Rio de Janeiro, Brazil — For many years, South Africa has been on the epicentre of the worldwide HIV epidemic. Immediately, it’s turning into the testing floor for what many scientists consider could possibly be an important advance in HIV prevention since day by day pre-exposure prophylaxis (PrEP): a twice-yearly injection that has proven nearly full safety in opposition to HIV.
Often known as lenacapavir, or LEN, the long-acting injection requires simply two doses a yr, providing a strong various to day by day capsules that many individuals battle to take constantly. For a rustic the place an estimated eight million persons are dwelling with HIV and about 160,000 individuals nonetheless purchase the virus yearly, researchers say the drugs may remodel prevention – significantly for adolescent ladies and younger girls, who proceed to face the very best danger of an infection.
South Africa turned the ninth African nation to introduce lenacapavir into public HIV prevention companies in June, rolling it out throughout six provinces as a part of an formidable effort to broaden prevention selections and scale back new infections. However the launch comes at a tough second, with worldwide HIV funding underneath stress, civil society organisations warning of the affect of cuts to U.S.-backed programmes, and generic variations of the drugs nonetheless not less than a yr away.
These alternatives and challenges dominated discussions on the Worldwide AIDS Society’s AIDS 2026 convention in Rio de Janeiro, the place scientists, policymakers, pharmaceutical corporations and group advocates agreed on one factor: the science has moved quicker than anybody imagined. The query now could be whether or not entry can maintain tempo.
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Opening a media roundtable on long-acting HIV prevention at AIDS 2026, Beatriz Grinsztejn, President of the Worldwide AIDS Society (IAS) and Worldwide Co-Chair of the convention, stated the world was witnessing one of the important advances in HIV prevention for the reason that introduction of day by day pre-exposure prophylaxis (PrEP).
Researchers, she stated, are not speaking about prospects however about prevention instruments able to essentially altering the trajectory of the epidemic. New knowledge introduced in Rio included up to date 52-week findings from the PURPOSE 1 and PURPOSE 2 research of twice-yearly lenacapavir, rising implementation expertise with long-acting injectable cabotegravir, and promising analysis into future choices, together with a once-monthly oral prevention tablet.
“Many people consider we’re getting into a brand new period for HIV prevention. We now have scientific instruments with the potential to essentially change the course of the epidemic. However scientific progress alone just isn’t sufficient,” Grinsztejn stated.
That message resonated strongly in South Africa, the place well being officers hope long-acting prevention may assist reverse stubbornly excessive an infection charges amongst populations which have remained tough to achieve with present prevention strategies.
Regardless of working the world’s largest HIV therapy programme, South Africa continues to document about 160,000 new HIV infections every year. Adolescent ladies and younger girls stay among the many hardest hit, with round 1,000 buying HIV each week. Many infections happen inside unequal relationships with older males, highlighting the pressing want for prevention choices that don’t rely on day by day pill-taking or frequent clinic visits.
Grinsztejn cautioned that the outstanding scientific progress showcased on the convention would solely matter if international locations may make the medicines obtainable to the individuals who wanted them most.
Quoting a message delivered by Brazil’s Ministry of Well being, she stated the problem dealing with the worldwide HIV response was not merely innovation however equitable entry.
“Innovation with out entry just isn’t innovation. It’s injustice,” she stated.
That query has turn out to be much more pressing as governments grapple with shrinking worldwide well being budgets and uncertainty surrounding future HIV financing. All through AIDS 2026, delegates repeatedly returned to the identical concern: whether or not international locations would have the ability to afford and maintain long-acting HIV prevention programmes regardless of mounting funding pressures.
For South Africa, these issues are particularly acute.
Though the nation funds most of its HIV response domestically, current reductions in United States world well being help, together with cuts affecting PEPFAR-supported programmes, have positioned further stress on prevention companies delivered by means of civil society organisations. All through the convention, activists staged demonstrations calling on donor international locations to reverse funding cuts, warning that scientific breakthroughs alone wouldn’t finish the epidemic if well being methods lacked the sources to ship them.
But audio system confused that necessary progress is already being made.
South Africa turned the ninth African nation to introduce lenacapavir as a part of its public HIV prevention programme in June, rolling out the six-monthly injection throughout Gauteng, KwaZulu-Natal, the Japanese Cape, Mpumalanga, North West and the Western Cape. Limpopo, the Northern Cape and the Free State are anticipated to hitch the programme subsequent yr as lower-cost generic variations turn out to be obtainable.
The rollout types a part of the federal government’s built-in, differentiated and people-centred HIV prevention technique, which goals to broaden prevention selections for populations at biggest danger, together with adolescent ladies and younger girls, intercourse employees and males who’ve intercourse with males.
Scientists consider the potential affect could possibly be profound.
Lenacapavir has demonstrated nearly full safety in opposition to HIV an infection in scientific trials whereas requiring simply two injections a yr, dramatically lowering the burden of day by day treatment. Modelling research counsel that if between one and two million HIV-negative South Africans obtain the injection over the approaching many years, AIDS may ultimately stop to be a serious public well being risk within the nation.
However translating scientific success into public well being affect would require way over an efficient medication.
Jean van Wyk, Chief Medical Officer at ViiV Healthcare, stated the dialog has shifted from proving that long-acting HIV prevention works to making sure it reaches the individuals who stand to learn most.
“Our mission on the firm may be very easy,” van Wyk stated. “We’re the one firm that is absolutely devoted to HIV, whether or not that’s individuals dwelling with HIV or those that can profit from PrEP, and we’ve a easy mission, and that’s to depart no one behind.”
Echoing Grinsztejn’s remarks, he stated innovation has little worth if individuals can’t entry it.
“Innovation is meaningless until there’s entry and until we are able to present it to the those that want it most,” he stated.
Whereas ViiV has expanded entry to long-acting injectable cabotegravir by means of voluntary licensing agreements and not-for-profit provide programmes, implementation scientists say the following problem is knowing how these medicines match into individuals’s on a regular basis lives.
That work is already underway in South Africa.
Elzette Rousseau, a socio-behavioural and implementation scientist on the Desmond Tutu Well being Basis, is main the ALIGN implementation research, which is evaluating how younger individuals use long-acting HIV prevention exterior the managed atmosphere of scientific trials.
The research, which started earlier this yr, is enrolling 3,700 individuals aged 15 to 35 by means of public well being amenities and cell group clinics. Contributors can select between day by day oral PrEP, injectable cabotegravir or twice-yearly lenacapavir, giving researchers a uncommon alternative to know each product preferences and long-term adherence underneath real-world situations.
Early findings counsel demand for long-acting prevention is robust.
“Up to now what we have seen is that LEN may be very extremely acceptable and chosen by most individuals, adopted by cabotegravir after which oral PrEP,” Rousseau stated.
She stated researchers have additionally been inspired by the variety of heterosexual males selecting injectable PrEP, an necessary growth in a rustic the place HIV transmission continues to happen between older males and youthful girls.
Authorities management has additionally helped construct public confidence, she stated, with South Africa’s nationwide launch lowering uncertainty across the new medication and inspiring uptake amongst communities, together with pregnant girls.
But Rousseau cautioned that an important query stays unanswered: whether or not individuals will proceed returning for injections each six months as soon as the programme expands.
“We have not but reached the purpose the place we’re seeing individuals coming again,” she stated. “In a real-world setting we need to perceive how individuals match these longer-acting merchandise into their lives.”
For Gilead Sciences, the corporate behind lenacapavir, South Africa has turn out to be one of the necessary demonstrations of how scientific breakthroughs can transfer quickly into public well being programmes.
Jared Baeten, Senior Vice President for Medical Growth and Head of Virology Therapeutic Space at Gilead Sciences, stated the corporate had labored with governments, regulators and world companions to speed up entry from the second the landmark PURPOSE research confirmed unprecedented ranges of safety.
Trying again over the previous 15 years of HIV prevention analysis, Baeten stated the sphere has developed from demonstrating that day by day oral PrEP may stop HIV an infection to growing medicines that require solely two injections a yr. PURPOSE 1, in girls, confirmed zero HIV transmissions amongst these receiving twice-yearly lenacapavir – 100% efficacy and superiority to day by day oral Truvada. That was adopted months later, on the R4P assembly, by PURPOSE 2 leads to a world inhabitants of males and gender-diverse individuals, which additionally demonstrated excessive efficacy. The primary regulatory approval adopted roughly a yr after that.
“The place this world has are available in 15 years is great, and the place we must always proceed to go needs to be equally imaginative,” he stated.
South Africa’s rollout, he stated, illustrates what could be achieved by means of political management and worldwide collaboration.
Lenacapavir is now obtainable in a number of African international locations, with many extra anticipated to introduce the drugs earlier than the top of the yr. Gilead has additionally signed voluntary licensing agreements masking 120 international locations, permitting generic producers to start producing lower-cost variations anticipated to turn out to be obtainable from 2027.
Till then, nonetheless, provide stays restricted.
South Africa’s preliminary rollout depends on branded lenacapavir equipped by means of World Fund help, with generic variations anticipated to scale back prices considerably as soon as manufacturing begins.
A group perspective
Group advocate Adaobi Lisa Olisa of Root to Rise stated entry will in the end decide whether or not long-acting HIV prevention fulfils its promise. “The science just isn’t failing. The science is progressing. However the place we’ve the chance is in implementation,” she stated.
From a group standpoint, she stated, there’s important pleasure round long-acting prevention, largely due to its potential to deal with longstanding limitations individuals have confronted with present choices – day by day tablet burden, frequent clinic visits, and points round disclosure. However she argued the central query has shifted: it’s not whether or not these merchandise maintain promise, however whether or not they’ll attain the individuals who want them most. “It’s entry that’s an important factor proper now,” she stated.
She argued that communities will likely be central to constructing belief, producing demand and making certain individuals perceive the advantages of long-acting prevention.
In Nigeria and 5 different international locations, Root to Rise is working with the Elton John AIDS Basis to coach present and potential PrEP customers as HIV Prevention Ambassadors, equipping them with the data and confidence to coach their friends, reply questions, and construct belief within the new prevention choices. This system identifies present or potential PrEP customers and trains them to turn out to be champions who can carry messaging and drive demand inside their very own communities.
“A product won’t be impactful if it would not get to the individuals who want it essentially the most. If it simply sits on the shelf, amassing mud, it won’t ship on the promise.”
For the primary time in additional than a decade of HIV prevention, she stated, there at the moment are a number of instruments obtainable but in addition extra constrained sources than ever earlier than. Balancing these two realities, she argued, means the precedence can’t merely be growing extra new merchandise.
“We have to try in direction of new merchandise, however we have to make sure that the merchandise we’ve proper now really attain the individuals who want them essentially the most,” she stated. She stated that investments in scientific analysis should be matched by investments in group organisations, consciousness campaigns and supply methods that allow individuals to entry and proceed utilizing long-acting HIV prevention.
Trying past right now’s improvements, researchers are already growing the following era of HIV prevention applied sciences.
Merck Analysis Laboratories is evaluating alimantavir, an investigational once-monthly oral tablet that would present one other long-acting prevention choice. On the similar time, organisations resembling Unitaid proceed investing in implementation analysis to make sure international locations can efficiently introduce these medicines.
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Eliav Barr, Senior Vice President, Head of World Medical Growth and Chief Medical Officer at Merck Analysis Laboratories, stated that increasing the variety of prevention choices will likely be important if the world hopes to achieve the objective of greater than 20 million individuals receiving HIV pre-exposure prophylaxis (PrEP) by 2030. “We all know that there are numerous potential interventions, however we’d like interventions that make sense for the communities most affected. We want many selections.”
He outlined three components of that technique. First, early generic licensing throughout a broad territory: for the primary time, Merck’s licensing covers all of Africa and 129 low- and middle-income international locations in whole, representing the substantial majority of world HIV acquisition danger. Non-exclusive licenses have been signed with seven generic producers, together with three in Africa – one other first, he stated.
Second, help for regional manufacturing, with generic companions in Uganda, Kenya and South Africa positioned to offer the African continent larger management over manufacturing and distribution. He additionally famous that, simply earlier than the roundtable, Merck had signed an settlement with Fiocruz to speed up entry and manufacturing of islatravir in Brazil and throughout Latin America.
Third, Merck will make its personal provide obtainable from the purpose of launch, relatively than ready for generic producers to finish their very own regulatory and manufacturing processes, to bridge international locations till generic provide comes on-line. He added that Merck plans to file for regulatory approval in different markets concurrently, or near it, with its U.S. submitting.
Innovation is nice so far as entry is nice
Philippe Duneton, Government Director of Unitaid, stated the lesson from 4 many years of the HIV response is evident. “There is no such thing as a one magic bullet,” he stated. “We have to ensure that the best medication is in the best palms.”
“Innovation is nice so far as entry is nice,” he stated, arguing that getting supply proper requires working carefully with communities to design approaches that meet individuals’s precise wants. He praised pharmaceutical corporations for persevering with to spend money on new prevention applied sciences however argued that scientific innovation achieves little until it reaches the individuals most weak to HIV.
Though questions stay about whether or not the world can obtain its objective of ending AIDS as a public well being risk, Duneton stated right now’s scientific advances present causes for cautious optimism. He believes the instruments now obtainable make it achievable, contingent on continued collaboration between corporations, generic producers and governments. “Now we have, and we may have, hopefully, the instruments to make it occur. It is a query of collaboration.”
As South Africa embarks on one of many world’s largest rollouts of twice-yearly HIV prevention, the nation is as soon as once more on the centre of the worldwide HIV response.
The science has delivered instruments that many specialists consider may dramatically scale back new infections. Whether or not these breakthroughs fulfil their promise will rely not solely on continued innovation, however on sustained political dedication, inexpensive entry, group management and the sources wanted to make sure that nobody is left behind.
