Brad Smith, Senior Advisor, Bureau of Global Health Security and Diplomacy

Becky Bunnell, Principal Deputy Assistant Secretary, Bureau of Global Health Security and Diplomacy

Daniel O’Day, Chairman of the Board of Directors and CEO of Gilead Sciences

Peter Sands, Executive Director of the Global Fund to Fight AIDS, Tuberculosis, and Malaria

Africa Regional Media Hub

MODERATOR:  Good morning and welcome, everyone, to today’s press briefing from the U.S. Department of State’s Africa Media Hub.  Today, we are discussing the America First Global Health Strategy and the U.S. Government’s commitment to meaningfully reduce the number of new HIV infections.  This initiative is led by the U.S. Department of State in close coordination with the American company Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, showing what is possible when the United States Government, industry, and global institutions unite around a shared purpose.

My name is Philip Assis and I’m the director of the Africa Media Hub.  Before we begin, I would like to state that today’s call is on the record, and all remarks may be attributed to each speaker by name and title.

Today, we are very pleased to welcome the Principal Deputy Assistant Secretary, or PDAS, for the U.S. Department of State’s Bureau of Global Health Security and Diplomacy Becky Bunnell, and the Senior Advisor for the Bureau of Global Health Security and Diplomacy Brad Smith.  Joining from a conference room at the ministry of health in Eswatini, where the Lenacapavir is being rolled out today, we also welcome the chairman of the board of directors and chief executive officer of Gilead Sciences, Daniel O’Day, and the executive director of the Global Fund, Peter Sands.

We’ll begin today with opening remarks from our speakers, and then we will turn to your questions.  And we we’ll get to as many of your questions as we can during the time we have.

With that, I’d like to turn to Senior Advisor Brad Smith for your opening remarks.  Thank you.

MR SMITH:  Thank you so much, Philip, and it’s great to be here virtually with Peter and Dan, who have become good friends through this work.  Over the past several decades, America’s investment in Africa has saved millions of lives, helped transform economies, and bolstered local health systems.  That said, the U.S. historical approach to global health programs has not done enough to move Africa toward self-reliance and building sustainable and durable health systems.

The America First Global Health Strategy that we rolled out in September transforms America’s global health work into one focused on strengthening African health systems and strengthening market-driven partnerships like we’re here today to talk about.

Under this strategy, America will continue to be the world’s global health leader.  However, we will do so in partnership with African governments.  As they increase their investment of domestic resources in health, the U.S. will make strategic investments that help build capacity in local health systems and that help fund frontline services and delivery.  We will also focus on leveraging American technology leadership to support Africa while opening markets to American innovation.

Today’s announcement represents the best of our partnership with Africa.  We’re here today to specifically celebrate the historic next step in the United States Government’s partnership with the Global Fund and Gilead to provide Lenacapavir to high-burden HIV countries.  Lenacapavir, as many of you know, is a new, highly effective HIV prevention injection that only has to be taken twice a year.  With the ability to avert nearly 100 percent of new HIV infections, Lenacapavir has the potential for high impact when deployed in high-incidence geographies.  Lenacapavir is an American innovation from an American company, and it demonstrates American excellence in science and leadership in HIV prevention.

The U.S. Department of State and Global Fund are collaboratively buying over $2 million – or 2 million doses of Lenacapavir.  We initially intended to buy 500 doses in year one of the program; however, due to the early demand signs we were receiving from countries in Africa and around the world, but mostly in Africa, we are increasing the U.S. commitment from 250,000 doses to 325,000 doses in year one, 2026.  Gilead’s available volume in 2026 is 600,000 doses, and with the U.S.’s increased commitment alongside the commitment from the Global Fund, we together have reserved 100 percent of those 600,000 doses.

We anticipate a continued increase in demand and production capability over time to help us enable to meet the 2 million doses sometime in mid-2027, or hopefully before.  As Philip mentioned, the first of these purchases and deliveries is taking place today in the Kingdom of Eswatini.  Eswatini is one of the countries that’s been most affected by HIV.  At the peak of the epidemic in 2015, almost one out of three people were living with HIV.  Today, Eswatini stands proudly as one of the countries that has surpassed the 95-95 targets, with a remarkable 98 percent of people living with HIV on treatment.

Recent estimates indicate that there are 220,000 people living with HIV in Eswatini.  PEPFAR, the U.S. Government program, currently funds treatment for 216,000 of these people – over 95 percent of the people in Eswatini who are receiving treatment is funded by PEPFAR.  Nonetheless, the risk of acquiring HIV remains high.  This new phase of programming with Lenacapavir will support over 6,000 people at high risk of HIV in Eswatini with a focus on eliminating transmission of HIV from mothers to their newborns.

In Eswatini, the U.S. Government and Global Fund have developed an integrated distribution process for products in coordination with the government that will leverage PEPFAR-supported supply chains to deliver Lenacapavir to the patients who need it.

We’re really excited to be here today, very excited to be celebrating with Peter and Dan, and with that, I will turn it over to them for comments.

MODERATOR:  Great.  Thank you.  Thank you so much, Senior Advisor Smith.  And next we welcome the CEO of Gilead Sciences, Daniel O’Day.

MR O’DAY:  Thank you, I’m really honored to be here today in Eswatini.  Great to be on this particular session here with Brad and Becky and Peter.  I just want to say it’s quite an extraordinary moment to be here.  I actually just arrived.  It’s the first time in history that a new HIV medicine is reaching a country in Sub-Saharan Africa in the same year as approval in the United States.  I think this is extraordinary.  It sets a new bar for global access, and it’s something that Gilead Sciences, in addition to our partners, we’ve been working on for many years to achieve.

The focus all along with this groundbreaking medicine has been on speed and partnership in the service of reaching the communities most affected around the globe with this groundbreaking innovation to fight the disease and really help to end the HIV epidemic.

I know I speak on behalf of all my colleagues when I say that all of us at Gilead Sciences are very proud that because of our work with the U.S. Government, via PEPFAR, and our work with the Global Fund, we can provide Lenacapavir at no profit to Gilead to the countries with the highest burden of HIV.

It’s very meaningful that some of the first supplies are reaching Eswatini today, in fact.  This is the country with the highest incidence of HIV in the world.  So, we’re very pleased that Lenacapavir – the world’s first twice-yearly HIV prevention, more than 17 years in the making – is now going to be part of the efforts to end HIV in this country.  Thank you.

MODERATOR:  Thank you.  Thank you, CEO Daniel O’Day.  And finally, Global Fund Executive Director Peter Sands, the floor is yours.

MR SANDS:  Thank you, and it’s great to be physically alongside Dan of Gilead and virtually alongside Becky and Brad, because it’s been this partnership that is making things happen.

Look, innovations are the key to accelerating progress against the deadliest infectious diseases, but they only have an impact if they can be deployed at scale and at speed to the people who can benefit the most – and that’s exactly what together we are doing here.  And look, it’s a real privilege to be here in Eswatini witnessing the first deliveries of Lenacapavir.  These are the first tranche of Lenacapavir injectables that the Global Fund has procured from Gilead under the terms of the global access agreement we signed earlier this year.

Lenacapavir is a game-changer.  There’s no way of understating – it’s a fantastic achievement by the scientists at Gilead.  It brings forward the promise of ending HIV as a public health threat in a very, very short time if we deploy at scale and at speed.  And that’s not just about saving – not just about saving millions of lives and reducing the burden on communities, but it’s also about making it much more feasible for countries to transition to nationally owned, nationally financed systems for health no longer reliant on external support.

If I may be permitted a small advertisement, later this week it’s the Global Fund replenishment, and this – what’s happening right now with Lenacapavir is a fantastic example of the power of this unique public-private partnership: the power of being able to accelerate access to innovations, to save lives, reduce the burden of the disease, and accelerate countries’ journey on the path to self-reliance.  So this is a great moment and a great partnership.

MODERATOR:  Thank you for that.  Appreciate that.  Thank you to all of our speakers, and now we will begin the question-and-answer portion of today’s briefing.

Our first question comes from – and apologies if I mispronounce your names or media affiliation – but Ms. Mia Malan from the Bhekisisa Centre for Health Journalism in South Africa asks:  “Will the commitment to reach 2 million people with Lenacapavir be shared between the Global Fund and PEPFAR, and if so, which body will provide it and how many doses and which – will it be for the same group of countries from both sides?”

MR SMITH:  I’m happy to start and then Peter can jump in.  Yes, the Global Fund and the U.S. Government are coordinating very closely together and with Gilead on this.  In general, we’re splitting the procurement approximately 50/50.  We are working out between ourselves exactly who will distribute and procure for which country; in many cases we’re both procuring a set of doses for individual countries.  When the drugs arrive in the country, we’re working with the government to determine the supply chain and the distribution system that we’ll be using.  In many cases, they’re PEPFAR or U.S. Government-supported supply chains, but it’s really a collaboration between ourselves, the Global Fund, and each individual country to figure out how we most effectively distribute the drugs out.

But with that, Peter, you might want to add to that.

MR SANDS:  No, I think you’ve captured it perfectly, Brad.  I mean, this is – and it’s going to be a dynamic collaboration working in conjunction with governments and communities on the ground so that we together ensure that we’re making the most of this innovation and supporting the practical implementation.  But it’s very much a shared responsibility as we work together.

MODERATOR:  Great.  Okay, thank you.  Our next question comes from Mr. Hassifu Ssekiwunga from BBS TV in Uganda.  “Are there any side effects of using this” – using Lenacapavir – “for a long time?  Is it addictive, and what happens if someone does not use it in the proper order, every six months?”

MR O’DAY:  Right, this is Daniel O’Day.  I would say that this has been studied in very large clinical trials across every population that could benefit from PrEP in countries around the world.  Lenacapavir has been shown to have very good tolerability.  It’s highly efficacious.  In one study it was 100 percent of participants did not contract HIV that were on the study medicine.  In another study it was 99 percent of patients, of people, did not contract HIV.  And all had very tolerable side-effect profiles, and everybody remained on the medicine also after the conclusion of the study.

This medicine does not have any addictive properties to it.  It has no addictive nature to it.  And what is important about this medicine is that people stay compliant with it.  So it is effective for six months.  Working with the Global Fund and with PEPFAR to make sure that on the ground we have appropriate health systems that remind people to come back every six months, because you need to take the medicine every six months to be fully protected against HIV.  That’s the nature of the trial and the way that the medicine works.  Thank you.

MODERATOR:  Thank you.  Thank you.  Our next question is from Mr. Michael Gwarisa of the Health Times in Zimbabwe, who asks:  “What lessons from Eswatini’s rollout could Zimbabwe and other African countries adopt to maximize the impact of Lenacapavir?”

MR SMITH:  I’m happy to start with that and then let others jump in.  The first doses are being delivered today, so obviously it’s very early in the process.  But I’ll speak more broadly.  The new Global Health Strategy from the U.S. Government is really focused on helping move countries to more self-reliance over time and also deploying innovative technologies, and we think that’s going to be new for the U.S. Government and in many ways new for the countries that we’re working with, at least the speed and scale at which we’re doing that.  And we think sharing lessons across countries is going to be a really important part of that work, whether it’s around Lenacapavir, whether it’s around how to increase domestic resources for health, or a wide variety of other topics.  So, we along with the Global Fund and others are really committed to helping facilitate that discussion across different countries, although we know that countries will naturally do that.  They’re already picking up the phone and calling each other to say, hey, how are you thinking of this, about this, how are you thinking about that?

But maybe, Becky, do you want to speak to – from other deployments of long-acting HIV medications, some of the lessons that we’ve learned?

MS BUNNELL:  Sure.  I think we’ve learned that to maximize the impact, we have to make sure that we really do focus on those geographies most at risk and that we do good demand creation.  And when we do that, we are able to not only provide the long-acting prevention, but also we invigorate our efforts to get people tested, to identify people with undiagnosed HIV infection and get them on treatment.  So, there are all these additional benefits that come from this innovation.  And it really can be a catalytic tool to help us in our efforts to end mother-to-child transmission by focusing on women of reproductive age, on women who are pregnant and breastfeeding.  We really can help countries achieve that goal.

MODERATOR:  Thank you.  One more question from Zimbabwe —

MR SANDS:  Can I just —

MODERATOR:  Sorry.  Yes.

MR SANDS:  Can I just jump in here very briefly?

MODERATOR:  Please do.  Of course.

MR SANDS:  I mean, I think it’s important to – building on the point – the opportunities for one country to learn from another are very strong, also to learn from the experience with other PrEP tools, including oral PrEP.  And Zimbabwe has considerable experience with oral PrEP.  And one of the big advantages of Lenacapavir is that it addresses some of the impediments to effective utilization of oral PrEP, be it stigma or be it adherence.  And so there’s a lot to be learned both from the oral PrEP experience and from other countries.  Sorry – thank you.

MODERATOR:  No, thank you.  That’s very helpful.  Thank you.

Mr. Farai Mutsaka from the Associated Press in Zimbabwe asks:  “How many countries in Africa” – I believe you did address this already, but, “How many countries in Africa will eventually benefit and what are the quantities?”  If you wouldn’t mind repeating that.

MR SMITH:  Yeah, so we’re starting with 10 countries in Africa.  The procurement for 2026 is 600,000 doses; that is all of Gilead’s capacity for the year.  Our hope is over time, and the plan is over time, that both Gilead’s capacity will continue to increase so that we can procure 2 million doses by the middle of 2027, but we also believe that demand will increase in Africa.  We’ve already seen very strong demand signals, many countries wanting access to Lenacapavir, and that’s part of the reason that we’re increasing our initial purchase from the 250,000 to the 325,000.  And so, what we hope happens over the next year or two is really to both see an increase in demand and an increase in supply.  Part of the reason that we made this investment with the Global Fund is to really help shape the market, help folks get up to speed on the impact the medicine could have; and then also through some of the work that really the Global Fund is leading, and with Gilead, helping bring down the price of the product over time so that countries themselves can have even more access to it.

But Peter and Dan, anything to add?

MR O’DAY:  I could just add there – thanks, Brad, and thanks for the commitment to continue to increase supplies and also with the Global Fund.  I want to be – I want to be clear that from a Gilead perspective, we’re fully committed to fulfilling the demand in this time period between now and when generics become available.  And I just want to make one point on that.  So, we’re targeting 2 million people, but if it’s – if it needs more than that and we can implement more, we have the capability to produce more.

But the sustainable model, which is really important, is what we did – again, first time ever that we – voluntary license (inaudible) to six generic manufacturers right after the clinical trial results came out and before we ever even filed in the United States, and then technology transferred the product to those six generic manufacturers.  As a result of that, we anticipate that generic manufacturers will begin to be able to supply markets as early as 2027.  And there are other partners we’re working with, like the Gates Foundation and also CHAI and others, that are working to support those generic manufacturers to make sure that they have appropriate demand to be able to eventually supply sustainably through a generic program, which, to Brad’s point, would be at a significantly reduced cost to even what Gilead can produce.  And that’s the sustainable model over time to end the epidemic throughout the world.

MODERATOR:  Great, thank you.  I’d like to ask a question that comes in from Mr. Favour Ulebor from the Vanguard newspaper in Abuja, Nigeria, who says it’s very laudable from the U.S. Government, but he’s asking if this medication has already been tested in the United States.  And related to that, why Africa?  Why provide this vaccine to Africa immediately after its production or after it’s been approved?

MR SMITH:  Dan, you want to take that one?

MR O’DAY:  Well, maybe I’ll just start – this is Dan – to say that this medicine was tested for years in America, in the United States, and in Europe.  But importantly, the very first trial to show the effect of this medicine was actually done in Sub-Saharan Africa.  Really, the largest population of people contracting HIV in Africa, they account for more than two-thirds of new HIV infections in the country – women aged 15 to around 24.  And then that is what this Purpose 1 trial, the first trial that showed this effect was done in thousands of women and girls in Africa, and that’s the study that showed 100 percent effectiveness at preventing HIV in that population.  Purpose 2, which was the second trial that was done in parallel to Purpose 1, was done in other countries around the world with other populations.  And those two studies, those two main studies – and we have others going on – are the source of the regulatory approvals in the United States and in countries here in Africa and around the world.

MODERATOR:  Great, thank you.  We have time for just one last question, and the question has asked – actually been asked by two of our participants, one from the BBC in Nairobi, Kenya – that’s Anne Soy – and also from Michael Gwarisa and the Health Times in Zimbabwe, which is:  What is the criteria that you use to select these 6,000 individuals?  What specific groups are you prioritizing, and who gets priority?

MR SMITH:  So I can start and then others can hop in.  So, the first step was allocating by country, and we generally looked at HIV disease burden and are allocating the medications to the countries with the highest burden of HIV.  Within the country, we’re working with each country government to develop a distribution plan that would target the highest-burden subgeographies or populations within the country.  But it’s really a partnership with the government to figure out how to target the distribution within the country.

But Peter, anything you want to add?

MR SANDS:  Yeah, I think that’s absolutely right.  I mean, essentially to maximize the impact of this innovation, we need to follow the epidemiology and we need to be protecting the people who are most at risk, and that drives both the allocation across countries but it also drives the prioritization within a country of who is going to be – who is going to be prioritized for Lenacapavir.  And as Brad says, countries are well advanced – I know Zimbabwe, for example, has made a lot of progress on developing a national introduction plan, like many others.  And so they’re well advanced and we are working with them, we and PEPFAR and together are working with them on exactly how it’s going to be implemented.

MODERATOR:  Great.  Thank you.  Before we wrap up, I would like to turn the floor back to Senior Advisor Brad Smith for any final words.

MR SMITH:  Yeah, thank you so much.  Thanks to you all for joining us today.  As you’ve heard, the Trump Administration is very committed to making targeted and high-impact investments and breakthrough health innovations like Lenacapavir that we know will both bend the curve of the HIV epidemic and help African countries decrease their reliance on external health assistance thoughtfully and over time.  The United States is proud to be a champion of American biomedical achievements just like Lenacapavir alongside the Global Fund, and we will continue to make catalytic investments like the one we discussed today in the future.  So again, thank you all so much for your time this morning.

MODERATOR:  Thank you very much.  That concludes today’s briefing.  I do want to thank again Special Advisor for the Bureau of Global Health Security – Senior Advisor, excuse me, for the Bureau of Global Health Security and Diplomacy Brad Smith, and also the Principal Deputy Assistant Secretary for the Bureau Becky Bunnell, and also I’d like to thank the chairman of the board of directors and the CEO of Gilead Sciences, Daniel O’Day, and the executive director of the Global Fund, Peter Sands, for all joining us.  But thank you as well, journalists, for participating in this call today.  A recording and a transcript of today’s briefing will be distributed to all journalists who have registered for this call as soon as we produce them today.  If you have any questions about today’s briefing, please contact us at the Africa Regional Media Hub – that’s AFMediaHub, A-F-M-e-d-i-a-H-u-b, @state.gov.  And if you publish any articles or broadcasts from today’s briefing, please do share a link with us at the same email.  I’d also like to invite everyone to follow us on Twitter at our handle – or on X, excuse me – which is AfricaMediaHub.

Thank you all and I wish you a good day.  Thank you.

# # #