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This transcript is from a CSIS event hosted on December 5, 2024. Watch the full video here.
Katherine E. Bliss: So as we look ahead to 2030 and the global goal of ending HIV as a public health threat by that point, it’s clear that preventing new infections has to be a key element of a sustainability strategy. Now, currently some 30 million of 40 million people estimated to be living with HIV worldwide are on antiretroviral treatment. And this is with the expectation that they will need to take antiretrovirals for the rest of their lives, potentially several decades, to suppress the virus, reduce the likelihood of transmission, and to lead healthy lives.
Now, ensuring people at risk of HIV have access to a variety of prevention options that they can use when needed can be a huge step forward in limiting the number of new infections and eventually reducing the need for people to be on lifelong treatment. How to make a variety of prevention options available, affordable, and acceptable to people who need them is the critical question.
Hello, and welcome to CSIS. My name is Katherine Bliss. I’m a senior fellow with the Global Health Policy Center here, and I direct our work on immunizations and health systems resilience. And it’s really a pleasure to have an opportunity today to moderate this conversation about HIV prevention options, including daily PrEP and long-acting PrEP methods, PrEP being pre-exposure prophylaxis, and what it will take to make sure people at high risk of HIV are able to affordably and equitably access highly effective products.
We have a fantastic lineup of speakers, including Ambassador John Nkengasong, U.S. global AIDS coordinator and senior bureau official for global health security and diplomacy at the U.S. Department of State; Jared Baeten, Senior Vice President for clinical development and virology therapeutic area head at Gilead Sciences; Alex Rinehart, joining us online, Senior Director and medical development lead for prevention at ViiV Healthcare; and Zonke Tembe, DREAMS Ambassador in Eswatini. And DREAMS, of course, is the public-private partnership for Determined, Resilient, Empowered, AIDS-free, Mentored and Safe, a partnership focused on adolescent girls and young women.
Now, for a little bit of background, oral daily PrEP was first approved by the U.S. Food and Drug Administration in 2012. The World Health Organization recommended it three years later. But it’s really just been in the last three years, since 2021-2022, that access to an update of daily oral PrEP has really scaled up, particularly in the low- and lower-middle-income countries where the HIV burden is the greatest. And there may be many reasons for this delay, from supplies and financing arrangements to planning gaps and, of course, challenges with how PrEP has been marketed or recommended for vulnerable populations. And daily PrEP, while it is highly effective, taking a daily pill for – to prevent an infection of having to return to clinics for regular monitoring may be challenging for people who are on the move or who don’t want to have to go to a clinic in the first place, who may be looking for something more discreet.
So now, with several long-acting options including the monthly vaginal ring, the bimonthly injectable cabotegravir, the new long-acting options working their way through research and development and regulatory approval such as lenacapavir, and others, it’s really important to consider what can be done to close the gap in access to newer products for people at highest risk.
Now, from June to October of this year, the CSIS Bipartisan Alliance for Global Health Security convened a working group with support from Gilead, and the focus was really on considering what steps may be helpful in working now – as products are coming online, as they move through regulatory approval, and as they really become available, what can be done to ensure accelerated access to new tools in the settings where they’re needed the most. In putting together a brief analysis, the working group assessed gaps in clinical, behavioral, and implementation science; country needs with respect to financing, regulatory approvals, and planning; and importantly, the critical role of community groups in raising awareness and driving demand about PrEP. We also looked at the opportunities that exist for organizations like – and programs like PEPFAR, The Global Fund, and national governments in collaboration with the private sector and civil society to really move the agenda forward. So we hope that the analysis, you know, may provide lessons not just for continued focus by PEPFAR and other organizations on PrEP, but also, you know, really looking ahead at some of the multipurpose tools such as combinations of PrEP and contraceptives or STI management, as well as other kinds of long-acting tools that may be relevant in terms of thinking about affordability, access, and acceptability over the longer period.
So to get our conversation started, I’m really pleased to turn to Ambassador John Nkengasong to offer some keynote remarks really helping to set the stage for how PEPFAR, which has historically in the last period really been the largest procurer and driver of purchases and delivery of PrEP in the countries where PEPFAR is working around the world, how does PEPFAR really see PrEP within the larger context not just of HIV prevention, but really the sustainability agenda? As you think about the work that you’ve done over the past few years and, you know, the challenges that lie ahead, what are – what are you really – what are the priority actions that you see over the next critical period?
Ambassador John Nkengasong: Thank you, Katherine, for the invitation to share these reflections this afternoon.
Let me start with this, that we’ve come a long way, and I’ll approach this from where PEPFAR sits. Look at 21 years ago where we were and see where we are today. So that is one.
Second thing I would really like to underscore is that we are dealing with a retrovirus, so we may not be able to use the word “eradicate” or “eliminate” like we did for smallpox. It’s a retrovirus. I remind myself about that every day. It’s a very basic concept, but I remind myself about that every day.
But, look, we have the tools that – I’ve called it combination tools. That is treatment and this, the new tools that are coming on the long – the long-acting injective one.
Our unique focus in the fight against HIV/AIDS has to be our ability to reduce the rates of new infections to a level that – (coughs) – excuse me – we can consider that we are controlling the virus. Not eradicating it, not eliminating it, but controlling the virus.
I say this because I always like to celebrate our progress. Many countries – over 10 countries have achieved and exceeded three 95 – 95 percent of people who are infected knowing their status, 95 percent on treatment, 95 percent receiving viral suppression. Even when you look at those countries that have exceeded that, what bothers me a lot is the rate of new infections – rate of new infections.
Just a couple of weeks ago, Dr. Bunnell and I were in Botswana to look at their data, congratulated them, but warned them. I said, look, you have 4,300 new infections.
Last week or two weeks ago, I was in Malawi. Same story. Look, a small country – relatively small country of 21 million people, 14,000 new infections mainly amongst adolescent – young people as a whole. So that’s not a winning formula. We cannot.
So, first of all, we have to put this long-acting injectable or prevention as part of the sustainability program. How do we sustain the gains we’ve achieved over the gains? That is to say, shrink the pool of people that will be requiring treatment between now and 2030 and beyond, and reduce the rate of new infections – what we commonly call close the top of that. I think that is where I would like to focus the second part of my reflection.
Now, if you look the UNAIDS incident projection, it tells you that last year we have about 1.3 million new infections. Yes, we are bending the curve, but the curve is not bending fast enough. We were supposed to be at this point projected to be having less than 500,000 cases of new infections. We are 1.3 million. So, again, making progress; we should avoid confusing that progress with success or declaring victory. We still have a lot of work to do. But we are very fortunate that we have some new tools there.
Now, the new tools that we have, we have been – we have been asking for these new tools from the private sector, the companies, to develop it. We have them now. What would be a tragedy, and a tragedy of unimaginable proportion, is to have these tools and get into the valley of death where we have the tools sitting on the shelf and we do not get that into the right population, the right population, that is. And one of those, in my view, very early on it should be young men who have sex with men, because that is – if you look at outside of Africa, that is where the rates of new infections are rising significantly. Philippines, I was there this year, and over the last 10 years or so the rate of new infections have increased by almost 400 percent, mainly amongst young MSM. It should be about discordant couples in countries – high-burden countries. It should be about young people, adolescent girls and young women and others that we really,
So the point I’m making is that we should be excited with these new tools, but be very clever in the way that we deliver the tools in a way that is very targeted, is driven by science and evidence, is driven by our ability to scale up rapidly – scale-up rapidly and scale-up consistently, because, again, there is a whole education that needs to occur and information that needs to occur around the availability of new tools. For example, this is not a vaccine. So if you get a young person, you make sure they know that if you go get your one shot preventable, we call it CAB-LA or lenacapavir, that is not a vaccine; that you have to be obedient, you have to come back every two months or every six months and do that. And we have to be determined that we are committing ourselves with the partner countries and donors and partners like PEPFAR, The Global Fund, Gates Foundation, that we will do this consistently for about five years. So, OK, that is where we begin to see that – a tipping point where we see the rates of the infections coming down to a level that you can control it.
I would love to see this in Botswana, where the next time I go in five years I look at their data, you’re seeing 500 new infections or less a year amongst young people because we’ve learned them or we’ve started to see them consistently for five years and you reduce that. At that point, you begin to see the pool of people that you are treating shrinking because people will live their normal lives and then, of course, they will all subsequently die naturally because of – but then you are not increasing that pool.
That is part of sustainability. Sustainability should not be seen only in the lens of financial, but it should be looked at in the lens of the political leadership of the countries that are beginning to be vulnerable to their own success. When you go to the countries, you don’t see the head of states talking about HIV as a priority, but they are aware of the danger that it created to them. So my message to them is that, please, let’s go back to elementary school and have primary prevention. Make sure that you talk to the young people. Use your voice. Your voice matters in this, I mean.
So the point that I’m making is that, yes, it’s about long-acting injectable or prophylaxis, but it’s also about primary prevention. It’s about biomedical prevention. But it’s also about treatment. Just, in sum, reducing the rate of new infections through treatment scale up, but also reducing the rate of new infections by the new tools that are becoming available will be critical.
Ms. Bliss: Thank you.
So, Jared Baeten, let me – let me turn to you. You know, the Ambassador has, you know, really reminded us the goal by this point was to get to 500,000 new infections or fewer in a given year, yet in the past year we saw more than a million. And you’ve been involved in PrEP both through the research of oral daily PrEP and then now the – more recently the work on lenacapavir as PrEP, you know, through the different purpose trials. What have you seen over this process, you know, really about the importance of making sure, you know, as products, you know, become available and as options are made available to have the production, financing, and regulatory, and planning issues really kind of considered from the outset? You know, what do we need to be thinking about, you know, in terms of advanced planning to make sure this can be a reality?
Jared Baeten: You’re exactly right. And thank you. I think earlier you introduced me as having done this for many, many years.
Ms. Bliss: Many, many. (Laughs.) Yes.
Mr. Baeten: And it’s – so I’ll say it back on myself. I think, for those of us – and I have done this for many, many years. I think I would reflect back on what PEPFAR has brought to the world, because I have practiced HIV care here in the United States in public hospitals and in – and in other settings, as well as in – as well as in East Africa, and I can remember very well when the coffin makers went out of business because there were fewer deaths because of the work that PEPFAR has done. And so that investment in reducing deaths first, now it needs to be translating into reducing new infections because we have come very far and we’re also far behind where we could be.
You know, now, I’m – I work on making new HIV medicines for treatment and for prevention. And we’ve been doing work this last year on an investigational medicine for HIV prevention that can be a lot – that’s delivered twice a year, that has the potential to provide a new prevention option to people. And all whatever scientific – all that scientific innovation has no benefit unless it actually translates into equity and access, and that’s something that is done in partnership and that’s something that’s done with planning.
To your question, the work to be able to think about long-term planning for access has to happen at the same moment as you’re thinking about the beginning of the science work that you’re doing. And that is, for our – for our programs, that has been engaging community and policymakers and scientists and governments in the planning of the trials that we’re doing so that the trials are – have been able to be as inclusive as possible; to be able to include adolescents and women who become pregnant through the – through pregnancy and breastfeeding, to be able to include populations from across multiple continents so that the work speaks across multiple places.
That’s also planning for access from the beginning. And that is – that is licensing to be able to – for example, for our investigational product, at the time we had a readout from the phase three trials we also announced voluntary licenses for generic manufacturers to make high-quality, low-cost generic products for places like where PEPFAR works and in 120 countries around the world. To be able to then facilitate those generic manufacturers to be able to make products sooner, because it’s the technology scale up to make something new, is not – is not a trivial process and needs support and partnership. And then to work with procurers and governments and other stakeholders to be able to make – to make both the case for ongoing HIV prevention and to be able to make the planning for it.
This is work that’s an ecosystem. And it is all of us playing our part together and really leaning in. I think, to the ambassador’s point, we have tremendous opportunity that we – that many of us who worked on HIV for a very long time don’t think we’ve had before to be able to think about really making a difference across all of the things that we do and all of the places that we work from to be able to turn off new infections, really, all around the world. And that is every piece of the work. That is science. That is equity. That is access. That is delivery. The work does not end with a P value or a – or a fancy publication. I like being a scientist and I’ve done this work for a long time for P values, but that’s not what actually gets – that’s not actually what gets impact to populations in this country or anywhere else. It is working all together in partnership, and planning, and leaning in, and going for the long haul because this is – this is work that can make a tremendous difference.
Ms. Bliss: Great. Well, thank you. So really, you know, taking that long, multiyear approach to planning for not just the research, but really the full implementation.
Alex Reinhart, let me – let me turn to you. Thank you for joining us today. So ViiV’s long-acting product, cabotegravir for PrEP, was introduced in 2022, if I’m not mistaken, and it’s now starting to be – it was available in some of the high-income countries and is now starting to be introduced more widely in the low- and lower-middle- and upper-middle-income countries. And I know there are – in addition to the approvals, there are a number of implementation studies going on. What lessons have been learned over the last couple of years with this – the long-acting injectable that you see helping to or that could be applied to accelerate availability and affordability?
Alex Reinhart: Yeah. Thank you. So thanks to the organizers, CSIS, for the opportunity to speak on behalf of ViiV, and apologies that I – that I can’t be there in person.
You know, we’re in the unique position now that we’re beginning to see long-acting cabotegravir move out into the wild, so to speak. Now we’re well past phase three. The open-label extensions are winding up, and we’re beginning to introduce cabotegravir now into implementation science projects. I think there are about nine of them going on globally right now, with a few in the U.S. and some in southern – in Eastern Africa as well as Latin America. And now we’re beginning to see programmatic rollout through PEPFAR and other donors as well.
I think, to build on the comment that Jared made about kind of the impact to populations, I think what we’re seeing now as data emerge from these projects I think is very, very encouraging and I think bodes well for the future for all long-acting products. And what we’re seeing is we’re seeing very, very high rates of persistence now with long-acting cabotegravir; 80 percent or higher, in some cases greater than 90 percent now people are returning for their injections. I think from a public health point of view, what’s maybe even more exciting now is we’re seeing the expansion of the populations that we’re reaching. People who had never used PrEP before are now coming in large numbers now to receive cabotegravir. This is evident now in the Search Sapphire project in Kenya and Uganda. We’ve seen it in Cape Town in South Africa. We’ve seen it here in the U.S. as well. These are all really positive markers, I think, now for the introduction of yet a new option in addition to daily oral therapy and the vaginal ring.
We’re seeing also, you know, we can’t underestimate the importance of the continued efficacy that we observed in phase three in the HPTN studies. We’re still seeing that very, very high level of efficacy maintained even in these implementation studies. It’s too early to determine for programmatic rollout that’s just really beginning, but I think the early returns are very, very positive.
And frankly, I think it’s important now that we have some real choice available for participants. As you mentioned earlier, 2012 was when daily oral TDF-FTC was available, and then there was quite a period of time where nothing else was available. And then the vaginal ring came, and now we’ve seen CAB, and probably lenacapavir is waiting in the wings. So now we have some real opportunities for choice for participants, that they can choose whatever works best for them at that moment of time in their lives to help prevent the acquisition of HIV.
Ms. Bliss: Great. Well, thank you very much.
And kind of building on your point about choice, I want to turn to Zonke Tembe, who’s joining us as DREAMS ambassador from Eswatini. And, Zonke, you work through your ambassadorship with young women – adolescents and young women, and really youth kind of across your country but also with the other ambassadors as well. Could you say a bit about the – you know, the way in which the groups that your peers who you’re engaging with are thinking about HIV prevention at this point, and the importance of choice and having options, you know, in the – in the consideration around prevention?
Ntombizonke Tembe: Thank you so much for the opportunity. And I would really like to also appreciate our previous speaker on raising the importance of choice. As young people, adolescent girls and young women, we appreciate all the commodities that have come into play. Thank you to PEPFAR funding, the Ambassador initiating the funding.
Maybe even looking back in Eswatini, we received oral PrEP, firstly, dating back in the year 2021. And we then received the ring recently. And then the CAB-LA, which is a long-acting injectable. We appreciate the variety of options because we do not have the same lifestyles.
We are also experiencing gender-based violence in our different spaces of life. Some supporters are not supportive when they are seeing that Zonke has the PrEP pills or the boxes. It has been quite an issue also with our parents who are not clearly knowledgeable in terms of understanding what is PrEP. And with the choices, or the varieties of forms of PrEP methods coming into play, the discretion and this privacy which has given us the opportunity to go to a clinic and only take what I feel is comfortable for me, because having to explain to other people, it has also exposed us not only to GBV but also to stigma and discrimination amongst our peers because if they – when they see us trying to access these commodities through mobile clinics and our community-based centers, there has been a concern that we are already on ARVs.
So we really appreciate the awareness of creation that has been going on through our social media platforms, PEPFAR social media platforms, and through U.S. Ambassadors in my community. We have been raising awareness. So I would say the variety of options that are out there are really working for us as adults and girls and young women. And through the feedback that we’ve been gathering and trying to solicit and inform programming, which is the DREAMS program, has been very much helpful in terms of packaging for the PrEP pills. Some people have concerns that the pill has a burden. Some people have felt like I would like to go for CAB-LA because I only have to go not every day to the clinic, or not take the pill every day, but I have to only go once in two months.
And also, there’s a concern of misconceptions and myth, which we are trying to correct. And there’s also the concern of using the ring only for 30 days. But sometimes you find that my relationship is going to end before when the 30 days come into play. So now it is easy for us to say, I have a choice to use the ring because I’m in a relationship. There’s also the concern of that if I start the CAB-LA, the long-term one, and then my relationship ends, what am I then going to do? Because now it means I might be at risk again of exposure. So the commodities coming into play are giving us a variety of choices as adolescent girls and young women. Thank you.
Ms. Bliss: So, depending on somebody’s situation, or, you know, if works for them to take a pill on a daily basis, fine, but if they prefer the discretion of an injection or not having to go to a clinic, then having those options makes it easier.
Ms. Tembe: Yes, that’s very true. It makes it easier, because also with the ring you can also insert it yourself. But firstly, through guidance from the health-care workers, which is – (inaudible) friendly – services that we have back in Eswatini, we have mobile clinics coming to us. And we really like to appreciate also that approach, because it is very expensive also to reach out to other community areas. There’s no transportation. But at the same time, we’re at the center stage of HIV and AIDS. So with the mobile clinics coming to us, it’s easy to just access the commodity and receive the knowledge. So I think those options are also coming into play, and we are going to be ensuring that adults and girls and young women, critically, understand the importance of adherence to these commodities. Thank you.
Ms. Bliss: OK. Thank you. So I want to shift a little bit just to kind of consider the role of civil society more broadly in raising awareness and generating demand for PrEP. Ambassador, let me start with you. I mean, certainly, PEPFAR has supported a number of civil society organizations in building educational campaigns and carrying out, you know, awareness. What – in terms of prevention, what do you see as the role of civil society as, you know, in kind of strengthening the connection that, you know, you talked about, that, you know, extending access to long-acting prevention tools kind of builds a bridge, in some ways, between prevention and the longer treatment and sustainability process. Can you say a bit about the role of civil society in that?
Amb. Nkengasong: Absolutely. Let me say this first, that when I look at Zonke and Talin, they are example of all people in their age groups, not them per se, but they are sitting here. Let me use them as an example. It’s very possible that the close to 8 million children that, because of PEPFAR, have benefited from the interventions, have been born free of HIV/AIDS, 20 years ago are in front of us today, OK? That’s I mean – so as you just say, let’s move away from the P values. Let’s move to real human being, OK?
When I was working for CDC in Cote D’Ivoire, people like Talin used to be, what, would go to PMTCT clinics and prick their toes and test the DBS, dried blood spot. So they were specimens at that time. And today she’s an ambassador, DREAMS ambassador sitting here with us. I mean, so we saved people like this at that time, 21 years ago, from HIV. Let’s not lose them now to HIV, because it will be a terrible dramatic that we did all of the work and suddenly at this point we kind of take our eyes off the ball.
So I say that because civil society has brought us a long way to where we are today in the treatment program. The same partnerships that we have driven the treatment program to scale up are required if we have to be successful in protecting the gains that we’ve had and closing those taps, the taps of new infections, especially amongst adolescent people. The civil society in the ecosystem, which I usually like to look at it as a triangle, has to be able to work with the governments of partner countries directly, without us interfering in that relationship. And then we, as donors and partners, i.e., The Global Fund, the Gates Foundation, and others, PEPFAR, have to work in that triangle together.
Again, it is only through that triangle of government leading and owning the response, the civil society holding everybody accountable, including themselves. I’ve always said to the civil society, your role is not to hold us accountable. Your role is to make sure that we are all accountable, OK? And we are all accountable. So I think that is important to the partnership and to government. I think the one thing that HIV has – the HIV response has benefited a lot over the last, I’d say, a quarter of a century, 25 years, is the civil society. I don’t know of any other disease grouping that has that kind of amount of civil society – even infectious disease. I don’t know a civil society group for malaria or tuberculosis. In non-communicables, I don’t know a civil society group for cancers and for diabetes and hypertension.
So I think it’s a wonderful tool that I will go out of the HIV prevention room and said, I wish that we have civil society working across other public health threats that we have. Not just for HIV, but infectious diseases and noncommunicable diseases. So, again, I would just submit by saying that – repeating what I said. The gains we’ve made over the years, they’re not just statistics. It’s people that are sitting in front of us, the young people that will benefit from these interventions. And the civil society must play a critical role in that equation.
Ms. Bliss: Thank you. Alex and Jared, let me turn to you just to ask, you know, in the research and development space, as you carry out clinical trials, you know, could you just say a bit about the role of civil society in, you know, advocating and informing the work that you’ve undertaken? Alex, let me – I’m looking up here, but I look over here. (Laughter.) Let me start with you, and then I’ll come to Jared.
Mr. Rinehart: Sure. I’ve been in HIV clinical research since 1996. And I’ve seen countless examples of the benefits of having civil society involved in in all facets of, essentially, HIV drug development. You know, for the – I think you know that the phase three studies that we did for registration of cabotegravir were done in conjunction with the HIV Prevention Trials Network, which is an NIH-funded prevention network. Our engagement with civil society started there, with the community working groups that are formed for each protocol, and still continue. We continue to meet with those groups. And even beyond that process, we continue to meet with, say, AVAC, for example, and many, many other groups, civil society groups.
And have had numerous discussions, especially about some of the challenges that we’ve had with rolling cabotegravir out. They’re, you know, an incredibly important part of the conversation and all the work that goes into it. All those discussions are still ongoing. You know, again, even at the level that I work at, for development of even brand-new protocols, civil society is involved in the design and the review of those studies before we even enroll our very first participants. So we can’t underscore enough the importance that civil society plays in all of drug development. And they’re just – they’re kind of a built-in piece now. It’s hard to imagine them not being a part of it anymore.
Ms. Bliss: Thank you. Long-term relationship, it sounds like. Jared.
Mr. Baeten: Nicely said. I think the – I think, for many of us who work in HIV, it is advocacy – even our scientists – I think it’s advocacy that drives much of what we do as well. And engagement with civil society and engagement with our own – with our own hearts and our own motivations – is what gets us up every day, because we – I think many of us would like nothing more than to not work on HIV, if we could. In our drug development process, I think – civil society, I think, as the ambassador said, is part and parcel of HIV work all along the way. And that is from the products or potential products that we make, to how we do the science, and then to how do we gain access.
So, you know, to Zonke’s point, about choice, I’ve been – I’ve been very fortunate to actually be a part of all of this – of a little bit in all of the science for all the PrEP products that have been developed. And the – when I look across the 15 years of PrEP work that’s been – plus years – have been going on, it has been driven by community, by civil society, by individuals telling us, this is what I need.
Ms. Tembe: This is what we want.
Mr. Baeten: And that’s what the difference in the products we have is for being able to fit really into people’s lives. And when I think about, you know, investigational, lenacapavir, and how we developed it, it was people saying: I would like something that could be discrete and private, that would be empowering for me, that I would – that that does not – I don’t have to bring home that bottle of pills.
Ms. Tembe: That’s very true.
Mr. Baeten: And then in the trials. For us at Gilead, it is – the engagement of advocacy in civil society is from before a word goes on paper to write a protocol. The purpose programs that are the two phase three studies of lenacapavir, for HIV prevention, and additional studies looking at additional populations, have had standing community advisory boards before work – before the – before the study started, before words went on to paper. And helped us figure out how to do those studies, how to design and execute those studies better.
It is because of that civil – that civil society engagement that adolescents were included in the phase three program, that women who became pregnant were allowed to – consented to continue the study drug, and to be able to gather information on safety in pregnancy and lactation, because community said to us: You cannot make a new HIV prevention medicine that might work if you cannot say whether it could be used in pregnancy and breastfeeding. And it was community that said the diversity of geography and of gender is also incredibly important, from the get-go.
And once you – as much as we like P values – once you have your P values, when you move for access, it is civil society that helps shape all of our – all access planning, so that equity and access and partnership actually reach the impact that we all want. And in these last months since we’ve had results for lenacapavir, and way back to Gilead’s very – Gilead was the first to give generic medications for HIV treatment. It is civil society who has said this is the right thing to do, and help think about the pathways that can make that successful. Because it takes many, many pieces to make that all work. But it’s also the engagement to make that all happen. And everyone leaning in together makes it true. So it’s the entire drug development process, from what you ideate, to how you do it, to how you really make it real.
Ms. Bliss: So really starting from the absolute beginning.
Mr. Baeten: Yeah.
Ms. Bliss: So I want to shift gears a little bit. You know, it’s kind of an interesting period for global health right now. We see funding challenges. You know, donors are seized by many, many other issues – conflicts, climate change. Lots of – lots of competing priorities. We’ve got the traffic jam of replenishments that’s coming up. The Global Fund replenishment is certainly on the horizon. You have the looming PEPFAR reauthorization in March of next year. So pressures for many governments to kind of move on from HIV in some places. Yet, you know, at the same time, there’s also a push by the HIV Control Working Group to push for an Africa-led and financed response to HIV on the continent. And, you know, lots of other dynamism, you know, that we’re seeing in terms of prioritization and really kind of shining a light and focusing on HIV.
So, you know, at this kind of critical juncture, you know, all of these new and, you know, innovative tools, and really, you know, lessons and opportunities for moving forward on prevention and really kind of thinking about the sustainability of the HIV effort. You know, at the same time, you know, with all these pressures on the financial side, what are your – as we kind of wrap up here – what are your top, you know, one or two priorities or hopes, you know, as you think about where we are at this critical inflection point?
So, Alex, let me – let me start with you, since you’re here with us coming in.
Mr. Rinehart: Boy, I certainly don’t want to speculate on what’s going to happen after January 20th. I see it as an opportunity, really. I think we’re gathering enough evidence now to show the importance of HIV prevention. And so I’m hoping that we can, you know, convince the powers that be, as it were, about the importance of HIV prevention, that prevention is the best form of treatment. The idea is to not wait for people to acquire the infection and then treat them. That if we have the opportunity, and we do now. We have these – we’re going to have these incredible tools available to us – that it’s better to do it earlier than to wait for treatment.
I just hope that – and we’re certainly able to help out as best we can to build that quantity of evidence to make this understood as, you know, this is a normal part of wellness now. That this is so critical. And we’re – and we’re so close. I really do honestly believe now, with the advent of the long-acting injectables, that we’ll be able to really bend the curve, that we’ll really be able to make an impact on the epidemic. And it would be just a shame to take our foot off the gas right now.
Ms. Bliss: Great. Thank you. So, Jared, let me – let me come back to you. As you think about kind of the one message you might say at this critical juncture of so many new tools and innovations on the one hand, but so many pressures on the other, what’s kind of your one message?
Mr. Baeten: And I had a few minutes to think about it, it’s still hard. (Laughter.) You know, the one – we have the tools in hand. We have the tools in hand to potentially end new infections in this country and around the world. And we’ve had the goals in place to end new infections, both a global goal and the epidemic initiative in the United States goal, to be able to drop new infections by 2030 – which we’re now five years and 22 days away from. And that is – we now have this – we have this short time window to really lean in to be able to make that – to be able to make that a reality.
And I think that is really world changing, compared to all of the world changing things that have been done for HIV treatment all over the world, to be able to turn off the tap of new infections – this country and all around the world, including in PEPFAR countries which have such potential to implement PrEP at large, large scale. This is a real opportune moment.
Ms. Bliss: OK. Thank you.
Zonke, your message?
Ms. Tembe: My message to who, exactly? Because I would also like to send it out to young people.
Ms. Bliss: Yes, please.
Ms. Tembe: Thank you. But firstly, I would like to take it to our previous conversation on civil society. That civil society has a very pivotal role to play in our lives as young people, as adolescent girls and young women, as we are disproportionately affected. We appreciate the platform that DREAMS has given us as ambassadors to be at the platforms of programmatic decision planning processes, where our voices are not only heard but they’re also actioned upon. And today, that is why in Eswatini we are having the different varieties of PrEP, the pill, the injection, and the ring.
Civil society has a role to play in terms of lobbying not only – the ambassador mentioned that there’s an importance of collaboration. We really need to resource more funding for those commodities for us young people. We are the backbone of our own countries, of the future. We are the seeds of tomorrow. And in the ambassador’s word, if we were there 20 years ago seeing how HIV was – really was, we wouldn’t be as relaxed as we are as young people, finding ourselves engaging on this risky behavior. So as young people, I would urge my peers out there – adolescent girls, mostly, in Eswatini – that the sense of studies or data shows that approximately 4,000 adults and girls have been infected with new HIV infections. So I believe that we’re at a time where civil society needs to engage our communities and it needs to give us ownership, because we are taking more influence from our leaders. We are taking more influence from our parents and caregivers.
So there comes a point in time where PEPFAR might not be there. Not that it would not be there, but we need to be – as a country, be readily available to keep on funding these methods that are coming into play. And also, I believe that now is not the time to take our foot off the gas pedal because we can see that, as much – as the ambassador has mentioned, that as much as we have achieved on 95-95-95, new infections are accumulating every year. So as young people, we need to ensure that we lead a healthy lifestyle. But also at the center stage of creating awareness advocacy, we need to be leading healthy lifestyles as well.
Thank you.
Ms. Bliss: Thank you.
So, Ambassador, turning to you for the – your message at this kind of critical juncture of opportunity, on the one hand, and challenges on the other.
Amb. Nkengasong: Absolutely. I think there are two messages, actually. One is global health as a whole. We have to look at, borrowing your words, the traffic jam that we have with all these important initiatives that are going on – the Gavi, The Global Fund, PEPFAR reauthorization. We have to be able to remind ourselves what the fundamentals of global health is all about, about inequities and security, and that it is not – and I speak from the United States’ perspective – that it’s not about others; it’s about all of us. That – can we afford not to do what we have been doing in terms of vaccinations, in terms of Global Fund, and in terms of PEPFAR? The threats that are out there, as we learned during COVID, that a threat anywhere in the world is a threat in the United States almost immediately.
HIV. If we do not continue with our efforts in HIV as our modeling showed in 12 high-burden countries, we easily see increase in death rates over 400 percentage points. OK. And HIV, as I said earlier – let me conclude with what I said earlier – HIV is a retrovirus. It will come right back. And who knows what will happen to here, right, here in the United States, and it’s true for others. So I think on the global health as a whole, a question should be can we afford not to do that, OK, rather than can we afford to continue to do that.
On HIV we find ourselves in the response at what I call a crossroads to 2030. Come 2030, the question that we need to answer is: Did we get anywhere? Did we get somewhere? And did we get nowhere in 2030? And 2030 is just six years from now. I think we ought to be. I hope, that when we get to 2030 we could really turn around and say, look, we went some – we got somewhere, and if you just support us a little bit, we could finish those remaining hotspots that are still there for HIV. That is six short years from now.
So, again, we have the tools in our hands. We have to make sure that the political awareness is maintained, that we are not victims of our own success, that PEPFAR – what PEPFAR, Global Fund, and others have done – the private sector and all these new molecules do not take off – take off a market that is no longer thriving in many countries, that we do not declare premature victory but we finish it there.
One, the people that are sitting here in the next generation – HIV is generational now. The next generation should be able to sit here and said: They got it right. They control HIV. You don’t want the next generation to sit here and said: They mess up. They lift their eyes off the ball. They repeated the errors of malaria.
In 1955, WHO launched an aggressive malaria eradication program. Fairly successful. Many countries were about to eradicate – eliminate malaria. 1969-70, what – the discussion we are having now happened, financial constraints and whether we leave our eye off the ball. Malaria came back aggressively, and the gains that were made were completely eroded.
HIV, we should not fool ourselves. We may find ourselves in that the 2030 where we said we threw our hands up there. We didn’t go anywhere with that. And the politicians will follow through and say, well, we’ve supported it for more than 28 years. In 2030, The Global Fund would have been 28 years or 30 – close to 30 years. They will say, we supported it for 30 years and then we didn’t get this right. So we just left. Sustain the HIV. Not sustain the HIV responders; sustain the HIV. That is living with HIV. That’s not what the people that want to sit here, the Zonke and the talent of the world that want to sit here and moderate the other session, should know us that we did.
Ms. Bliss: Well, thank you. Thank you to all of our speakers for joining today.
We came together to talk about HIV prevention and preexposure prophylaxis but – and the opportunities really available with respect to, you know, existing products and many of those that that are new and forthcoming, and the long-acting opportunities.
But in our conversation we’ve talked about partnerships and the importance of planning, and, you know, I think really we’ve heard a lot about the nature of persistence – persistence in research, persistence in engaging with civil society.
There was even a P in terms of the scientific, you know, publications and others but really the importance of maintaining a focus on the purpose that has driven this programmatic work and research for so many years and really, you know, seeing the ways in which HIV prevention really does contribute to that sustainability agenda overall.
So I want to thank all of you for joining us today online and here in the room, and please join me in thanking our speakers for taking time to share their expertise with us today. (Applause.)
(END.)