This World AIDS Day is marked by a paradox that captures the current moment. On the one hand, science has delivered tools with the potential to significantly reduce new HIV acquisitions. On the other, commercial barriers, delays in access and shrinking international funding are preventing these innovations from reaching the people who need them most. The combination of these factors threatens to slow or reverse the progress achieved over the past two decades.
Lenacapavir is a twice-yearly injection that can be used as pre-exposure prophylaxis (PrEP), a prevention strategy that very effectively reduces the risk of acquiring HIV before a possible exposure. Its six-monthly schedule makes adherence easier and offers a particularly useful option for people who face challenges taking a daily pill, including young women, LGBTQ+ people, sex workers and other populations who face stigma, logistical barriers or limited access to health services.
However, access to lenacapavir is highly unequal. Although it has already been approved for HIV prevention use in the United States and the European Union, millions of people in other countries lack affordable access to the medicine at its current price and will not benefit from the voluntary license controlled by Gilead Sciences. This license allows the manufacture of affordable generic versions only in a limited group of countries and excludes 26 others across different regions where there are still high numbers of new HIV acquisitions, especially in Latin America. Several of these excluded countries even took part in the clinical trials of the medicine. People from those communities participated in the trials to demonstrate its safety and efficacy, yet today they cannot register it or include it in their public HIV prevention programmes.
This situation is compounded by the extremely high price of the branded product in higher-income countries. In European countries, including Spain, the treatment indication costs more than 40,000 euros per year, despite independent studies estimating that it could be produced for around 25 dollars. In Spain, although lenacapavir has already been authorised for preventive use, it has not yet been included in the public health system because of the price and conditions proposed.
Within Gilead’s voluntary license, agreements have been announced in recent months with two generic manufacturers in India to produce low-cost versions from 2027 onwards, with an estimated price of 40 dollars per person per year. These initiatives are supported by Unitaid and are complemented by the Global Fund’s pooled procurement mechanisms, which help secure lower prices and ensure supply in many countries. Even so, these generic versions will not be available for several years and will not address the current exclusion of countries that Gilead has left outside the license.
Less funding, higher risk of losing ground
The debate around lenacapavir is unfolding in the context of a broader decline in resources for the global HIV response. UNAIDS estimates that new HIV acquisitions are rising again after years of progress. In 2023 there were about 3,500 new HIV acquisitions every day, and by 2025 that figure could reach 5,800 per day. If this trend continues, between 2025 and 2029 there could be millions of additional new HIV acquisitions and millions of HIV-related deaths.
In this context, the Global Fund’s Eighth Replenishment Conference, held a few days ago in South Africa, mobilised 11.34 billion US dollars to continue funding the response to HIV, tuberculosis and malaria. This is a significant effort given the current global situation, but still falls short of the 18 billion dollars needed to adequately meet current needs. While some donors have reduced their contributions, others — including several African countries, India and Ireland — have increased their commitments.
Spain is maintaining its contribution at 145 million euros, an increase compared to the previous replenishment, which Salud por Derecho welcomes. However, we continue to call on the Spanish Government to move towards a contribution of 200 million euros, in line with the scale of the global challenge and the country’s international responsibilities.
We also call on the European Union to strengthen its leadership and to announce its contribution as soon as possible, as no figure has yet been made public. This delay could make it harder for the Global Fund to plan and allocate resources in a timely manner, which in turn could put essential programmes at risk in many countries. We believe the EU should commit at least 800 million euros, a contribution needed to avoid service interruptions, leverage additional funding and keep the global HIV response on track.
A response based on rights, not exclusions
To prevent backsliding in the global HIV response, it is essential to put the right to health above commercial interests. Ensuring access to prevention tools such as lenacapavir, strengthening multilateral funding and moving towards fair pricing are fundamental steps to protect the progress made and avoid thousands of new HIV acquisitions and deaths in the coming years.
Spain and the European Union now have an opportunity to play a decisive role. A stronger commitment and an active defence of equitable access can help keep the world on course so that HIV ceases to be a threat to public health.
