NHS England, in collaboration with Public Health England, has announced in a press release today that a major new implementation trial of pre-exposure prophylaxis (PrEP) will start next year. It is planned to enrol at least twice as many as previously anticipated and the funding announced is five times higher than the money for a trial originally announced in March this year.
NHS England says that the three-year trial will start in “early financial year 2017/18”, which implies next April-June. It will seek to enrol “at least” 10,000 participants over the three years, and will not be directed exclusively at gay men or any other population.
Up to £10 million will be provided for the trial by NHS England. This is five times the previous offer of £2 million for a two-year PrEP pilot, though considerably less than the £16-20 million a year for five years originally recommended by a PrEP development committee. The money will cover all aspects of the trial including both the treatment costs that NHS England would normally cover anyway, and the monitoring and clinic costs which would normally be borne by local authorities as part of their public heath remit. It is hoped that this will cushion the impact on local authorities' budgets and allow them time to prepare for fully supporting PrEP in three years' time.
Only a few details of the trial have been settled. “Detailed planning will now take place to ensure the launch and the clinical trial phase can begin as swiftly as possible,” say NHS England’s press release.
What this means in practice is a good deal more hard bargaining with both Gilead, manufacturers of the branded PrEP drug Truvada, and other companies that make generic versions of the same tenofovir/emtricitabine combination pill. NHS England are clear that a bidding process will take place to supply drug for the trial. NHS England say: “Next steps will include asking both the manufacturer of the branded PrEP drug Truvada, as well as generic manufacturers to make proposals to participate.”
Routinely commissioned NHS services could not use generic versions of Truvada while it remains protected by a patent, but a research study is able to use generics.
Despite the upbeat tone of the press release, members of NHS England and Public Health England have told aidsmap.com that the trial’s feasibility still depends on a good deal being struck. One said: “The real crunchpoint is whether or not we can obtain suitable antiretrovirals at a price that makes the proposed trial feasible. There remain roadblocks to the quotations I’ve heard about so far.”
According to the press release, the study aims to answer a number of questions about the implementation of PrEP in England. PrEP will primarily be delivered through sexual health clinics, but it remains unknown what proportion of clinic attendees would be assessed as eligible for PrEP and what proportion would actually accept an offer of PrEP. The trial may assess methods to identify and engage potential PrEP users, including in other settings.
While the study will not seek to make direct comparisons between daily and event-based PrEP dosing regimens, it will gather data on who chooses to use each approach and on their outcomes.
Finally, the study will assess the incidence of new HIV and STI infections in individuals who get PrEP (including individuals who stop taking it), and this could be compared with data from other people using sexual health clinics.
NHS England and Public Health England hope that a large trial, with many participants, will produce a large amount of data on all these points. However more precise details of how the trial will be run in practice have not yet been developed.
The figure of the trial enrolling 10,000 people over three years is broadly in line with the estimations of demand that were made for the PrEP commissioning proposal that was submitted to NHS England earlier this year. It relies on the expectation that people will go on and off PrEP as their needs evolve, with most people only needing PrEP for about a year. Most of all, the number of people who could take part will depend on the price of the drug that is negotiated.
The previous commissioning plan found that the number of people in England whose HIV risk suggests eligibility for PrEP is considerable; between 8000 and 12,000 gay men per year, plus in the region of 1000 people from other groups. However it is assumed that actual uptake will be lower, and the commissioning model assumed no more than 50% uptake in those eligible. So uptake for the study may build over time – perhaps 2000 people enrolling in its first year of availability, 3000 in the second, 5000 in subsequent years.
Will Nutland of activist group PrEPster told aidsmap.com that the 10,000 figure would probably meet a large part of the current demand for PrEP but a smaller proportion of the actual need. Moreover, those conducting the trial would need to make particular efforts to engage individuals and communities who are not already aware of the benefits of PrEP. While affluent gay men may seek PrEP quite readily, the trial needs also to reach black communities, trans people and those on low incomes.
Eligibility criteria for PrEP are likely to be similar to those used in the earlier commissioning proposal – men who have sex with men who have recently had anal sex without a condom, trans people who have done the same, heterosexuals assessed to be at similar high risk to men who have sex with men, and partners of HIV-positive people who are not taking treatment.
The decision follows the Court of Appeal’s ruling on 10 November that NHS England, alongside local authorities, has the power, although not the obligation, to fund PrEP and should plan how to provide it. Deborah Gold, Chief Executive of the National AIDS Trust, who took the case to the court, said that the trial would not be happening without the legal challenge, a series of parliamentary questions and strong community pressure for PrEP.
“We are absolutely delighted that following our wins in Court, NHS England, working with Public Health England and local government will be now making PrEP available on a large scale, and quickly, to those who need it,” she said.
NHS England says that in addition to PrEP it has still been able to commission a list of ten new specialised treatments for uncommon conditions ranging from cystic fibrosis to lymphoma. The list includes two new high-tech advances: microprocessor-controlled artificial knee joints, and brainstem implants for congenital deafness. However, three specialised commissioning proposals formerly on the list will now have to wait till spring 2017 to be considered again.
Kevin Fenton, Director of Health and Wellbeing at Public Health England commented: “We’re delighted to be working in partnership with NHS England on this major new addition to the national HIV prevention programme. This comes after much planning and preparation to ensure we can successfully coordinate this extremely important and large-scale clinical trial.”
He urged local authorities to fund another innovative HIV prevention method, home testing kits.
Greg Owen of iwantPrEPnow commented: "Today's announcement is the next step in getting PrEP to people who will most benefit from it. PrEP has been available in the USA for 4 years. England, the UK, and the rest of Europe now have the opportunity to use PrEP to turn the tide of HIV infections across the continent." However, he noted that the plans are not a permanent solution to wider PrEP provision and called on NHS England to ensure that the limited availability of PrEP is targeted so it does not enhance existing health inequalities.
Izzi Seccombe, Chairman of the Local Government Association’s Community Wellbeing Board, said: "We are pleased that NHS England has acted quickly and chosen to fund the commissioning of this trial and rollout of PrEP. We now want to stand united with the NHS to defeat the spread of HIV.”
Ian Green, Chief Executive of Terrence Higgins Trust welcomed the fact that PrEP will be made available to 10,000 people who are at risk over three years. “However there are many questions that need to be answered about the proposed trial,” he said. “We need to know how it will work in practice and understand how those at risk, no matter where they live, will be able to access PrEP. This trial alone does not provide the long-term stability that is needed – NHS England must make a commitment now that when the trial ends they will fully fund PrEP for all those who are at risk.”
Dr Jonathan Fielden, NHS England’s Director of Specialised Commissioning commented that this “groundbreaking national programme for PrEP that will benefit at least 10,000 people…has, in part, been made possible by the willingness of many pharmaceutical and device companies to come forward with lower and more responsible prices.”
The NHS England press release is at https://www.england.nhs.uk/2016/12/hiv-prevention-pregramme/