NHS England has announced it will fund a large-scale clinical trial on the use of pre-exposure prophylaxis (PrEP) for the prevention of HIV ahead of a national roll-out.
The announcement follows the Court of Appeal ruling in November 2016 that said NHS England does have the power, although not the obligation, to fund the provision of antiretroviral drugs for the prevention of HIV.
The three-year trial, which is expected to start early in the 2017–2018 financial year and include at least 10,000 people, will focus on how long participants at high risk of HIV infection stay on PrEP and what impact the preventative product has on the incidence of HIV and sexually transmitted infections.
The trial is expected to cost up to £10m and will be fully funded by NHS England, which will work with local authorities, the Local Government Association (LGA) and Public Health England (PHE) to implement the findings as part of a wider national roll-out.
Although there is strong evidence supporting the clinical effectiveness of PrEP, PHE says there are questions to consider before use of the product is implemented on a substantial scale in England. These include what proportion of genitourinary medicine (GUM) clinic attendees will be assessed as eligible for PrEP; how to identify and maintain other eligible PrEP users; what proportion of eligible people will accept PrEP; and whether participants choose daily or intermittent dosing.
Ian Williams, chair of NHS England’s clinical reference group for HIV, says: “This announcement demonstrates NHS England’s commitment to fund PrEP and provides the chance to best prepare England for optimal roll-out following this large-scale clinical trial.”
Izzi Seccombe, chair of the LGA’s community well-being board, says: “We are pleased that NHS England has acted quickly and chosen to fund the commissioning of this trial and roll-out of PrEP.”
Gilead Sciences, the manufacturer of the branded PrEP drug Truvada, as well as generic firms, are now invited to make proposals to participate in the trial.
Jonathan Fielden, director of specialised commissioning and deputy national medical director at NHS England, says the trial “has, in part, been made possible by the willingness of many pharmaceutical and device companies to come forward with lower and more responsible prices”.
However, he adds that NHS England has had to make “some tough decisions”, which means some specialised treatments for other conditions could not be funded this year. “We will ensure those treatments have the opportunity to be considered as part of the next annual prioritisation round in spring 2017.”