Landmark HIV prophylaxis trial to begin next month

Around 10,000 people in England will get access to preventive HIV drugs in a landmark government-funded trial aimed at lowering infection rates among high-risk individuals.

The trial, which will cost around £10 million over three years, involves patients getting treatment with generic emtricitabine and tenofovir supplied by Mylan in a commercially confidential deal.

A generic version of Gilead’s Truvada, the combination has been shown to reduce the risk of HIV infection in people exposed to the virus through sex or injected drug use.

The trial will begin next month, with clinics in London, Brighton, Manchester, Liverpool and Sheffield expected to be among the first to start enrolling people.

Full implementation is expected by April 2018 at the latest, and lessons learned from the trial will inform routine commissioning once the trial is complete.

The £10 million cost includes the price of the medicine and includes costs for local authorities and sexual health clinics involved in delivering and monitoring the trial intervention.

People living and registered with a GP in England will also be able to enrol for potential participation at their local participating sexual health clinic.

Clinics will identify eligible participants who consent to the trial, including men, women, transgender people, and individuals who have a partner whose HIV status is not known to be controlled by anti-retroviral treatment.

The trial is the result of a lengthy legal campaign by HIV campaigners after NHS England opted not to commission a national PrEP scheme despite supportive findings from the PROUD trial.

Deborah Gold, chief executive at the National AIDS Trust, which campaigned to get PrEP commissioned last year, said: “This is a pivotal moment in the fight against HIV. PrEP, if targeted properly at those in need and at risk, offers the possibility of transforming the English HIV epidemic.”

Ian Green, chief executive of the Terrence Higgins Trust, said: “The priority must now be to make sure that the trial reaches everyone at risk of HIV, and that it is rolled out speedily across the whole country, by the end of this year at the very latest. Spring 2018 is not soon enough.”

He added: “It is crucial that at the end of this trial in three years’ time, a clear process for routinely commissioning PrEP on the NHS is agreed.”

NHS England chief executive Simon Stevens said: “This major new intervention should complement and supercharge the wide-ranging and increasingly successful effort to prevent HIV. It’s another milestone in more than three decade’s worth of progress in tackling one of humanity’s major health challenges.”

In addition to investing in the PrEP trial, NHS England already invests in a ‘treatment as prevention’ (known as TasP) policy to start HIV treatment earlier for people with diagnosed HIV to protect HIV-negative partners. This programme, combined with other prevention measures, has led to a drop of over 20% in new HIV diagnoses in large London clinics.