Jeremy Lewin, Senior Bureau Official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom; Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences; and Peter Sands, Executive Director of the Global Fund to Fight AIDS, Tuberculosis, and Malaria

MS HOUSTON:  Good morning and welcome, everyone, to today’s press call on the America First Global Health Strategy and its groundbreaking partnership to expand access to lenacapavir in high-burden HIV countries.  This initiative, led by the Department of State in close coordination with Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, is a powerful demonstration of what is possible when government, industry, and global institutions unite around a shared purpose.  Today’s press call provides important updates following our on-the-record call in September, when this partnership was first announced.  Since then our collective work has continued with urgency and a shared belief in the transformative potential of this collaboration. 

I am Mignon Houston, the deputy spokesperson for the Department of State, and I’ll serve as your moderator for today’s call.  Before we begin, I would like to go over a few ground rules.  Today’s call is on-the-record, and all remarks may be attributed to each speaker by name and title.  The contents of this call are embargoed until 5:00 a.m. Eastern Time.  Once again, the contents – we ask the contents are embargoed until 5:00 a.m. Eastern Standard Time. 

We are honored to welcome back our three distinguished speakers for the on-the-record remarks and Q&A.  Our first speaker, Jeremy Lewin, senior official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom here at the Department of State; Daniel O’Day, chairman and chief executive officer of Gilead Sciences; Peter Sands, executive director of the Global Fund to Fight AIDS, Tuberculosis, and Malaria. 

At this time, we are ready to begin our on-the-record opening remarks, and we’ll begin with our senior official from the Department of State, Mr. Jeremy Lewin.  Jeremy, you have the floor.

MR LEWIN:  Thank you.  I’m sure there’ll be many questions.  I just wanted to start out with a real thanks to the team that’s worked really, really hard on this when we announced this initiative in September.  This is really a groundbreaking partnership.  I think our first collective press briefing together was, I think Mignon said, one of the first times that they had had folks from the Global Fund, from Gilead, in our press room doing a joint briefing – so really just sort of underscoring how unique and close the collaboration has been on this.

We initially said, at that time, that we’d be providing at least 2 million doses, and by 2028, and we are proud that with the progress we’ve made we think we’re going to hit that target sometime in sort of mid-to-early 2027.  We’re going to be procuring more than half a million doses collectively next year with a significant increase in 2027 as Gilead continues to increase its manufacturing capacity. 

And so today, the first doses are being delivered in Eswatini and Zambia – high-burden countries.  And just as a moment of reflection, this is really – the Secretary always talks about moving at the speed of relevance, and this is an example of that.  I mean, the Trump Administration championed this medication.  It was approved by President Trump’s FDA in June, and less than six months later we’re delivering the first doses in high-burden countries in Africa in the same year that it’s approved and delivered in the United States.  And so that’s – a huge amount of thanks is due to Gilead, who obviously developed this medication, is providing it at no cost as part of their tremendous philanthropy that the organization and company does; but also to the work of the folks that we have on our PEPFAR team, who have engaged with the Global Fund, are working hard, and the financial commitments that we’ve made to backstop this.

This is an example of we’re creating a new innovation fund as part of the America First Global Health Strategy, which we also announced in September, and I think this is a prime example of what we can do to accelerate progress on global health through championing American innovation and American enterprise.

Gilead is an American company, a proud American company, and this medication is truly – it’s a remarkable breakthrough.  It’s more than 99 percent effective, and that has particular utility when it comes to mother-to-child transmission of HIV.  The Trump Administration has a goal of ending – substantially ending mother-to-child transmission of HIV by the time that President Trump ends his second term.  And we think we can hit that and achieve that goal precisely because of investments and innovations like this.  Twice yearly, with two shots, you can cover the period in which a woman is pregnant and breastfeeding, which is just a tremendous breakthrough.  And so, thanks to innovation like this we can bend the curve of the epidemic, and ultimately, as we bring infections down and are able to deliver commodities like this scale, we can achieve the administration’s goal of allowing countries in Africa particularly, but all of our health recipient countries, to achieve genuine self-reliance. 

So, we’re baking in innovative investments like this into our ongoing negotiations around our health – bilateral health compacts, which are really the star of the show in our America First Global Health Strategy, but our investments in innovation are equally if not more important.  And so, we’re really grateful to be here talking about what we’re doing and how we’re doing it really quickly, because we know when it comes to fighting diseases like HIV we really want to make sure that we act with the requisite urgency, and that’s exactly what this State Department under Secretary Rubio is doing.

MS HOUSTON:  That’s excellent.  Thank you, Senior Official Lewin.  We always welcome you here with our bullpen.  We want to thank you for your remarks and your continued leadership in spearheading this accelerated progress.

Next, we are also privileged to have on-the-record remarks from Gilead’s chairman and executive officer, Daniel O’Day.  Mr. O’Day, you have the floor.

MR O’DAY:  Thank you very much and hello, everybody.  Just following up on Jeremy’s comments, this is a really important moment in the history of HIV.  This is the first time in the history that a new HIV medicine is reaching the continent of Africa in the same year as it was approved in the United States.  I think this is a bold new bar for global access and something that we, at Gilead Sciences, have been working on really hand-in-hand with the extraordinary science which is lenacapavir.

And I just want to focus on aspects of our strategy, which were really around speed and partnership.  And Jeremy just mentioned the importance of the partnership, because it’s through these two things – keeping speed in mind, and partnership – that allow us to reach the communities most affected around the world with a groundbreaking innovation to fight disease.  And all of us at Gilead Sciences are really proud that because of our work with the U.S. Government, via PEPFAR and the Global Fund, we can provide lenacapavir at no profit to Gilead to countries with the highest burden of HIV – again, in the same year it was approved in the United States.

It’s very meaningful that some of the first supplies are reaching Eswatini, the country with the highest incidence of HIV in the world, and we’re very pleased that lenacapavir, the world’s first twice-yearly HIV prevention, is now going to be part of the efforts to end HIV in this country and many other countries in Sub-Saharan Africa.

So, with that, I will turn it back to the moderator and be willing to take your questions as well.  Thank you.

MS HOUSTON:  Thank you, Chairman O’Day.  Just an excellent example of partnership, and we certainly look forward to hearing more from you.

Our final on-the-record remarks will be delivered by Peter Sands, the executive director of the Global Fund.  Mr. Sands, you have the floor.

MR SANDS:  Thank you, and it’s great to be alongside both Jeremy and Dan talking about what is an extraordinarily exciting moment in the history of the fight against HIV/AIDS. 

Look, innovation is the key to making accelerated progress against the deadliest infectious diseases.  To maximize the impact of such innovations, one needs to get them out to the people who can benefit the most, at speed and at scale.  And that’s exactly what is happening here – first, with the arrival of lenacapavir in Zambia and Eswatini, and then with the planned rollout across a number of different countries, at scale. 

And this is testimony to partnership – to the partnership between the Global Fund, Gilead, the United States, and also the partnership with the ministries of health in Eswatini and Zambia, and the communities and civil society groups on the ground that play such a big role in ensuring it gets to the people who can benefit the most.

If I can be excused a moment of advertisement.  The Global Fund’s replenishment is at the end of this week, and actually this moment, this accelerated path to ensuring that an innovation is brought to the people who need it most to maximize impact, is a great example of how the Global Fund as a unique public-private partnership with the generous support of donors, led by the U.S., makes a big difference saving lives, reducing the burden of disease, and putting countries on the path to self-reliance.

I’ll hand it back to you.

MS HOUSTON:  Wonderful.  Thank you, Executive Director Sands, for your historic engagement with the Department of State.  You’ve also set the stage nicely for our question-and-answer portion.

I’d like to ask all of our participants on the call who would like to ask a question to remember you would need to raise your hand, use the raise your hand feature, to be called upon, and unmute yourself before speaking.  Once again, this is a call that is on the record, so the Q&A portion will remain on the record as well.  If you encounter any technical difficulties unmuting yourself, I will need to move on to the next person in the queue, and if we have time, I’ll come back, circle back to you. 

So, at this time, I’m looking at our queue to see who we have with hands raised.  I’m going to call on our first hand that I see, which is from Carmen Paun.  Carmen, if you can unmute yourself, give the name of your outlet, and begin with your question.

QUESTION:  Thank you so much, Mignon.  And thank you, all, for doing this.  Two questions if I may.  The first one is: can you tell us how many doses of lenacapavir will reach Zambia and Eswatini?  And are – they’re being delivered today as we speak, or is it this week, over the next few days?  And the second question, if I may, since Peter just mentioned this, I was wondering if there’s been any update on the U.S. pledge, if any, to the Global Fund for their next replenishment, which I know is happening on Friday.  Thank you.

MR LEWIN:  Let me just answer the question about the U.S. pledge to the Global Fund.  We are in the midst of active consultations with Congress, and as Peter mentioned, the replenishment will close soon, and we will be making a pledge.  We’ll announce that in the coming days, after our consultations with Congress. 

MR SANDS:  On the question of volumes, these first batches, I think – correct me if I’m wrong, Dan – are 500 doses to both Zambia and Eswatini.  But these will be very quickly followed up by further doses.  This is just the absolute sort of initial deliveries, and the deliveries have been made.

MR LEWIN:  Yeah, and —

MR O’DAY:  Yes, that’s – oh, go ahead, Jeremy.

MR LEWIN:  Oh, no.  I was just going to say they have been made, and an important part of that is also training local health care workers to be able to administer these doses.  And so that process is ongoing with these first doses.  The Global Fund, and PEPFAR are helping, and with Gilead’s help as well, to understand how to administer this medication.  And as local health care workers become well-versed in administering it, additional doses will follow. 

MR O’DAY:  Yeah, that’s great.  I’ll just add my voice.  This is Dan O’Day.  So, Peter’s numbers is – are correct for these two countries.  I just want to point out that Gilead – at the moment that we knew that we had a medicine – has been ramping up supply.  We do have supply to send to markets when they have the appropriate regulatory approval, and obviously the replenishments for Eswatini and Zambia.  Our commitment in working with the State Department and PEPFAR is to have up to two million doses between now and when voluntary license, royalty-free, generic manufacturers will be able to supply these countries, which we anticipate to be around 2027.  But to be clear, our ability to supply is not constrained and will be driven by the needs on the ground and our work with our partners.

MS HOUSTON:  Okay.  Great.  That question was, again, from Carmen Paun from Politico.  Next, we’re moving to Reuters, Daphne Psaledakis.  Daphne, if you can unmute yourself, you may proceed with your question. 

Daphne, can we ask you to try to unmute yourself once again?  We’re unable hear you. 

Okay.  Daphne, we’ll come back to you.  Our next question is from Jonathan Lambert from NPR.  Jonathan, if you’re unable to unmute yourself, we invite you to begin your question at this time.

QUESTION:  Hello.  Thanks for taking my question.  I’m wondering, one, if you could speak to – a little bit more about who is training the health care workers to administer and sort of how that’s being funded.  And then also I wonder about the regulatory environment in other affected Sub-Saharan African countries and if regulatory approval is expected soon or if that’s a potential hurdle to getting this to other countries.  Thank you.

MR SANDS:  I’m happy to jump in on the training.   The model varies slightly depending on which country you’re talking about, but fundamentally we have deep involvement of the ministries of health and sometimes other technical partners.  But fundamentally, it’s the ministries of health that are taking on the main responsibility for ensuring that their health workers are able to administer these injections effectively.

MR LEWIN:  And —      

MR SANDS:  In terms of the – sorry, Jeremy.

MR LEWIN:  Oh no, I was just going to say, to build on that, that’s exactly the model, and that’s why the Global Fund is an important partner in our America First Global Health Strategy.  We’re delivering commodities at scale and we’re helping work with innovative companies like Gilead to provide sort of a global backstop and to help them stimulate demand and manufacturing capacity.  But ultimately, it’s the local health ministries that have to be responsible for this.  And so, this is part of our pathway to self-reliance, is making sure that the national health care systems become responsible for administering these doses and integrating them into their national health care systems, rather than running a parallel delivery system.

MR SANDS:  And the regulatory process.

MR O’DAY:  Yes.  Oh, yeah.  I was going to –

MR SANDS:  I was going to say, Dan – I was going to say – (laughter) – (inaudible) to that one.  

MR O’DAY:  Yeah. 

MR SANDS:  It’s complicated. 

MR O’DAY:  No, I – yeah, but happy to update you on where we stand.  Gilead is responsible for the regulatory approvals throughout Sub-Saharan Africa.  So maybe just to bring you up to speed – in November, the Zambia Medicine Regulatory Authority approved lenacapavir for prevention of HIV as PrEP.  And then also following that, there was approval by the South African Health Product Regulatory Authority. 

In terms of Eswatini, there is no registration process so a separate regulatory review is not required, but products can be imported under an import authorization issued by the Ministry of Health that relies upon stringent regulatory authority approval from the FDA or EMA and WHO prequalification.  So again, it’s quite extraordinary that this marks the first time that countries in Sub-Saharan Africa received access to an HIV prevention medicine in the same year as the U.S. 

Now, obviously, we are working with other governments at this time, in partnership with the Global Fund and PEPFAR.  I can let you know that in November we submitted market authorizations to Rwanda and Tanzania, following October submissions in Botswana, Kenya, Malawi, Namibia, Uganda, and Zimbabwe.  So, these regulatory reviews are generally expected to take up to about 90 working days, and we’ll be working very closely – obviously – with the Global Fund and PEPFAR, prioritizing the additional Sub-Saharan African countries to receive first deliveries of lenacapavir between now and early 2026. 

MS HOUSTON:  Next, we will move to our next person in the queue.  We have Mike Stobbe.  Mike is from the Associated Press.  Mike, you have the floor if you’re able to unmute yourself. 

QUESTION:  Hi.  Thanks.  Can you hear me? 

MS HOUSTON:  Yes, we can. 

QUESTION:  Great.  Thanks.  Just want to – just a couple clarification questions.  It’s 500 doses each – one – to both each of the countries that you talked about, and you’ve said they’ve already been delivered.  When were they delivered, and can you say more about when you anticipate that the first doses will go to patients?  I wasn’t clear on that.  You said there’s some training going on, but how long until that happens? 

MR SANDS:  Dan, you may have the precise details on the dates of delivery, but my understanding was that most of these doses were delivered to Eswatini and Zambia during the course of the last few days – several days – and that we should be seeing injections actually administered for – to patients sort of from tomorrow. 

MR O’DAY:  Yeah, that’s correct.  So to clarify the question, it is 500 doses to each country, not combined, and they’re – the medicine is in country right now.  And I think – Peter, you’re probably better versed or others on the call exactly when the first administration will occur. 

MR SANDS:  Yeah, it’s definitely this week though.  Because the training actually began – some of the training actually began before the doses arrived in country so it’s not like they’ve just started from a cold start.

MS HOUSTON:  Okay.  Mike, if that’s the conclusion of your question, we’re going to circle back to Daphne.  We also have a few minutes left for additional hands in the chat, if you have questions for our panelists.  Daphne, if you’re able to unmute yourself, we’d love hear your question at this time. 

QUESTION:  Hi.  Are you able to hear me?

MS HOUSTON:  We are. 

QUESTION:  Okay.  Not sure what happened the first time, but thank you for doing this.  I wanted to ask – you’ve mentioned PEPFAR.  Can you clarify the role that PEPFAR is playing in this and more generally how much money is still going to PEPFAR?  And is this meant to replace the funding that was going to fight – going to fighting HIV that PEPFAR was receiving?  Thank you. 

MR LEWIN:  Sorry, I’m not sure I understand what exactly your question is.  I mean, I think the Secretary has been very clear that PEPFAR remains ongoing.  We are working hard on implementing our new America First Global Health Strategy, which is moving a lot of our implementing sort of mechanisms away from the NGOs, and instead giving local control to national health care governments through these bilateral compacts that require co-investment and regulatory harmonization and a bunch of things that are going to help countries achieve self-reliance. 

So, I think PEPFAR is ongoing.  Obviously, Congress appropriates a very significant amount of money, about $6 billion a year, to PEPFAR.  And so, our contribution to this initiative is from the money that’s appropriated to PEPFAR as part of the new innovation fund that we’ve set up within the broader PEPFAR budget. 

MS HOUSTON:  Okay.  Thank you, Daphne.  I’m going to move a hand that I have not seen yet and that’s Adam Taylor.  Adam, if you’re able to unmute yourself, you have the floor at this time. 

QUESTION:  Great, thank you.  And can you hear me? 

MS HOUSTON:  Yes, we can. 

QUESTION:  Great.  And this is another point of clarification.  I believe I heard a reference to the South African Health Products Regulatory.  I just wanted to check – is that – will doses be going to South Africa, or is that just in relation to Eswatini?  Thank you. 

MR LEWIN:  The United States will not be contributing doses to South Africa.  Obviously, we encourage every country, especially countries like South Africa, that have significant means of their own to fund doses for their own population and this innovative drug, American-made drug, that Gilead has developed.  U.S.-funded doses will not be going to South Africa.

MS HOUSTON:  Okay, great.  That question was from The Washington Post.  We’ll move next to Ed Silverman.  Ed Silverman, if you’re able to unmute yourself, Ed is from STAT News.  Okay, Ed, we’re unable to hear you —

QUESTION:  Can you hear me now?

MS HOUSTON:  Yes, we can.  That’s great.

QUESTION:  Yes.  And I’m with STAT News.  Thanks for taking the question.  Dan, if you could just go – you went a little fast.  You listed some countries.  And I just wanted to ask you to clarify, because I know previously you said that Gilead was looking to pursue a very rapid process in getting medication authorized by regulators in 18 countries.  Could you give us an update on – in addition to the countries you mentioned, I think there was authorization in October, November, if I heard that right.  Again, if you can repeat those countries, and could you give us an update on where you’re at?  Are you still looking at 18 countries?  Has that expanded to a larger number?  In any event, how soon do you expect to be able to get authorization in all of those 18 countries?

MR O’DAY:  Thanks.  Yes, sorry if I went too fast before.  But I can confirm that we are – we continue to prioritize registrations in 18 high-burden countries representing 70 percent of the HIV epidemic.  And obviously, we won’t stop there; this is the prioritization.  We will – we are working with all countries in the regulatory systems to get lenacapavir approved.

Back to where we stand with the registrations, and I’ll slow down here a little bit.  But we’ve already filed in Botswana, Kenya, Malawi, Namibia, and Rwanda, Tanzania, Uganda, and Zimbabwe – with additional submissions based upon the particular government’s plan by the end of 2025 for the remaining 18 high-burden countries.  And just to clarify also the previous questions, we do have approvals – have been received in South Africa and Zambia, and we’ll be working with partners for those countries as well.  Hopefully that helps.

MS HOUSTON:  Perfect.  And that question was from Ed Silverman from STAT News.  Thank you, Ed.

We’ll move now – we have time for – we’ll take one additional question.  Our next question I’ll give to Julia Jester.  Julia is from MSNBC.

QUESTION:  Hi.  Thanks so much for doing this briefing.  I wanted to ask – you mentioned that this is a shift away from relying on NGOs as implementing partners; a lot of the reform at State and USAID have been to streamline efficiency and cost effectiveness.  I was wondering if you could just kind of chat about the overall cost of this partnership and new program, and the way that the current (inaudible) system is perhaps enabling the local governments to take on more versus relying on NGOs and nongovernmental entities.  So, if you could just kind of speak to the financial aspect as we look at how this administration has been saving costs.  Thank you.

MR LEWIN:  Thanks.  It’s a great question.  So I mean, if you back up and think about the money that we spend on our health programs – PEPFAR and the other global health programs that we have – 30, 35 percent is spent on direct frontline costs.  So that means commodities, which is about 20 percent, and then all of the frontline health care workers, which is another, like, 10 to 15 percent.  And the rest of the pie goes to technical assistance and NGO overhead and stuff like that in the old system, right?  And so, investments like this, I mean, really innovative and high-impact commodities, are relatively cheap compared to all the overhead of having all these NGOs profiting off of the health care system, right? 

So when we remove all of those costs, and put delivery back in the national health care system – so I mean, in some of these health care compacts, some of the stuff we’re working on is finally getting HIV treatment on the national health care reimbursement system and insurance system for the first time, or helping to support the rollout of a modernized medical record system that allows much better data granularity and much more efficiency in the delivery of care.

What we see with the NGOs often is that what we’ll do is you contract with the NGO, and then they actually bid out and they use a faith-based hospital or a national health care system as the delivery mechanism anyway, and they’re just taking sort of some money as a middleman.  So, when you cut out all of those costs and you put responsibility where it belongs, which is in the hands of the national health care system and the government, what you see is you actually have a lot more money available.  You have efficiencies and you have cost savings, but you also have more money to invest in groundbreaking commodities and medical innovations, biopharmaceutical innovations, like lenacapavir.  So actually, the – Gilead is generously donating this drug to us without profit for delivery in these high-burden countries, but the cost of this medication, the cost of commodities generally pales in comparison to all the waste that we saw with the technical assistance and NGO overhead running those parallel delivery systems. 

So, I think the hope with the strategy here is that – and this is what we’re seeing in the negotiations that we have ongoing with 70 countries right now – is that we actually have more to contribute to commodities and more to contribute to innovation by really focusing the delivery on the national health care systems.

MS HOUSTON:  Okay, we’ll end today’s call with one final question.  This looks like it’s going to go back to Jonathan Lambert from NPR.  Jonathan, I’d like to you to round us out.  

QUESTION:  Thank you.  I wonder if you can say anything about whether the first doses that are being delivered will be targeted to certain populations and if they come with kind of strings attached or if it’ll just be up to the national departments of health.  Thanks.

MR LEWIN:  I think that the Trump Administration is focused on mother-to-child transmission.  Some these doses are funded by the Global Fund.  Some are funded by the Department of State and our integrated supply line in most of these places – Eswatini, Zambia.  So, they’re not coming with formal constraints, but at least from the State Department, PEPFAR perspective, we are encouraging countries to allocate as many doses as possible to mother-to-child transmission prevention. 

MR SANDS:  To add from a Global Fund perspective, I mean, the fundamental approach the Global Fund takes is to follow the epidemiology.  So, we will be working – we are working with our in-country partners to work out where we can get the most impact from deployment of this incredibly powerful tool.  And that does mean focusing very much on the people who are most at risk, and that will differ depending on which country you’re talking about. 

MS HOUSTON:  That’s great.  Everyone, I just want to say thank you on behalf of the Department of State.  This has been a fantastic call with wonderful turnout from our press colleagues.  To our panelists, once again, we appreciate your time in providing insight on the speed and progress of this important global health initiative and partnership.  We are grateful to our press contacts, once again, for joining and for your invaluable contributions to U.S. health policy.