NHS England has announced the start of the trial to provide pre-exposure prophylaxis (PrEP) to people at high risk of HIV infection in England, in order to gather clinical evidence on optimal targeting, uptake and implementation of PrEP on a large scale.
From September, PrEP will be provided to to an estimated 10,000 people by the NHS in an initial three-year impact trial. Sexual health clinics in London, Brighton, Manchester, Liverpool and Sheffield are expected to be among the first to start enrolling people in the impact trial with more clinics joining from October and full implementation expected across England by April 2018.
The outcome of the trial, which will be the largest single study of its type in the world, will help inform the potential rolling out of the provision of PrEP nationwide.
“This major new intervention should complement and supercharge the wide-ranging and increasingly successful effort to prevent HIV,” said Simon Stevens, chief executive of NHS England. “It’s another milestone in more than three decades’ worth of progress in tackling one of humanity’s major health challenges.”
Deborah Gold, chief executive at National AIDS Trust described the start of the trial in England as a “pivotal moment in the fight against HIV”.
“PrEP, if targeted properly at those in need and at risk, offers the possibility of transforming the English HIV epidemic.”
Ian Green, chief executive of Terrence Higgins Trusts said the priority should now be to make sure the trial is rolled out speedily across the country and that no one at risk of HIV is left behind.
“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,” he said.
NHS England announced its plans to start the trial of PrEP in December 2016 after it lost its Appeal Court action, which challenged an earlier High Court ruling that NHS England has the power, although not the obligation, to fund PrEP.
A similar three-year PrEP trial was announced in Wales by Welsh health secretary, Vaughan Gething, in July 2017. In Scotland, the use of Truvada for PrEP on the NHS was approved by the Scottish Medicines Consortium on 10 April 2017.
A recent study of gay and bisexual men, published in The Lancet HIV (online, 23 July 2017), found that men at risk of HIV infection can safely take PrEP when they need it, instead of every day
. By taking four doses of PrEP around the time of sexual activity the relative risk of being diagnosed with HIV was cut by 97%.