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Africa: South Africa's Next HIV Battle Isn't About Science, It's About Access

Rio de Janeiro, Brazil — For decades, South Africa has been at the epicentre of the global HIV epidemic. Today, it is becoming the testing ground for what many scientists believe could be the most important advance in HIV prevention since daily pre-exposure prophylaxis (PrEP): a twice-yearly injection that has shown almost complete protection against HIV. Known as lenacapavir, or LEN, the long-acting injection requires just two doses a year, offering a powerful alternative to daily pills that many people struggle to take consistently. For a country where an estimated eight million people are living with HIV and about 160,000 people still acquire the virus every year, researchers say the medicine could transform prevention - particularly for adolescent girls and young women, who continue to face the highest risk of infection. South Africa became the ninth African country to introduce lenacapavir into public HIV prevention services in June, rolling it out across six provinces as part of an ambitious effort to expand prevention choices and reduce new infections. But the launch comes at a difficult moment, with international HIV funding under pressure, civil society organisations warning of the impact of cuts to U.S.-backed programmes, and generic versions of the medicine still at least a year away. Those opportunities and challenges dominated discussions at the International AIDS Society's AIDS 2026 conference in Rio de Janeiro, where scientists, policymakers, pharmaceutical companies and community advocates agreed on one thing: the science has moved faster than anyone imagined. The question now is whether access can keep pace. Keep up with the latest headlines on WhatsApp | LinkedIn Opening a media roundtable on long-acting HIV prevention at AIDS 2026, Beatriz Grinsztejn, President of the International AIDS Society (IAS) and International Co-Chair of the conference, said the world was witnessing one of the most significant advances in HIV prevention since the introduction of daily pre-exposure prophylaxis (PrEP). Researchers, she said, are no longer talking about possibilities but about prevention tools capable of fundamentally changing the trajectory of the epidemic. New data presented in Rio included updated 52-week findings from the PURPOSE 1 and PURPOSE 2 studies of twice-yearly lenacapavir, growing implementation experience with long-acting injectable cabotegravir, and promising research into future options, including a once-monthly oral prevention pill. "Many of us believe we are entering a new era for HIV prevention. We now have scientific tools with the potential to fundamentally change the course of the epidemic. But scientific progress alone is not enough," Grinsztejn said. That message resonated strongly in South Africa, where health officials hope long-acting prevention could help reverse stubbornly high infection rates among populations that have remained difficult to reach with existing prevention methods. Despite operating the world's largest HIV treatment programme, South Africa continues to record about 160,000 new HIV infections each year. Adolescent girls and young women remain among the hardest hit, with around 1,000 acquiring HIV every week. Many infections occur within unequal relationships with older men, highlighting the urgent need for prevention options that do not depend on daily pill-taking or frequent clinic visits. Grinsztejn cautioned that the remarkable scientific progress showcased at the conference would only matter if countries could make the medicines available to the people who needed them most. Quoting a message delivered by Brazil's Ministry of Health, she said the challenge facing the global HIV response was no longer simply innovation but equitable access. "Innovation without access is not innovation. It is injustice," she said. That question has become even more urgent as governments grapple with shrinking international health budgets and uncertainty surrounding future HIV financing. Throughout AIDS 2026, delegates repeatedly returned to the same concern: whether countries would be able to afford and sustain long-acting HIV prevention programmes despite mounting funding pressures. For South Africa, those concerns are especially acute. Although the country finances most of its HIV response domestically, recent reductions in United States global health assistance, including cuts affecting PEPFAR-supported programmes, have placed additional pressure on prevention services delivered through civil society organisations. Throughout the conference, activists staged demonstrations calling on donor countries to reverse funding cuts, warning that scientific breakthroughs alone would not end the epidemic if health systems lacked the resources to deliver them. Yet speakers stressed that important progress is already being made. South Africa became the ninth African country to introduce lenacapavir as part of its public HIV prevention programme in June, rolling out the six-monthly injection across Gauteng, KwaZulu-Natal, the Eastern Cape, Mpumalanga, North West and the Western Cape. Limpopo, the Northern Cape and the Free State are expected to join the programme next year as lower-cost generic versions become available. The rollout forms part of the government's integrated, differentiated and people-centred HIV prevention strategy, which aims to expand prevention choices for populations at greatest risk, including adolescent girls and young women, sex workers and men who have sex with men. Scientists believe the potential impact could be profound. Lenacapavir has demonstrated almost complete protection against HIV infection in clinical trials while requiring just two injections a year, dramatically reducing the burden of daily medication. Modelling studies suggest that if between one and two million HIV-negative South Africans receive the injection over the coming decades, AIDS could eventually cease to be a major public health threat in the country. But translating clinical success into public health impact will require far more than an effective medicine. Jean van Wyk, Chief Medical Officer at ViiV Healthcare, said the conversation has shifted from proving that long-acting HIV prevention works to ensuring it reaches the people who stand to benefit most. "Our mission at the company is very simple," van Wyk said. "We are the only company that's fully dedicated to HIV, whether that is people living with HIV or those who can benefit from PrEP, and we have a simple mission, and that is to leave nobody behind." Echoing Grinsztejn's remarks, he said innovation has little value if people cannot access it. "Innovation is meaningless unless there is access and unless we can provide it to the people that need it most," he said. While ViiV has expanded access to long-acting injectable cabotegravir through voluntary licensing agreements and not-for-profit supply programmes, implementation scientists say the next challenge is understanding how these medicines fit into people's everyday lives. That work is already underway in South Africa. Elzette Rousseau, a socio-behavioural and implementation scientist at the Desmond Tutu Health Foundation, is leading the ALIGN implementation study, which is evaluating how young people use long-acting HIV prevention outside the controlled environment of clinical trials. The study, which began earlier this year, is enrolling 3,700 people aged 15 to 35 through public health facilities and mobile community clinics. Participants can choose between daily oral PrEP, injectable cabotegravir or twice-yearly lenacapavir, giving researchers a rare opportunity to understand both product preferences and long-term adherence under real-world conditions. Early findings suggest demand for long-acting prevention is strong. "So far what we've seen is that LEN is very highly acceptable and chosen by most participants, followed by cabotegravir and then oral PrEP," Rousseau said. She said researchers have also been encouraged by the number of heterosexual men choosing injectable PrEP, an important development in a country where HIV transmission continues to occur between older men and younger women. Government leadership has also helped build public confidence, she said, with South Africa's national launch reducing uncertainty around the new medicine and encouraging uptake among communities, including pregnant women. Yet Rousseau cautioned that the most important question remains unanswered: whether people will continue returning for injections every six months once the programme expands. "We haven't yet reached the point where we are seeing people coming back," she said. "In a real-world setting we want to understand how people fit these longer-acting products into their lives." For Gilead Sciences, the company behind lenacapavir, South Africa has become one of the most important demonstrations of how scientific breakthroughs can move rapidly into public health programmes. Jared Baeten, Senior Vice President for Clinical Development and Head of Virology Therapeutic Area at Gilead Sciences, said the company had worked with governments, regulators and global partners to accelerate access from the moment the landmark PURPOSE studies showed unprecedented levels of protection. Looking back over the past 15 years of HIV prevention research, Baeten said the field has evolved from demonstrating that daily oral PrEP could prevent HIV infection to developing medicines that require only two injections a year. PURPOSE 1, in women, showed zero HIV transmissions among those receiving twice-yearly lenacapavir - 100% efficacy and superiority to daily oral Truvada. That was followed months later, at the R4P meeting, by PURPOSE 2 results in a global population of men and gender-diverse people, which also demonstrated high efficacy. The first regulatory approval followed roughly a year after that. "Where this world has come in 15 years is tremendous, and where we should continue to go should be equally imaginative," he said. South Africa's rollout, he said, illustrates what can be achieved through political leadership and international collaboration. Rather than waiting until regulatory approvals were secured, Baeten said Gilead and its partners began planning for global access while the science was still unfolding. "We said we would do something, and then we did it," he said. Baeten said that Gilead worked with partners across the field to translate those results into what he called an unprecedented access effort. One built around commitments made in advance and then delivered on. He said that Gilead has continued expanding availability through both implementation science, citing Unitaid and research partners at the table, and access partnerships with the Global Fund, PEPFAR and the U.S. government. At the end of 2024, Gilead and PEPFAR announced an initial target to supply enough lenacapavir for two million people as a bridge before generic versions become available. Notably, Baeten said, voluntary licenses were signed with six generic manufacturers across three countries before Gilead had even submitted to a single regulatory agency - and before the manufacturing process itself was fully finalized. He said he remains hopeful that generic manufacturing could come online by the end of this year. That bridge commitment, made with PEPFAR and the Global Fund, has since grown from two million to three million people's worth of product, intended, he said, to be "catalytic" both to establish what good implementation looks like and to demonstrate a market that generic manufacturers could commit to. He noted with some satisfaction that the Global Fund and PEPFAR have now set a target of 600,000 people on lenacapavir by the end of this year through that collaboration, a figure he compared directly to the total number of people currently on any form of PrEP in the United States. He said that number is projected to surpass one million by the beginning of next year. Lenacapavir is now available in 10 African countries, with that number expected to increase to 24 before the end of the year. He also said six generic manufacturers are now preparing to produce lenacapavir for 120 countries covered under those agreements, raising hopes that lower-cost supplies could begin reaching countries in the near future. Until then, however, supply remains limited. South Africa's initial rollout relies on branded lenacapavir supplied through Global Fund support, with generic versions expected to reduce costs substantially once manufacturing begins. A community perspective Community advocate Adaobi Lisa Olisa of Root to Rise said access will ultimately determine whether long-acting HIV prevention fulfils its promise. "The science is not failing. The science is progressing. But where we have the risk is in implementation," she said. From a community standpoint, she said, there is significant excitement around long-acting prevention, largely because of its potential to address longstanding barriers people have faced with existing options - daily pill burden, frequent clinic visits, and issues around disclosure. But she argued the central question has shifted: it is no longer whether these products hold promise, but whether they will reach the people who need them most. "It is access that is the most important thing right now," she said. She argued that communities will be central to building trust, generating demand and ensuring people understand the benefits of long-acting prevention. In Nigeria and five other countries, Root to Rise is working with the Elton John AIDS Foundation to train current and potential PrEP users as HIV Prevention Ambassadors, equipping them with the knowledge and confidence to educate their peers, answer questions, and build trust in the new prevention options. The program identifies current or potential PrEP users and trains them to become champions who can carry messaging and drive demand within their own communities. "A product will not be impactful if it doesn't get to the people who need it the most. If it just sits on the shelf, collecting dust, it will not deliver on the promise." For the first time in more than a decade of HIV prevention, she said, there are now multiple tools available but also more constrained resources than ever before. Balancing those two realities, she argued, means the priority cannot simply be developing more new products. "We need to strive towards new products, but we need to ensure that the products we have right now actually reach the people who need them the most," she said. She said that investments in scientific research must be matched by investments in community organisations, awareness campaigns and delivery systems that enable people to access and continue using long-acting HIV prevention. Looking beyond today's innovations, researchers are already developing the next generation of HIV prevention technologies. Merck Research Laboratories is evaluating alimantavir, an investigational once-monthly oral pill that could provide another long-acting prevention option. At the same time, organisations such as Unitaid continue investing in implementation research to ensure countries can successfully introduce these medicines. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer at Merck Research Laboratories, said that expanding the number of prevention options will be essential if the world hopes to reach the goal of more than 20 million people receiving HIV pre-exposure prophylaxis (PrEP) by 2030. "We know that there are a lot of potential interventions, but we need interventions that make sense for the communities most affected. We need many choices." He outlined three elements of that strategy. First, early generic licensing across a broad territory: for the first time, Merck's licensing covers all of Africa and 129 low- and middle-income countries in total, representing the substantial majority of global HIV acquisition risk. Non-exclusive licenses have been signed with seven generic manufacturers, including three in Africa - another first, he said. Second, support for regional manufacturing, with generic partners in Uganda, Kenya and South Africa positioned to give the African continent greater control over manufacturing and distribution. He also noted that, just before the roundtable, Merck had signed an agreement with Fiocruz to accelerate access and manufacturing of islatravir in Brazil and across Latin America. Third, Merck will make its own supply available from the point of launch, rather than waiting for generic manufacturers to complete their own regulatory and production processes, to bridge countries until generic supply comes online. He added that Merck plans to file for regulatory approval in other markets simultaneously, or close to it, with its U.S. filing. Innovation is good as far as access is good Philippe Duneton, Executive Director of Unitaid, said the lesson from four decades of the HIV response is clear. "There is no one magic bullet," he said. "We need to make sure that the right medicine is in the right hands." "Innovation is good as far as access is good," he said, arguing that getting delivery right requires working closely with communities to design approaches that meet people's actual needs. He praised pharmaceutical companies for continuing to invest in new prevention technologies but argued that scientific innovation achieves little unless it reaches the people most vulnerable to HIV. Although questions remain about whether the world can achieve its goal of ending AIDS as a public health threat, Duneton said today's scientific advances provide reasons for cautious optimism. He believes the tools now available make it achievable, contingent on continued collaboration between companies, generic manufacturers and governments. "We have, and we will have, hopefully, the tools to make it happen. It's a question of collaboration." As South Africa embarks on one of the world's largest rollouts of twice-yearly HIV prevention, the country is once again at the centre of the global HIV response. The science has delivered tools that many experts believe could dramatically reduce new infections. Whether those breakthroughs fulfil their promise will depend not only on continued innovation, but on sustained political commitment, affordable access, community leadership and the resources needed to ensure that no one is left behind.

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