Department of State, Gilead Sciences, and The Global Fund Announcement of Lifesaving and Innovative PEPFAR Initiative

MS HOUSTON:  Welcome, everyone, to those joining virtually and in the room.  We appreciate seeing this full room here today.  We are here today to hear more about the department’s response to HIV, an innovative breakthrough that our team will discuss with us today, a team of experts we have here.  We’re excited about this discussion and glad that you could be here with us.

Today we have leading this discussion a face that is very familiar to our gaggles and to the department, our senior official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom, and that is Jeremy Lewin.  Thank you for coming, Jeremy.  And we’re also very lucky and fortunate to have two guests joining us here with this initiative.  We have here with us the chairman and CEO of Gilead Sciences, Daniel O’Day, as well as the executive director for the Global Fund, Peter Sands.

Fantastic.  Today, everyone, we will structure our call, our gaggle similar to a press call.  Therefore we will start with on-the-record remarks by our panel and then move to a more moderated Q&A for the benefit of those joining us virtually.  We ask that the contents of today’s gaggle be embargoed until the conclusion of today’s gaggle, and of course, because we are on the record, you may use quotes by name and attribute to the name and the title of our speaker.

So thank you again.  We are excited about today’s discussion and glad you could be here.  At this time I would like to turn it over to our senior official, Jeremy Lewin.

MR LEWIN:  Thank you.  We’re very excited to be here today and to announce this partnership with the Global Fund and, of course, with Gilead Sciences, an innovative American company which this year under President Trump’s administration received FDA approval for lenacapavir, which is a breakthrough medication in the HIV prevention space. 

The administration and Secretary Rubio have been doing a lot of work to refocus and make PEPFAR more effective.  Our focus area is in commodities and medical breakthroughs.  For too long, PEPFAR’s budget has been drained by sort of NGO implementing partners that are charging very high indirect cost rates and has been sort of focused on non-core activities.  But the core of PEPFAR, what’s made it so effective for so many years, has been the delivery at scale, the procurement and purchasing of medications, whether that’s sort of conventional antiretrovirals, prevention medication, or sort of medical breakthroughs like lenacapavir. 

So we’re very excited to help support this medication.  Our investment is going to be a catalyst for sort of multilateral capital.  Obviously we’re partnering with the Global Fund.  It’s also going to be a catalyst for recipient countries to put in resources, for other donors, for private capital to purchase doses.  It’s going to help bring down the cost for Americans and for people around the world, and it’s going to help increase access to this important sort of medication.

This is the type of thing we’re going to do more of.  As we think about – there’s been a lot of sort of media attention on some of the programs that we have cut because they’re no longer aligned with our priorities.  This is where sort of our focus is going to be, on the purchasing at scale of commodities that can really help have an outsized impact in fighting HIV and across our various global health disease areas.

MS HOUSTON:  Thank you, Jeremy.  Next I’ll turn the floor over to our chairman and CEO of Gilead Sciences, Daniel O’Day.

MR O’DAY:  Good.  And thank you, Jeremy.  It’s great to be here with you and Peter, and I just want to say good morning.  It’s been a really important day here today in what I know Gilead Sciences’ objective is and are shared by the folks that I’m here with today, which is our effort to end HIV around the world.  I’m here representing the Gilead scientists, actually, who spent 17 years researching and developing what would become lenacapavir.  It’s been quite a journey.  Literally, these people have devoted their career to ending the HIV epidemic around the world, and for them and for all of us, today’s announcement is a critical step towards achieving that goal.

lenacapavir has been described as one of the most important scientific breakthroughs of our time.  As you’ve heard, it’s the world’s first twice-yearly HIV prevention medicine, and it’s already been approved in the FDA and also the European Commission.  Just to put a point on this, in clinical trials, it was nearly a hundred percent of people taking lenacapavir remained free of HIV. 

But we know at Gilead Sciences that scientific breakthroughs only matter if they reach the people who need them, and ensuring access to lenacapavir is just as critical as the scientific innovation that brought us to this point.  And that’s why today’s announcement is so important.  It cements a partnership that will strengthen access to lenacapavir.  The support of the U.S. Government through PEPFAR means that we can get to places with the greatest need faster.  Gilead is providing lenacapavir at no profit to the company so that in partnership with PEPFAR and the Global Fund, we can put the potential of this medicine to work for more people in more countries.

I just want to say Gilead is honored to partner with PEPFAR.  We’ve done this for almost two decades now, and it’s for us the most important public health program in terms of it saving more than 26 million people’s lives since it went into place 22 years ago.  I think that this ongoing relationship and where we’re heading will be very important to ending the epidemic. 

So partnerships are critical to ending HIV, so infrastructure, resources, education, knowledge of local communities, and a commitment are all essential to preventing new transmissions of HIV, which are on the rise here in the United States and globally.  And so the leadership and commitment shown by the U.S. and PEPFAR today will make a remarkable impact on ending the HIV epidemic, and our work together will make America stronger and have a significant impact on global public health.

MS HOUSTON:  Thank you, sir.  Next we’ll turn to our executive director, Mr. Sands.

MR SANDS:  Thank you, and it’s actually great to be here with Jeremy, with Dan, to be talking about something that could bring an end or bring much closer to an end the AIDS epidemic, a disease that has already killed some 40 million people, and it’s an extraordinarily exciting moment.  Kudos to the scientists at Gilead Sciences for coming up with this innovation.  It’s a fantastic tool.  It’s not often in clinical trials you get things producing sort of effectiveness rates of a hundred percent or effectively a hundred percent. 

And it’s great to be working in partnership with PEPFAR.  We will be working in very close collaboration with PEPFAR and our in-country partners on the in-country deployment of this tool so we maximize the impact of it.  And I think it’s really significant not just in the fact that this is an opportunity to significantly reduce the 1.3 million new HIV infections there are every year; if we can reduce that, we can change the nature of the HIV/AIDS pandemic quite dramatically.  That will obviously save lives, but it’ll also reduce significantly future health system costs because if an 18-year-old gets infected with HIV, you’re talking about 50-60 years of antiretroviral treatment which someone in the system is going to have to bear, on top of, of course, the human costs – the impact on the individuals. 

The other aspect of it that I think is significant is that by reducing the numbers of new infections, we can actually see transition to reducing reliance on external funding happening faster.  It is much easier for countries to take on the funding responsibility of a disease with very few new infections with a long liability in terms of keeping people on antiretroviral treatment but ultimately a declining one, than asking them to take on responsibility for a problem that is still growing.  With lenacapavir, I think we have the opportunity to make that shift.  So this is a really significant moment in the history of the fight against HIV/AIDS, and so we at the Global Fund are delighted to be in partnership with PEPFAR, with the United States Government, with Gilead in really ensuring that we can make the most of this innovation while it has scaled and really change the path of HIV/AIDS.  Thank you. 

MR LEWIN:  If you just let me add one more thing, I think a couple of points that Peter mentioned are sort of worth noting insofar as they give an indication of where we’re going with the PEPFAR program.  We are – the Global Fund and PEPFAR have tremendous scale.  We have sophistication.  We have resources.  And if we dedicate those towards purchasing innovative drugs, purchasing commodities at scale, and doing so in the most efficient way possible – and I think this is an example – there are no NGOs involved in this.  There are none of those sort of beltway bandits here.  Right?  We are making a deal to help purchase a tremendously innovative medication and get it to the countries.  And it’s going to be the countries that are going to be the ones that are going to be responsible for distributing it through their national healthcare systems. 

And that’s exactly where we see PEPFAR going – where we’re a partner. where we give the tools, we give the resources, we help – especially with those sort of complex health supply chains of commodities.  We help the countries have the tools to fight the epidemic but also help them build their own national capacity, their own national healthcare systems, rather than distributing medication through NGOs that were operating as a shadow healthcare system. 

So this is where we see a lot more of our resources going, and so we’re really excited.  This is only the beginning.  This is an anchor commitment right now; but in our view, as Peter was saying, this is a tremendously exciting medical innovation.  And PEPFAR, we hope, will continue to support this medication and at greater scale as generic manufacturing sort of scales up like Gilead offering a licensing agreement to allow scalability of generic production. 

And so as that sort of kicks off, this is just the beginning, I think, of our partnership both at the Global Fund on these issues, and we’re going to be working more closely with them on these issues.  And I think the Global Fund has done, frankly, a better job than PEPFAR in the past of doing this type of work and requiring co-invest and working with the national healthcare systems and not working with some of these expensive 40, 50 percent overhead American international NGOs.  The Global Fund is really a leader on that.  And so we want to actually take their example in a lot of respects and also work on the commodities side more closely with Gilead and other innovative American companies.

MS HOUSTON:  Great.  Fantastic.  Thank you very much to our panel.  We’re now going to open the floor for questions.  I’d like to start with an individual from our online audience if we have a hand raised.  We are also very happy to say that today’s panel is another example of this administration’s commitment to press, being fairly open and transparent about our initiatives and our advancements.  And so we’re grateful for their time, and we look forward to taking your questions. 

We have one question here.  Mr. Adam Taylor from The Washington Post, if you can unmute yourself and please ask your question as loudly as you can.

QUESTION:  Hey, can you hear me okay?

MS HOUSTON:  Yes, we can.

QUESTION:  Great.  Great.  Thank you for doing this.  So I was just looking over some of the past releases from the Global Fund, and I saw in December the Global Fund and PEPFAR announced a coordinated effort to reach 2 million people within lenacapavir for PrEP.  Could you sort of walk us through what’s new, then, about this?  Is this – I don’t totally know the sort of whole backstory.  But how is this different than what was announced in December?  And there was also an announcement in July about something similar as well.  Thank you.

MR LEWIN:  So last year, there was sort of an agreement in principle to work together on this.  The medication wasn’t approved until middle of 2025.  The Global Fund made their own commitment.  We’ve been working very closely with them, and then now this is a follow-on commitment.  But we’ve put all the details together.  We’ve sort of worked through the details both with Gilead and the Global Fund to make this a real commitment, to make sure that we are actually purchasing medication and sort of how we’re going to operationalize this quickly and help scale up manufacturing at scale.  So there’s a lot of work that happened in the last few months, and the team here, if you’re in global health security and diplomacy has been doing fantastic work for many months with Gilead’s team and with the Global Fund team.

MS HOUSTON:  Fantastic.  We’ll go next to one additional question online before going to our bullpen.  This next question is from Gabrielle Emanuel from NPR.  Gabrielle, if you’ll unmute yourself, you can now ask your question.

QUESTION:  Thank you very much for taking my question.  I just wanted to see if I can get a couple specific numbers in terms of how much money the U.S. is committing to this, how much is being paid for, say, each person each year for a dose of lenacapavir as well as a sense of what countries will be receiving these doses and how quickly we can expect the first countries to get it.  Thank you very much.

MR LEWIN:  Gilead is very generously offering us the product at no cost, so we’re not going to give away exactly what their cost per dose is.  But we’re grateful to them for offering it at a price that makes this possible.  The U.S. commitment is significant, but again, this is only the beginning.  We have a floor of doses that we’ve agreed to commit.  We also have a three-year goal.  But we expect that as manufacturing scales and if manufacturing is in a place that can accommodate a much larger order, we could be talking about millions of doses.  So right now we’re hoping, with the Global Fund, to help two million people get on the mediation over the next three years, but we could easily see several times that if manufacturing can scale quickly enough.

MR O’DAY:  Well, I think that’s absolutely right, Jeremy.  So – I mean, just to be clear, the costs is a confidential part of our agreement.  But it is only the cost that takes us to manufacture the medicine and deliver the medicine and nothing more.  And what I would say to Jeremy’s point is – and he mentioned this before – as innovative as this medicine is, so has the access program been innovative, so the first-ever medicine to ever be voluntary licensed to generic manufacturers before regulatory approval.  So immediately last summer after we received these kind of groundbreaking results, we had already agreed with six generic manufacturers on a royalty basis, and from October 2024 we had already tech-transferred the product to generic manufacturers.

So the sustainable model here that Jeremy talked about and we talked about with Peter is that it will take – even with that very fast timeline, it will take perhaps up to two years for these generic manufacturers to have product at scale.  And so what this is, is a really important program to allow us to save lives in this two-year period until it becomes even more self-sustainable with generic manufacturers manufacturing for these 120 low- and middle-income countries.  And that’s a model, I think, that we’ve all held hands on and partnered with, and I think it’s another part of the self-reliance that the U.S. Government is very focused on which we support.

MS HOUSTON:  Thank you.  I’ll begin now with questions from within the room.  If you have a question and you’d like to raise your hand – yes, we’ll start with Jennifer here.

QUESTION:  Hi, thanks.  Just following up on NPR’s question, which countries are expected to receive doses of this drug?  And are you saying no nonprofits are going to receive any doses?  How do you deal with folks who may be uncomfortable going to government-run facilities to receive such treatments – gay men, for example, and some of —  

MR LEWIN:  Well, our – with this medication in particular is pregnant mothers and breastfeeding mothers.  President Trump has a goal of ending mother-to-child transmission of HIV by the end of his second term in office.  And so I think this medication has significant advantages for pregnant women and breastfeeding mothers because you can give just two doses of it and cover the entire period of pregnancy and sort of breastfeeding postpartum which is tremendously effective with just two doses. 

So that’s where we’re really targeting this at the moment.  Again, we have a list of eight to 12 countries that we have made agreements with.  The State Department isn’t publicizing our list of countries at this moment as we work through sort of bilateral health plans.  But we hope to share with you in the next few weeks.  We’ll have more details about how that works.

As to the question about modalities of care, ultimately that’s going to be something that the local governments are responsible for.  I mean, we have to acknowledge that for too long we’ve had this patronizing view that it’s our responsibility to reach really deep into these countries, to be telling them what they can and can’t do, should and shouldn’t do with their own health care systems.  But ultimately, public health is a domestic responsibility.  We can support countries financially through agreements like this that give them access to medications they might not be able to purchase on their own, but it is not the United States’s job to be paying shadow health care workers, Americans, to be in these countries telling local health care systems that they’re doing things wrong and sort of offering a competitor to the health care system that creates a bad incentive for the country not to develop its own national healthcare infrastructure plan.

MS HOUSTON:  Thank you.  Do we have another hand within the room?  Yes, sir.

QUESTION:  Andrew Roth from The Guardian.  Just also following on NPR, first, I was just wondering if you can say what the floor is in terms of the number of doses that you’ve agreed to purchase.  And secondly, is there going to be an announcement of the size of the grant in terms of how much this is going to cost in total?  And how do you manage to maintain the secrecy about how much the cost is per dose if you have to announce the overall grant amount?

MR LEWIN:  So again, I think our three year commitment with the Global Fund is – it’s to try to reach at least two million people.  Again, that’s just the – that’s really the floor for us over the three-year period.  I would say, like, instantly we’re going to be purchasing hundreds of thousands of doses, but again, this is going to be dependent upon the scale of manufacturing, right. 

I mean, we can tell – and that’s, I think, a lot of the work that we’ve been doing over the last few months to figure out how we can actually make this real.  It’s nice and easy to say, oh, I’ll pledge a bunch of money to purchase doses, but we won’t actually get the doses to the field.  We want to get them made. And so that’s going to be the work that the team’s going to continue to do over the next few months, and we’ll continue to publicize additional details as manufacturing scales up.

MR SANDS:  If I may go on Jeremy’s point, I think it’s important to recognize that the cost of making the most of lenacapavir is not just the cost of lenacapavir, but there’s – typically the way you would deploy this is you would be doing a testing program in a particular community, so you’d need the testing.  And because this is going to be most effective in the higher-risk communities, some of those people are likely to be HIV-positive.  So one, we’ll enroll those people onto treatment, and then those who are HIV-negative but at significant risk, it makes sense to put them on lenacapavir.  So as you think about sort of the scale of what we’re doing, it’s not just an isolated product, but it’s an integration into a very effective prevention strategy that includes testing and enrollment onto treatment. 

MR O’DAY:  I’ll just say one other thing to add to my colleague’s comments here.  With the letter of intent that we had kind of in December of last year, we’ve been manufacturing at risk.  So we have – we’ll have product available as soon as we’re ready to deploy it.  And by the way, the regulatory process has been very rapid.  So many of these countries can deal with both the WHO Prequalification Program or EU-M4all.  And we have prioritized the top 18 countries that represent more than 70 percent of HIV incidents for very rapid regulatory approval.  Our, I think, joint objective is to have the first country on board by the end of this year.  So that’s what we’re working on.  

MS HOUSTON:  Fantastic.  We have time for one – one more question from within the room. 

I saw this hand first, Said.  I’m sorry.  Okay.  Yes, sir.

QUESTION:  Yeah, thanks.  Gram from Reuters.  So obviously this is focused on expectant and breastfeeding mothers.  You said you’re working with – you’re going to work with the local health authorities in the countries where this is deployed.  Is this – is – do you expect that this only goes towards those individuals, or if, for instance, a recipient country wants to make it available to other populations, is that okay?

MR LEWIN:  I – there’s no formal restriction.  That’s our strong recommendation, and many of the countries agree with that.  Obviously, the mother-child HIV transmission is really so tragic, and a lot of the countries are working with us to try to eradicate it.  So I think that’s – and it is so effective for that population in particular, so that’s where the first doses are going to go, in most cases.  We haven’t put a formal restriction on it.  We’re working with the countries to meet their needs in their high-risk populations.  And the Global Fund, of course, is targeting their doses in their own manner as well.

MR SANDS:  Yeah.  And fundamentally, we want to maximize the impact of lenacapavir, which means understanding the epidemiology and where it’s going to be deployed in a way that will reduce the most infections.  And we are already engaged with countries on looking at how to deploy it in the most effective way.

MS HOUSTON:  Fantastic.  Everyone, thank you so much.  Do you want – you have time?

MR LEWIN:  One more.  Yeah.

MS HOUSTON:  All right.  Said, you’re up.

QUESTION:  Thank you.  So a very quick question; I may have missed it.  You’re saying that this drug will not be available domestically under any circumstance, right? 

MR LEWIN:  No.  I mean, I think —

MR O’DAY:  Did you say domestically?

QUESTION:  I may have missed it.  It’s not going to be available domestically?

MR O’DAY:  No, it’s already available domestically.

QUESTION:  It is available?  So when —

MR O’DAY:  Yes, yes.  We launched this medicine within 24 hours of FDA approval.

QUESTION:  Will it be covered by private insurance?

MR O’DAY:  Yes, yes.  We’re in the process now of attaining insurance coverage for lenacapavir.  It’s going as planned.  We expect within six months of launch to have around 75 percent of insurers covering lenacapavir and about 90 percent in 12 months.  And that plan is very actively underway right now for Americans.

MR LEWIN:  And I would say we’re working both with Gilead and Secretary Kennedy’s team at HHS to ensure that our support helps increase access for Americans.  And sort of – we’re proud that HHS is doing a lot of work to approve the medication for Americans and is helping Dan’s team at Gilead ensure that Americans have tremendous access to this medication.

MS HOUSTON:  I want to say thank you to everyone in the room.  This is our first time having this panel of experts here.  Thank you very much to all of our speakers for joining us, and we are looking forward to hearing more about this breakthrough.  If you have additional questions, you know how to reach us.  The embargo is now up, and we look forward to continuing these conversations with you all.  Thank you.

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