The South Wales Gay Men's Chorus performing at a World AIDS Day event at Amgueddfa Cymru in Cardiff.
A twice-yearly injection has just cleared another year of scrutiny, and the trial that produced the headline number was built around our communities. New open-label results for lenacapavir PrEP, presented at the International AIDS Conference in Rio de Janeiro in late July, recorded a single HIV infection across 2,452 patient-years of follow-up.
Patient-years is the measure researchers use to combine everyone’s time in a study, so 2,452 of them means roughly that many years of collective exposure with one infection to show for it. For a population that has spent four decades being told to manage risk daily, that is a different kind of arithmetic.
What the Rio Data Actually Showed
The findings come from the open-label extensions of the PURPOSE trials, with details released ahead of the conference by HIV i-Base and the full presentations given on 30 July.
In PURPOSE 2, presented by Losso and colleagues, there was one new HIV infection across 2,452 patient-years of follow-up. In that single case, the injections had been given on time and drug levels were not yet available, which is the sort of detail that will matter once the full analysis lands. In PURPOSE 1, presented by Kiwanuka and colleagues and conducted among women in Uganda and South Africa, there were no new infections at all across 4,493 patient-years.
No new safety concerns were reported in either study. That is not a small line: long-acting injectables live or die on whether people tolerate them well enough to keep coming back twice a year.
Who Was in the Study That Matters Most to Queer Men
PURPOSE 2 is the trial closest to home for a large part of this readership. It enrolled cisgender men alongside trans and non-binary people who have sex with men, across Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
That matters because HIV prevention research has not always been designed with trans and non-binary participants meaningfully included rather than folded into a category that did not fit them. A trial that recruits across seven countries and holds this kind of result is evidence generated with the community it is meant to serve, which is the standard advocates have been demanding for years.
It is also worth saying plainly what this is not. It is not a cure, it is not a vaccine, and it does not protect against other sexually transmitted infections. It is a prevention option, and a remarkably effective one, for people who choose it.
The Numbers Behind Twice a Year
The efficacy figures only mean something if people stay on the schedule, and this is where the open-label data is quietly encouraging. Injection adherence in PURPOSE 2 was 96 per cent at week 26 and 92 per cent at week 52. In PURPOSE 1 it was 96 per cent. In both studies, more than 95 per cent of eligible participants chose to continue into the open-label extension.
Anyone who has tried to keep to a daily pill through shift work, travel, a breakup or a bad month will understand why that gap matters. Two appointments a year removes the daily reminder, the bottle in the bathroom cabinet, and the conversation with a flatmate or family member who spots it. For people living somewhere that queerness still carries risk, that last point is not a convenience. It is the whole thing.
It is worth being clear about what adherence figures do and do not tell you. Trial participants get reminders, appointments and a research team, none of which come as standard in an ordinary clinic. Real-world continuation is almost always lower than trial continuation. But the direction of travel is the point: an intervention that asks for two visits a year rather than 365 decisions starts from a structurally easier position, and lenacapavir PrEP is the first prevention option where that gap is this wide.
Where You Can Actually Get It
Rollout is running well ahead of where most people assume. In April the Global Fund and the United States expanded their joint commitment to reach three million people by 2028, adding a million to the original target.
Eswatini, Kenya, Lesotho, Nigeria, Zambia and Zimbabwe have started rolling it out, with Mozambique, South Africa and Uganda having received deliveries. A further group including Benin, Botswana, the Dominican Republic, Fiji, Georgia, Haiti, Honduras, Indonesia, Morocco, Papua New Guinea, Rwanda and Thailand is receiving support to follow.
What that list makes obvious is how much of the early rollout is concentrated where donor funding is doing the work. The countries named are largely those supported through global health financing, which is the right priority given where the burden sits, but it leaves a gap that queer readers in high-income countries will notice: availability at home depends on national health systems making their own funding decisions, and those are moving at very different speeds.
Eswatini’s health minister, Mduduzi Matsebula, framed the appeal directly: lenacapavir “represents a breakthrough in HIV prevention, especially for communities that face barriers to daily treatment adherence”. Mark Edington of the Global Fund made the same point from the other side, saying countries recognise its potential “to reach populations that have not been adequately served by existing tools”. Read that phrase honestly and it describes a lot of queer and trans people.
The Price Gap Nobody Has Closed
This is where the celebration has to slow down. Writing in Annals of Medicine and Surgery in February, Goshen David Miteu set out the gap: a United States list price of $28,218 per person per year, against a generic target of roughly $35 to $46 per person-year, potentially falling towards $25 at high production volumes.
More than 120 low- and middle-income countries are covered by voluntary licences through six generic manufacturers, but Miteu is blunt about the limits, arguing that “voluntary licensing serves more as public relations than enforceable access guarantees”. Regulatory approvals are still pending in many countries, manufacturing scale-up takes time, and there is no access through the Medicines Patent Pool.
UNAIDS has been pressing the same case. Its executive director, Winnie Byanyima, called the expanded rollout “an important step forward” while adding that to end AIDS “we must urgently go further”. With around 1.3 million new HIV infections a year globally, and a target of 20 million people on antiretroviral-based prevention by 2030, the maths does not work on goodwill alone.
What Comes Next for Queer Communities
The pattern here is familiar to anyone who knows the history. A treatment advance arrives, the science is extraordinary, and then the fight moves to who is allowed to have it and how quickly. That fight has always been won by organised communities rather than by patience, which is exactly the protest tradition Pride grew out of.
The practical questions now are national ones. Which health systems will fund twice-yearly injections for gay, bi and trans people rather than restricting them to narrower groups. Whether clinics have the staffing to deliver a long-acting product at scale. Whether trans people can access it without being routed through services that do not understand them.
For readers wondering what to do with this today, the honest answer is that the data is strong and the availability is uneven, and the only way to know your options is to ask a sexual health clinic what is funded where you live. What the Rio results change is the strength of the case you are making when you ask. Lenacapavir PrEP has now held near-total protection through a second year, in a study built around queer men and trans and non-binary people. The science has done its part.
This article was AI-assisted and edited for accuracy.
