NHS England announces world’s largest single PrEP implementation trial to prevent HIV infection.
Pre-exposure prophylaxis (PrEP) will be available through the NHS from September, as part of a three-year trial.
The announcement comes a year and a day after an historic win for NAT (National AIDS Trust) at the High Court that confirmed the NHS’s legal ability to fund the drug, which stops people from getting HIV.
The trial will provide PrEP to a minimum of 10,000 participants. Eligible participants for the trial will be able to access PrEP through sexual health clinics and will include men, women, transgender people, and individuals with HIV positive partners whose viral load is not known to be controlled by HIV medication.
Simon Stevens, Chief Executive of NHS England, said: “This major new intervention should complement and supercharge the wide-ranging and increasingly successful effort to prevent HIV. It’s another milestone in more than three decade’s worth of progress in tackling one of humanity’s major health challenges.”
The medical effectiveness of the drug in preventing HIV infection is well established. The NHS will use this trial to gather evidence on how to optimise uptake and implementation of a PrEP programme on a large-scale.
Deborah Gold, chief executive at NAT (National AIDS Trust), said: “We already know that PrEP brings down rates of HIV infection, changing lives for those at risk and saving public money. We now need to work with NHS England, local authorities, and the sexual health sector to make sure the widest possible range of eligible people at high risk of HIV have access to the trial. We will continue to monitor the uptake of PrEP, aiming to learn as much as possible about how to get PrEP to all those who need it most.
“This is a pivotal moment in the fight against HIV. PrEP, if targeted properly at those in need and at high risk of HIV, offers the possibility of transforming the English HIV epidemic. From September, people at high risk of HIV will have access via the NHS in England to an empowering new tool that is truly individual controlled and not subject to negotiation with a partner, leading to the improvement of many, many lives. We warmly welcome this announcement.”
PrEP involves HIV negative people taking an antiretroviral drug to avoid getting HIV. Multiple studies around the world have shown the drug is highly effective in reducing the risk of contracting HIV.
The results of the PrOUD trial in England, released in 2015, prove that PrEP works and that concerns about it not working in a real world setting, were unfounded.
Most trials of PrEP involve taking the drug daily, however a French study, ANRS IPERGAY, has looked at the efficacy of PrEP when taken ‘on demand’, in other words not daily but only before and after sex and shows significant preventive benefit.
Ian Green, Chief Executive of Terrence Higgins Trust, added: “We’re pleased that NHS England has announced a start date for the much anticipated PrEP trial. This PrEP trial has been gaining momentum in England, and is vital as we work towards ending HIV transmissions across the UK.
“The priority must now be to make sure that the trial reaches everyone at risk of HIV, and that it is rolled out speedily across the whole country, by the end of this year at the very latest. Spring 2018 is not soon enough.
“Now that the PrEP trial drug has been procured, we’re well on the way to protecting over 10,000 people at risk of HIV. To make sure no-one at risk of HIV is left behind, it is crucial that at the end of this trial in three years time, a clear process for routinely commissioning PrEP on the NHS is agreed.”
Dr. Will Nutland co-founder of PrEPster said: “PrEPster applauds the commencement of the IMPACT trial. International evidence on PrEP clinical efficacy is now so compelling that access to PrEP through the trial will have a significant impact on HIV in England. PrEPster will work alongside our colleagues for swift implementation across the country, and for diverse recruitment to the trial.”
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