Europe is missing HIV targets but EACS now recommends event-based PrEP for all using 2:1:1 or 2:7 dosing

27 October 2025. Related: Early access, Special reports, Conference reports, HIV prevention and transmission, EACS 20 Paris 2025.

Simon Collins, HIV i-Base

EACS 2025 was an essential meeting for the numerous presentations about PrEP that included far more than news about injectable formulations, which for all their promise, are still hardly used by anyone.

Cabotegravir-LA (CAB-LA) and lenacapavir (LEN) are important of course, and they are included below, but the most sobering results related to the current limited access to oral PrEP, reported on Friday morning, in a plenary lecture by Teymur Noori from the ECDC on Europe’s uncertain health targets. [1]

Ten years after FTC/TDF was approved by the EMA, PrEP is only being widely used in a few countries, with many barriers and inequalities even to low-priced generics.

These details need to be taken together with the announcement that the EACS guidelines now support event-based dosing for everyone. [2]

Event-based PrEP: 2:1:1 and 2:7 dosing

The major update to the EACS guidelines this year didn’t technically change PrEP dosing, as the recommendation for everyone to start with two pills was made last year. This double dose gives rapid protection for everyone within two hours, including cisgender women and trans and non-binary people, who previously could only use daily PrEP. Stopping PrEP in these cases just involves taking daily PrEP for seven days after sex. Last year however, the guidelines panel was uncertain about calling this event-based dosing. [3]

This year, during the discussion in the guidelines session, the panel confirmed that cisgender women can use event-based 2:7 dosing, similar to the recent UK guidelines. Although not part of the discussion, the UK guidelines are clear that this option also covers transgender and non-binary people using oral PrEP. [4]

The reason this should be headline news is that it might make oral PrEP far more acceptable as a highly safe and effective option for people who do not want to take daily pills – and to only use PrEP when needed.

Access to oral PrEP in Europe in 2024

The urgency of alternatives to daily oral PrEP from a public health perspective was highlighted in the overview by Dr Noori, which reported that seven out of the eight HIV-related European health targets for 2025 will not be reached this year. While many countries in Western Europe are either meeting or close to these targets, the region as a whole is much more complicated (see Table 1). [1]

Table 1. ECDC HIV health targets for EU/EEA in 2025

For example, two missed targets include (i) the modest 2025 goal of 500,000 people having access to PrEP – missed by 155,000; and (ii) just as worryingly, the aim to reduce HIV incidence by 75% by 2025, which has instead been replaced by a 5% overall increase in HIV incidence across the region. These are both connected.

Of the 345,000 people in the EU/EEA region who used PrEP at least once last year, more than 70% were from only four countries. These were the UK (110,000), France (60,000), Germany (40,000) and Spain (34,000) – and some of these countries have a waiting list to access PrEP that is over a year. The next countries were Italy (16,000), Ukraine (14,000) and the Netherlands (12,000), but of the remaining 28 countries, 10 have 1,000-8,000 people assessing PrEP and the remaining 18 countries have less than 1,000 people each.

Across the region, PrEP is only funded publicly in half the countries, even when recommended in national guidelines, and although more than half of new diagnoses are among migrant communities, they access less than 5% of PrEP. Just as shocking, is that only 2.5% of people accessing PrEP in Europe overall are women. On this metric, Ukraine reached 27% women, with 3% in the UK.

Although the prices for generic oral PrEP ranged from less than €3 to €207 per month, out-of-pocket expenses charged to people accessing PrEP in six countries were >€500 per month and the charges ranged from €100 to €500 in 13 others.

By comparison, the current out-of-pocket expenses for lenacapavir, even if available, would be unaffordable for everyone at €1500 per month. A late-breaking moderated poster presented by Cassie Fairhead from the Royal Free in London and colleagues also focussed on lenacapavir costs and pricing. This study showed that lenacapavir could be produced for low- and middle-income countries at an annual for-profit price of $25 per person when produced at scale for five million people. [5]

The same research group, working with Andrew Hill, previously reported that generic lenacapavir could be produced at $40 a year for use in low- and middle-income countries and last month this was the generic price negotiated by Unitaid, CHAI and WITS university, which was a remarkable achievement. [6]

Although Gilead is involved in providing access to lenacapavir in 120 countries until generic manufacturers can meet demand in 2027, and PEPFAR, the Global Fund and CIFF are fundraising for the programme to reach two million people, this Gilead price has not been released. There are also concerns for the countries left out of this arrangement, especially in Central and South America. [7]

These projected costs clearly leave a lot of room for Gilead to considerably drop the price of lenacapavir in high-income countries. For example, the current US price of $28,000 has been rejected by some mainstream insurance-based pharmacies including CVS, which has refused to stock lenacapavir PrEP for months. [8, 9]

Dr Fairhead also presented a second moderated poster on PrEP at EACS. This study highlighted how the test and treat component of effective PrEP is likely to avert more new cases than PrEP itself. This was shown in the PURPOSE 1 and 2 studies where hundreds of people coming to enrol were diagnosed with HIV when being screened for the studies. This makes affordable access to these high-demand options even more important in all countries. [10]

Injectable PrEP: CAB-LA and LEN

EACS also had plenty of sessions with presentations about injectable PrEP, together with dozens of posters about all aspects of PrEP. [11]

These included surveys showing high acceptability and interest among people already using oral PrEP and small short-term demonstration projects with donated drugs, which were generally successful. The fact that not everyone wanted injectable PrEP however shows the importance of expanding the options available to give people choice..

Given the high level of interest in lenacapavir, it was also unexpected that an adherence substudy in 10% of participants in the phase 3 PURPOSE 2 study reported that only 63% were persisting with lenacapavir after a year. This seems low, even though the study used a conservative definition of persistence and even though this was significantly higher than the 37% of participants taking oral F/TDF (p<0.003). The discussion also included a question suggesting that many of the people in the oral PrEP arm might have discontinued due to no longer needing PrEP. [12]

An EACS 2025 session on Thursday included lectures and oral abstracts looking at the importance of PrEP equity within countries, as well as differences within countries from a public health and human rights perspective. [13]

This covered some of the structural, cultural, geographical, economic and systemic barriers and included a talk by Sinead Delany from the University of Witwatersrand, South Africa, that focussed on meeting the PrEP needs of women; injectable PrEP is urgently needed but is taking a painfully slow pathway, blocked by cost, lack of generic competition and limited capacity to manufacture locally. The UNAIDS 2025 target to have 20 million people already on PrEP only reached about seven million people – more than 40% of whom discontinued within six months. And these data are from 2024 which was when PEPFAR still covered 90% of global PrEP programmes – now dismantled since 20 January this year.

An oral presentation by Haoyi Wang from Maastricht University, reported that less than 700 transgender and non-binary people accessed PrEP in the five years from 2018 to 2022, with lower uptake and higher discontinuation of daily oral PrEP reported in a separate survey. Although this showed that current PrEP use and patterns were suboptimal in this population, the survey reported a high awareness and interest in injectable PrEP. [14]

Jean-Michel Molina from the University of Paris also presented an oral abstract on the diversity of enrolment into the Gilead PURPOSE 5 study being conducted in the UK and France. This study is currently the only way to access lenacapavir in these countries and the company has committed to continued access for participants until regulatory approval. [15]

This lively session ended with a practical suggestion from the session co-chair Sheena McDonald – that everyone starting injectable PrEP should also be given a month of oral PrEP.

comment

The PrEP experience at EACS was driven by still having such low and unequal access to PrEP across the EU/EEA region – an inequity that continually upsets UK activists even though we are providing access to roughly one-third of the PrEP in the region.

It is also clear that, at least based on the UK experience, the limited access to injectable PrEP will only account for less than 1% of people using PrEP.

This is likely to be similar in every country but the decision by the EACS guidelines panel to approve event-based dosing for everyone using either 2:1:1 or 2:7 dosing might grant new access for people who don’t want to take a daily pill.

Several delegates also referenced a new modelling study published last month in JID, reporting that 2:1:1:1 dosing for cisgender women – i.e. continuing daily PrEP for only three days after sex rather than seven – would provide sufficient drug levels to effectively protect against HIV. [16]

This supports the comment in the UK guidelines that 2:7 dosing was being cautious and that fewer post doses might be sufficient.

An important next step will be for WHO guidelines to consider the modelling and PK studies given that data on this important question will never be produced in large randomised clinical studies or even large observational studies. This is such an important option that providing direction based on this accumulating evidence and support in other guidelines, however qualified, is too important to simply defer to needing more data. [17]

In the meantime, especially while waiting for alternatives such as injectable PrEP (or once-monthly oral MK8527), everyone should be able to use on-demand PrEP when they need and want to.

References

1. Noori T. “Five years left!” What targets are in reach in Europe and which will we struggle to make? EACS 2025, Paris. Plenary lecture 3, Friday 17 October 2025, 9.15 am.
   https://player.vimeo.com/video/1128511583?h=f6e69df235&title=0&byline=0&portrait=0&badge=0&autopause=0&player_id=0&app_id=58479 (webcast)
2. EACS guidelines major update: ART, OIs, on-demand PrEP for women, weight gain, HIV-2, pregnancy, infant feeding, sleep disorders and more. HTB (21 October 2025).
   https://i-base.info/htb/52581
3. EACS guidelines 2024: Double dose start for oral PrEP – rapid protection in two hours. HTB (20 November 2024).
   i-base.info/htb/49351
4. Why the new HIV PrEP guidelines from the UK are so exciting (2025). HTB (2 July 2025).
   https://i-base.info/htb/51432
5. Fairhead C et al. Generic lenacapavir HIV pre-exposure prophylaxis could be produced for $25 per person per year. EACS 2025, late-breaker poster abstract MeP09.6.LB.
   https://eacs2025.abstractserver.com/program/#/details/presentations/1218
6. Unitaid CHAI and Wits RHI enter into a landmark agreement with Dr. Reddy’s to make HIV prevention tool lenacapavir affordable in LMICs. (24 September 2025).
   https://unitaid.org/news-blog/lenacapavir-for-hiv-prevention/
7. Gilead press statement. Gilead Signs Royalty-Free Voluntary Licensing Agreements with Six Generic Manufacturers to Increase Access to Lenacapavir for HIV Prevention in High-Incidence Resource-Limited Countries. 2 October 2025.
8. Fierce Pharma. For now CVS declines to cover Gilead’s long-acting HIV PrEP treatment Yeztugo. 21 August 2025.
   https://www.fiercepharma.com/pharma/now-cvs-declines-cover-gileads-twice-yearly-hiv-prep-treatment-yeztugo
9. The Advocate. CVS tells HIV activists that pharma company Gilead needs to lower price of PrEP drug if it wants it covered. 24 October 2025.
   https://www.advocate.com/news/cvs-gilead-prep4all-lenacapavir
10. Muraleetharan A et al. Comparative benefits of pre-exposure prophylaxis versus test-and-treat to reduce community viral load: a systematic review of PrEP trials. EACS 2025. Moderated poster MeP20.2.
    https://eacs2025.abstractserver.com/program/#/details/presentations/1047
11. HIV Prevention: Current modalities and Future Horizons. EACS 2025, Paris. Parallel Session 08. Friday 17 October, 11.00 am.
    https://eacs2025.abstractserver.com/program/#/details/sessions/136 (programme)
    https://player.vimeo.com/video/1128506741?h=c5247765fd&title=0&byline=0&portrait=0&badge=0&autopause=0&player_id=0&app_id=58479 (webcast)
12. Ogbuagu O et al. Annual persistence to twice-yearly lenacapavir versus daily oral F/TDF for PrEP in the PURPOSE 2 trial. PS08.
    https://eacs2025.abstractserver.com/program/#/details/presentations/607
13. Scaling up PrEP to meet the needs of everyone. EACS 2025, Paris. Parallel Session 02. Thursday 16 October 2025. 11.00 am.
    https://eacs2025.abstractserver.com/program/#/details/sessions/129 (programme)
    https://player.vimeo.com/video/1128311235?h=c113f30acb&title=0&byline=0&portrait=0&badge=0&autopause=0&player_id=0&app_id=58479 (webcast)
14. Wang H et al. Extended PrEP cascades and determinants of long-acting PrEP intention and unmet PrEP needs among transgender women, transgender men, and non-binary individuals in 20 European countries. EACS 2025, Paris. PS 02.1.
    https://eacs2025.abstractserver.com/program/#/details/presentations/655
15. Molina JM. Recruitment of Disproportionately Affected Populations in the PURPOSE 5 Study Evaluating Lenacapavir for PrEP in France and the UK. EACS 2025, Paris. PS02.4.
    https://eacs2025.abstractserver.com/program/#/details/presentations/588
16. Enge N et al, Optimizing On-Demand Tenofovir Disoproxil Fumarate/Emtricitabine Dosing in Women for HIV Prevention, The Journal of Infectious Diseases, 2025; jiaf459.
    https://doi.org/10.1093/infdis/jiaf459
17. IAS 2025: WHO guidelines: major updates on injectables, AHD, breastfeeding, infant prophylaxis and peer support. HTB (2 August 2025).
    https://i-base.info/htb/52185