NHS England has announced a start date for the pre-exposure prophylaxis (PrEP) trial that will provide preventative drugs to people at high risk of HIV infection.
From September, PrEP will be provided by the NHS through an initial three-year trial to an estimated 10,000 people, it said.
“This major new intervention should supercharge the increasingly successful effort to prevent HIV”
The trial will assess the full additional potential of PrEP, by gathering clinical evidence on optimal targeting, uptake and implementation on a large scale, said NHS England.
It will also be the largest single study of its type in the world, noted the government arm’s-length body.
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 from early September.
More clinics will join in October, with full implementation across England by April 2018 at the latest, stated NHS England.
It added that lessons learnt during the trial would inform follow-on routine commissioning after the end of the three-year research period.
“The start of the PrEP trial is welcome and long overdue”
In addition, to support the study, NHS England said it had “concluded a successful international competitive procurement to source the PrEP drugs for the trial”.
It said a contract signed this week with pharmaceutical company Gilead had secured pricing within the programme’s £10m budget, which also included costs for councils and clinics involved in delivering and monitoring the intervention.
Clinics will identify eligible participants who consent to the trial, including men, women, transgender people, and individuals who have a partner whose HIV status is not known to be controlled by anti-retroviral treatment.
People living and registered with a GP in England will also be able to enroll for potential participation at their local participating sexual health clinic, it said.
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.
simon stevens confed 1
Source: Neil O’Connor
“It’s another milestone in more than three decades’ worth of progress in tackling one of humanity’s major health challenges,” he said.
The announcement follows a stand-off among public sector bodies over who would fund PrEP in England, which delayed its availability and angered charities.
NHS England had argued that it should solely be the responsibility of councils to fund PrEP, rather than the NHS, following the transfer of responsibility for public health commissioning.
However, in December 2016, NHS England changed its stance and announced that the PrEP implementation trial would take place to “pave the way” for its full roll-out.
The joint move, with Public Health England, followed a Court of Appeal ruling that NHS England, alongside local authorities, had the power, although not an obligation, to fund PrEP.
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Deborah Gold, chief executive of the National AIDS Trust, described today’s announcement 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,” she said.
Ian Green, chief executive of Terrence Higgins Trust, said: “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.”
He added: “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.”
Labour public health spokeswoman Sharon Hodgson said: “The start of the PrEP trial is welcome and long overdue after months of delays and heel-dragging by the government.
“Now it is important that this trial is rolled out as quickly as possible across the country,” she said.
Liberal Democrat health spokesman Norman Lamb said: “Thousands of people will breathe a sigh of relief that a start date for this important trial has finally been announced.
However, he also highlighted that the announcement followed a “stark warning” earlier today that sexual health services were at a “tipping point” due to funding cuts.
“As a matter of urgency, the government must end this short-sighted approach and reverse the disastrous cuts to public health grants we have seen in recent years,” he said.
However, question marks remain over whether PrEP will be available to patients across the UK, with the potential creation of a so-called postcode lottery.
In March, Scotland became the first UK nation to approve its use for health service patients. However, in April, an advisory body recommended that PrEP should not be funded on the NHS in Wales.