Injectable PrEP in Leeds and London: criteria, approval and continuation

In February this year, the UK government announced that it was expanding NHS England’s initial rollout of long-acting injectable HIV PrEP to 2000 people rather than the 1000 it initially announced last November.

This number is less than 2% of the roughly 111,000 people who have ever started PrEP in England. Although the actual cost negotiated by the NHS is confidential, and likely to be considerably discounted, the list price for the six two-monthly injections of long-acting cabotegravir (Apretude) is roughly £7000 a year. This compares with less than £350 for generic daily PrEP using tenofovir disoproxil/emtricitabine (TDF/FTC) pills.

Given these supply and cost restrictions, local NHS trusts will have to develop their own access criteria for people in need of injectable PrEP. Two presentations at the recent British HIV Association (BHIVA) and the British Association of Sexual Health and HIV (BASHH) joint conference in Liverpool gave details of how this is being achieved.

Implementing injectable PrEP in Leeds

Dr Alex Langrish of Leeds Sexual Health told the conference that a multidisciplinary team (MDT) had been formed to discuss and approve cabotegravir prescriptions and that between September 2023 and March 2026, 28 cases had been discussed and 27 approved.

Cabotegravir was prescribed to 23 men, all but one gay or bisexual, as well as four cisgender women and one transgender woman. Their average age was 40, but with a considerable range – the youngest was 17 and the oldest 65. Most were of White ethnicity, but four were Black and three Asian.

The MDT had drawn up four primary criteria for referral to cabotegravir. These were:

• They were unable to tolerate or absorb oral tablets: 46% of people were in this category
• Their adherence to oral PrEP was suboptimal (given their level of risk to HIV): also 46% in this category
• They were unable to have tablets due to social or personal circumstances (such as their living situation): 39% in this category
• TDF/FTC was medically contraindicated (for instance, if they had chronic kidney disease): 11% in this category

Twelve people (43%) met more than one of these criteria.

Leeds Sexual Health opted for a ‘loading dose’ regimen whereby people initially take four weeks of oral cabotegravir pills to assess possible intolerance to cabotegravir. Up to March 2026, 22 of 27 people (81%) had taken at least one cabotegravir pill. Fifteen people were on regular injections, three had an appointment booked for their first injection, and four were either still in their first month or had not started injections.

One person decided not to start due to concern about being able to come to the clinic every two months; Alex Langrish noted that two-monthly clinic visits were not only a barrier for this person, and that seven of the 28 people approved for PrEP lived outside the Leeds postal code.

Because of this, models of care are being developed to provide ongoing injections at local GP practices and women’s health hubs, and for outreach teams working with vulnerable clients (see this report for how Leeds Sexual Health is also developing outreach provision of doxyPEP for syphilis prevention in sex workers). A PrEP clinical nurse specialist role is also being recruited to expand the service’s capacity.

Before reimbursement: compassionate access at Dean Street

Another presentation documented the barriers that had to be surmounted before people could start cabotegravir PrEP before the NHS decision to reimburse. While clinicians could apply on behalf of their patients to a Compassionate Use Authorisation (CUA) scheme run by cabotegravir’s manufacturer, ViiV Healthcare, only 16 people attending the 56 Dean Street clinic started cabotegravir in over three years.

In contrast, 56 Dean Street prescribed oral PrEP, nearly all of it TDF/FTC tablets, at least once to 30,000 people last year. It processes 150 consultations a day, many of them conducted with the help of home testing.

Before a CUA application could be made, people having difficulty using TDF/FTC PrEP had to try four steps:

• Supportive therapies to help with adjusting to oral PrEP
• A gradual increase in PrEP dosage, if done at a time when HIV risk was minimal
• Switching to a different generic brand of TDF/FTC (in case side effects were caused by non-active ingredients)
• Trying tenofovir alafenamide/emtricitabine (TAF/FTC) oral PrEP (this includes a different formulation of tenofovir, which isn’t associated with the kidney and bone problems TDF can cause.)

Twenty-six applications were made under the CUA scheme. Three were rejected: one was on anticoagulant medication, a contraindication for cabotegravir injections. Two did not proceed because they were managing to take TAF/FTC. Decisions were still pending for another six when the NHS began to reimburse cabotegravir.

Of the 17 approved, 13 were approved due to intolerance of oral PrEP side effects; two due to chronic kidney dysfunction (eGFR under 30); and two could not swallow tablets. They were all men, including at least one trans man; their average age was 34, and all but three were of White ethnicity.

One of the 17 decided not to start after all. Of the other 16, four stopped cabotegravir within a short time; three because of side effects (no further details were given, but in other studies, nearly all intolerance has been due to injection site reactions) and one found attending regularly difficult.

Since NHS approval, the 12 people who continued to take cabotegravir have been getting it from the NHS, as have the six people whose CUA decision was still pending. A further 11 people have been approved by the local MDT, including one cisgender woman and one transgender woman. However, one person stopped during their lead-in month on cabotegravir pills, and five either decided not to start or have not re-attended so far.

This means that a total of 23 people at Dean Street are continuing on cabotegravir (12 approved before the NHS decided to reimburse it, and 11 afterwards) out of a total of 34 originally approved for cabotegravir – a 32% attrition rate, which is much higher than reported elsewhere.

However, the first individuals to take cabotegravir may not be typical of future users – many had documented intolerance to oral PrEP, for example. The researchers say that “As NICE-approved access expands, understanding outcomes in populations with long-acting PrEP needs will support appropriate patient selection and counselling.”