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People at-risk of HIV in England could get PrEP from September

10,000 people will use Gilead’s Truvada in the upcoming trial

Gilead

NHS England has started what it says is the world's largest single trial of a Gilead-developed therapy that protects high-risk patients from contracting HIV.

The study of Gilead's pre-exposure prophylaxis (PrEP) therapy Truvada (emtricitabine and tenofovir disoproxil) - which was approved by the EMA last year - follows a pilot that saw the drug prevent transmission of the virus by cutting new infections by up to 86%.

News of the PROUD trial - which will see 10,000 people given access to the combination over three years - comes after a protracted and emotive battle by NHS England not to make the drug routinely available, arguing that responsibility for funding it should lie with local authorities, and specifically public health budgets.

NHS England lost a lawsuit last year, and its opposition to routine provision was further weakened after the National Institute for Health and Care Excellence (NICE) published an evidence summary in September concluding that the drug was not only effective in reducing transmission, but also encouraged uptake to other health services such as HIV testing and sexually-transmitted infection (STI) screening.

NICE did not deliver a verdict on the cost-effectiveness of the therapy, however, saying it would be dependent on a host of variables including uptake and adherence, sexual behaviour, the emergence of drug resistance etc.

Now, NHS England says the new trial will provide the data it needs on "optimal targeting, uptake and implementation on a large scale" before moving ahead with full-scale commissioning of PrEP. It has reached an agreement on the supply of a generic version of Truvada from Mylan that will allow it to keep the cost of the trial down to £10m (around $13m). The cost of the generic is unknown, but Truvada's UK list price is around £350 for 30 tablets.

"Whilst HIV infection rates in England are falling due to increased prevention, diagnosis and treatment programmes, this major new NHS-England funded intervention will now assess the full additional potential of PrEP," it said in a statement.

From September, clinics in London, Brighton, Manchester, Liverpool and Sheffield will identify eligible participants - including men, women, transgender people, and individuals who have a partner whose HIV status is not known to be controlled by anti-retroviral treatment.

"There is a more diverse population of high risk individuals for whom PrEP and its associated risk reduction support could mean the difference between staying HIV negative or becoming HIV positive," said Professor Brian Gazzard, chair of St Stephen's AIDS Trust.

"The data and evidence we generate will not only be of international interest but more importantly will enable commissioners in England to plan for a PrEP programme that benefits individuals and the taxpayer."

Ian Green, chief executive of HIV charity Terrence Higgins Trust (THT), said the priority now is to "make sure that the trial is rolled out speedily across the country, and that no-one at risk of HIV is left behind".

Article by
Phil Taylor

7th August 2017

From: Healthcare

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