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New trial to expand NHS use of PrEP for HIV prevention, says NHS England

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NHS England has announced a major extension of the national HIV prevention programme via a largescale trial of pre-exposure prophylaxis (PrEP) in order to “pave the way” for its planned full roll-out.

The joint move with Public Health England marks a significant change in its stance on the provision of anti-retroviral drugs for prevention, collectively known as PrEP.

“We need to use all tools available to save lives and money”

Kevin Fenton

The new HIV initiative follows a recent Court of Appeal ruling that NHS England, alongside local authorities, has the power, although not an obligation, to fund PrEP.

NHS England had previously 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.

The first phase of the new scheme’s implementation will be the launch of a clinical trial in 2017-18, involving at least 10,000 participants over the next three years, said NHS England.

Though evidence on the clinical effectiveness of PrEP was “strong”, it said PHE had advised there were “significant outstanding implementation questions that should be answered prior to using PrEP in a sustained way on a substantial scale”.

“The trial will provide access to PrEP for thousands of people most at risk of acquiring HIV”

Ian Williams

In a statement released on Sunday, NHS England said: “These questions will be answered by the clinical trial, paving the way for full roll-out.”

NHS England will meet the trial’s £10m price tag and will then work with local authorities, the Local Government Association and PHE to implement the findings as part of a wider national roll-out.

Next steps will include asking both the manufacturer of the branded PrEP drug Truvada, as well as generic manufacturers to make proposals to participate in the trial.

Professor Kevin Fenton, director of health and wellbeing at PHE, said: “Currently 13,500 people are living in the UK with undiagnosed HIV and we are still seeing around 5,000 new infections each year.

“Given we are in the fourth decade of this epidemic there are too many new infections occurring, and we need to use all tools available to save lives and money,” he said. “We’re delighted to be working with NHS England on this major new addition to the national HIV prevention programme.”

“PrEP is a ground-breaking method of treatment that has the potential to save lives”

Izzi Seccombe

Izzi Seccombe, chair 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.

“PrEP is a ground-breaking method of treatment that has the potential to save lives and councils want to work with the NHS to help roll out the trial,” she said.

Dr Ian Williams, chair of NHS England’s clinical reference group for HIV from Central and North West London NHS Foundation Trust, said the trial’s announcement provided the “chance to best prepare England for optimal roll-out”.

“For now, the trial will provide access to PrEP for thousands of people most at risk of acquiring HIV,” he said.

The PrEP clinical trial will answer questions raised by PHE about six key outstanding questions:

1. What proportion of genitourinary medicine (GUM) clinic attendees will be assessed as eligible for PrEP?

2. How to identify, engage and maintain other eligible PrEP users?

3. What proportions of the eligible will accept PrEP and will choose daily or intermittent dosing?

4. For how long will those beginning at high risk stay on PrEP?

5. What impact will PrEP have on HIV incidence?

6. What impact will PrEP have on STI incidence?

But Ian Green, Chief Executive of Terrence Higgins Trust, said the county needed to be “bold and ambitious” in its approach to HIV prevention and called for a stronger commitment on PrEP.

“We welcome the fact that PrEP will be made available to 10,000 people who are at risk over three years,” said Mr Green.

“Preventing the spread of HIV is good news for everyone,” he said. “For every person who would have become HIV positive without PrEP, the NHS will save £360,000 in lifetime treatment costs.

“However, there are many questions that need to be answered about the proposed trial. 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,” he said.

“This trial alone does not provide the long-term stability that is needed”

Ian Green

He added: “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 at risk.”

Meanwhile, last week PHE and NICE also announced the roll-out of new guidance to increase the uptake of HIV testing.

NHS England also announced on Sunday that it had decided to routinely commission 10 new specialised treatments, it said, as part of the annual prioritisation process for specialised treatments

The decision was based on advice from NHS England’s clinical priorities advisory group, which assessed the relative priority of investing in a new range of specialised treatments and interventions.

This took into account revised prices submitted by some manufacturers since provisional investment decision were published in July. The 10 specialised treatments are:

  • Pegvisomant for acromegaly as a third-line treatment for adults
  • Auditory brainstem implants for congenital abnormalities of the auditory nerves or cochleae
  • Haematopoietic stem cell transplant : Lymphoplasmacytic lymphoma /Waldenstrom’s Macroglobulinaemia (adults)
  • Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
  • Rituximab for immunoglobulin-G4 related disease (IgG4-RD)
  • Microprocessor controlled prosthetic knees
  • Tolvaptan for hyponatraemia secondary to the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) for patients who require cancer chemotherapy
  • Ivacaftor for children (2-5 years) with cystic fibrosis (named mutations)
  • Sodium oxybate for symptom control for narcolepsy with cataplexy (children)
  • Pasireotide for Cushing’s Disease

 

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