NHS England finally approves lenacapavir for ART

28 August 2026. Related: Antiretrovirals, Treatment access, Women's health.

Community activists demonstrate the urgency of access to lenacapavir, February 2026

Simon Collins, HIV i-Base

After years of protracted discussions between NHS England and Gilead, long-acting lenacapavir injections will finally be routinely available as a life-saving drug.

The indication is for people who are unable to construct an active combination due to either multi-drug resistance (MDR) or intolerance to other drugs. These limited circumstances are only expected to initially affect about 100 people.

The 45-page evidence review is also posted online. [2]

Inclusion criteria

• Adults aged 18 years and over.
• Weight >35 kgs.
• MDR HIV-1 infection and are either:
   
  (i) not virally suppressed with existing ART regimen
   
  OR
   
  (ii) are virally suppressed but on a highly complex regimen with concerns of tolerance, resistance or safety where the addition of lenacapavir could simplify the regimen and optimise individuals’ outcome and experience.

They must also meet all the following criteria:

• Individuals have limited or no therapeutic options remaining.
   
  AND
• The use of lenacapavir has been discussed and agreed with the individual or individual’s representative and the HIV specialist MDT.
   
  AND
• The individual or individual’s representative is able to agree to the required injection schedule.
   
  AND
• Lenacapavir is to be added to an optimised background ART regimen.

Please see full document for full details.

comment

Lenacapavir was approved by the MHRA in 2022 as a treatment for MDR-HIV and the delay by NHS England for access to a life-saving drug with expected low use and a relatively low price is shocking.

Immediately after approval, Gilead established a free named-patient access programme but after three years with no outcome, this programme was closed to new participants in April 2025. NHS Scotland agreed a price and approved lenacapavir in April 2025.

HIV community advocates should not have to hold street protests for such medicines – although ACT-UP London, BHIVA, the UK-CAB, cliniQ, Sophia Forum, NAT, i-Base and numerous HIV organisations did this as part of an access campaign earlier this year.

As with all approvals for new drugs to treat MDR-HIV, it is important that the indication  for lenacapavir includes use to achieve viral suppression that isn’t possible with current ART.

One of the benefits of long-acting injections is to support people who for complex reasons have adherence difficulties that risks developing further drug resistance.

For example, several independent research groups, including in the US, have achieved viral suppression, often for the first time, by using 6-monthly lenacapavir in combination with CAB-LA, in the setting of NNRTI-resistance. [4]

References

1. NHS England. Lenacapavir for multi-drug resistant Human Immunodeficiency Virus 1 infection (HIV-1) (adults) [URN: 2344]. Clinical Commissioning Policy. Reference number: 2344. (16 July 2026).
   https://www.england.nhs.uk/publication/clinical-commissioning-policy-lenacapavir-for-multi-drug-resistant-human-immunodeficiency-virus-1-infection-adults/ (web page)
   https://www.england.nhs.uk/wp-content/uploads/2026/07/2344-commissioning-policy-lenacapavir-for-hiv.pdf (PDF file)
2. NHS England. Evidence review. (45 pages). (16 July 2026).
   https://www.england.nhs.uk/publication/clinical-commissioning-policy-lenacapavir-for-multi-drug-resistant-human-immunodeficiency-virus-1-infection-adults/
3. Lenacapavir EAP in the UK closed to new referrals: NHS England and Gilead fail to agree a price after more than two years. HTB (20 April 2025).
   https://i-base.info/htb/50940
4. Gandhi M et al. Case Series of People With HIV on the Long-Acting Combination of Lenacapavir and Cabotegravir: Call for a Trial. Open Forum Infect Dis. 2024 Apr 16;11(4):ofae125. doi: 10.1093/ofid/ofae125.
   https://pubmed.ncbi.nlm.nih.gov/38628952