The NHS in England will miss its own target for providing the "game-changing" drug that prevents HIV, medical and policy experts have warned.
In a press release published in December 2016, NHS England announced that its trial offering the medication regime known as PrEP – pre-exposure prophylaxis – to 10,000 people over three years would begin in the "early financial year 2017/18".
But the new financial year begins next week and, according to two of Britain's biggest HIV charities and other leading figures in the sector, there is no sign of the trial procedures being implemented, no clear plan in place, and almost no prospect of the pills reaching patients within the next three months.
The National AIDS Trust (NAT), which last year won a high-profile legal battle against NHS England to bring the health body back on the path to providing PrEP, on Thursday accused both NHS England and Public Health England of unnecessary delays.
"A lot has to be put in place for the trial to begin but we fear that timelines are slipping badly," an NAT policy spokesman told BuzzFeed News, before referring to the chief executives of the respective organisations. "Simon Stevens at NHS England and Duncan Selbie at Public Health England have to pay attention and take an immediate personal responsibility for getting the trial back on track timings-wise. There can be no more broken promises."
The spokesman added: "Seventeen people a day are getting diagnosed with HIV – we need PrEP urgently on the NHS. Further delay is unacceptable."
In correspondence seen by BuzzFeed News, the charity last week wrote a joint letter with the Terrence Higgins Trust, Britain's largest HIV charity, to both public bodies expressing concern over the apparent delays.
They called on the chief executives to reveal a timetable for the path to the launch date. Neither charity has yet received a response.
Neither of the public bodies responded to questions put to them by BuzzFeed News about when the trial will begin.
Ian Green, chief executive of the Terrence Higgins Trust, told BuzzFeed News: “Four months since we welcomed the news that 10,000 people would be protected from HIV thanks to a major new trial for game-changing drug PrEP, we’re back to asking the same question that we’ve been asking for the past two years: Where is PrEP?
“The trial was promised ‘early’ in this financial year – this seems highly unlikely at this stage. There are big and essential steps that need to be taken before a trial of this size can get off the ground, and there is no evidence they have happened yet."
Four months ago a #PrEP trial was announced for 10,000 people. Why are we still asking #WhereisPrEP?
Green said his charity's helpline (THT Direct) has been regularly receiving calls from members of the public "who have identified that they’re at risk and want to take control by accessing PrEP. People saw the media coverage about the trial months ago, and understandably want to know if they’re eligible for the trial and how they can access it."
He added: "Sadly, we still don’t have the answers for them. We’ve already lost so much time on PrEP and ‘later’ may be too late for someone who is at high risk of HIV right now. We urgently need clarity on how this trial will work and what the barriers are to making it happen.”
The trial is funded by NHS England, but will be a joint partnership with Public Health England and the Local Government Association – which also refused to answer any questions posed by BuzzFeed News.
In order for a trial of this size and nature to be launched, a series of key undertakings have to be performed first.
These include: recruiting people to sign up; gaining approval regarding the ethics of the trial; securing a deal with pharmaceutical companies to buy the drugs; linking up with sexual health clinics to deliver the drugs to patients; and agreeing on the "protocols" involved – the parameters of how, who, why, and when participants will be given the drugs.
BuzzFeed News understands that only the last of these areas have been submitted for approval. But there is further cause for concern that the trial remains months off, according to the one of the key figures in the PrEP field.
Public health specialist Dr Will Nutland from the London School of Hygiene and Tropical Medicine, who also runs leading PrEP information source Prepster.info, said: "We're getting loads of queries, both from people who want to know how to go on to the trial and from clinics contacting us saying, 'Do you know how we can get our clinic onto the trial?'"
In other words, said Nutland, the sexual health clinics that should shortly be administering the drugs don't even know how they go about signing up for access to them.
This is perhaps not surprising, he added, when "Public Health England has put no new updates into the public realm, nor has NHS England, so people who want PrEP are relying on community activists to share information that these organisations should themselves be putting into the public domain, which in itself is telling."
It is, he said, "indicative of the lack of communication coming from the relevant bodies ,who will say, 'We don't know yet, there will be a process, we can't yet explain what that process is and we can't give you that information.' It's bonkers."
According to Nutland, who has been attending meetings held by these bodies, the indications are that even the recruitment of participants in the trial – members of the public – won't begin until July.
"It's a scandal, an absolute scandal," he said. "Our public health organisations have fobbed us off with a trial for a whole set of reasons and no there's no guarantee that a trial is the right thing or that the reasons we were sold a trial as a good thing will ever materialise."
There is also, he added, "no guarantee that generics can or will be used". The pharmaceutical company Gilead, which makes Truvada, the brand name for the drug used in PrEP, has not yet indicated whether it will allow the NHS to use non-branded – generic – versions of the drug, which are significantly cheaper. This, said Nutland, is likely to have a significant impact on how many people will actually be recruited for the trial, despite the 10,000 figure given by NHS England.
Asked by BuzzFeed News when, given what he has heard from all the organisations involved, a likely start date will be for the trial, Nutland replied that even the second quarter of the coming financial year – July, August, or September 2017 – is only "50/50".
Unlike Where's Wally, the search for #PrEP is delaying treatment that can save lives and prevent #HIV infection!… https://t.co/lrphPENs1Q
Meanwhile, on social media, the hashtag #WhereIsPrEP has resurfaced as fears grow that PrEP won't reach those most at risk of infection.
The hashtag was first used as a rallying call for action a year ago when NHS England first derailed the process by which PrEP would be considered for commissioning, which led to the legal action by the NAT.
Every day that passes without the #PrEP trial sees avoidable #HIV transmissions. #WhereIsPrEP?
In a Westminster Hall debate about PrEP this week, the Conservative MP and junior public health minister Nicola Blackwood said the trial would be "underway this summer".
The Terrence Higgins Trust has since asked her to be more specific and said it has not received a response.
UPDATE
Following the publication of this article, a statement was sent to BuzzFeed News by Professor Noel Gill, head of Public Health England’s HIV and STI department:
“We remain committed to launching a large scale clinical trial of PrEP with NHS England and work is continuing to finalise the trial design, governance, recruitment and drug procurement. It is important that we get the planning for a trial of this scale, complexity and importance absolutely right. Engagement events have been held with stakeholders to keep them informed of progress and involve them in the planning and design of the trial. We have told stakeholders at these meetings that our aim is to have the trial up and running as quickly as possible and by the Summer of 2017.”