• NHS England’s “implementation” trial of HIV preventative treatment delayed by at least three months with no start date fixed
  • Trial may generate a “postcode lottery” and prevent eligible people from accessing the drug, charity warns
  • National commissioning of PrEP delayed until 2020 and charities say the commissioning process is unclear

People in England are still waiting to access the HIV prevention treatment PrEP, five months after the court of appeal ruled that NHS England was responsible for its funding.

Truvada prep hiv

Aids therapy treatment Truvada

Truvada PrEP HIV

In an unusual step, NHS England has said a three year “implementation” trial of the drug is needed to ensure it can be funded in a “sustained way on a substantial scale”. Scotland gave the drug outright approval this week and HSJ understands Wales is likely to follow suit later this month.

However, the English trial of PrEP, a course of treatment taken by HIV-negative people to stop them from getting the infection, is subject to months of delay with no start date yet given.

The trial, to be overseen by Public Health England with up to £10m from NHS England, was meant to start “in early financial year 2017-18”. However, an update from PHE this week said it will now launch in “summer 2017”.

Professor Chloe Orkin, chair of the British HIV Association and a consultant physician at the Royal London Hospital, said: “Seventeen people every day are infected with HIV and this will continue as long as the drug is not available.

“The fact [the trial has] not started yet is extremely worrying and the fact that no date is set is also extremely worrying. It is very disappointing for patients and its devastating to know that people are at risk every day when people in Scotland now have access to the drug”.

She added: “We are concerned that because we haven’t been given an actual start date [for the trial] that [summer] target may well slip.”

The Terrence Higgins Trust, a charity dedicated to preventing and treating HIV, has raised concerns that the way the trial is being set up may also result in a “postcode lottery”. The drug will be only be available through 200 specialist sexually transmitted infection clinics, not from a person’s usual care provider, and each clinic will have a fixed number of people it can admit to the trial.

A spokeswoman for the charity also said while NHS England’s intention to admit at “least 10,000 participants” to the trial is “broadly comparable” to the number of people eligible for PrEP, the trial population is “possibly very slightly lower” than the number of all those in need.

Professor Orkin raised a similar concern. “By having a quota as soon as you get to person 10,001 [they] would be denied access and could then go on to get HIV – that is not an equitable system,” she said.

THT has also expressed concern about the commissioning process for after the three year trial has ended. The trial means PrEP will not be nationally available in England until at least 2020. A spokesman for NHS England said: “PrEP is not routinely commissioned at present and this position is unlikely to change until we have the outcome of the trial.”

Robert McKay, national director for THT Scotland, said: “We urgently need… assurance that the NHS will retain responsibility for PrEP in England when the trial comes to an end.”

NHS England has resisted funding PrEP since early 2016 as it said as a preventative treatment it was the responsibility of local authorities. In November, the Court of Appeal found it was responsible for funding the drug. NHS England said the judge had ruled it had “the power, although not the obligation” to fund it.

NHS England has said the evidence that PrEP works “is strong” but insists the implementation trial will answer “outstanding implementation questions… raised by Public Health England”. These include the proportion of people eligible, what impact PrEP will have on HIV and sexual disease incidences, and what strength and length of treatment will people need.

THT said PrEP has been shown to be “nearly 100 per cent effective when taken as prescribed”.