Not If, But When: Gay men gather in Jo-burg to plot PrEP access

It’s been 12 years since I first encountered the notion of PrEP, which was at the AIDS 2004 conference in Bangkok. Before activists trashed Gilead’s booth for alleged trial misconduct, I sat in a session listening to then-Family Health International (now FHI 360) describe its trial designed to see if daily oral tenofovir could prevent HIV in sex workers in Cambodia. I was intrigued by the idea but later on, after several of the PrEP trials were shut down in a swarm of controversy, I lost both hope and track of the trajectory of PrEP. Fast forward over a decade later and PrEP is poised to become a success story. This is why last week’s meeting of mostly gay African men devising advocacy plans for PrEP access felt long overdue, but also perfectly timed.

First of all, the meeting, which was spearheaded by a coalition of out, proud, gay African men from AMSHeR, AVAC, Desmond Tutu HIV Foundation and MSMGF, among others, fell right in the wake of the musician Prince’s death. The gender-bending legend broke all rules about what black men should be and took ownership of his own path. Likewise, the PrEP meeting of over 80 participants made history as the largest gathering of gay and MSM African men to demand PrEP for HIV prevention as part and parcel to achieving social justice.

Keletso Makofane (MSMGF and Anova Health) summarized the importance of PrEP when he opened the meeting by stating, “PrEP is overdue but supposed to be delivered by the very systems that are failing us.” He went on to explain that PrEP is necessary for gay men on the continent “because of its efficacy and prevention power and because of the excitement of having sex in a way we haven’t for 30 years.” He also asserted that PrEP could be used as a catalyst to improve HIV care and health services in general. This set the tone for the remainder of the meeting which mapped out how to bring PrEP to scale for gay and MSM communities in Africa.

It’s difficult to capture all that was shared in the three-day meeting but below are some recurring themes.

One of the agreed-upon tactics was to ally with other “key populations”—those over-burdened and underserved communities—so that the push for PrEP for gay men is embedded within the demand for PrEP for all those at substantial risk. This would help avoid gay “exceptionalism” of which there are already reported rumblings.

Convincing national governments that PrEP for MSM would not be an added burden to already strapped health systems is key. To get around this, participants discussed the need for innovative service models that minimize impact on doctors, perhaps through nurse-led PrEP implementation, community-based delivery and self-testing. There’s also a need to tap existing providers such as STI clinics and reproductive health units. Activists at the meeting also discussed that another key way to convince governments of PrEP’s worth and desirability is through costing studies looking at models of test and start along with PrEP.

Jim Pickett (IRMA), the formidable gay prevention activist with folk hero status, entertained participants with snapshots of PrEP promotions from around the globe. The audience was riveted by his hometown Chicago’s prep4love campaign, with pretty yet provocative pics of queer couples. But afterwards, some delegates were disheartened, saying they could not run such gay-forward campaigns in their countries. Not yet, at any rate.

Members from each of the 14 countries represented at the meeting caucused and drafted advocacy plans to jumpstart the post-meeting national coalition work. A WHO rep in attendance promised she’d take these national priorities directly to the WHO representatives of each country to be shared with their health ministers.

The meeting closed on an inspirational note. We now have a roadmap for PrEP as an entry point to bring real change, leading human rights activist and former AVAC Fellow Gift Trapence noted. Or, as another dearly beloved leader put it, “I got a lion in my pocket and baby he’s ready to roar.”

New Film Series Captures Activists United by Urgency for HIV Prevention in Europe

In January 2016, the European AIDS Treatment Group (EATG) and AVAC jointly convened the Second European HIV Prevention Summit in Brussels. This unique meeting brought pharmaceutical companies, public health experts, academics and leading scientists in the field of prevention research together with over 50 European community-based advocates for three days of information exchange and debate.

Participants discussed the latest scientific and policy developments in the field of HIV prevention and formulated demands for researchers, medicine manufacturers and decision makers. The community urged concerted action and clear financial and political commitment to achieve effective prevention of HIV/AIDS in Europe. Specifically, the Summit called for the accelerated approval and rollout of PrEP in countries across the region, following France’s recent example as the first and only in Europe to officially implement and fund PrEP programs for men and women at substantial risk of HIV. The meeting also concluded with a call for the continuation of research for HIV vaccines, and rectal and vaginal microbicides, along with better systems for tracking the epidemic, including where new cases occur and where and how access is happening.

The packed agenda of the European HIV Prevention Summit included detailed reports on and discussions about groups of people at highest risk of HIV across Europe, including gay men, trans people, sex workers, people who inject drugs, migrants and the African diaspora. Timely information from completed, on-going and planned PrEP implementation studies was presented along with new civil society initiatives to provide PrEP and other prevention tools to those who need it. For a rare moment, stakeholders involved in the field of HIV prevention could gather in a space to exchange scientifically sound and politically meaningful ideas about way of slowing down the HIV epidemic in Europe.

In order to make the meeting accessible to those who were unable to attend in person, EATG and AVAC commissioned a three-part video series designed to give an overview of the main topics of the meeting: PrEP, Testing & Treatment, and the Future of HIV Prevention. The first of these films, focusing on PrEP, is now available here. The meeting report is also available for download.

Px Wire April-June 2016, Vol. 9, No. 2

Px Wire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. This issue is an advocate’s guide to the past, present and future of the dapivirine ring for HIV prevention. Featuring a timeline of key milestones that could lead to licensure, a simple comprehensive Q & A, and a closer look at where sub-Saharan African women will have access to daily oral PrEP and/or the Ring via open-label extension studies.

Patchwork of Prevention for Women: Oral PrEP and the Dapivirine Ring

Participants in the ring efficacy studies will get extended access to the ring via open-label studies. But will they have access to PrEP? This map shows which sites will provide PrEP and which will not. Excerpted from Px Wire.

Dapivirine Ring—Past, Present and Future

AVAC’s new issue of Px Wire is an advocate’s guide to the past, present and future of the dapivirine ring for HIV prevention. It features a timeline of key milestones that could lead to licensure, a simple comprehensive Q & A, and a closer look at where sub-Saharan African women will have access to daily oral PrEP and/or the Ring via open-label extension studies. We hope this resource will be used to spark discussion and guide plans for further engagement.

Click to download the new issue of Px Wire.

The full issue of Px Wire, as well as our archive of old issues and information on ordering print copies, can be found at www.avac.org/pxwire.

Introducing Implementation and Access Resources on PrEP Watch

Daily oral PrEP is moving from an idea to an offering in more countries and communities every day. And in the places where it isn’t being offered, demand is growing!

To help advocates track implementation on the ground in detail, AVAC has developed a new section of PrEP Watch (a clearinghouse of information on PrEP science, research, cost, access and advocacy) focused specifically on implementation efforts underway.

On the Implementation Initiatives page, you can find information about some of the different initiatives funding PrEP implementation in sub-Saharan Africa, including the USAID-supported OPTIONS Consortium and the PEPFAR DREAMS Initiative. Information about funder-defined initiatives can help advocates understand who’s who and what’s planned—and to follow the money!

You can also learn about the full spectrum of work happening at country level in Kenya, South Africa and Zimbabwe. As PrEP is rolled out in additional countries, more case studies will be added.

PrEP Watch will continue to grow as PrEP introduction and rollout moves forward and as new efforts and initiatives are started.

Reach us at [email protected] if you have comments or questions.

Antibody Research Advances to Prevention Efficacy Trial(s): An Advocates’ Perspective

This week the NIH-funded HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) announced the launch of the HVTN 704/HPTN 085 trial, also known as “AMP” (Antibody-Mediated Prevention). The Phase IIb trial is designed to measure the safety and effectiveness of an intravenous infusion of the broadly neutralizing antibody VRC01 for HIV prevention. The infusion will be delivered to participants every eight weeks over the course of a year and a half (participants are also followed for 20 weeks after their last infusion).

AMP consists of two parallel trials conducted collaboratively by the the HVTN and HPTN. The trial that just initiated (HVTN 704/HPTN 085) has 24 sites across Brazil, Peru and the US and plans to recruit 2,700 men and transgender people who have sex with men. The other study, HVTN 703/HPTN 081, will be initiated later this year and will enroll 1,500 women at 15 sites across Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania and Zimbabwe.

For the past several years, scientists have been working with potent antibodies that neutralize many different strains of HIV. These broadly neutralizing antibodies, or bNAbs, include VRC01. Antibodies are substances made by the immune system; these bNAbs have been isolated from people living with HIV. Researchers have purified the bNAbs and modified them to make them even more effective against HIV. The antibodies in trials like AMP are delivered via infusion—meaning intravenous administration. The approach of delivering an immune defense directly is called passive immunization, and it stands in contrast to vaccination or immunizations that teach the body how to mount an immune defense itself, via a vaccine. In the AMP trial study visits are expected to take approximately 90 minutes and participants are scheduled to come to the clinic every eight weeks.

Many scientists in the field say that the point of bNAb trials isn’t to identify a new strategy for widespread use. Instead, a positive result could lead to more focused vaccine development efforts. Other researchers say that more potent antibodies that could protect in smaller, more easily-administered doses, could perhaps make it to market one day. For this to happen, all agree that the dosage (the amount delivered to a person) would need to come down from where it is in the AMP trial, and the half-life (a measure of the time that protective levels of antibody stay in the blood) would need to go up.

The AMP trials will contribute significantly to the field’s understanding of how to fight HIV. AVAC and other advocates have urged that the trial sponsors and implementers ensure consistency in the messaging about and expectations for VRC01—especially given that other, more potent antibodies may be ready for additional testing by the time the AMP trials are over, alone or in combination. (This is a common conundrum in research: first-in-class products break new ground but may not be the optimal choices for introduction.)

Extensive and continuous stakeholder engagement is essential to ensure that passive immunization trials and product development plans are clearly articulated.

The AMP trials are among the first prevention efficacy trials to start in the “post-PrEP-approval” era, raising an issue that’s challenging prevention stakeholders everywhere: the need to define the standard of prevention in trials to include daily oral PrEP, which is now recommended by the WHO for all people at substantial risk of HIV. People who participate in efficacy trials are, by definition, at substantial risk of acquiring HIV and therefore there is an ethical imperative to include PrEP. The question is how—and how to design trials that can answer questions about new products, even as incidence may go down due to PrEP use.

The AMP trial that launched this week has this to say about its approach to PrEP:

“Volunteers in the AMP Studies will be referred to available local programs where they may obtain the oral medication Truvada [TDF/FTC] to take daily for HIV prevention, a highly effective practice called pre-exposure prophylaxis (PrEP). Volunteers’ access to PrEP will expand as more host countries approve Truvada for PrEP and develop the infrastructure to support its use.”

The prevention standard of care is defined as, “condoms and lubricant, counseling on how to reduce behaviors that increase risk for infection, and counseling and referral for antiretrovirals to take immediately following suspected exposure to HIV (post-exposure prophylaxis).”

ACT UP New York member and long-time activist Luis Santiago responded, “Should Truvada/PrEP be more than just an ‘option’? Should it be actually provided in the studies in the control arm? Are we back to the ethical discussion of the 1990s?”

These questions, which were a key part of the prevention advocacy agenda years ago, still apply today—how does the field ensure that trials are not responsive to context but help to shape it? There is precedent for this, as the HVTN ensured access to antiretroviral therapy for individuals who seroconverted in vaccine trials before ART was widely available in Africa, and subsequently ensured access to voluntary medical male circumcision (VMMC) in its vaccine trial in South Africa before there was national policy on that strategy.

The reality of HIV prevention programming is rapidly evolving. In just the past four months, three of the AMP trial host countries (Kenya, Peru, South Africa) joined the US in approved TDF/FTC for daily oral PrEP, joining the USA in this decision. This leaves six AMP countries that have not: Botswana, Brazil, Malawi, Mozambique, Tanzania and Zimbabwe. But approval doesn’t mean access, and these countries may or may not have programs set up to which AMP participants can be easily and effectively referred. In that case, it’s up to the trial site to sort out provision of this key service.

At the end of the day, everyone is after the same thing—access to new options that can prevent HIV today and in the future, whether that’s a pill in hand for a young woman at risk today or a vaccine or antibody for the generations to come.

Additional Information
John Mascola of the Vaccine Research Center (VRC) that isolated the VRC01 antibody recently presented on the use of antibodies for both prevention and treatment, which provides helpful background and context for these recent developments, Harnessing Antibodies for HIV Prevention and Treatment.

Additional study info can be found in AVAC’s prevention research and development database (PxRD) and at ampstudy.org.

Testing Integration of PrEP into Prevention Services for Sex Workers in Senegal

It’s been slow and somewhat piecemeal—but around sub-Saharan Africa, countries are beginning to explore PrEP using daily oral TDF/FTC for HIV prevention for women, gay men and other men who have sex with men and other vulnerable groups. In the first of a series of visits to PrEP programs in action or soon to be underway, AVAC’s Policy Director, Kevin Fisher, visited a program underway in Senegal. Here is his update.

In October 2015, I visited a PrEP demonstration project focused on female sex workers which began earlier in the year in four suburban communities ringing Dakar. One of my hosts, Daouda Gueye, from the site explained that Senegal has a nationwide prevalence below 1 percent, but approximately one in four sex workers in Dakar are women living with HIV.

Gueye, whose serves as a project manager, said that the demonstration project will provide PrEP to female sex workers recruited through Senegalese health department clinics and hospitals. The demonstration project was fully enrolled with 273 women by November 2015. In Senegal, the official policy is that all women who exchange sex for money have to register with the Institute d’Hygiene Sociale or other government-run designated clinics where they are issued a health card and required to visit for bi-monthly checkups for STIs and HIV testing. Registered sex workers are given free condoms and, if they are positive, antiretroviral therapy. This PrEP project will include both government registered and unregistered sex workers who do not receive services.

Registered sex workers have lower HIV incidence than unregistered sex workers, according to Gueye. If the program is successful, Senegal will consider integrating PrEP into its suite of prevention services for registered sex workers, if support can be found to fund the program, said Dr. Moussa Sarr, one of the principal investigators.

Across Africa, many programs piloting PrEP for women are reaching out to sex workers. Some, especially through the PEPFAR-funded DREAMS program, are also exploring delivery to adolescent girls and young women.

These programs are happening in dialogue with policy makers, advocates and, in some cases, potential users. UNAIDS released in 2014 recommendations on community-based PrEP services for sex workers developed in consultation with sex workers from India and South Africa in November 2013 in Johannesburg. Sex workers have begun to explore the potential benefits of PrEP for HIV prevention in the US, too. One issue that is consistently raised is how to ensure that individuals at high risk get access to needed services—without stigmatizing the intervention—leading it to be seen as something that is only used by certain types of people. There are also concerns among some sex workers about PrEP not destabilizing their use of other prevention tools, such as condom negotiation.

This certainly isn’t the intention of the WHO’s Recommendation On Oral Pre- Exposure Prophylaxis Of HIV Infection released in September 2015. This document addresses both when to start antiretroviral therapy as well as the offer of PrEP to those at substantial risk. The Guideline recognizes that some people at substantial risk may fall into the categories of “key populations” (like sex workers or men who have sex with men) but that others, like young married women, may not.

This is a promising move—as long as programs for all people, including those specifically marginalized and discriminated against due to who they have sex with, are rolled out. We don’t want a world without sex work-specific PrEP programs (designed with the community as full partners), but we also don’t want a world where these are the only PrEP programs around.

By including both registered and unregistered sex workers, after consultations with both, the Senegalese demonstration project will hopefully provide insights into how to reach women who have different identities or have made different choices about formally adopting the label of “sex worker.”

The challenge in implementing PrEP will be to find those at substantial risk without sweeping in all sex workers or MSM or IDUs. The PrEP study in Senegal may provide one path.

UK NHS Punts on PrEP: Advocates call for decision reversal and wide access to PrEP

Early yesterday, long-time activist and aidsmap.com editor Gus Cairns wrote a piece in Huffington Post UK, “Where is PrEP?” highlighting the UK National Health Service’s silence around PrEP. In the piece he recapped an 18-month process by which he and myriad stakeholders worked towards a UK plan for PrEP, the impact of which could be significant in a county that is home to one of the largest HIV epidemics in western Europe. He encouraged fellow Britons to join him in a letter-writing campaign to the CEO of NHS England—#whereisprep?

Just hours later, NHS England released a statement on PrEP. Advocates were disappointed to learn that a PrEP policy would not be included in the NHS’ June decision-making process as was originally expected. The NHS statement noted that it was “not responsible for commissioning HIV prevention services” [like PrEP] but that it would work with other stakeholders on making PrEP available, including providing up to £2m over two years. These funds are expected to support PrEP for around 500 gay men at “early-implementer test sites”.

HIV groups in the UK quickly condemned the announcement and pushed for clarity on whose role it is (NHS, local authorities) to ensure that PrEP is widely available to all who need it, not a few hundred gay men.

For more on advocacy and letter-writing efforts, please visit the following:

Move On Down the Road: The vaginal dapivirine ring will enter open-label extension trial

Over the weekend, the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), announced that it would move forward with an open-label extension (OLE) study of a vaginal ring for HIV prevention. This welcome development is the latest step in the journey of a unique, woman-controlled prevention option.

It’s been almost exactly three weeks since the world got its first look at data from the ASPIRE trial and The Ring Study, both of which found that a vaginal ring containing the antiretroviral dapivirine provided women in the trial with a modest level of protection against HIV. Both trials had similar results: among all women in the ASPIRE study, the ring reduced the risk of transmission by 27 percent; in the Ring Study, the overall reduction was 31 percent; and effectiveness varied by age—with higher levels of protection seen in older women, possibly because of more consistent use in this age group.

The trial data caused celebration and immediate conversation about what would happen next given that the trial showed both that the ring works and that there may be real challenges with adherence, particularly in younger women. These are the kinds of questions that open-label trials are meant to answer (for a description of the types of studies that follow efficacy results, click here). By definition, in an open-label extension (OLE) study, everyone knows that they are receiving the product, and they receive information learned from the previous clinical trials of the product. Women participants in the open-label extension study of ASPIRE, known as HOPE, will be told that the product reduces risk of HIV if it is used correctly and consistently—worn in the vagina for roughly a month at a time. This type of information may lead more women to use the product versus the trial, where they are told at every study visit that they may have received the placebo, and that there is no evidence that the experimental product provides protection.

NIAID reached its decision to move forward after last week’s consultation with a panel of outside experts that included physicians, scientists, advocates, ethicists and statisticians – including two AVAC Advocacy Fellows from Malawi and Zimbabwe.

NIAID announced that they will also fund additional studies to help answer additional questions that the OLE is not designed to answer. One of these is a study with adolescents and young women (ages 16-21) to look at safety, adherence and acceptability of the dapivirine ring and oral PrEP. This is an important development, and one that will help ensure that the world has the information it needs about the ring should it receive regulatory approval. This regulatory approval process, which is being pursued in tandem with the open-label extensions, involves preparation and submission of an extensive dossier of information on the product from the clinical trials. The International Partnership for Microbicides (IPM), the ring’s developer, is expected to submit for approval in about one year’s time.

Now that NIAID has agreed to fund HOPE, the extension of ASPIRE, it is essential that IPM’s donors similarly support the Ring Study’s proposed open-label extension, DREAM. AVAC and our advocacy partners will be working with urgency in the coming weeks to amplify demand for this study, as well as additional research needed to understand the potential role of the ring in women’s lives. At the same time, we continue to emphasize the urgent need to roll out daily oral PrEP as a tool that can be used right now to reduce risk for women and men and to maintain a robust prevention research pipeline of additional options that will, over time, provide a wider range of options from which women and men can choose.