Protection only lasts as long as someone continues taking it
In a country where HIV has long shaped the contours of daily life and public health, South Africa has taken a quiet but consequential step: offering a twice-yearly injection that blocks the virus with near-perfect efficacy, free of charge, at hundreds of government clinics. Lenacapavir asks nothing of its recipients each morning — no pill, no daily discipline — only a return visit every six months. The ambition is vast and the current supply modest, but the mathematics of possibility suggest that if the rollout reaches its targets over the next two decades, the country could halve its annual infections and bring AIDS within reach of a public health reckoning long deferred.
- South Africa still records roughly 140,000 new HIV infections every year, a number that lenacapavir's near-perfect efficacy now makes preventable in ways daily pills never fully achieved.
- Only 115,320 doses have arrived so far — a fraction of the 18 to 36 million needed by 2043 — exposing the vast distance between a promising launch and a transformative national programme.
- Three provinces remain excluded until 2027, and private sector access is entirely absent, meaning the most vulnerable populations must navigate an uneven geography of protection.
- Generic manufacturers, local production proposals, and a Global Fund commitment of under one million branded doses represent the scaffolding being assembled to hold up a much larger structure.
- If uptake reaches between one and two million people annually, researchers project annual infections could fall to 65,000 by 2043 — a threshold that would mark the effective end of AIDS as a public health emergency.
South Africa has begun distributing lenacapavir — a six-monthly HIV prevention injection — at 360 government clinics across six provinces, marking a meaningful shift in the country's approach to prevention. Unlike daily oral pills that demand consistent adherence, LEN is injected into the abdomen twice a year, slowly releasing medication that blocks HIV from entering immune cells at all. Clinical trials showed a 96 to 100 percent reduction in new infections across multiple high-risk groups, including teenage girls, gay and bisexual men, and transgender people.
The current rollout covers Gauteng, KwaZulu-Natal, the Eastern Cape, Mpumalanga, North West, and the Western Cape, with Gauteng hosting the most sites. The three remaining provinces will gain access in 2027 when cheaper generic versions become available. So far, only 115,320 branded doses — funded by the Global Fund — have been delivered, enough to cover roughly 456,000 people. This represents just 3 to 5.5 percent of the doses South Africa will ultimately need.
Researchers at the University of the Witwatersrand estimate that if one to two million HIV-negative people take LEN at least once a year through 2043, annual new infections could fall from 140,000 to around 65,000 — a level low enough to end AIDS as a dominant public health crisis. Reaching that scale requires between 18 and 36 million doses, making the arrival of generics essential. At least one Indian manufacturer has applied for registration, with approval expected by early 2027, after which the government plans to purchase doses from its own budget.
The government is also pursuing local manufacturing, having invited domestic pharmaceutical companies to propose producing LEN either fully or in part. A shortlist is due to reach Gilead Sciences by the end of June for generic licence consideration. Priority access is being directed toward those at greatest risk: teenage girls and young women account for a third of new infections despite being 8 percent of the population; sex workers face nine times the average risk; gay and bisexual men face a 26-fold elevated risk. For now, LEN remains a public health tool only — free at clinics, unavailable privately — and the true measure of its promise will come when generics arrive and the programme must scale to meet the full weight of the epidemic.
South Africa has begun distributing lenacapavir, a six-monthly injection that prevents HIV infection, at 360 government clinics spread across six provinces. The rollout marks a significant shift in how the country approaches HIV prevention—moving away from daily pills that require consistent adherence toward a long-acting shot administered twice a year with near-perfect efficacy.
The injection, known as LEN, works by interfering with HIV's ability to enter immune cells. It's injected into the fatty tissue of the abdomen and slowly releases medication over six months, creating what researchers call a depot. Unlike vaccines, which train the immune system to fight infection, LEN simply blocks the virus from entering cells in the first place—which means protection only lasts as long as someone continues taking it. The drug has shown remarkable effectiveness in clinical trials: a 2024 study of teenage girls and young women demonstrated near-perfect protection, though two infections occurred after the study ended. A second trial among gay and bisexual men and transgender people showed a 96 percent reduction in new infections, with three infections among 2,179 participants.
Currently, the jab is available at clinics in Gauteng, KwaZulu-Natal, the Eastern Cape, Mpumalanga, North West, and the Western Cape. Gauteng has the most sites with 133 clinics, while the Western Cape has 22. The three remaining provinces—Northern Cape, Limpopo, and Free State—will receive access next year when cheaper generic versions become available. So far, South Africa has received only 115,320 doses of the branded version made by Gilead Sciences, funded by the Global Fund to Fight Aids, TB and Malaria. The fund has promised just under one million branded doses over two years, enough to keep roughly 456,000 people on the medication. This represents only 3 to 5.5 percent of the total doses the country will need.
The mathematics of the rollout reveal both the ambition and the challenge. Researchers at the University of the Witwatersrand have modeled that if between one and two million HIV-negative people take LEN at least once per year through 2043, South Africa could reduce its annual new infections from approximately 140,000 to about 65,000—a rate low enough to end AIDS as a major public health crisis within 18 years. Achieving this would require between 18 and 36 million doses over that period. To make this possible, the country is counting on generic manufacturers. At least one Indian company, Hetero, has applied to register a generic version with South Africa's Health Products Regulatory Authority, with approval expected by the end of January 2027. Once generics arrive, the health department says it will purchase LEN with its own budget on a much larger scale, though it has not yet announced how many doses it plans to buy.
The government is also pursuing local manufacturing. The South African National Aids Council asked domestic drug companies to submit proposals for making LEN either from scratch or by performing parts of the manufacturing process. A committee is evaluating these proposals and will submit a shortlist to Gilead for consideration of generic licenses by the end of June. This dual approach—importing generics while developing local capacity—reflects the scale of the need and the urgency of bringing costs down.
For someone seeking LEN at a clinic, the process begins with an HIV test to confirm they are negative. The first dose consists of two injections totaling 927 milligrams, split because the full amount won't fit in a single syringe. Alongside the injections, patients take four 300-milligram pills—two at the clinic and two at home the next day—to ensure protective drug levels build quickly enough. Follow-up doses come every six months, though patients must return within 28 weeks or restart the loading protocol. The most common side effects are pain at the injection site, small lumps under the skin, and occasionally swelling or redness. The drug is not suitable for people taking certain medications, including the TB drug rifampicin or certain anti-seizure medicines, and it cannot be purchased over the counter—only a doctor or nurse can prescribe and administer it.
The government is prioritizing groups with the highest risk of infection. Teenage girls and young women account for roughly one-third of South Africa's new infections despite making up only 8 percent of the population, partly because their vaginal tissue is still developing and partly because economic inequality often forces them into relationships with older men where they have little power to negotiate condom use. Sex workers are nine times more likely to contract HIV than the general population. Gay and bisexual men face a 26-fold increased risk, while transgender people are 13 times more likely to have HIV, with transgender women facing a 20-fold risk. Pregnant and breastfeeding women also have elevated risk, and early data suggests LEN is safe for them, though more evidence is needed before explicit recommendations can be made.
Private sector access remains unavailable for now. Gilead Sciences has not yet registered a private price for LEN in South Africa and is still evaluating its strategy for private distribution. Once generics become available in 2027, private availability may follow, though government demand for millions of doses will likely constrain supply. For now, LEN remains a public health tool, distributed free at clinics in the six provinces where the rollout has begun. The next phase—when cheaper generics arrive and the program expands to the remaining provinces—will determine whether South Africa can achieve the infection reductions its researchers have modeled.
Citações Notáveis
In the end, people will use what works for them. This is why choice matters.— Katherine Gill, HIV scientist
Inflamed tissue makes it easier for HIV to enter someone's cells, because it increases the risk of tearing in the vagina during sex.— Dvora Joseph Davey, associate epidemiology professor at the University of Cape Town
A Conversa do Hearth Outra perspectiva sobre a história
Why does this injection work so differently from the daily pill that's been available since 2020?
The daily pill requires someone to remember to take it every single day. Miss a few doses and you lose protection. LEN works differently—it sits under your skin releasing medicine slowly over six months. You show up twice a year, get the shot, and you're protected. For people whose lives are chaotic or unpredictable, that's a fundamental difference.
The numbers seem almost impossible. You need 18 to 36 million doses but you've only received 115,000. How does the country bridge that gap?
It doesn't, not yet. That's why the generic versions matter so much. Right now, Gilead is the only supplier and the doses are expensive. Once Indian manufacturers can make it cheaply and legally, the health department can buy in bulk with its own budget. That's when the scale changes.
I notice the source mentions that two girls got infected even in the trial showing perfect protection. How do you explain that to someone considering the shot?
You tell them the truth: it's 96 to 100 percent effective depending on the population studied. That's not perfect, but it's close enough that if millions of people use it, the math works. No prevention method is foolproof. But you also have to test negative before each dose, so you catch infections early.
Why is the government focusing so hard on teenage girls and young women when they're only 8 percent of the population?
Because they account for a third of new infections. It's basic epidemiology—you get the most prevention bang for your buck by reaching people in high-transmission groups. And the reasons they're vulnerable aren't mysterious: their bodies are still developing, which makes infection easier, and poverty often puts them in relationships where they can't negotiate safer sex.
What happens to someone if they stop taking LEN?
The drug stays in your system for up to a year, but at levels too low to protect you. If you get infected during that window, you could develop resistance to a whole class of HIV drugs. So you need to switch to something else—the daily pill or condoms—and test regularly. It's not like you stop and you're suddenly vulnerable. But you're not protected either.