On 3 November, Tashkent is hosting the “Multi-Stakeholder Dialogue on Expanding Access to Modern HIV Pre-Exposure Prophylaxis”, part of the meeting “Preparing Central Asian Countries for Access to and Introduction of Long-Acting Medicines for HIV Prevention”. With the first generic lenacapavir injection receiving tentative US FDA approval, the question is no longer only what science can deliver — but whether people can access it. The event was organized by ITPC EECA and the Eurasian Community for Access to Treatment (ECAT), with the support of UNAIDS.
Sixteen months from innovation to a generic
On 2 November 2026, the US Food and Drug Administration granted tentative approval to the first generic injectable lenacapavir for HIV pre-exposure prophylaxis (PrEP). Developed by Dr. Reddy’s Laboratories with financial, technical and regulatory support from Unitaid, Wits RHI and the Clinton Health Access Initiative (CHAI), the generic reached this milestone just 16 months after approval of the originator product.
The price contrast is striking: the US list price of the branded product Yeztugo is approximately US$28,218 a year, while the agreed generic price is US$40 per person per year in the 120 low- and middle-income countries covered by Gilead’s voluntary licence. These are different markets and pricing arrangements. Initial generic supplies are expected before the end of 2026, with wider availability in 2027.
Tentative FDA approval does not permit US sales while patent and exclusivity restrictions apply, nor does it replace national regulatory approval. And a US$40 price will mean little if manufacturers do not supply smaller markets.
“We really hope that we will be able to achieve our goal — not just to exchange information about new medicines, but to understand exactly what needs to be done to make them available in Central Asian countries.” — Denis Godlevskiy, Regional Coordinator, ITPC EECA
“The epidemic is moving faster than our response collectively”
Opening the dialogue, Eamonn Murphy, UNAIDS Director of the Regional Support Teams for Asia and the Pacific and Eastern Europe and Central Asia, stressed that a scientific advance will not change the HIV response on its own.
“It’s an opportunity to change the trajectory of HIV prevention in a region where the pace and scale of the response are not yet matching the pace of the epidemic, which is moving faster than our response collectively.” — Eamonn Murphy, UNAIDS
“A breakthrough product or products becomes a public health breakthrough only when it reaches the people who need it, at a price countries can afford through systems that can deliver it sustainably and over the long term.” — Eamonn Murphy, UNAIDS
Long-acting PrEP can offer greater privacy, convenience and choice. But, Murphy warned, it must not displace existing prevention methods or create a two-tier system in which the newest options reach only those who can afford them.
“Inclusion in licences doesn’t mean access”
Othoman Mellouk, ITPC Global’s Access to Diagnostics and Medicines Lead and coordinator of Make Medicines Affordable, pointed to Morocco, where an initial supply was sufficient for just 50 people despite the country being ready to introduce lenacapavir.
“We have countries who are ready, like mine, but unfortunately, there isn’t enough. There is no supply because there is no production and we just managed to get 50 doses for 50 people this year.” — Othoman Mellouk, ITPC Global
Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan and Uzbekistan are covered by Gilead’s voluntary licence, allowing a route to generic supply. But that does not ensure product availability.
“I have spoken to a few ones and I say, once you are ready, what will be your commercial territories? And many of them are not interested in small markets like Morocco or maybe some countries here.” — Othoman Mellouk, ITPC Global
“Inclusion in licences doesn’t mean access.” — Othoman Mellouk, ITPC Global
The market faces a demand-and-supply dilemma: manufacturers want predictable procurement volumes, while countries struggle to plan demand for a product that is not yet available. Regional demand forecasting and coordination could help smaller markets make a stronger case for supply.
US$40 may not be the floor — but price is only part of the problem
Mellouk said Make Medicines Affordable and the University of Liverpool had previously modelled a generic price of US$40 a year based on production costs. That benchmark is now reflected in agreements with manufacturers.
“According to our analysis, this price can go even down to $25 per year if we manage to put five or ten million [people] on PrEP per year.” — Othoman Mellouk, ITPC Global
That is a scenario dependent on scale, not a current agreed price. Nor does affordability alone close the prevention gap. Mellouk cited an estimated need for PrEP among nearly 21 million people, compared with around 2.3 million currently using it. The priority is not simply switching existing PrEP users from pills to injections — it is reaching people who have not had meaningful access to prevention.
The Global Fund: reaching three million people by 2028
Aliza Monroe-Wise, Senior Advisor, HIV Prevention and Care, at the Global Fund, described lenacapavir as one of the most important HIV prevention advances in decades. Clinical trials demonstrated efficacy approaching 100% in the populations studied.
“We’re seeing an expansion of the numbers of people using PrEP overall, not just … replacing people who were already using PrEP.” — Aliza Monroe-Wise, the Global Fund
The Global Fund and the US government jointly aim to reach at least three million people with lenacapavir PrEP by the end of 2028. Yet countries need much more than doses: regulatory pathways, budgets, procurement, delivery systems, trained health workers and continuity of prevention services.
“Communities should be engaged prior to the planning process. They should be part of the planning process from the beginning.” — Aliza Monroe-Wise, the Global Fund
Access is the real test for Central Asia
The Tashkent dialogue makes clear that the window to prepare is open, but registration, financing, demand forecasting and supply still require concrete action. Success will be measured not by a licence on paper, but by sustained, equitable access to PrEP that reflects people’s needs and choices.
US$40 changes the economics of prevention. Whether it changes the number of HIV acquisitions prevented will depend on how quickly countries and partners turn that price into access.