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Hundreds of people living with HIV that is resistant to all other treatments will now receive a life-saving new drug on the NHS.
While existing antiretroviral treatments work for most people with HIV to help them live long and healthy lives, there are a very small number of people for whom the virus has not responded to conventional treatments, putting their lives at risk.
NHS England has announced that, for the first time, a “trailblazing” drug called lenacapavir will be made routinely available to this group on the NHS, to help save their lives, reduce the risk of serious illness and prevent passing the virus on to others.
The new drug works by targeting the virus’ protective outer shell (known as the capsid) to preventing it from reproducing. This novel approach is different to the way most existing HIV treatments work, which targeting the enzymes that the virus uses to make copies of itself.
The breakthrough treatment, which is the first-of-its-kind, is administered as a combination of daily pills followed by long-lasting injections.
Patients initially take a tablet for two days, then have a follow-up tablet on day 8, after which they will have two injections on day 15, before switching to a bi-annual injection – making it much more convenient to keep on top of treatment.
It is estimated that nearly 300 people in England could be eligible to receive the drug in the first three years, with the NHS contacting those currently eligible within weeks to begin treatment as soon as possible.
HIV (human immunodeficiency virus) is a virus that weakens the immune system and increases the risk of serious illness.
There are over 100,000 people living with HIV in England – and while there is no cure, the vast majority of people are on effective antiretroviral therapy that suppresses the virus.
John Stewart, National Director for Specialised Commissioning at NHS England, said:
“This trailblazing drug will offer a lifeline to people living with HIV for whom conventional treatments have not worked and options are currently limited – giving them the opportunity to live a normal, healthy and long life.
“It’s fantastic news that this treatment will offer fresh hope to hundreds of patients going forward and help transform HIV into a manageable condition for them.
“Alongside the NHS’s opt-out blood testing programme in A&Es, which is finding thousands of undiagnosed cases every year, and the rollout of home-testing kits and new injectable treatments, this is another step forward in care that will bring us closer to our goal of eliminating HIV in England the next decade.”
The rollout of this new treatment follows a rigorous assessment by a group of NHS experts and clinicians who have reviewed multiple specialist medicines, medical devices and treatments, with funding agreed for those with the greatest benefit for patients and value for money.
Today’s announcement is a part of a wider drive to end HIV transmissions in England by 2030, in addition to other initiatives including opt-out testing at A&E departments, at-home test kits which can be ordered via the NHS App and a national programme to re-engage people back into life-saving HIV care and treatment.
One person who has already benefited from this treatment said it was ‘lifesaving’ for her.
Jane was born with HIV infection. She was prescribed multiple different medications throughout childhood and developed a fear of swallowing large tablets. Unfortunately, she developed resistance to first line HIV treatments.
Her medical team applied for injectable Lenacapavir through a compassionate access programme offered by the drug’s manufacturer, which she combines with two other medications.
Before starting Lenacapavir, her immune system was dangerously low, and she had several hospital admissions with complications of HIV infection. The treatment worked for her, and she now has undetectable HIV levels, and her immune system has recovered.
She says: “Lenacapavir has been life saving for me. Before this medication, I was really unwell. Now I am working full time and am living a normal life. I’m not worried anymore and feel a lot happier.
“I’m so pleased that more people living with HIV that is resistant to treatment will now be able to get this treatment from the NHS, it can make all the difference.”
Health Minister Baroness Merron said:
“For people living with drug-resistant HIV this landmark treatment will totally transform their lives and, even better, it’s available on the NHS.
“We’re determined to end new HIV transmissions by 2030 and this life-saving drug alongside our new HIV Action Plan, demonstrates this government’s commitment to give people living with HIV every opportunity to live long and healthy lives.”
Daniel Fluskey, Director of Policy at the National AIDS Trust, said:
“This is a huge decision for people who need life-saving treatment and takes us a step closer to ensuring that no one dies from AIDS-related illnesses here in the UK. Over years too many people have lost loved ones, family, and friends because of a lack of access to medicine and the harm caused by stigma, prejudice, and discrimination – so when a new life-saving treatment is available it must get to the people who need it.
“We’ve come so far with HIV treatment that people can now expect to live long and healthy lives with HIV, and alongside improvements in HIV prevention we have all the tools needed to achieve the UK Government’s goal of ending new HIV transmissions and AIDS-related deaths by 2030 – as long as those tools can be easily accessed by everyone who needs them.”
Richard Angell OBE, Chief Executive of Terrence Higgins Trust, said:
“It’s a great step forward and relief for those who need it that Lenacapavir is now available as HIV treatment. For the vast majority of people living with HIV, existing treatments mean that they can live long, healthy lives and can’t pass on HIV. However, for the small number of people for whom a daily pill does not work – most likely those who took earlier HIV medication or acquired HIV at birth – the option of injectable treatment presents them with hope. For them, this news is not just game-changing, it’s lifesaving. We’re grateful to everyone who has worked so hard to make this happen.”
Chair of the British HIV Association, Dr Tristan Barber said:
“This NHS decision reflects its stated commitment to ensure that the benefits of cutting-edge HIV research reach the people who need them most. Treatment resistance creates enormous clinical and emotional challenges for the small but highly vulnerable group who have exhausted treatment options and cannot achieve viral suppression. Lenacapavir is a major scientific advance that can help these people regain control of their health and regain confidence in their future.”
NHS England’s Clinical Priorities Advisory Group (CPAG) looks at drugs and treatments that are not being assessed by NICE, for example where they are not licenced for the clinical indication in question.
More information about the CPAG process is available here.