Judul : Transcript & Audio | Nov 18 Digital Press Briefing on Lenacapavir and the America First Global Health Strategy
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Transcript & Audio | Nov 18 Digital Press Briefing on Lenacapavir and the America First Global Health Strategy
MODERATOR: Good morning and welcome, all, to today's press briefing hosted by the U.S. Department of State's Africa Media Hub. Today, we are focusing on the America First Global Health Strategy and the U.S. Government's dedication to significantly lowering the rate of new HIV infections. This effort is spearheaded by the U.S. Department of State in collaboration with the American firm Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, demonstrating what can be achieved when the U.S. Government, private sector, and international organizations work together toward a common goal.
My name is Philip Assis, and I am the director of the Africa Media Hub. Before we start, I would like to mention that today's conversation is on the record, and any comments made can be attributed to the respective speaker by their name and position.
Today, we are honored to have with us the Principal Deputy Assistant Secretary, also known as PDAS, of the U.S. Department of State's Bureau of Global Health Security and Diplomacy, Becky Bunnell, along with the Senior Advisor for the same bureau, Brad Smith. Also joining us from a conference room at the Ministry of Health in Eswatini, where Lenacapavir is being introduced today, are 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 will start today with opening comments from our speakers, followed by an opportunity for your questions. We will do our best to address as many of your inquiries as possible within the time available.
With that, I'll now invite Senior Advisor Brad Smith to deliver the opening remarks. Thank you.
MR SMITH: Many thanks, Philip, and it's wonderful to be virtually joined by Peter and Dan, who have turned into close friends through this collaboration. In recent decades, the United States' investment in Africa has saved countless lives, supported economic transformation, and strengthened local healthcare systems. However, the U.S. traditional approach to global health initiatives has not adequately promoted self-sufficiency in Africa or fostered sustainable and long-lasting health systems.
The America First Global Health Strategy, launched in September, redefines the nation's global health efforts by prioritizing the enhancement of African health systems and promoting market-oriented partnerships, such as the ones we are discussing today.
Under this approach, the United States will remain the world's leading force in global health. Nevertheless, we will achieve this by collaborating with African governments. As they boost their own funding for health initiatives, the U.S. will make targeted investments aimed at strengthening local health systems and supporting essential services and care delivery. Additionally, we will concentrate on utilizing American technological expertise to aid Africa while promoting access for American innovations in the market.
The current announcement highlights the strongest aspects of our collaboration with Africa. We are here today to specifically acknowledge the significant progress in the United States Government's partnership with the Global Fund and Gilead, aimed at delivering Lenacapavir to countries with high HIV prevalence. As many of you are aware, Lenacapavir is a novel, highly effective HIV prevention injection that requires administration only twice annually. It has the potential to prevent almost all new HIV infections, making it highly impactful when used in areas with high infection rates. Lenacapavir is an American invention developed by an American company, showcasing American excellence in scientific innovation and leadership in HIV prevention.
The U.S. Department of State and the Global Fund are jointly purchasing more than $2 million worth of 2 million doses of Lenacapavir. Initially, we planned to acquire 500 doses in the first year of the program; however, due to early indications of strong demand from countries in Africa and globally, particularly in Africa, we are raising the U.S. contribution from 250,000 doses to 325,000 doses in the first year, 2026. Gilead has a total supply of 600,000 doses in 2026, and with the U.S.'s expanded commitment combined with the Global Fund's pledge, we have secured 100% of those 600,000 doses.
We expect a growing demand and production capacity over time, which will help us achieve the 2 million doses by mid-2027, or ideally earlier. As Philip noted, the first of these purchases and deliveries is happening today in the Kingdom of Eswatini. Eswatini is among the countries most impacted by HIV. At the height of the epidemic in 2015, nearly one in three people were living with HIV. Today, Eswatini is proud to be one of the countries that has exceeded the 95-95 targets, with an impressive 98 percent of people living with HIV receiving treatment.
Current data suggests that approximately 220,000 individuals are living with HIV in Eswatini. The PEPFAR initiative, an American government program, provides treatment for 216,000 of these individuals—more than 95% of those receiving care in the country are supported by PEPFAR. However, the likelihood of contracting HIV is still significant. This new stage of programming involving Lenacapavir aims to assist over 6,000 people at high risk of HIV in Eswatini, with a particular emphasis on preventing the transmission of HIV from mothers to their infants.
In Eswatini, the U.S. Government and the Global Fund have created a combined distribution system for supplies, working alongside the government to utilize PEPFAR-backed supply networks to provide Lenacapavir to those in need.
We are truly thrilled to be here today, extremely eager to celebrate with Peter and Dan, and with that, I'll hand it over to them for their remarks.
MODERATOR: Excellent. Thank you. Many thanks, Senior Advisor Smith. And now, we welcome the CEO of Gilead Sciences, Daniel O'Day.
Mr. O'Day: Thank you, I'm truly honored to be here today in Eswatini. It's great to be part of this specific session with Brad, Becky, and Peter. I just want to say that this is an extraordinary moment for me. I actually just arrived. This is the first time in history that a new HIV medication is being introduced in a country in Sub-Saharan Africa in the same year it was approved in the United States. I believe this is remarkable. It establishes a new standard for global access, and it's something that Gilead Sciences, along with our partners, has been working towards for many years.
The main emphasis throughout this revolutionary treatment has been on rapid action and collaboration to deliver this innovative solution to the communities hardest hit by the disease worldwide, truly aiming to help put an end to the HIV epidemic.
I am certain I represent all my colleagues when I state that everyone at Gilead Sciences is deeply proud of the fact that through our collaboration with the U.S. Government via PEPFAR and our efforts with the Global Fund, we are able to offer Lenacapavir at no profit to Gilead in nations facing the greatest HIV burden.
It's highly significant that some of the initial supplies are arriving in Eswatini today. Indeed, this nation has the highest rate of HIV globally. Therefore, we are delighted that Lenacapavir—world's first twice-yearly HIV prevention method, developed over more than 17 years—is now set to contribute to the fight against HIV in this country. Thank you.
MODERATOR: Thank you. Thank you, CEO Daniel O'Day. And lastly, Executive Director of the Global Fund Peter Sands, the floor is yours.
MR SANDS: Appreciate it, and it's wonderful to be physically with Dan from Gilead and virtually with Becky and Brad, as this collaboration is driving progress.
Consider, breakthroughs are essential for speeding up advancements in combating the most severe infectious diseases, yet they only make a difference when they can be implemented widely and quickly to those who need them the most—and that's precisely what we're accomplishing together here. And let me say, it's a genuine honor to be in Eswatini, observing the initial shipments of Lenacapavir. These are the first batch of Lenacapavir injections that the Global Fund has acquired from Gilead under the conditions of the global access agreement we finalized earlier this year.
Lenacapavir represents a major breakthrough. It's impossible to overstate - it's an outstanding accomplishment by the researchers at Gilead. It accelerates the potential to eliminate HIV as a public health issue in a remarkably short period, provided it is implemented widely and quickly. This goes beyond just saving lives - it's not only about preserving millions of lives and easing the strain on communities, but also about enabling countries to shift towards locally managed, self-funded health systems that no longer depend on outside assistance.
If I may share a brief advertisement, later this week we will have the Global Fund replenishment. What is currently happening with Lenacapavir is an outstanding example of the strength of this one-of-a-kind public-private collaboration: the ability to speed up access to new innovations, save lives, lessen the impact of the disease, and help nations progress toward self-sufficiency. This is a significant opportunity and a strong partnership.
MODERATOR: Thanks for that. I appreciate it. Thank you to all our presenters, and now we will start the question-and-answer segment of today's update.
Our first question is from - and I apologize 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 pledge to assist 2 million individuals with Lenacapavir be divided between the Global Fund and PEPFAR, and if so, which organization will cover it and how many doses will be provided, and which ones - will it apply to the same set of countries from both entities?"
MR SMITH: I'm pleased to begin, and then Peter can join in. Yes, the Global Fund and the U.S. Government are working very closely together with Gilead on this. Generally, we are dividing the procurement roughly equally. We are determining among ourselves who will handle distribution and procurement for each country; in many instances, both of us are procuring a batch of doses for specific countries. Once the medications arrive in the country, we collaborate with the government to establish the supply chain and distribution method we will use. In many cases, these are PEPFAR or U.S. Government-backed supply chains, but it's essentially a joint effort between us, the Global Fund, and each individual country to decide the most efficient way to distribute the drugs.
But regarding that, Peter, you may wish to add something.
MR SANDS: No, I believe you've described it accurately, Brad. I mean, this is - and it will involve a vibrant partnership with governments and local communities so that we collectively maximize the potential of this innovation and assist in its real-world application. However, it's definitely a joint effort as we collaborate.
MODERATOR: Great. Thank you. Our next question is from Mr. Hassifu Ssekiwunga of BBS TV in Uganda. "Are there any adverse effects of using Lenacapavir over an extended period? Is it habit-forming, and what occurs if it isn't taken correctly, every six months?"
MR O'DAY: Correct, this is Daniel O'Day. I would state that this has been examined in extensive clinical trials across all populations that could gain from PrEP in nations worldwide. Lenacapavir has demonstrated excellent tolerance. It is highly effective. In one trial, 100 percent of participants did not acquire HIV while taking the study medication. In another trial, 99 percent of individuals did not contract HIV. All participants experienced manageable side effects and continued taking the medication even after the study ended.
This medication does not possess any addictive characteristics. It is also non-addictive. What is crucial regarding this medicine is that individuals adhere to it properly. It remains effective for a period of six months. Collaborating with the Global Fund and PEPFAR ensures that we have suitable health systems in place on the ground, which remind people to return every six months, as the medicine must be taken every six months to provide full protection against HIV. This is how the trial operates and how the medication functions. Thank you.
MODERATOR: Thank you. Thank you. Our next question comes from Mr. Michael Gwarisa of the Health Times in Zimbabwe, who asks: "What insights can Zimbabwe and other African nations gain from Eswatini's implementation to effectively utilize Lenacapavir?"
MR SMITH: I'm pleased to begin with this and then allow others to join in. The initial doses are being delivered today, so it's still very early in the process. However, I'll address it more generally. The new Global Health Strategy by the U.S. Government is primarily focused on assisting countries in becoming more self-sufficient over time and implementing innovative technologies. We believe this approach will be a new initiative for the U.S. Government and, in many cases, for the countries we collaborate with, especially regarding the pace and scope of our efforts. We also see sharing experiences among nations as a crucial component of this work, whether it involves Lenacapavir or strategies to boost domestic health funding, or other various subjects. Therefore, along with the Global Fund and other partners, we are strongly dedicated to promoting these discussions across different countries, although we understand that countries will naturally engage in such exchanges. They are already reaching out to one another to ask, "How are you approaching this? What are your thoughts on that?"
But perhaps, Becky, would you like to discuss the insights gained from previous uses of long-acting HIV treatments?
MS BUNNELL: Certainly. I believe we have discovered that to achieve the greatest effect, we must ensure we concentrate on the regions most vulnerable and implement effective strategies to generate demand. When we do this, we not only offer long-acting prevention methods but also boost our initiatives to encourage testing, detect individuals with undiagnosed HIV, and connect them with treatment. These additional advantages arise from this innovation. It can truly serve as a powerful catalyst in our mission to stop mother-to-child transmission by targeting women of childbearing age, those who are pregnant, and those who are nursing. We can significantly assist countries in reaching this objective.
MODERATOR: Thanks. Another question from Zimbabwe --
MR SANDS: May I just -
MODERATOR: Sorry. Yes.
MR SANDS: May I interject for a moment?
MODERATOR: Go ahead, please. Naturally.
MR SANDS: I believe it's crucial to build on this point—there are significant opportunities for one country to learn from another, as well as from the experiences with other PrEP methods, including oral PrEP. Zimbabwe has substantial experience with oral PrEP. One major benefit of Lenacapavir is that it helps overcome some of the challenges associated with the effective use of oral PrEP, whether it's stigma or adherence issues. There's a lot to gain from both the oral PrEP experience and insights from other countries. Sorry—thank you.
MODERATOR: No, thanks. That's quite useful. Appreciate it.
Mr. Farai Mutsaka of the Associated Press in Zimbabwe asks: "How many countries in Africa" – I think you have already covered this, but, "How many countries in Africa will ultimately gain and what are the amounts?" If you don't mind, could you repeat that?
MR SMITH: So, we are beginning with 10 countries in Africa. The procurement for 2026 is 600,000 doses; this represents all of Gilead's production capacity for the year. Our aim, over time, and as part of our plan, is for Gilead's production to keep growing so that we can acquire 2 million doses by mid-2027. We also expect demand in Africa to rise. We have already observed strong demand signals, with many countries seeking access to Lenacapavir, which is one reason we are increasing our initial order from 250,000 to 325,000. Therefore, what we hope to see over the next year or two is a growth in both demand and supply. Part of the reason we made this investment with the Global Fund is to help shape the market, assist others in understanding the potential impact of this medicine, and through the initiatives led by the Global Fund in collaboration with Gilead, work towards reducing the cost of the product over time, allowing countries to have even greater access.
But Peter and Dan, is there anything else to add?
MR O'DAY: I'd just like to add - thank you, Brad, and thank you for the commitment to keep increasing supplies, as well as with the Global Fund. I want to be clear from Gilead's standpoint that we are fully dedicated to meeting the demand during this period until generic versions become available. I just want to make one point on that. We are aiming to provide treatment for 2 million people, but if more is needed and we can produce more, we have the capacity to do so.
However, the sustainable approach, which is crucial, is what we implemented—once again, the first time ever that we—voluntarily licensed (inaudible) to six generic manufacturers immediately after the clinical trial results were released and before we even submitted our application in the United States, and then transferred the technology for the product to those six generic manufacturers. As a result, we expect that generic manufacturers will be able to start supplying markets as early as 2027. Additionally, we are collaborating with other partners, such as the Gates Foundation and also CHAI and others, who are helping support these generic manufacturers to ensure they have sufficient demand to eventually supply sustainably through a generic program, which, as Brad mentioned, would come at a significantly lower cost than what Gilead can produce. This is the sustainable model aimed at ending the epidemic globally over time.
MODERATOR: Thank you. I have a question from Mr. Favour Ulebor of the Vanguard newspaper in Abuja, Nigeria. He commends the U.S. Government, but he is asking whether this medicine has already been tested in the United States. Additionally, he wonders why Africa? Why is this vaccine being provided to Africa right after it is produced or approved?
MR SMITH: Dan, would you like to handle that one?
MR O'DAY: Well, perhaps I'll begin – this is Dan – by stating that this medication was tested for many years in America, specifically the United States, and in Europe. However, importantly, the very first trial demonstrating the effectiveness of this medicine was actually conducted in Sub-Saharan Africa. Indeed, the largest group of individuals contracting HIV in Africa makes up more than two-thirds of new HIV infections in the country – particularly women between the ages of 15 and 24. This was the focus of the Purpose 1 trial, the initial study that showed this effect, which involved thousands of women and girls in Africa, and it was this study that demonstrated 100% effectiveness in preventing HIV among this population. Purpose 2, the second trial carried out simultaneously with Purpose 1, took place in other countries across the globe with different populations. These two main studies – and we have additional ones underway – are the basis for the regulatory approvals in the United States as well as in various African countries and around the world.
MODERATOR: Thank you. We have time for just one more question, which has been raised by two of our participants—one from the BBC in Nairobi, Kenya, named Anne Soy—and also by Michael Gwarisa from the Health Times in Zimbabwe. The question is: What criteria do you use to choose these 6,000 people? Which specific groups are you focusing on, and who is given priority?
MR SMITH: I can begin, and others can join in later. The first step involved assigning resources by country, and we typically considered the burden of HIV disease to allocate medications to countries with the highest HIV prevalence. Within each country, we collaborate with the local government to create a distribution strategy that focuses on the subgeographies or populations with the greatest burden. It's essentially a collaborative effort with the government to determine the most effective way to distribute the supplies within the country.
But Peter, is there anything else you'd like to contribute?
MR SANDS: Yes, I believe that's completely accurate. In essence, to achieve the greatest effect from this innovation, we must adhere to the patterns of disease spread and focus on safeguarding those individuals who are at the highest risk. This approach influences both the distribution among nations and the selection of priority groups within each country for Lenacapavir. As Brad mentioned, many countries are significantly ahead in this process—Zimbabwe, for instance, has made substantial progress in creating a national implementation plan, similar to other regions. They are well on their way, and we are collaborating with them, along with PEPFAR, to determine the exact method of implementation.
MODERATOR: Excellent. Thank you. Before we conclude, I'd like to give the floor back to Senior Advisor Brad Smith for any closing remarks.
MR SMITH: Yes, thank you very much. I appreciate all of you joining us today. As you have heard, the Trump Administration is strongly dedicated to making focused and impactful investments and groundbreaking health innovations such as Lenacapavir, which we believe will help slow the HIV epidemic and enable African nations to gradually reduce their dependence on external health support. The United States is proud to support American biomedical advancements like Lenacapavir in partnership with the Global Fund, and we will keep making significant investments like the one we discussed today in the future. Once again, thank you all for taking the time to be here this morning.
MODERATOR: Many thanks. This wraps up today's briefing. I would like to express my gratitude once more to Special Advisor for the Bureau of Global Health Security - Senior Advisor, sorry, for the Bureau of Global Health Security and Diplomacy, Brad Smith, as well as the Principal Deputy Assistant Secretary for the Bureau, Becky Bunnell. Additionally, I want to thank the chairman of the board of directors and CEO of Gilead Sciences, Daniel O'Day, and the executive director of the Global Fund, Peter Sands, for being with us today. Thank you also to the journalists for taking part in this call. A recording and a transcript of today's briefing will be sent to all journalists who have registered for this call as soon as they are ready today. If you have any questions regarding today's briefing, please reach out to us at the Africa Regional Media Hub - AFMediaHub, A-F-M-e-d-i-a-H-u-b, @state.gov. If you publish any articles or broadcasts from today's briefing, kindly share a link with us via the same email address. I would also like to encourage everyone to follow us on Twitter, or X, as it is now known, under the handle AfricaMediaHub.
Appreciate everyone and hope you have a great day. Thank you.
Original video and audio materials are available on the U.S. Department of State website.
Copyright 2025 U.S. Embassy. All rights reserved. Distributed by AllAfrica Global Media (okay1).
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