US National HIV/AIDS Strategy Gets A Reboot

Kevin Fisher is an AVAC staff member.

When the Obama administration released first US National HIV/AIDS Strategy (NHAS) in 2010 it was an overdue step forward and the product of years of advocacy. How could the US—with the eighth highest number of people living with HIV (PLWA)—have no strategy for getting more PLWA into care and reducing infections and health disparities?

Now on the fifth anniversary of the first NHAS, under the leadership of the Office of National AIDS Policy (ONAP), the NHAS is getting a reboot. The updated NHAS has renewed the focus on those most affected by HIV: gay and bisexual men of all races, but especially black men, heterosexual black women and men, young people, people who inject drugs and transgender women. There will be prioritization on places, like the southern US—where nationally 50 percent of new infections now occur—and key metropolitan areas. It takes responsibility for improving viral suppression and access to care in the US treatment cascade, which now lags behind many European, and some African countries. While not explicitly linked to the UNAIDS 90-90-90 goal, this new US strategy does align with the global focus on improving diagnosis, linkage to care and viral suppression. And, happily, this strategy puts the treatment cascade into the more comprehensive needs of primary prevention and addressing stigma and discrimination.

Even if the overall goals of the original NHAS—reducing infections, improving outcomes, eliminating disparities and a coordinated response—remain the same in the revised version, much has changed since 2010. In 2010 the iPrEx trial results first showed that pre-exposure prophylaxis (PrEP) is an effective HIV prevention option. In 2011 the HPTN 052 trial showed treatment and viral suppression can reduce risk of transmitting the virus and just recently, in 2015, data from both 052 and START showed that early treatment improves health outcomes for people living with HIV. The revised NHAS embraces these scientific advances adding new goals to improve the US treatment cascade, and making full access to PrEP services a cornerstone of the strategy. The full-throated endorsement of PrEP is welcome, needed, and will hopefully have impact.

The NHAS also importantly acknowledges the essential role of research in providing new tools and methods of achieving the goals of the strategy. The NHAS is unabashedly positive about research, with particular emphasis on research priorities for PrEP and innovative approaches to preventing new infections, importantly strengthening the case that now is not the time to scale back.

The updated strategy does make an important change from its predecessor, which raises some concern. The revised NHAS abandons incidence in favor of HIV diagnosis as a measure of the impact of prevention. ONAP believes it does not have the data to measure incidence, particularly in the context of increased testing. Do the data reflect higher rates of infection, or are more people being tested? This makes methodological sense but raises the question of how the impact of specific prevention interventions, or combination prevention, can be measured and assessed. The HIV field needs a tool to measure incidence to judge impact.

There will be more detail of the revised NHAS to come. A federal action plan for the revised NHAS is expected on Dec 1, 2015 and will operationalize the strategy. Now is the time for advocates and civil society to weigh in with ONAP on how these goals might be achieved in communities across the US.

Have a question about NHAS? Join the conversation on social media via #HIV2020 or Tweet your questions to @AIDSgov.

Visit aids.gov for more and download one-page infographics on “what you need to know” regarding the updated NHAS and one that outlines the five major changes since 2010.

A Pill That Prevents HIV

Micheal Ighodaro is an AVAC staff member.

Over the past few months I have spent a lot of time talking to LGBT people about PrEP. I have been at meetings that were specifically focused on HIV and meetings where HIV was a very, very small part of the agenda. And while it’s clear that PrEP is needed for LGBT people, it’s also clear that we have a lot of work to do.

Many members of the LGBT community are still struggling with the idea of PrEP, and many do not know about it or how it works. For example, I was at a conference this past June that brought together LGBT and sex worker activists from east Africa and around the continent. HIV was a very small part of the conference agenda. In fact, AVAC, amfAR and IAVI hosted the only HIV-related panel in the conference. I spoke about this new pill that prevents HIV. To some, this was a totally new concept, but to others PrEP sounded good. Others asked whether it would take away ARVs from people living with HIV who still can’t always access them?

But before I answered the questions, one of the panelists who was openly living with HIV as a gay man in Africa—a very brave individual—stood up and said that if there was a pill that could help prevent other members of his community from having to go through the same experience he has had to face as a gay man living with HIV in Africa, he wanted to make sure every member of his community knew about this pill and advocated for it.

But all these concerns are very valid. When the WHO’s recommendation for PrEP as a prevention option for gay men and other men who have sex with men came out in 2014, many LGBT activists around the world had mixed reactions. Some didn’t know very much about PrEP and didn’t pay much attention. For others the recommendation singling out MSM just proved the point that the LGBT community is viewed by many stakeholders primarily as the “carriers of HIV.” To get away from this perception, many LGBT Africans I know don’t want to work on HIV at all anymore. And so they weren’t excited when the WHO recommended this new pill just for gay men.

Now that the WHO seems likely to issue broader recommendations for all people at substantial risk, there is a chance that access efforts will focus on other populations.

Last week when I was in Thailand for several meetings with transgender groups, a very close friend of mine who is transgender asked me, “Why can’t people just use condoms? Why do we have to take this pill?” My answer was short and quick, “Condoms are great but not everyone can use them all the time, just like not everyone will use PrEP all the time. PrEP is just an added HIV prevention option.”

In contrast to my sense of the how gay men in Africa are viewing PrEP, which based on recent conversations is with some skepticism, the question for most gay men I met in Thailand was whether or not to start taking PrEP. Dialogues are happening in Thailand that are moving beyond whether this strategy is a good idea or whether it is stigmatizing a specific community. The Thai LGBT community is talking about this medication and what it can do for them and that should continue, not just in Thailand but in Africa and Europe.

Traversing the AIDS Vaccine Terrain in Vancouver

Amid the excitement in Vancouver over the START and PrEP results, conference-goers did hear several specific updates on progress in HIV vaccines. Here are a few highlights advocates seeking to track the vaccine field should check out.

One great place to start is with the slides from a presentation on delivered by Dr. Anthony Fauci, head of the US National Institute of Allergy and Infectious Diseases. The slide set, with Dr. Fauci’s instantly-recognizable font size and simple layout, has some familiar images from previous presentations—including the always-useful depiction of the HIV prevention continuum—but also provides crystal-clear explanations of the “empirical/intuitive” and “rational” pathways of vaccine development focused on producing antibodies against the virus. In the former category is the RV144-like regimen moving ahead in trials in southern Africa. In the latter are broadly neutralizing antibodies being studied in passive immunization and preclinical work. A commentary in Science published just after the conference by Dr. Facui and Dr. Hilary Marston provides additional perspective and depth to the discussion. 

RV144 was the name of the 16,000 person trial that took place in Thailand and found evidence of modest protection in data released in 2009. Just before Vancouver got underway, the research team involved with the trial published new data on why this protection might have occurred. Every person has a distinct genetic make-up that affects how our immune systems function. In analyzing volunteers’ HLA gentoypes (these contain the “instructions” for proteins that help regulate the immune system), the investigators identified specific genetic signatures associated with vaccine efficacy. This type of research can help scientists figure out how to make vaccines work even more effectively in the future.

The rational pathways also got attention at a Wednesday session, “Advances in B-cells and Antibodies,”” including an update from Joseph Jardine of Scripps Research Institute, on upstream work aimed at increasing the potency of the VRC-01 broadly neutralizing antibody. VRC-01 is a purified form of a potent antibody isolated from an individual living with HIV; it is in Phase I trials in adults and, as described at a cure satellite symposium, a safety and pharmacokinetic trial in infants is now enrolling.

Vaccine science is heady stuff and presentations of the hill-and-valley contours of antibodies can seem very far from the rural and urban landscapes where people live, work, encounter HIV and perhaps enroll in trials. A presentation on hypothetical willingness to participate in vaccine trials from the Perinatal HIV Research Unit in Soweto, South Africa, focused on that terrain. Pointing out the urgent need for HIV prevention strategies in 15-24 year olds, particularly young women, the research team asked people in this age group whether they would enroll in a trial. About half would, saying altruism would motivate them. About a quarter said that they wouldn’t, because they were worried about “becoming ill.”

Bridging the gap between landscapes of molecules and townships has always been the work of AIDS vaccine research. This bridging was highlighted by Glenda Gray, president of the South African Medical Research Council, in her Wednesday plenary on Advancing HIV Vaccines into Efficacy Studies—and though it was a quiet year, we can clearly expect more updates in Durban 2016 as the South African trials continue and basic science also proceeds.

Snapshot from IAS 2015

Several members of the AVAC team attended the meeting of the International AIDS Society in Vancouver which just completed. Along the way we presented our “take” on key conference events.

We invite you to learn more about:

In addition we held a post conference webinar, IAS 2015: What was presented and what it means on the road to Durban 2016. Slides, audio and a Flash presentation are available.

How Would Bob Say It?

Emily Bass is an AVAC staff member.

The first AIDS conference I attended was the 1999 Conference on Retroviruses and Opportunistic Infections. This annual meeting happens in the northern hemisphere’s winter time, and this particular gathering was in Chicago. It was cold on many levels. Chunks of ice floated in the river that ran between the hotel and the conference center. There was no consensus that AIDS drugs should be made available to poor people in developing countries. The scientists, activists (and hyphenate scientist-activist-journalist types that AIDS work breeds) all seemed fluent in a language I didn’t speak and was just beginning to understand.

The colleague who I’d traveled with said that activists met daily to discuss what they had learned and so at the end of the first day I hovered by an indoor water feature and waited. Slowly people began to arrive—there were men and women, nurses and educators and writers. And we sat down and everyone went around and said what they had seen that was most interesting about the day. There was tremendous warmth in that circle. Commitment, wisdom, frustration and, as I recall, a man with a beautiful smile. That circle is where I met Bob Munk for the first time.

Bob, who passed away earlier this month, has been on my mind as I have watched the events from IAS 2015 in Vancouver unfold. I have thought about him because he was a familiar, friendly face that I saw at AIDS conferences, and because so much of the road that lies ahead depends on the work that Bob, who founded and wrote for AIDS InfoNet, did better than anyone I have ever known.

The final day of the Vancouver meeting, July 22, the international NGO Medecins Sans Frontieres (Doctors without Borders) released a statement that the successful global HIV response will depend on a much greater emphasis on adherence. Adherence is just one of the many words that has crept from public health jargon into widespread use within the community of people living with and working on HIV. But even though it has crossed over, it hasn’t lost its scientific veneer.

Bob Munk’s genius lay, in part, in his ability to explain the most complicated terms in simple language. His black-and-white fact sheets, all designed to be read by someone who hadn’t completed secondary education, were and are unequaled in their accuracy and accessibility. There has not been a year in the two decades that I have done this work that I haven’t suggested that a colleague “see how Bob would say it” or contact him for advice on how to word something. The day that he got in touch with AVAC in recent years to look at the AIDS InfoNet PrEP fact sheet draft, was the day that I realized this intervention would “take off” in the US and around the world.

Adherence is critical, so is saying what that actually is: sticking to the plan. And going forward, it’s not just adherence by people living with HIV or people at risk who receive PrEP—it’s also adherence by the global leaders who promise so much at these meetings and hear so much and present so much of what might be possible, if only action is taken.

Sticking to the plan is only possible if you understand why you’re doing what you’re doing. For a whole generation of AIDS writers and activists and treatment educators, Bob Munk set the gold standard for this understanding. With so much work to be done, we’ll miss him dearly and carry on, as clearly as we can, in his name.

AVAC sends wishes for peace and ease to Bob’s family, friends and husband.

High-altitude PrEP: The birds-eye view of discussions and data in Vancouver

It speaks volumes about the, well, volumes of PrEP data emerging from the International AIDS Society meeting in Vancouver that we can’t even try to summarize all the findings here in P-Values. Excellent round-ups can be found on the NAM website and you can access some of the PrEP sessions online. In this post, we offer up a birds-eye view of what is known and what is anticipated in the coming weeks and months.

Guidelines are … coming!

On July 17, the Friday before the conference opened, UNAIDS released two new documents: a “Q and A” document on oral PrEP, and WHO/UNAIDS released a background paper, developed jointly with AVAC, titled “Oral Pre-exposure Prophylaxis: Putting a new choice in context”.

What context, you ask? Well, there’s the rub… at least for now. In the cover note from UNAIDS and in the actual text of the latter document, reference is made to a forthcoming recommendation from WHO on PrEP. This guidance is, “likely to be significantly broader than previously and creates real opportunities for moving forward with implementing PrEP as part of comprehensive HIV programmes.”

Exactly what the recommendation will be, and when in 2015 it will be released, remains to be seen (although at the meeting, WHO leadership has alluded to an expedited process—mentioning a September release in one public session). But the “PrEP in context” document spells out the scope: PrEP works for men and women when it’s taken correctly. It’s an important option for people at risk of HIV. It’s safe, needed and should be introduced in close collaboration with civil society and communities in need and at risk. In the absence of the actual recommendation, there may be little action—but this preview could and should catalyze action to be ready for when the recommendation comes as well as for action that can happen in the meantime.

The picture is getting clearer

Guidelines don’t turn into programs over night. And it’s important to anticipate the questions—many already being asked—that will only become more urgent when there is an official recommendation on PrEP. The conference provided some concrete info to consider and feedback to various partners on how PrEP is working in the real(-ish) world of open-label access and demonstration projects. Here are some key takeaways from sessions that can be found by the abstract numbers here:

PrEP is a needed, additional option. An unofficial (aka from a seat in the session) analysis of the baseline characteristics gay men and other men who have sex with men who participated in PrEP studies shows that the vast majority reported condomless anal sex at the time of trial enrollment. Some of these trials had prior condomless sex as an entry criteria, and self-reporting of sex acts can be unreliable. But with these caveats, it’s still useful to note where PrEP trial participants were, in terms of ability to negotiate condom use with every sex act, when they began research.

One concern some have raised is that PrEP is going to cause people to abandon condoms, and these data are a reminder that suggest that PrEP needs to be there for is going to be sought out by people who are already not able to use condoms all the time. The information shared by these participants bears out the argument that PrEP is an additional, needed option.

PrEP is feasible—with support. Data from the US PrEP demonstration (Demo) project in San Francisco presented by Albert Liu (San Francisco Department of Public Health) show that those gay men and other MSM at highest risk based on reported behaviors were able to adhere to PrEP regimens sufficiently well to achieve protective levels. Adherence happens in an environment—family, community, country—and the parameters of this environment need to be taken into account as PrEP rolls out. Sybil Hosek (Stroger Hospital of Cook County and ATN) also called for “more in-depth understanding of the historical, societal, behavioral, and attitudinal barriers to PrEP access and adherence among those most impacted in the US—young black MSM.” Dr. Liu also noted that participants in the Demo Project received a financial incentive (USD$25 per study visit). Retention was good in this trial, but the role of incentives need to be interrogated—see our blog here for more on this issue.

People can figure out whether they need PrEP. Beatriz Grinsztejn (Fundação Oswaldo Cruz (Fiocruz)) reported on a Brazilian demonstration project that is the first in a middle-income country in a trial-naïve population (i.e., not post-trial access.) Among gay men and other men who have sex with men, and transgender women offered PrEP, roughly half opted to use the strategy. Uptake was higher among those who self-referred (as opposed to learning about PrEP during an HIV testing visit). These data reinforce that people in some contexts can recognize risk and be interested in PrEP. Is 50 percent uptake success—e.g., people are assessing what will work for them? Or will patterns of uptake change over time? That’s exactly the kind of question that further investigation as PrEP rolls out.

PrEP works in women and men AND women and men are not the same. As we discussed in a blog on Tuesday, there have been various statements at the conference that PrEP doesn’t work as well in women. These need to be tempered and nuanced. No prevention strategy works all the time for every individual and sometimes this is related to biology, other times to culture, context and society. A poster presentation on barriers and facilitators to PrEP use from the ADAPT open-label study of PrEP in young women in South Africa, provides a fascinating, multi-faceted look at how many parameters affected participants’ choices. These sorts of investigations are crucial to introducing PrEP in ways that do work for both men and women. On the biological plausibility front, data reported from the Botswana TDF2 open-label extension trial in men and women found high levels of protection in both sexes—though the numbers were small. As Gus Cairns explains in a terrific post on PrEP for vaginal versus rectal exposure, there are areas for further investigation and a need for careful messaging. But when PrEP is taken by women in many settings, these women are protected. Let’s remember, and act, on that.

#bearsrepeating: New media at Vancouver focuses on familiar, essential concerns

The AVAC Twitter feed has been alight over the last several days as the team tries to capture, in 140 characters, some of the key findings and messages coming out of IAS 2015. A quick search of #IAS2015 shows the range of topics covered over days of concurrent sessions running morning to night. A lot has been covered but if one were to—albeit unscientifically—distill key take-homes based on retweets, favorited tweets and Twitter’s “top tweets” some perhaps unusual suspects rise to the top.

AVAC’s second-most-popular tweet of the week wasn’t on the exciting data from START, the final results of HPTN 052 or the announcement that a young woman remains “in remission” after 11 years. In fact, it was a tweet on the qualitative data presented from the ADAPT study. It noted a simple finding on a complex issue: the need for interventions to reduce HIV-related stigma to help ensure PrEP success.

Looking beyond the AVAC Twitterverse, among the top tweets when searching the #IAS2015 hashtag is one from UN Women linking out to data on barriers some women still face when trying to initiate and stay on treatment (and AVAC covered in an earlier IAS blog post).

Both of these “findings” could easily be filed under “non-shock of the week,” to borrow a phrase from the indomitable activist and writer Kenyon Farrow—but what is shocking in fact is that the statements still need to be made. (Looking for reasons why—consider elsewhere in social media, AIDS activists on Facebook fulminating about an all-male panel on HIV testing and the 90-90-90 goals, in a thread that included the suggestion: if you’re a man invited to be on an all male panel—decline.”)

The reason these tweets garner attention is because there’s a lot of talk, perhaps even lip service, and far too little action when it comes to reducing stigma, truly engaging people who are living with or at risk of HIV or violence or discrimination in programs that will meaningfully change their lives. It’s not that biomedical solutions can be set aside but they can’t work without action on these other fronts. #oldnews #bearsrepeating.

Fortunately, AIDS remains a place for activists who don’t give up—even if it means re-stating what ought to be operating principles. One source, at this meeting, is the Canadian Declaration by Persons Living with HIV, outlines how the goals of the Vancouver Consensus “will only be achieved through a comprehensive, community-driven, global response that respects the human rights of people living with HIV and communities affected by HIV”.

For more fresh ways to restate this imperative, check out Wednesday’s plenary presentation by Michel Kazatchkine (UN Special Envoy for HIV/AIDS in Eastern Europe and Central Asia), who reminded the audience of the harm of stigmatization and social marginalization experienced by some vulnerable populations in Russia, Eastern Europe and Central Asia—and the detrimental effect on access to services and health. Policies that criminalize—whether by official or unofficial policy—and drive people underground and away from care.

Follow the Money

AIDS is inextricably linked to inequitable distribution of resources—money, medications, legal protections, education and more. AIDS activism has long been dedicated to redistribution of all of the above in ways that would make the world a more just place. But does this extend to actually giving people money or other compensation (a gift card, food and so on to change their behavior or get circumcised or keep coming to their clinic visits?)

The answer isn’t exactly clear. For many activists and people on the frontlines, especially those who are well-versed in the potential coercive impact of financial compensation for trial participation, the idea of offering people money to change behavior is a finger in the dike or a band-aid on the problem of major inequities that need reform at the level of international trade, governance and accountability.

Nevertheless, the issue bears exploration and yesterday’s presentations at IAS 2015 added information that will undoubtedly fuel discussions and programming going forward.

NAM provided an excellent summary of data on cash compensation for men coming for VMMC and for women living with HIV attending antenatal services and, in a different write up, a summary of data presented on the use of cash transfers for young women to remain in school (in a study called HPTN 068) and for young men and women conditional on life skills training, educational attainment and HIV testing (a study called CAPRISA 007).

The very brief summary of these findings is that cash offers improved uptake of VMMC and clinic attendance for women in antenatal care, but that it didn’t reduce HIV incidence among young women who received the contributions to stay in school—compared to their age-matched counterparts who were also in school but didn’t receive cash bonuses. The CAPRISA 007 study found a reduction in HSV-2 incidence associated with individuals who received cash, but did not find an impact on HIV incidence.

These are not the first studies to investigate the use of such structural interventions on reducing HIV incidence—Julia Kim and colleagues are one of many teams that did groundbreaking work on this topic over a decade ago in rural South Africa (summaries of some work by Kim and others can be found here and here.) And as Helen Rees has eloquently stated in her discussion of the full spectrum of strategies needed for an effective AIDS response, structural strategies such as girls’ education, economic empowerment for women and effective programming to reduce gender-based violence are essential, whether or not they turn up a statistically significant result in a randomized trial.

But these newest data come at a time when cash transfers are getting increasing attention from global leadership seeking to define the package of interventions needed to “end AIDS.” And for this reason, it’s important to track the findings carefully as they may inform what gets rolled out or called for in the near future.

Most specifically, it’s quite possible that cash transfers will turn up in an expanded set of Fast Track goals from UNAIDS. Regular readers of AVAC materials over the past six-plus months are well aware that we’ve been calling on UNAIDS to release comprehensive targets for prevention and non-discrimination, and that we’ve also been urging that these targets—which are available in draft/unofficial form—are defined in ways that match the intervention. So, for example, VMMC lends itself to numerical and coverage targets—a certain number of men reached by a specific deadline. Newer strategies like PrEP need targets that reflect how much still needs to be learned about delivery for maximum impact. That’s even more true for cash transfers for young women—an intervention that has turned up in official UNAIDS documents since World AIDS Day, and that has been included—based on data from World Bank-funded research—in the modeling that underpins the 90-90-90 goals.

As we stated in AVAC Report 2014/15, the term “cash transfers for young women” isn’t nearly specific enough to be operationalized. All sorts of variables are in play—from the amount of money, to the conditions for receiving it, to the recipient—whether communities or individuals. And we’ve clearly stated that defining these variables needs to be part of any target-setting for such an intervention (e.g., the target would be having a clear definition of the intervention, based on evidence, by a specified deadline).

With the new data, and with work we’ve done over the recent months related to both VMMC and women’s access to ART, we want to add a few more questions to this discussion.

  • Could—or should—cash transfers “for” young women include cash transfers uptake of VMMC?
    VMMC programs face funding shortfalls in some places and, in others, are looking for ways to reach men who did not take up the strategy during early, successful roll-out. VMMC is a one-off strategy that reduces individual risk and population level incidence. As Audrey Pettifor, one of the investigators who led the cash transfer study in South African young women observed, it’s important to think about the terms of “conditional” cash transfers. VMMC may be suited to this type of offer, since it is a single procedure. Conditional transfers tied to ongoing behavior change could be less successful, she suggested. This doesn’t mean that conditional transfers can’t work for women, but achieving saturation coverage of VMMC will reduce women’s incidence, along with men’s. In early versions of at least one PEPFAR Country Operational Plan, money from the DREAMS initiative for reducing incidence in adolescents and young women was earmarked for VMMC. With scant resources for adolescent women and young girls, no one wants to see resources earmarked for women going to young men. But the data on VMMC, including the cash transfer study, are a reminder that both men and women need to be involved and reached to impact women’s risk of HIV.

  • What is the need for additional research/interventions that focus on pregnant women from third trimester through immediate post-partum—versus those that encompass many stages of the lifecycle?
    A study in the Democratic Republic of Congo found that incrementally increasing cash transfers (starting at USD$5 and adding one dollar at subsequent intervals) significantly increased pregnant women’s attendance at clinic visits from roughly 32 weeks pregnant through six weeks post partum. As Option B-plus programs grow, there is also an expanding body of evidence of when and how women are lost to follow up and, arguably, any intervention that improves retention should be considered. But the question should be raised by review committees funding trials, advocates asked to consult on protocols, and agenda-setters at every level working on women’s sexual and reproductive health: given all that is known about the complexities of reaching and keeping women in care, should research continue to have a narrow focus on third trimester and early antenatal periods?

  • Education reduces HIV incidence. What are UNAIDS, PEPFAR, WHO, GFATM and national governments going to do about it?
    In the South African study that didn’t find a link between cash transfers and HIV risk, there was a clear link between staying in school and staying HIV negative. This echoes trends detected in Botswana, Zambia and other countries—where additional years of education are protective in terms of reducing young women’s incidence. The structures that need to be in place to support a functioning free and/or accessible secondary education system are quite different from those that need to be in place to deliver cash transfers to selected adolescents and young women. The global and national stakeholders don’t need to forgo cash transfers for large-scale structural work on education for girls—but they ought not imagine that the former will do away with need for the latter.

Finally, on the subject of money, one of the most striking images from activist actions at this conference came from a gathering of women living with HIV, holding handmade signs. Jessica Whitbread, an artist, activist and organizer with ICW Global made a lace-trimmed, hand-lettered blanket that reads: “I am glad my AIDS is paying for your mortgage.” AVAC is part of the professional world that now defines much of the response. We work to remind ourselves, our partners and our funders of the very high bar of accountability for all of the resources available in the global fight. And when it comes to eloquence about following the money—this is exactly the kind of reminder that we need.

Science, Solutions and Questions at Vancouver IAS Conference

“Science has delivered solutions. The question is: When will we put it into practice?”

So says the last line of the Vancouver Consensus Statement, a stirring call for expanding access to antiretrovirals for treatment and prevention as part of a comprehensive response to AIDS. AVAC signed the statement, released at the start of this year’s conference of the International AIDS Society. So did virtually every notable scientist and physician in the field. And we firmly believe in the contents of the statement.

Over Sunday and Monday pre-conference satellite sessions and in the official program, we heard a lot of science. On Monday, there were presentations of data from HPTN 052 and START—two complementary trials of ART in people living with HIV. There were also data from the ADAPT and IPERGAY PrEP trials and a press conference looking ahead to news from later this week.

For all of this, the Vancouver Consensus Statement is the backdrop—as is the news, released by UNAIDS just prior to the launch of the conference, that the global total of people initiated on ART has exceeded 15 million, and that incidence has begun to drop in some places.

Overall, it is a very good time to be on the side of scientific solutions to the HIV pandemic. And that’s where AVAC stands. But listening closely at the conference and in recent months, we’d offer this additional formulation of the consensus statement’s closing line: “Science has delivered the questions. The solution is: Not shying away from the answers.”

One of the primary solutions that science has delivered is the use of antiretroviral therapy for people living with HIV, both for their own health and to reduce the risk of onward transmission. In a special presentation on Monday (The Strategic Timing of Anti-Retroviral Treatment (START) Study: Results and Their Implications (Monday 20 July, 11:00-12:30), Jens Lundgren (University of Copenhagen) presented data from the START trial, which showed significant benefits for people living with HIV who started ART regardless of CD4 cell count, versus those who started treatment as indicated by the guidelines where they lived. As described in May, when data from the study were first reported, immediate initiation more than halved the risk of serious adverse events, serious non-AIDS events, or deaths.

This is the first major meeting since the START data started making waves (between START and PrEP, this may be the most pun-able conference to date), reaffirming global campaigns to expand ART coverage and to make ART the cornerstone of efforts to end AIDS.

If START has a twin, it is HPTN 052, which also saw data presented on Monday. Mike Cohen (UNC and HIV Prevention Trials Network) delivered the complete findings from HPTN 052, which first reported interim results in 2011 (View slides and abstract via the Conference Programme, session MOAC01: TasP: Just Do It. Monday 20 July, 11:00–12:30)

In that preliminary report, immediate initiation of ART (in this trial, at CD4 cell counts above 350) dramatically reduced the chances that an individual would pass HIV to his or her primary partner.

In the data Cohen presented here, the initial finding holds true. Over the course of the trial, there were eight “linked” transmission events (where the virus acquired matched that of the partner enrolled in the study) in couples where the HIV-positive partner had initiatied ART. Where transmission did occur, it usually happened in the context of incomplete virologic suppression—either a person had started ART too recently to be completely suppressed or because of adherence challenges.

The bottom line: virologic suppression makes HIV transmission between individuals where one person is living with HIV and the other is not highly unlikely. The treatment that has a prevention benefit is also good for the individual—so on every count, the science appears to have provided the solution.

And yet. The real world is a decidedly unscientific place.

In HPTN 052, there were 26 unlinked transmission events, where a person with a known HIV-positive partner acquired HIV from outside the primary partnership followed in the study. So having one partner who is virologically suppressed isn’t protective for an HIV-negative person who, for a variety of reasons, may have other partners and/or other sources of risk, such as injection drug use.

This reality is one of the many places where science and social, cultural and personal realities demand multiple solutions. The number of unlinked cases of HIV is a reminder that people exist in complex realities, with multiple partners and various behaviors.

Another powerful reminder of this context came at a pre-conference satellite on the global status of women’s access to ART. That session presented preliminary findings from an ongoing investigation commissioned by UN Women and carried out in collaboration with the ATHENA Network, Salamander Trust and AVAC. Combining a participatory methodology in which women living with HIV defined, delivered and assessed questions about health care experiences and an in-depth literature review, the work to date shows that women are being reached by ART but that the rights-based framework that allows them to remain on ART after initiation is, in many instances, lacking.

What to do with these data?

One answer does lies in science. Earlier this year, at the Conference on Retroviruses and Opportunistic Infections, the investigators of the Partners Demonstration Project presented the results of their combination PrEP and treatment study in which the HIV-negative member of a serodiscordant couples was offered PrEP as a “bridge to ART” for the person living with HIV. Right now, the data say that PrEP reduces risk of HIV acquisition regardless of who your partner is or how many partners you have (for more on PrEP, see below). And it turned out that, over the course of the study, very few new cases of HIV occurred. For 48 percent of the time, couples were using PrEP alone. PrEP and ART overlapped during 27% of the time, ART was used alone 16% of the time, and neither was used 9% of the time.

WHO did not formally publish their new ARV guidelines at this meeting. However, Gottfried Hirnschall, who directs WHO’s HIV department, did say that additional formal guidance on both PrEP and ART would be released by the end of the year. It is even possible that “rapid advice” could be available sooner—perhaps even in a matter of weeks. Hirnschall anticipated that these new ARV guidelines would recommend the offer of treatment for all adults and adolescents regardless of CD4 count as well as PrEP being offered as an additional prevention choice for people at substantial risk of HIV infection.

As Ambassador Debbi Birx, head of the US PEPFAR program stated in her Monday morning plenary, “Don’t wait for the paper” from WHO or other agencies. “Act on the science and evidence now.”

Acting on science is, as Ambassador Birx and other speakers have noted, just part of the solution. Success depends on non-scientific solutions that are, in some cases, getting lip-service but struggling for real traction today. Women in the global survey described above consistently reported the benefit of peer-delivered treatment literacy, non-stigmatizing sexual and reproductive health care, and rights-based care for all women, including those who aren’t pregnant when they enter the health system.

The science, if we really listen, says something slightly different. It says that ART for people living with HIV and PrEP for people who are at risk, and peer-delivered treatment literacy, and rights-based health care environments for women, men, young people and all key populations can begin to end the epidemic—if and only if other strategies are scaled up at the same time.

PrEP Talk: Promising, Perplexing
Monday was also a big day for PrEP data (slides can be downloaded from the session MOAC03 from the online conference programme), with data from the ADAPT trial that evaluated various dosing strategies, including once-daily, fixed intermittent dosing and event-driven dosing. The study enrolled South African women and gay men and transwomen in Thailand and the US. Overall, people were able to take PrEP, reported principal investigator Bob Grant. Individuals who were counseled to take the drug on a daily basis had a higher coverage of sex acts than those who were advised to use a non-daily strategy. For this group, the missed dose was usually post-sex—a finding that echoes reports from women who participated in the FACTS 001 trial of 1% tenofovir gel, which also tested a coitally-related dosing schedule. In both ADAPT and FACTS 001 cases, the dose after sex proved difficult—participants weren’t at home and/or weren’t in the emotional or physical space where they felt they could swallow a pill or insert a gel.

The good news from ADAPT is that PrEP continues to be feasible and acceptable in a variety of settings and demographics—bolstering the call for this strategy to be rolled out as an additional prevention option for all individuals at high risk.

Of concern and for careful tracking by advocates, is messages coming from the podium that PrEP may not work as well for women as it does for men whose primary risk is via anal sex. It is clear that women need to take daily oral PrEP for longer periods of time before they have protective levels in their vaginal tissue. It is also clear that adhering to a daily oral regimen may be difficult for some women, just as it is for some men. But what’s happened over the past few days with casual references from NIAID Director Tony Fauci and other leading scientists is a sowing of confusion that appears to contradict the US FDA recommendation and data from the Partners PrEP and TDF2 trials that found comparable protection for men and women.

Sometimes science raises questions, and we’re all for these questions coming to light. But it’s essential that the language be clear and that the way to certainty be mapped out. Right now, the discussion feels more risky than scientific—at a time when science is supposed to reign.

Living Below Detection: Another case of HIV remission

Jessica Handibode is an AVAC staff member.

Whenever I see or deliver a presentation about the state of HIV cure research one of the most interesting topics is how the field is defining what it means to be cured of HIV infection. Many researchers and community groups have pushed for the term “remission” to be used since there are no scientifically proven tests to determine whether an individual’s HIV will return. Recent cases of HIV “cures”—as they were reported in the media—like the two men from Boston and the Mississippi Child, have all ended in viral rebound. This further strengthens the case for the use of the term remission.

At the IAS 2015 conference on Monday, Dr. Asier Sáez-Cirión, of the Pasteur Institute in Paris, the same researcher working with the VISCONTI Cohort, introduced the world to an eighteen-year-old HIV-positive female living without treatment for over 11 years. This young woman offers a proof-of-concept for long-term control of HIV without treatment and pushes how the field might define remission of HIV.

What are the facts?
This young woman was born to a woman living with HIV who did not have viral control. Shortly after birth, the young woman was put on antiretroviral therapy and confirmed to be HIV-positive four weeks later. The mother reports that her daughter had challenges taking medication consistently during the first seven years of her life and that she stopped ART altogether twice.

During both treatment interruptions she experienced viral rebounds 75,190 copies/mL of blood & 97,000 copies/ mL of blood respectively. After both viral rebounds, she started treatment again and achieved virologic suppression. When the girl was about six years old, she stopped treatment and doctors’ visits. In research parlance, she was “lost to follow-up”. When the young woman returned to care a year later, she had an undetectable viral load. Since then, this young woman, who is now 18 years old, has remained undetectable without treatment except for two viral blips. Viral blips, or viremia, are periods where the number of viral copies rises above the limit of detection (40 viral copies/mL of blood). The first viral blip occurred at 11 years (509 copies/mL of blood) and the second at 14 years (48 copies/mL of blood). However she hasn’t been cured. In lab tests, HIV can be isolated and grown from cells from her blood.

What does this all mean?
Well, first it means that this young woman can control her virus without treatment, but her virus has not been eradicated. Since researchers can stimulate her cells to start producing virus in the lab, it is possible that she could experience another rebound. This is also supported by the two viral blips she experienced at 11 and 14 years old. In spite of this, she is capable of long-term virologic control—without ART.

Is she in remission or is she just controlling her virus?
She’s doing both! Long term post-treatment control has become a new area of discussion as cases like the VISCONTI cohort and this young woman are introduced to the field. The VISCONTI cohort, a group of French post-treatment controllers, were all treated early (within the first six months of infection) and were on suppressive treatment for a median time of three years before stopping treatment. The individuals in this cohort have been able to maintain control at very low or undetectable levels for about nine years off treatment. Post-treatment controllers differ from rare natural controllers known as “elite controllers” and “long-term non-progressors”. Both elite controllers and long-term non-progressors have protective immune responses that allow these individuals to control HIV without treatment. These individuals also have greater immune and inflammatory responses than HIV-positive individuals on ART. Remission, like cure, is a term with a specific emotional resonance. It is often thought about as the period of time where the disease is absent but could return. Both terms are fairly commonly used in the cancer field where, for instance, you are considered “in remission” for a certain number of years before you are “cancer-free”.

But there are so few cases of either remission or cure in HIV that it is very difficult to say when and how they should be used—or how to define them. With an individual like this young woman, it’s not possible to predict—because there are no comparators for her experience—when, if ever, she might have a rebound of HIV. She has been undetectable longer than the Berlin Patient has been cured, yet the presence of virus in her body means that she doesn’t meet the criteria for being cured. With so much uncertain science, the language sometimes fails us. But regardless of whether you describe this young woman as being in remission or a post-treatment controller, her experience pushes the science of HIV cure research forward and offers new hope for the future.