MODERATOR: Good morning and welcome, everybody, to as we speak’s press briefing from the U.S. Department of State’s Africa Media Hub. Today, we’re discussing the America First Global Health Strategy and the U.S. Government’s dedication to meaningfully cut back the variety of new HIV infections. This initiative is led by the U.S. Department of State in shut coordination with the American firm Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, displaying what is feasible when the United States Government, business, and international establishments unite round a shared goal.
My title is Philip Assis and I’m the director of the Africa Media Hub. Before we start, I want to state that as we speak’s name is on the file, and all remarks could also be attributed to every speaker by title and title.
Today, we’re very happy 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 convention room at the ministry of well being in Eswatini, the place the Lenacapavir is being rolled out as we speak, we additionally welcome the chairman of the board of administrators and chief govt officer of Gilead Sciences, Daniel O’Day, and the govt director of the Global Fund, Peter Sands.
We’ll start as we speak with opening remarks from our audio system, and then we are going to flip to your questions. And we we’ll get to as a lot of your questions as we will throughout the time we now have.
With that, I’d like to show to Senior Advisor Brad Smith in your opening remarks. Thank you.
MR SMITH: Thank you a lot, Philip, and it’s nice to be right here nearly with Peter and Dan, who’ve develop into good buddies by means of this work. Over the previous a number of many years, America’s funding in Africa has saved tens of millions of lives, helped remodel economies, and bolstered native well being programs. That mentioned, the U.S. historic strategy to international well being applications has not completed sufficient to maneuver Africa towards self-reliance and constructing sustainable and sturdy well being programs.
The America First Global Health Strategy that we rolled out in September transforms America’s international well being work into one centered on strengthening African well being programs and strengthening market-driven partnerships like we’re right here as we speak to speak about.
Under this technique, America will proceed to be the world’s international well being chief. However, we are going to achieve this in partnership with African governments. As they improve their funding of home assets in well being, the U.S. will make strategic investments that assist construct capability in native well being programs and that assist fund frontline providers and supply. We may also focus on leveraging American expertise management to help Africa whereas opening markets to American innovation.
Today’s announcement represents the better of our partnership with Africa. We’re right here as we speak to particularly have fun the historic subsequent step in the United States Government’s partnership with the Global Fund and Gilead to supply Lenacapavir to high-burden HIV international locations. Lenacapavir, as a lot of , is a brand new, extremely efficient HIV prevention injection that solely must be taken twice a 12 months. With the potential to avert almost one hundred pc of latest HIV infections, Lenacapavir has the potential for top affect when deployed in high-incidence geographies. Lenacapavir is an American innovation from an American firm, and it demonstrates American excellence in science and management in HIV prevention.
The U.S. Department of State and Global Fund are collaboratively shopping for over $2 million – or 2 million doses of Lenacapavir. We initially meant to purchase 500 doses in 12 months one among the program; nonetheless, as a consequence of the early demand indicators we have been receiving from international locations in Africa and round the world, however largely in Africa, we’re rising the U.S. dedication from 250,000 doses to 325,000 doses in 12 months one, 2026. Gilead’s accessible quantity in 2026 is 600,000 doses, and with the U.S.’s elevated dedication alongside the dedication from the Global Fund, we collectively have reserved one hundred pc of these 600,000 doses.
We anticipate a continued improve in demand and manufacturing functionality over time to assist us allow to fulfill the 2 million doses someday in mid-2027, or hopefully earlier than. As Philip talked about, the first of those purchases and deliveries is happening as we speak in the Kingdom of Eswatini. Eswatini is one among the international locations that’s been most affected by HIV. At the peak of the epidemic in 2015, virtually one out of three individuals have been dwelling with HIV. Today, Eswatini stands proudly as one among the international locations that has surpassed the 95-95 targets, with a outstanding 98 p.c of individuals dwelling with HIV on remedy.
Recent estimates point out that there are 220,000 individuals dwelling with HIV in Eswatini. PEPFAR, the U.S. Government program, presently funds remedy for 216,000 of those individuals – over 95 p.c of the individuals in Eswatini who’re receiving remedy is funded by PEPFAR. Nonetheless, the threat of buying HIV stays excessive. This new part of programming with Lenacapavir will help over 6,000 individuals at excessive threat of HIV in Eswatini with a spotlight on eliminating transmission of HIV from moms to their newborns.
In Eswatini, the U.S. Government and Global Fund have developed an built-in distribution course of for merchandise in coordination with the authorities that may leverage PEPFAR-supported provide chains to ship Lenacapavir to the sufferers who want it.
We’re actually excited to be right here as we speak, very excited to be celebrating with Peter and Dan, and with that, I’ll flip it over to them for feedback.
MODERATOR: Great. Thank you. Thank you a lot, Senior Advisor Smith. And subsequent we welcome the CEO of Gilead Sciences, Daniel O’Day.
MR O’DAY: Thank you, I’m actually honored to be right here as we speak in Eswatini. Great to be on this specific session right here with Brad and Becky and Peter. I simply need to say it’s fairly a rare second to be right here. I truly simply arrived. It’s the first time in historical past {that a} new HIV drugs is reaching a rustic in Sub-Saharan Africa in the similar 12 months as approval in the United States. I believe that is extraordinary. It units a brand new bar for international entry, and it’s one thing that Gilead Sciences, along with our companions, we’ve been working on for a few years to attain.
The focus all together with this groundbreaking drugs has been on velocity and partnership in the service of reaching the communities most affected round the globe with this groundbreaking innovation to struggle the illness and actually assist to finish the HIV epidemic.
I do know I converse on behalf of all my colleagues once I say that each one of us at Gilead Sciences are very proud that due to our work with the U.S. Government, through PEPFAR, and our work with the Global Fund, we will present Lenacapavir at no revenue to Gilead to the international locations with the highest burden of HIV.
It’s very significant that a few of the first provides are reaching Eswatini as we speak, the truth is. This is the nation with the highest incidence of HIV in the world. So, we’re very happy that Lenacapavir – the world’s first twice-yearly HIV prevention, greater than 17 years in the making – is now going to be part of the efforts to finish HIV on this nation. Thank you.
MODERATOR: Thank you. Thank you, CEO Daniel O’Day. And lastly, Global Fund Executive Director Peter Sands, the flooring is yours.
MR SANDS: Thank you, and it’s nice to be bodily alongside Dan of Gilead and nearly alongside Becky and Brad, as a result of it’s been this partnership that’s making issues occur.
Look, improvements are the key to accelerating progress towards the deadliest infectious ailments, however they solely have an effect if they are often deployed at scale and at velocity to the individuals who can profit the most – and that’s precisely what collectively we’re doing right here. And look, it’s an actual privilege to be right 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 beneath the phrases of the international entry settlement we signed earlier this 12 months.
Lenacapavir is a game-changer. There’s no manner of understating – it’s a incredible achievement by the scientists at Gilead. It brings ahead the promise of ending HIV as a public well being menace in a really, very quick time if we deploy at scale and at velocity. And that’s not nearly saving – not nearly saving tens of millions of lives and decreasing the burden on communities, however it’s additionally about making it way more possible for international locations to transition to nationally owned, nationally financed programs for well being not reliant on exterior help.
If I could also be permitted a small commercial, later this week it’s the Global Fund replenishment, and this – what’s taking place proper now with Lenacapavir is a incredible instance of the energy of this distinctive public-private partnership: the energy of having the ability to speed up entry to improvements, to save lots of lives, cut back the burden of the illness, and speed up international locations’ journey on the path to self-reliance. So it is a nice second and an awesome partnership.
MODERATOR: Thank you for that. Appreciate that. Thank you to all of our audio system, and now we are going to start the question-and-answer portion of as we speak’s briefing.
Our first query comes from – and apologies if I mispronounce your names or media affiliation – however 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 pleased to begin and then Peter can soar in. Yes, the Global Fund and the U.S. Government are coordinating very intently collectively and with Gilead on this. In normal, we’re splitting the procurement roughly 50/50. We are understanding between ourselves precisely who will distribute and procure for which nation; in lots of instances we’re each procuring a set of doses for particular person international locations. When the medication arrive in the nation, we’re working with the authorities to find out the provide chain and the distribution system that we’ll be utilizing. In many instances, they’re PEPFAR or U.S. Government-supported provide chains, however it’s actually a collaboration between ourselves, the Global Fund, and every particular person nation to determine how we most successfully distribute the medication out.
But with that, Peter, you may need to add to that.
MR SANDS: No, I believe you’ve captured it completely, Brad. I imply, that is – and it’s going to be a dynamic collaboration working at the side of governments and communities on the floor in order that we collectively be sure that we’re making the most of this innovation and supporting the sensible implementation. But it’s very a lot a shared accountability as we work collectively.
MODERATOR: Great. Okay, thanks. Our subsequent query comes from Mr. Hassifu Ssekiwunga from BBS TV in Uganda. “Are there any side effects of using this” – utilizing 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, that is Daniel O’Day. I’d say that this has been studied in very giant scientific trials throughout each inhabitants that would profit from PrEP in international locations round the world. Lenacapavir has been proven to have excellent tolerability. It’s extremely efficacious. In one study it was one hundred pc of members didn’t contract HIV that have been on the study drugs. In one other study it was 99 p.c of sufferers, of individuals, didn’t contract HIV. And all had very tolerable side-effect profiles, and all people remained on the drugs additionally after the conclusion of the study.
This drugs doesn’t have any addictive properties to it. It has no addictive nature to it. And what’s vital about this drugs is that individuals keep compliant with it. So it’s efficient for six months. Working with the Global Fund and with PEPFAR to be sure that on the floor we now have applicable well being programs that remind individuals to return again each six months, as a result of you must take the drugs each six months to be totally protected towards HIV. That’s the nature of the trial and the manner that the drugs works. Thank you.
MODERATOR: Thank you. Thank you. Our subsequent query 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 pleased to begin with that and then let others soar in. The first doses are being delivered as we speak, so clearly it’s very early in the course of. But I’ll converse extra broadly. The new Global Health Strategy from the U.S. Government is de facto centered on serving to transfer international locations to extra self-reliance over time and additionally deploying progressive applied sciences, and we expect that’s going to be new for the U.S. Government and in some ways new for the international locations that we’re working with, a minimum of the velocity and scale at which we’re doing that. And we expect sharing classes throughout international locations goes to be a extremely vital part of that work, whether or not it’s round Lenacapavir, whether or not it’s round improve home assets for well being, or all kinds of different matters. So, we together with the Global Fund and others are actually dedicated to serving to facilitate that dialogue throughout completely different international locations, though we all know that international locations will naturally try this. They’re already choosing up the cellphone and calling one another to say, hey, how are you pondering of this, about this, how are you desirous about that?
But perhaps, Becky, do you need to converse to – from different deployments of long-acting HIV medicines, a few of the classes that we’ve realized?
MS BUNNELL: Sure. I believe we’ve realized that to maximise the affect, we now have to be sure that we actually do focus on these geographies most in danger and that we do good demand creation. And once we try this, we’re capable of not solely present the long-acting prevention, but additionally we invigorate our efforts to get individuals examined, to determine individuals with undiagnosed HIV an infection and get them on remedy. So, there are all these further advantages that come from this innovation. And it actually generally is a catalytic instrument to assist us in our efforts to finish mother-to-child transmission by focusing on ladies of reproductive age, on ladies who’re pregnant and breastfeeding. We actually might help international locations obtain that objective.
MODERATOR: Thank you. One extra query from Zimbabwe —
MR SANDS: Can I simply —
MODERATOR: Sorry. Yes.
MR SANDS: Can I simply soar in right here very briefly?
MODERATOR: Please do. Of course.
MR SANDS: I imply, I believe it’s vital to – constructing on the level – the alternatives for one nation to study from one other are very robust, additionally to study from the expertise with different PrEP instruments, together with oral PrEP. And Zimbabwe has appreciable expertise with oral PrEP. And one among the huge benefits of Lenacapavir is that it addresses a few of the impediments to efficient utilization of oral PrEP, be it stigma or be it adherence. And so there’s so much to be realized each from the oral PrEP expertise and from different international locations. Sorry – thanks.
MODERATOR: No, thanks. That’s very useful. Thank you.
Mr. Farai Mutsaka from the Associated Press in Zimbabwe asks: “How many countries in Africa” – I consider you probably did tackle this already, however, “How many countries in Africa will eventually benefit and what are the quantities?” If you wouldn’t thoughts repeating that.
MR SMITH: Yeah, so we’re beginning with 10 international locations in Africa. The procurement for 2026 is 600,000 doses; that’s all of Gilead’s capability for the 12 months. Our hope is over time, and the plan is over time, that each Gilead’s capability will proceed to extend in order that we will procure 2 million doses by the center of 2027, however we additionally consider that demand will improve in Africa. We’ve already seen very robust demand alerts, many international locations wanting entry to Lenacapavir, and that’s part of the purpose that we’re rising our preliminary buy from the 250,000 to the 325,000. And so, what we hope occurs over the subsequent 12 months or two is de facto to each see a rise in demand and a rise in provide. Part of the purpose that we made this funding with the Global Fund is to actually assist form the market, assist people stand up to hurry on the affect the drugs might have; and then additionally by means of a few of the work that actually the Global Fund is main, and with Gilead, serving to deliver down the value of the product over time in order that international locations themselves can have much more entry to it.
But Peter and Dan, something so as to add?
MR O’DAY: I might simply add there – thanks, Brad, and thanks for the dedication to proceed to extend provides and additionally with the Global Fund. I need to be – I need to be clear that from a Gilead perspective, we’re totally dedicated to fulfilling the demand on this time interval between now and when generics develop into accessible. And I simply need to make one level on that. So, we’re concentrating on 2 million individuals, but when it’s – if it wants greater than that and we will implement extra, we now have the functionality to supply extra.
But the sustainable mannequin, which is de facto vital, is what we did – once more, first time ever that we – voluntary license (inaudible) to 6 generic producers proper after the scientific trial outcomes got here out and earlier than we ever even filed in the United States, and then expertise transferred the product to these six generic producers. As a results of that, we anticipate that generic producers will start to have the ability to provide markets as early as 2027. And there are different companions we’re working with, like the Gates Foundation and additionally CHAI and others, which might be working to help these generic producers to be sure that they’ve applicable demand to have the ability to finally provide sustainably by means of a generic program, which, to Brad’s level, can be at a considerably decreased value to even what Gilead can produce. And that’s the sustainable mannequin over time to finish the epidemic all through the world.
MODERATOR: Great, thanks. I’d prefer to ask a query that is available in from Mr. Favour Ulebor from the Vanguard newspaper in Abuja, Nigeria, who says it’s very laudable from the U.S. Government, however he’s asking if this medicine has already been examined in the United States. And associated to that, why Africa? Why present this vaccine to Africa instantly after its manufacturing or after it’s been permitted?
MR SMITH: Dan, you need to take that one?
MR O’DAY: Well, perhaps I’ll simply begin – that is Dan – to say that this drugs was examined for years in America, in the United States, and in Europe. But importantly, the very first trial to point out the impact of this drugs was truly completed in Sub-Saharan Africa. Really, the largest inhabitants of individuals contracting HIV in Africa, they account for greater than two-thirds of latest HIV infections in the nation – ladies aged 15 to round 24. And then that’s what this Purpose 1 trial, the first trial that confirmed this impact was completed in hundreds of girls and ladies in Africa, and that’s the study that confirmed one hundred pc effectiveness at stopping HIV in that inhabitants. Purpose 2, which was the second trial that was completed in parallel to Purpose 1, was completed in different international locations round the world with different populations. And these two research, these two essential research – and we now have others going on – are the supply of the regulatory approvals in the United States and in international locations right here in Africa and round the world.
MODERATOR: Great, thanks. We have time for only one final query, and the query has requested – truly been requested by two of our members, one from the BBC in Nairobi, Kenya – that’s Anne Soy – and additionally from Michael Gwarisa and the Health Times in Zimbabwe, which is: What is the standards that you simply use to pick out these 6,000 people? What particular teams are you prioritizing, and who will get precedence?
MR SMITH: So I can begin and then others can hop in. So, the first step was allocating by nation, and we typically checked out HIV illness burden and are allocating the medicines to the international locations with the highest burden of HIV. Within the nation, we’re working with every nation authorities to develop a distribution plan that might goal the highest-burden subgeographies or populations inside the nation. But it’s actually a partnership with the authorities to determine goal the distribution inside the nation.
But Peter, something you need to add?
MR SANDS: Yeah, I believe that’s completely proper. I imply, basically to maximise the affect of this innovation, we have to observe the epidemiology and we must be defending the people who find themselves most in danger, and that drives each the allocation throughout international locations however it additionally drives the prioritization inside a rustic of who’s going to be – who’s going to be prioritized for Lenacapavir. And as Brad says, international locations are effectively superior – I do know Zimbabwe, for instance, has made a variety of progress on creating a nationwide introduction plan, like many others. And so that they’re effectively superior and we’re working with them, we and PEPFAR and collectively are working with them on precisely the way it’s going to be carried out.
MODERATOR: Great. Thank you. Before we wrap up, I want to flip the flooring again to Senior Advisor Brad Smith for any ultimate phrases.
MR SMITH: Yeah, thanks a lot. Thanks to you all for becoming a member of us as we speak. As you’ve heard, the Trump Administration could be very dedicated to creating focused and high-impact investments and breakthrough well being improvements like Lenacapavir that we all know will each bend the curve of the HIV epidemic and assist African international locations lower their reliance on exterior well being help thoughtfully and over time. The United States is proud to be a champion of American biomedical achievements identical to Lenacapavir alongside the Global Fund, and we are going to proceed to make catalytic investments like the one we mentioned as we speak in the future. So once more, thanks all a lot in your time this morning.
MODERATOR: Thank you very a lot. That concludes as we speak’s briefing. I do need to thank once more 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 additionally the Principal Deputy Assistant Secretary for the Bureau Becky Bunnell, and additionally I’d prefer to thank the chairman of the board of administrators and the CEO of Gilead Sciences, Daniel O’Day, and the govt director of the Global Fund, Peter Sands, for all becoming a member of us. But thanks as effectively, journalists, for collaborating on this name as we speak. A recording and a transcript of as we speak’s briefing can be distributed to all journalists who’ve registered for this name as quickly as we produce them as we speak. If you’ve any questions on as we speak’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 when you publish any articles or broadcasts from as we speak’s briefing, please do share a hyperlink with us at the similar e-mail. I’d additionally like to ask everybody to observe us on Twitter at our deal with – or on X, excuse me – which is AfricaMediaHub.
Thank you all and I want you day. Thank you.
Original (*18*) and Audio may be discovered at the U.S. State department website
