassment of riches, Sachs quotes the US$2.5 billion the US military spends per day.

Reuben Granich, of IAPAC, and midwife to the model of ending the AIDS crisis through treating all, pokes fun at Sachs’ appropriations panacea. He points out that funding has been flat-lined since 2010. “We cannot just print money… we need efficiencies.”

In addition to flat-lined spending, the Global Fund’s pivot out of middle-income countries may also thwart Sachs’ solution. Médecins Sans Frontières’ Sharonann Lynch predicts that a number of countries won’t meet the 90-90-90 targets. She specifically cites countries in Eastern Europe and Central Asia. Even before losing Global Fund support, nations in these regions are struggling to meet expectations that they pay for 60 percent of ARVs and diagnostics, and 50 percent of second-line TB drugs.

Drug prices: Money spent on inflated drug costs should be reinvested elsewhere in the AIDS response

The next ingredient for Sachs’ elixir is the fixing of high drug prices in the US and some other countries. Treatment programs in most highly resourced nations show a reasonably strong rate of linking people to care once someone is diagnosed with HIV. Not the case in the US: only 40 percent of those who test HIV-positive are linked to care in the richest economy in the world—that’s lower than the global average of 46 percent.

“US funding goes to drug companies,” says Sachs, instead of domestic health spending. He points out that ARVs currently cost US$20,000 per year in the US (compared to about US$235 for the Global Fund). Drug costs are almost half of the annual US$45,000 total price tag per person in the US; this excess cumulatively adds up to US$33 billion per year. Sachs suggests this money would be better spent funding the country’s feeble public health system to bring more people into treatment and care. But Sachs fingers the US political system as a major obstacle, “Drug companies own the Congress and price-gouging is killing Americans.”

Sachs continues on a rant, raking Gilead in a way one rarely sees at such genial gatherings: “Gilead is pure greed and disgusting,” he continues in his Midwestern twang. “It charges US$1,000 for a pill that takes one dollar to make, totaling US$84,000 for a treatment dose.” He’s referring to the hepatitis C drug, Sovaldi. Then he goes on to say that Gilead’s blockbuster drug tenofovir was not even invented by the pharma giant. (Indeed, it was synthesized by an institute of the Czech Republic.) And furthermore, Sachs fumes, the company escapes paying billions in taxes by transferring assets to Ireland.

Labor: A systemized, funded cadre of community health workers as the backbone of services

The final addition to Sachs’ trifecta for ending HIV/AIDS crisis by 2030 is the deployment of community health workers (CHWs) in all countries to expand and deepen the response. These are community members who provide support, bringing medications and connection to services for hard-to-reach people. They can be members of key populations who receive proper training and are supervised by a clinic. Sachs’ calculations show such a corps of CHWs could be implemented at around US$1,000 salary for each worker per year.

Most in the room agree that CHWs are an indispensable part of the answer. Mark Heywood, long-time activist and co-founder of South Africa’s Treatment Action Campaign, now director of human rights group Section 27, says no 90-90-90 targets will be reached without robust and funded plans for human resources. However, he challenges Sachs’ US$1,000 salary: “It’s hypocritical to ask them to play such a critical role for next to nothing.” Heywood makes the case that spending US$1 million on CHWs would save US$21.7 billion over time by averting new transmissions and attendant care and treatment costs.

While Sachs is still indeed a provocative speaker, only time will tell if his rhetoric becomes reality. In the meantime, every week 37,000 people are newly infected with HIV and 21,000 more die from AIDS.

Like Super Models? Check This Out!

This week, PLoS ONE released a special issue devoted entirely to the subject of voluntary medical male circumcision—one of the most effective biomedical prevention tools available today. This one-time procedure reduces men’s risk of acquiring HIV by up to 75 percent for life—and when sufficient numbers of men in a community have undergone the procedure, then women’s overall risk of acquiring HIV drops too. It’s an indispensable part of the effort to end epidemic levels of HIV.

One of the things that’s also unique about VMMC is that it was introduced at a public health level more than five years ago. So there’s a wealth of real-world information about the cost and effectiveness of reaching men at different ages, in different contexts and with different outreach strategies. That’s why we’re calling the information in this new supplement “super models”—because they are mathematical models that are based on a lot of real information (not just projections or best guesses). This gives them strength, specificity and urgency.

Pick up the journal or download the PDF and you will find an urgent call for scaling up VMMC and a compelling history of roll out to date. To begin with, most programs reached the men and boys who it was easiest to find, not necessarily the populations who needed the procedure the most. Reinforcing the call to action, the super models show the potential impact of VMMC, and how countries can make decisions according to their context. There is also a helpful question and answer post that simplifies some of the core messages.

As the lead editorial of the special issue concludes: “To achieve further scale-up, a combination of evidence, analysis, and impact estimates can usefully guide strategic planning and funding of VMMC services and related demand-creation strategies in priority countries. Mid-course corrections now can improve cost-effectiveness and scale to achieve the impact needed to help turn the HIV pandemic on its head within 15 years.”

This is dense material. It’s also super important for advocates to understand and to act on the recommendations laid out in this document. Please be in touch with AVAC and/or join our Truthtellers listserv to share your questions, ideas and priorities.

HIVR4P: “Where Are the African Americans?”

Rob Newells is an Associate Minister at the Imani Community Church in Oakland, California, and serves as Executive Director for AIDS Project of the East Bay—a community-based organization serving the most vulnerable and marginalized communities in Alameda County since 1983. He was a 2011 Fellow of the Black AIDS Institute’s African American HIV University Community Mobilization College and has been a biomedical HIV prevention research advocate with AVAC’s US PxROAR group since 2012.

I looked around a conference room at HIVR4P and said to myself (and my Facebook friends), “Where are the African Americans?” Chicago has lots of African Americans, but this research-heavy conference was lacking in community representation. (Shout out to the folks like Matthew Rose from NMAC and Noël Gordon from HRC, and also an R4P plenary speaker, doing the very necessary national and international policy and advocacy work, but as one colleague put it, “Who represents black and brown men in the US?”) African biomedical HIV prevention research advocacy is strong. African American research advocacy could use a boost.

It’s natural for black men working in HIV to attend conferences geared towards community like National African American MSM Leadership Conference on HIV/AIDS and Other Health Disparities (NAESM) and the United States Conference on AIDS (USCA), but we also need be in those spaces that are geared towards the researchers who are developing new strategies that will eventually be implemented in our communities. There’s no reason for the disparities in PrEP awareness between black people and white people that exist today.

Advocates like those I joined in being honored with receiving the 2016 Omololu Falobi Award for Excellence in Biomedical HIV Prevention Research Community Advocacy, have been trying to get the word to our communities since before the US FDA approved Truvada for PrEP in 2012. We’ve got to stay ahead of the curve.

After a few years of relative calm on the HIV prevention research front, the San Francisco Bay Area is now looking at four major studies, which will be recruiting participants at the same time (more info below). The HIV epidemic in the US disproportionately affects black MSM, which means they are also targeted for enrollment in these studies. And the way gentrification has affected demographics in San Francisco (black people made up 13.4 percent of the population in 1970, down to less than 6 percent today), black men 15 minutes across the bay in my hometown of Oakland which is still about 27.3 percent African American (down from 46 percent in 1980) will be heavily recruited to participate in these studies. And the data keep telling us that black men have lower health literacy than other groups – not only in the community, but also on the front lines of the HIV workforce as noted in the Black AIDS Institute’s 2015 “When We Know Better, We Do Better” report.

Black men need to be in the rooms where scientists are discussing their research because it affects us directly. As advocates, it’s our responsibility to help our communities understand sometimes hard-to-understand clinical trial results and their implications. We can’t wait to get to 1-in-2 black MSM diagnosed with HIV before we start taking HIV in black communities seriously.

On a community level, we have to talk about sex and sexuality. The young people who shared their experiences during the symposium “How to Talk to Me About Sex” told us that they learn from their friends and social media and the Internet. Not talking about sex responsibly in community is not helping prevent STIs, pregnancy, or HIV infections.

HIVR4P is focused on HIV prevention research, and black men from the United States were vastly underrepresented. The things being studied today may be the new prevention tools we’re rolling out in our communities in a few years. We have to be talking about them now. And for those of us who act as resources for clients and friends, we need to be able to answer (and ask) questions about these studies. Who should participate? Why would anyone participate? Which study might be the right study for you?

Locally, we have the AMP Study and Gilead’s F/TAF for PrEP study recruiting now. A long-acting injectable study is ready to start recruiting. And we expect to see a new vaccine trial start up in 2017. And California is a Medicaid expansion state, so most people already (theoretically) have access to Truvada for PrEP covered by their health insurance plans. You don’t have questions?

Conferences like HIVR4P are where advocates can engage in conversations with colleagues and researchers from around the world. It’s where we come to understand the issues around various biomedical HIV prevention methods and start to think about how to share what we learn with our communities. (Dennis Burton’s plenary presentation on “Progress in Neutralizing Antibody-based HIV Vaccine Design” helped me understand bNAbs for the first time since I started paying attention to them at HIVR4P2014 in Cape Town.)

I recognize my privilege. Not everyone gets awarded scholarships to attend meetings like HIVR4P. Fortunately, the conference sessions are available online for everyone to access. The Chicago Black Treatment Advocates Network hosted an AIDS2016 Report Back on the South Side at the same time as HIVR4P. (I missed a symposium session to Uber over for a couple of hours.) However we get the information, we have to improve our health literacy in general, and our biomedical HIV prevention research literacy specifically. Sharon Hillier’s plenary talk on “Rings and Things” is a reminder that Truvada for oral PrEP is just the tip of the iceberg. There are new options coming. We have to be ready. It’s past time for more African Americans to get with Solange and pull up “A Seat at the Table.”

“This sh*t is for us… Sometimes we don’t trust… This sh*t is for us.”

Who do you love? Finding treasure at the last day of R4P

Greetings from the last official day of R4P 2016! It’s been a week of conversations, presentations, celebrations and—sometimes—consternation. And yes, it’s been a lot of words. New terms, familiar ones and the occasional Greek character (we’re talking to you α4β7 integrin).

Speaking of ancient Greek and also words: did you know that “treasure” and “thesaurus” share a common Greek relative? Thesaurus originally meant storehouse and treasure. From that, it was borrowed for the usage current today: a storehouse of words.

However, at the end of any gathering of this dynamic, dedicated field, what becomes clear is that the treasures are not the words but the people. The friends, fighters, thought leaders who propel this work forward. For our final update from the final day of HIVR4P, we offer you a round-up of (inter)national treasures.

Treasure 1: The adolescent girls and young women of western Kenya

Yesterday morning Kawango Agot (IRDO) presented data from a study in western Kenya aimed at understanding who adolescent girls and young women are having sex with—and why. This work is part of Kenya’s DREAMS initiative. Supported by PEPFAR, the Bill & Melinda Gates Foundation and private sector partners, DREAMS is a multi-country effort aimed at reducing incidence in adolescent girls and young women by 40 percent by 2017. Success depends on identifying and reaching those girls and women most likely to acquire HIV—and to understand how and why they are at such high risk. The data from Agot’s presentation may not be not the last word, but it is a stirring example of research that clarifies the lived realities of people who need HIV prevention.

Young women and adolescent girls reported having sex because they wanted chips (French fries) or because they wanted someone to give them a ride. They said that they had sex for money and for prayers, which they hoped would help them to pass exams. Fifteen- to nineteen-year-old girls who were in school but lacking one or both parents reported that their teachers were the only men with whom they sometimes used condoms. Every column and cell of Agot’s slide contained a world. It is a world we all have to work together to imagine differently. We start this effort by recognizing how invaluable, beloved and needed these adolescent girls and young women are. They are resilient, resourceful, forthright—and urgently deserving of a world where they wake every day to a reality that treasures their young lives.

Treasure 2: Young African men making the decision to get circumcised

Thursday brought insights into the decision-making paths that men in sub-Saharan Africa travel before undergoing voluntary medical male circumcision (VMMC). Tremendous progress has been made in rolling out VMMC in priority countries in the region. Continued success depends on acting on the kind of information presented today. Karin Hatzold (PSI) presented market research conducted by IPSOS that helped generate an understanding of how men make the decision to undergo VMMC—and how long this decision takes. As Hatzold described, an average of two years and three months passes between the time that a man becomes aware of VMMC and decides to undergo the procedure. These and other data were used to inform a strategy to create demand in specific target groups of men in Zimbabwe.

Later that day, Bertran Auvert of the French National Institute of Health and Medical Research (INSERM) reported on a “short-time” intervention designed to increase uptake of VMMC in Orange Farm, South Africa. The site of the first randomized trial to show the impact of VMMC, Orange Farm had relatively stable prevalence of VMMC between 2010 and 2015. Since population-level impact depends on coverage, Auvert and colleagues designed a short, household-centered intervention and piloted it in 983 households in one site within Orange Farm. The intervention brought VMMC prevalence up from roughly 50 percent to 80 percent—a finding that supports further investigation of this approach. Why is coverage so important? John Stover (Avenir Health) gave a presentation on the estimated number of HIV infections averted by the rollout of VMMC in ten priority counties in Kenya. By 2015, over one million Kenyan men had undergone the procedure. Three different modeling groups calculated the number of infections averted—and all came to the same conclusion: by 2015 VMMC averted 5 percent of the HIV infections that would have happened in that period. Stover reported that the impact, and numbers of infections in both men and women that are averted by VMMC, only increases over time—a potent reminder of the need to pursue ambitious VMMC scale up as part of combination prevention.

None of this would be possible without the boys, young and adult men who undergo the procedure. It is a profound personal choice and one with tremendous impact on the effort to end AIDS. We treasure you.

Treasure 3: The CAPRISA 256 Antibody

“It’s a South African national treasure,” remarked a researcher to Penny Moore (University of the Witwatersrand) about CAP256, a broadly neutralizing antibody isolated from a South African living with HIV. Moore—who is an absolute treasure of lucid, engaging and enthusiastic information about all things antibody—described new insights into how CAP256 can show us how broadly neutralizing antibodies develop. We won’t seek to replicate her explanation in detail—check R4P for the webcast—but it appears that CAP256 is elicited by a rare group of HIV viruses that have holes in the sugary glycan shield that makes up most of the virus’s outer covering concealing key parts of the viral anatomy. (Antibodies emerge or are elicited by the parts of the virus that the immune system is able to “see”. The antibody then binds to that specific part of the virus. Many antibodies bind to HIV without impeding it. But some antibodies target hidden regions of HIV that may only be exposed for briefly when the virus is binding to a cell. These kinds of antibodies can neutralize and block HIV activity.)

Treasure 4: Omololu Falobi Award Winners

The fifth Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy was presented as part of the closing. The award is given in memory of Nigerian activist Omololu Falobi. Falobi is remembered by friends and fellow advocates as a talented journalist, an activist for social justice, an advocate for prevention research and a son of Africa who worked tirelessly to ensure Africans were taking ownership of their own HIV care and prevention. Since 2008, the award has been presented in his memory as an ongoing legacy to recognize his commitment and lasting contributions to HIV prevention research advocacy, and to honor those who follow in his footsteps. In a break with tradition, on the 10th anniversary of Falobi’s passing, the honor goes not to an individual, but the prevention advocacy movement. The 2016 award celebrates 85 advocates from 19 countries, all nominated by their peers in the field. These advocates represent thousands who are part of the movement that has helped fuel the great progress the field has seen over the last decade. Profiles of the 85 honorees are available online at www.avac.org/falobi.

Treasure 5: Ward Cates

We probably would have started this list with Ward, a beloved and sorely missed friend, colleague, mentor and advocate who passed away earlier this year. But Ward would have argued to put young African women first—the way he always did in his work as a researcher dedicated to advancing the sexual and reproductive health rights of all women and girls. And then he would have told us that you can’t just talk about the women—that men matter too. And we agree, as the list reflects. And then he probably would have wanted us to highlight the work of a younger investigator emerging as a thought leader in the field. So we did that too. Not stopping there, Ward would surely have urged us to recognize the critical role of advocates in shaping the HIV response. And then, and only then, might he have allowed us to celebrate him, as two long-time colleagues and friends, Mike Cohen (UNC) and Helen Rees (WRH), both did in talks at the conference’s closing session. In a way, this whole list is for—and because—of you, Ward. You taught us who and what to treasure. We will always treasure you.

Check out all the webcasts online—and stay tuned for future updates as we unpack our bags and all the data and discussions from Chicago!

Debate This: What do HIV prevention and elections have in common?

In a baseball-obsessed town (see Monday’s round-up) there was competition for TV viewers last night in Chicago as millions of people, including many conference-goers, watched the third and final debate between the two candidates vying to become the next US President. What do political campaigns and HIV prevention have in common? Read on for our (non-partisan) thoughts!

Lesson One: Tell a story, make it personal.

Politicians, advocates and parents—these are all groups that know the power of storytelling. Wednesday’s plenary session featured Noël Gordon Jr. (Human Rights Campaign) who told his unique story of getting on PrEP. He also shared his observations from working with gay men and transgender women, he talked about how their attitude toward HIV prevention, the threats to uptake and what opportunities we have to succeed. In advocacy, the best stories are the ones that (re)connect people to the issues. Gordon showed statistics on who is using PrEP in America—and the racial, age and gender demographics of PrEP users do not match those of people most at risk. Stigma also remains a huge issue.

Also in this plenary session, and available via webcast: two excellent research updates—Dennis Burton (Scripps Research Institute) on broadly neutralizing antibody-based vaccine design and Sharon Hillier (Microbicide Trials Network) on the state of the microbicide field.

Later that morning in the Advocates’ Corner, four advocates—Chilufya Kasanda, current AVAC Fellow at the Treatment Advocacy and Literacy Campaign (Zambia), Chamunorwa Mashoko, a leader of the Advocacy Core Team in Zimbabwe, Morenike Upkong, founder and leader of the Nigerian HIV New HIV Vaccine and Microbicide Advocacy Society and Amaka Enemo, current AVAC Fellow at the Heartland Alliance in Nigeria—shared personal stories about empowerment, advocacy and being human. All participated in a training for advocates earlier this year conducted by The Moth, a US-based organization focused on the art and craft of storytelling. Check back at avac.org to see video from their stories later this year.

Lesson Two: Exercise choice, give consent, show zero tolerance for sexual violence.

Some of the story lines in the American election have been a potent reminder of the fundamental right that all people, women and men, have to exercise choice about their bodies. In her plenary, Sharon Hillier (MTN) showed data that underscored the importance of full, free choice. Among women under 21 in the ASPIRE trial of the dapivirine ring, overall use was very low. But among women in this age range who were invested in using it—indicated by the amount of dapivirine still remaining in used rings, drug levels in samples, and self-report—use levels were stronger. And when they did use it, they were protected. Hillier reported analysis from the ASPIRE data indicating that the ring, used consistently, reduced risk by up to 84 percent compared to women under 25 using a placebo ring. This information complemented findings, also from ASPIRE, presented by Thesla Palanee-Phillips (WHRI) at the Tuesday press conference (and on the conference program today) that found that intimate partner violence—which can be physical and psychological—impeded adherence among ASPIRE trial participants. In this election and prevention season, it bears repeating: no biomedical prevention strategy will eliminate the need to prevent and address sexual, psychological and physical violence against women, sexual minorities and all people under threat because of how they live or what they do.

Lesson Three: Look who’s talking (or being talked about).

Sometimes the candidate who seizes the spotlight is campaigning for the next election. HIV prevention, like American politics, can gravitate towards the next big thing, be it a vaccine candidate or a presidential hopeful. The relatively untested is also relatively untarnished—and it can inspire hope for major change. Much of the vaccine discussion was not on the candidates now in efficacy trials but rather on candidates in earlier phases of development. On Tuesday, Chris Parks (IAVI) discussed the results of a trial in non-human primates of a vaccine that uses Vesicular Stomatitis Virus (VSV) as a vector. VSV is a replicating vector: a virus that has been disabled so that it doesn’t cause disease or carry risk but does have the ability to copy itself. It is thought that replicating vectors could prompt strong and sustained immune responses.

Later on Tuesday, Hanneke Schuitemaker from Janssen said that a decision is expected as early as the 4th quarter of 2016 about whether to move forward with a three-part vaccine strategy known as Ad26/gp140/MVA, which is currently under development in collaboration with a number of organizations including the HIV Vaccine Trials Network (HVTN), International AIDS Vaccine Initiative (IAVI), the US Military HIV Research Program (USMHRP) and Beth Israel Deaconess Center.

Interest in next-generation candidates also showed up in discussions of long-acting antiretrovirals, which could be used for both treatment and prevention. Data were shown on a new compound known as EFdA, which is in early animal studies, and on cabotegravir, the candidate moving toward possible efficacy trials in 2017. Politics remind us—don’t discount or count on any single candidate to get the job done!

Lesson Four: Money talks.

At an afternoon session, we heard that money for HIV prevention R&D has remained essentially flat for over a decade. These data come from a new report, HIV Prevention Research & Development Investments, 2000–2015: Investment priorities to fund innovation in a challenging global health landscape, from the Resource Tracking for HIV Prevention R&D Working Group, which AVAC leads. Read more on the new data in our blog post here.

Lesson Five: People in power can and must listen to and be guided by people “on the ground”.

Who are politicians or trial site staff responsible to—and dependent on—for success? The people in the communities in which they work. Without collaboration, there is no change. No engagement, no chance of making real progress. This is recognized across the field—and there’s expanding data on just how to engage. This contribution to the field is coming from widespread use of the Good Participatory Practice Guidelines (GPP) framework, which has been mentioned throughout the conference. In a presentation by Kenyan researcher Jane Ng’ang’a from the KAVI Institute of Clinical Research, she described how KAVI evaluated and improved its engagement plans using GPP. She credits the GPP framework for fostering community understanding and genuine support for the research. AVAC is proud to be the home of an online course on GPP—be sure to subscribe to the Advocates’ Network for announcements of when the next course will run.

When scientists work with (or as) advocates, or when politicians serve as (or team up with) activists, great things can happen. So one of our favorite moments of yesterday’s dialogues came at a “Meet the Experts Session”. Discussing their respective presentations, antibody expert Dennis Burton, and Noël Gordon, expert on the real world experience of people whose lives are affected by HIV in the US, realized they needed to connect. Business cards were exchanged—and perhaps the next prevention revolution was born.

For those on-site today, be sure to check out the final sessions at the Advocates’ Corner and grab some extra materials to take home! Thursday’s sessions include:

  • 10:00am – 10:30am: PrEP implementation in Chicago’s STI clinics
  • 12:00pm – 1:00pm: “It’s too complicated for them”: Service providers as gatekeepers to PrEP information and access

For the latest from the conference follow in real-time on Twitter and check out meeting coverage on aidsmap. The daily rapporteur summaries also provide report-backs on the conference. Missed a session? Visit here to see the webcasts as they become available.

Spreading Heat at R4P: AVAC’s daily round-up

Hello from Chicago! It’s unseasonably warm outside and predictably air-conditioned and chilly inside the conference center. As we don shawls and keep our jackets on, we’d be remiss if we didn’t note that this fair city is also home to one of the great PrEP marketing campaigns to date: the Chicago PrEP Working Group’s pro-PrEP, pro-sex PrEP4Love campaign has taglines like “contract heat,” “transmit love” and “spread tingle”.

It’s too chilly in the conference center for us to sport the sexy skin-to-skin styles of the PrEP, campaign, but we’ll try to use today’s update to transmit the heat of the conference—what got us thinking, talking and perhaps even tingling.

Let’s start with the warm fuzzies. There’s a lot of good feeling here. It’s as though the field of biomedical prevention has turned a corner and, recognizing there are more corners to go, is nevertheless enjoying a moment in the sun. Oral PrEP is rolling out—albeit slowly, the vaginal dapivirine ring continues to be explored, there’s that promising monkey study and then—to top it off—Tuesday brought the welcome news that the vaccine efficacy trial HVTN 702 has begun screening participants in South Africa.

This trial seeks to build on the positive result of the Thai trial known as RV144; it’s the first vaccine efficacy trial to launch in seven years. Kinda makes you tingle, right? If not, check out @vaccineadvocacy—the handle for the Vaccine Advocacy Resource Group. They’re at the conference, decoding science and setting advocacy goals in force. Follow along.

There was more heat—including the kind generated by friction—in sessions that tackled daily oral PrEP.

A small, prospective trial in Uganda looked at the amount of TDF/FTC in breastmilk among lactating women—and at the amount detectable in their breastfeeding infants. Even though TDF/FTC is widely used among women living with HIV throughout their pregnancy, there has been debate—often heated—about whether women who become pregnant while taking PrEP should discontinue it, or whether pregnant women should be allowed to initiate PrEP at all.

Excluding pregnant women could have a real impact on how programs are perceived—and how well they meet their goal of reaching people who need PrEP most. It’s already becoming an issue. Robyn Eakle (WRHI), presented initial data from a PrEP demonstration project in South Africa known as TAPS, noted that pregnancy was one of the main reason that HIV-negative women were excluded from joining the project. Women who became pregnant during the study could remain and choose whether to continue PrEP.

The Ugandan study shows very low to no drug in breastfeeding infants—which should provide additional reassurance to program implementers considering whether pregnant women should receive PrEP. There is a separate and equally urgent need to ensure that contraceptives are available to all women who want them, so that every pregnancy is wanted and planned. In other arenas, PEPFAR head Ambassador Debbi Birx has spoken about exploring co-packaging of PrEP and oral birth control pills as one way to get this “dual protection”—and a satellite session on Monday and Tuesday discussion in the Advocates’ Corner brought more on these multipurpose prevention technologies (MPTs).

Discussions got downright fiery on Tuesday when it came to the report, from Dr. Howard Grossman of the Cleveland Clinic that a man using oral PrEP had acquired HIV in spite of high adherence to his regimen. He acquired a multi-drug resistant strain of HIV that is resistant to TDF/FTC (and to other drugs)—and it may be that PrEP doesn’t protect against resistant strains. There’s a lot of research showing that drug resistant viruses are less likely to be transmitted than “wild-type” HIV—perhaps because the mutations that confer drug resistance also make it harder for the virus to establish new infections—but as these data show, it can still happen.

Do instances of people acquiring HIV mean PrEP is a no-go? Not at all. Anyone seeking eloquent expression of the complexities of communicating about, advocating for and using less-than-perfect prevention must read JD Davids’ piece, Two People Got HIV Despite PrEP—and Millions Get HIV Without It, at thebody.com.

Meanwhile, other PrEP data were a reminder that viruses aren’t the only ones that are resistant. Humans are too. Sarah Calabrese (George Washington University) presented on a significant barrier to PrEP uptake in some settings: providers.

Calabrese surveyed medical students in an effort to understand how patient risk behavior and motives may affect clinical judgement, and the results were sobering—willingness to prescribe PrEP was directly at odds with actual risk levels. When hypothetical patients were characterized as regular condom users, 90 percent of providers were willing to prescribe PrEP, but if patients indicated that they planned to discontinue condom use, willingness to prescribe dropped to 25 percent. Furthermore, providers were more comfortable with condom discontinuation in the context of patients seeking to conceive. Only a quarter found it acceptable to discontinue condom use in the service of greater intimacy.

Perhaps the only good news from these findings is a reminder that engaging providers is important everywhere—in the US, sub-Saharan Africa, Europe—everywhere that PrEP is being proposed, providers need to be part of the conversations about what it really means to PrEP4Love.

Providers wanting a real-time experience of this conversation should run, not walk, over to the Advocates’ Corner where Tuesday afternoon’s discussion was a terrific example of how global health really does include us all. In a discussion on women’s prevention, advocates, providers and programmers talked about what PrEP and female condom access—and lack thereof—looks like in their settings.

One Kenyan participant noted that she was surprised to hear about PrEP access issues here in the US, saying, “You were supposed to be a demonstration to us about how to do this.” In response, an American participant noted how African advocates had led the way by talking about PrEP even before it became available—and even as it rolls out slowly today.

A new report, PrEP Access in Europe, from the PrEP in Europe Initiative (PIEI) is another great reminder of how PrEP issues are truly global. The report tells the stories of people taking prevention into their own hands as they begin to seek ways to secure PrEP even though access is highly limited in a region with the fastest-growing HIV epidemic. The report calls on key stakeholders to take specific action.

Did some of the discussions have a little friction? Of course. That’s what happens when people get close to issues (or each other) in ways that matter. Be sure to check out our blog or watch the AN for a deeper dive into some of the issues coming up around discussions of the vaginal microbiome (the environment of healthy and not-so-helpful bacteria that live in our genital tracts). It’s a conversation that started in Durban, continued today—and that will be expanded even more in an upcoming webinar—stay tuned for details!

And for those on-site, be sure to add some Advocates’ Corner sessions to your conference itinerary. The full schedule of Advocates’ Corner is available here, and Wednesday’s sessions include:

  • 10:00am – 10:30am: Stories that Matter: Storytelling and Advocacy
  • 12:00pm – 1:00pm: HIV prevention for women and the dapivirine ring: Next steps for access and advocacy
  • 2:30pm – 3:00pm: Digital Media Strategies and Partnerships to Furthering Prevention Knowledge and Policies
  • 3:00pm – 3:30pm: Say It: Undetectable = Untransmittable
  • 5:00pm – 6:00pm: Let’s Talk about Sex, Baby: Desire in the context of HIV prevention
  • 6:00pm – 7:00pm: Launch for the SHARE.LEARN.SHAPE Survey

For the latest from the conference follow in real-time on Twitter and check out meeting coverage on aidsmap. And don’t just take our word for it, the Global HIV Vaccine Enterprise daily rapporteur summaries provide report backs from multiple viewpoints including a report from Morenike Ukpong from NHVMAS and others on yesterday’s sessions and opening. The conference organizers are archiving recordings of all sessions. Visit here to see the webcasts as they become available.

Not To Be Missed: New report on funding for prevention research

The span of a decade—that interval that’s neither too long nor too short to bring innovation—is one that’s often used in the HIV prevention research space, usually to convey optimism. Back in 1997, then President Bill Clinton called for a national commitment to develop an AIDS vaccine within ten years. Just this week, Bill Gates said, “With the right leadership and investments over the next decade, we can discover and deliver a vaccine for HIV.”

The success of these forward-looking claims has always depended on sustained funding. Note, in both cases, the emphasis on commitment and leadership. No one is promising a vaccine with anything less. A look back at the last ten years provides a warning on this front. Released today, the Resource Tracking for HIV prevention R&D Working Group’s latest annual report on global investment into biomedical HIV prevention reports that overall funding for HIV prevention research and development (R&D) has remained essentially flat for over a decade.

Close followers of the annual “RT” report take note—a preliminary version was released at AIDS 2016 in Durban in July. The final version contains slightly updated data and the same overall messages: with a slight fall from US$1.25 billion in 2014 to US$1.20 billion in 2015, overall funding for HIV prevention research and development (R&D) has been more or less level for the past ten years.

And what a decade it’s been! Consider the developments in PrEP, the pipeline of injectable ARVs for prevention and treatment, the continued advance of the ARV-containing vaginal dapivirine ring, and the insights and advances that have come from sustained scientific inquiry related to the search for an HIV vaccine. These are exciting times. And the fact that all of this happened in the context of flat funding for research doesn’t mean that flat funding will get us where we need to go next. As Tom Hope, PhD (Northwestern University) stressed at an opening plenary of the HIV R4P conference where the report was launched, the fact that funding is declining concurrent with new discoveries is a major challenge for the field.

The report notes that preventive vaccine research funding constituted the bulk of all investments, followed by investments in microbicides, TasP, PMTCT, PrEP, VMMC and female condoms. With the exception of vaccines and female condoms, every other HIV prevention option tracked by the working group experienced a decline. These trends are somewhat reflective of the cyclical nature of large-scale clinical trials—when trials end, funding drops off. Likewise, as some interventions enter full scale rollout, like VMMC and TasP, research in this arena can be expected to slow down. Nevertheless, the overall trends bear close watching and strong advocacy to ensure that research continues.

The right products need to be tested in the populations who need them most. The report is also a powerful reminder that this isn’t necessarily how research works. It provides information on the demographic breakdown of almost 900,000 participants in ongoing HIV prevention trials in 2015, with the majority of these volunteers residing in sub-Saharan Africa, most notably Uganda, Kenya, and South Africa. Only one in eight trial participants in 2015 belonged to a population most affected by HIV, including MSM and transgender women, injection drug users, and cisgender women.

These sobering facts come in the context of a vigorous period in research and development. It’s a time of growing recognition from the global community that research has to be part of the long-term fight to end the HIV epidemic. Taking stock of all that’s been accomplished with ten years of flat funding, now is the time to support continued progress with additional, well-targeted resources.

The Resource Tracking Working Group hopes that this tool provides strong facts for advocacy and supports efforts to assess public policy and its role in accelerating scientific progress. We thank all of the individuals who contributed data to the report and who gave time and effort as trial participants.

Check out the report, share it with your fellow advocates, and be sure to let us know if your organization is either a funder or recipient of HIV prevention grants or if you have further questions or information about resource tracking at all!

Desperate Times Call for Desperate Measures: DIY PrEP in Europe

Did you know there were more new diagnoses of HIV in Europe in 2014 than at any point since the 1980s? In fact, Europe is home to the fastest growing HIV epidemic on earth. Faced with this fact, many people are taking prevention into their own hands as they begin to seek ways to secure PrEP even though access is highly limited in the region. In a new report by the PrEP in Europe Initiative we tell these stories.

Oral PrEP using TDF/FTC, known to be almost 100 percent effective at preventing HIV infection when taken as prescribed, was recently approved by the European Commission. This allows for the ARV combination of tenofovir and emtricitibine to be marketed as HIV prevention across the European Union.

Yet outside of France, where PrEP is available through the national health system at no charge, it is not available to anyone in a European health system unless they pay full price for the medication and find a doctor willing to write a prescription for it. Costs can reach several hundred euros per month. It has been available in the US through public and private health insurance plans for over four years now.

Gay men and other MSM in Europe are aware of the unacceptably high numbers of new diagnoses in their communities. These rates tell us that condoms alone are simply insufficient to protect all those at risk all of the time. The analogy with birth control is worth considering: women do not solely rely on male condom use to prevent pregnancy. Gay men, and other people at high-risk are therefore desperate to get their hands on the new blue pill, trademarked by the company Gilead as Truvada.

In “PrEP Access in Europe” by the PrEP in Europe Initiative, we set out the ways in which people across the European region are securing PrEP outside of traditional health systems and often outside of medical supervision. These include sharing pills among friends, smuggling pills into Europe from abroad, ordering generic versions on-line, and buying them on the black market. Emergency HIV prevention regimens for the ‘morning after’, formally known as PEP, contain Truvada and are therefore also being mined for the blue pills, with the rest thrown in the bin.

These DIY (Do it Yourself) approaches are worrying to physicians and PrEP advocates alike. One concern is that some people may be taking PrEP without a confirmed HIV-negative test result. Being sure you are HIV-negative when starting PrEP, and going for regular HIV tests are key to safe, successful PrEP use. TDF/FTC can also have side effects, both minor and, in rare instances, severe that can only be dealt with in the context of a health setting—so home-based PrEP might be a risky manoeuvre. Lastly, inadequate dosing or irregular drug supplies are not suitable when it comes to PrEP, just as they aren’t suitable for ART. For example, popping only one pill at the weekend, or a few pills here and there, won’t provide protection.

The Report shows that, in the absence of government and health authority action, DIY PrEP is the outcome. The fault does not lie with people who are seeking to take control of their HIV prevention options but with the national authorities that have failed to act.

The report calls on European governments and health authorities to take immediate action to make PrEP available to populations at imminent risk of HIV as a matter of urgency. Read the full report here.

Rebekah Webb is an HIV advocate and policy analyst with over 20 years of experience. She is a founding member of the PrEP in Europe initiative, currently sits on the Prevention Portfolio Steering Committee of the European AIDS Treatment Group, and is a partner in the management of AVAC’s European ROAR advocacy program.

Baseball, Guts and Glory: R4P kicks off in Chicago

Happy Monday and welcome to the first of AVAC’s updates from and about HIVR4P, the biennial conference on all things biomedical prevention. As conference goers are already discovering, this gathering of advocates, researchers, clinicians, journalists and more is taking place in a city—Chicago—that’s gripped with baseball fever. The Chicago Cubs are in the midst of playoffs for the World Series. Looking for a conversation starter with a native Chicagoan? Try “How about them Cubs?” Looking for a guide to on what may spark conference fever—read on!

It takes guts! Unpacking the latest news in “cure” research
R4P features a plenary talk by Dr. Anthony Fauci, head of the US National Institutes of Allergy and Infectious Diseases, on a recently published paper that is the latest spark of hope in the field of cure research. This speech could trigger more US and European coverage of a story that has already gotten a fair amount of coverage in the past week. And it could help spread the buzz to sub-Saharan Africa and beyond, given the strong presence of international journalists at the conference. Here’s a quick walk through what people at R4P are likely to hear about these new data and what it might mean for advocates.

What’s the news?
The paper, published by a team out of Emory, reported on intriguing results from an experiment exploring HIV remission (also known as virologic suppression) in monkeys. The results have been explained fully and very clearly in this aidsmap article and by veteran science writer Jon Cohen. Very briefly, the study design involved infecting monkeys with the simian form of HIV (SIV). All of the monkeys were subsequently put on antiretroviral treatment (ART) which controlled their virus. Some monkeys were also dosed with a simian version of an antibody, known as vedolizumab. In human form, this antibody helps treat inflammatory conditions of the gut, such as Crohn’s disease and ulcerative colitis. Others monkeys received a placebo. All the monkeys stopped ART after 90 days. The antibody group stopped the additional treatment after 23 weeks.

Eight of the 11 monkeys in the antibody group sustained virologic control, showed evidence of immune system replenishment, and remained off treatment for almost two years. In other words, they were able to keep SIV replication below the limits of detection—and saw the recovery of immune cells in the gut tissue that had been attacked by HIV. ART alone can control the virus but does not lead to immune reconstitution in the gut—one of the regions of the body where HIV first establishes infection. This type of virologic control means that the virus is likely still present in the body but at levels under the limit of detection (50 copies/mL).

What does it mean?
Monkeys aren’t humans and SIV isn’t HIV. This is a mantra of HIV research and it bears repeating in this case. What’s seen in non-human primates doesn’t necessarily predict what will happen in humans. However, this is the first time this kind of result has been seen in non-human primates—so that’s an exciting development. It is an animal model “proof-of-concept” that gives researchers something to build on. One area for exploration is understanding why the regimen had the beneficial effects that it did. This involves unpacking the immune responses observed in the animals.

One important finding: some of the monkeys had brief peaks of detectable virus before their immune systems were back up to speed, called a viral “blip”. This is a critical piece of information for clinical trial design. Protocols involving treatment interruption will have to determine how quickly to put a participant back on treatment if a rebound occurs. It is also unclear what, if any, role early treatment played in the eight monkeys’ remission. Early treatment has been shown to reduce the overall size of an HIV reservoir, the collection of non-replicating cells that harbor HIV in the body.

As noteworthy as the results might be, it’s important to remember that the Mississippi Child was in remission for 28 months before viral rebound occurred. The questions raised by these new findings have implications beyond cure as well. Understanding why these study results can also help in the search for an effective HIV vaccine. Since the drug involved in this experiment is already in use in humans for other conditions follow-up can happen fairly quickly. And it is: a small study is underway in people living with HIV.

Advocates should be cautiously optimistic about results and ready with the facts. Remission implies the virus and can return, and a public eager to see HIV solved need to understand there’s a long road ahead.

To learn more about HIV cure research visit CUREiculum, TAG media monitor and the research database.

Stay tuned for additional coverage of the latest from the conference and follow in real-time on Twitter. And each day we will preview the sessions planned for the Advocates’ Corner, a dynamic space to exchange ideas, build solidarity, network, relax and socialize. The full schedule is available here, and tomorrow’s sessions include:

  • 10:00 – 10:30: Innovative prevention for women’s health: The promise of MPTs
  • 12:00 – 1:00: HPTN 083: Long-Acting Injectable PrEP HIV Prevention Trial for Transgender Women and Cisgender MSM in 8 Countries
  • 2:30 – 3:30: Moving Women’s Prevention out of the Siloes: A Discussion of Advocacy for PrEP and Female Condoms
  • 5:00 – 6:00: Launch of the PrEP in Europe report

Stay tuned for more tomorrow!

Preparing for HIVR4P

This week marks the start of the HIV Research for Prevention Conference (HIVR4P), the biennial meeting focused on biomedical HIV prevention research, and AVAC.org/HIVR4P is your one-stop shop for the latest on the data presented, hallway chatter and more!

At the end of each day you can expect a daily round-up of what we’ve seen and heard at the conference—which we’ll blast out on the Advocates’ Network list. For more real-time coverage check out our Twitter feed, which will be active throughout the week.

For those of you traveling to Chicago, we hope you’ll join AVAC and partners at a range of sessions (more on these satellites below) as well as the Advocates’ Corner. The Advocates’ Corner (located on the lobby level of the Sheraton between ChiBar and The Fountainview) will be open throughout the conference. In addition to the materials displays and opportunities for informal networking, the Advocates’ Corner will play host to a program of activities scheduled during breaks in the conference program. Click here for the full schedule.

Check out the entire R4P program online here and for those of you tracking from home, webcasts of the conference sessions will be available on the conference site the following day.

Satellites of Interest

MONDAY

Advocates’ Pre-Conference: Strengthening Advocacy for Research to Rollout
This pre-conference workshop will feature seasoned advocates and researchers from the HIV prevention research field who will provide new and experienced advocates, community representatives and trial staff with latest updates and previews on topics to be presented at the conference. Click here to register.
Monday, October 17, 8:30-15:00
Location: Superior

Engagement from All Angles: Advocates, Sponsors and Implementers Discuss GPP in Action
This satellite session will provide an update on global GPP implementation and an interactive discussion around roles and responsibilities of various research entities and advocacy groups. Case studies will be presented and a sponsor perspective will explore the benefit of an institutional approach to GPP.
Monday, October 17, 9:00-11:00
Location: Sheraton Ballroom II

Designing Prevention Clinical Trials in the Era of Highly Effective Combination Prevention
This session aims to gather perspectives from clinical investigators, statisticians, ethicists and community stakeholders on designing efficient and ethical trials for the pipeline of prevention agents.
Monday, October 17 13:30-15:30
Location: Chicago Ballroom IX

FRIDAY

Strengthening Community Advocacy and Solidarity for HIV Vaccine Research
Since 2014, the Vaccine Advocacy Resource Group has convened virtually to receive research updates, discuss advocates’ perspectives and priorities, and to move forward key actions. This satellite session aims to build the capacity of community advocates at R4P around HIV Prevention Research Advocacy, particularly how it relates to vaccine research.
Friday, October 21 9:00-12:00
Location: Sheraton Ballroom II

Implementing HIV/AIDS Combination Interventions Tailored to Populations and Geographies at Scale

The Kenya HIV Prevention Revolution Roadmap provides a framework for the future orientation of the national HIV prevention response. This session will share data, experiences and lessons in implementing the framework.
Friday, October 21 9:00-11:00
Location: Chicago Ballroom IX

Sex, Intimacy and HIV Prevention: What do women and their partners really want? Incorporating end-user input and developing a market launch strategy for PrEP
What do women really desire from an HIV prevention product? How can the HIV prevention field provide the optimal environment for women to adopt and adhere to these technologies? Team members from MPii Projects EMOTION, OPTIONS and POWER will provide an overview of each project and discuss how research and stakeholder engagement will be woven into an integrated launch plan for optimal results in PrEP introduction.
Friday, October 21 9:00-12:00
Location: Chicago Ballroom VIII