This table shows which MPTs are further along in testing for both sustained-release and on-demand products. Women will have different needs and preferences throughout their lives. An array of different types of products is key to meeting the varying needs of different women. Excerpted from the MPTs factsheet.
MPT Products in the Pipeline: Selected highlights
What Should the Next US President Do? Advice for Hillary and Donald.
On behalf of IFARA, thebodypro.com recently posted two videos. In the first, Jim Pickett, director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago, spoke with Robert Grant, MD, MPH, Mike Cohen, MD, Ian McGowan, MD, PhD, FRCP, and Mitchell Warren about HIV prevention research presented at this year’s Conference on Retroviruses and Opportunistic Infections (CROI).
New prevention tools, such as a safe and effective vaginal ring and the prospect of long-acting injectable agents are exciting news, panelists agreed. However, these tools are only as good as their implementation — as is the case with already approved methods, such as oral pre-exposure prophylaxis (PrEP). This includes finding and effectively treating people living with HIV, because those with an undetectable viral load do not transmit the virus.
Panelists would advise the next US President to invest in long-term research, including the search for a vaccine, cure, fund open-label studies of the vaginal ring, and provide treatment and prevention services to as many people as possible — especially women and men of color.
Watch the video on thebodypro.com.
In the second video, AVAC Policy Director Kevin Fisher spoke with Steven Wakefield and Ntando Yola about the development of a vaccine for HIV.
Wakefield called antibody-mediated prevention “the next holy grail.” Trials of broadly neutralizing antibodies that are infused every two months will start enrollment across the globe by mid-year, he said. However, a potential vaccine is just one component in a set of HIV prevention methods. Yola described HIV prevention as “a track field where products are racing each other.” Communities pin their hopes on each new prevention modality, but the focus needs to be moved from specific methods to overall prevention science, he believes. To that end, the science behind vaccine research needs to be explained in a way that people in the community can understand.
This video is also available at thebodypro.com.
Introducing PrEP Facts: Women’s Sexuality and HIV Prevention
Faith Landsman works for the CFAR Research Facilitation Core at the UCLA HIV Research Study Volunteer Project.
If women in the US want to start PrEP right now, most often they have to ask for it directly. The question is, how do women get PrEP if we don’t know that a pill to help prevent HIV even exists? While Planned Parenthood is rolling out PrEP services throughout the US, healthcare providers rarely offer PrEP to women, and even then often only if women disclose that their partner is HIV-positive. In a study published in the journal Contraception, (2016 May;93(5):463-9) researchers found that among family planning providers surveyed, most have limited knowledge about HIV PrEP and HIV testing, and report lack of provider training as the main barrier to PrEP provision.
In the Facebook group “PrEP Facts: Rethinking HIV Prevention”, founded by Damon Jacobs in 2013, its over 14,000 members have been promoting PrEP education and advocacy worldwide. Members advocate for one another with under-informed physicians, insurance companies, health departments and in interpersonal relationships. However, the membership is overwhelmingly men who have sex with men. “PrEP Facts: Women’s Sexuality and HIV Prevention”, a spin-off of the original PrEP Facts group, intends to do the same for women looking to take control of their sexuality and health. We want to empower women to be able to say, “I’m taking control over my risk for HIV infection.”
Join the conversation at www.facebook.com/groups/PrEP4Women!
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 avac@avac.org 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.