Daily pill to prevent HIV infection: the PROUD Study
1 Nov 2017
The ground-breaking results from the PROUD study indicate that a treatment known as PrEP is highly protective for a high-risk group of people, reducing the risk of HIV infection by 86%. PrEP is calculated to save the NHS over £1 billion over an 80-year period (£12.5m per annum). As a result, in July 2017 NHS Scotland has made PrEP available through sexual health clinics and both Wales and Northern Ireland have started offering PrEP through pilot trials. In 2016, NHS England launched a PrEP Impact Trial with the aim of recruiting 10,000 participants in three years.
PrEP is a type of infection control known as pre-exposure prophylaxis, which is the provision of antiretroviral drugs before HIV exposure to prevent infection. This prevention strategy targets people who are HIV-negative but at high risk of infection. Launched in 2012, the PROUD study looked at whether offering daily HIV PrEP to men who have sex with men was a reliable way to prevent them from becoming infected if exposed to the virus. This study was led by the MRC Clinical Trials Unit at University College London and Public Health England, in partnership with the pharmaceutical company Gilead (which manufactures the PrEP drug Truveda).
PrEP was already known to reduce the incidence of HIV infection in placebo controlled trials. The PROUD study was designed to see if the same effect would be found in a real-world situation where participants knew they were taking an active drug. It aimed to address outstanding questions such as whether taking PrEP would change sexual risk behaviour – for example increasing the number of partners they did not use condoms with and increasing the rate of other sexually transmitted infections (STIs) – and whether or not it would be cost-effective to make it available on the NHS.
The trial leader Professor Sheena McCormack and the rest of the team are now working with the NHS and local authorities about funding and administering this vital HIV prevention option to groups that are at high risk of infection. Based on the PROUD trial and population modelling, a 2017 Lancet paper has estimated that PrEP would save the NHS over £1 billion over an 80-year period (£12.5m per annum). PrEP has been made available to 10,000 individuals at risk in England to collect data on the longer-term aspects of this intervention. As of July 2018, this PrEP Impact Trial has recruited 7,000 participants across 139 clinics. The NHS has now made PrEP accessible to all high-risk people in Scotland, with pilot trials in Northern Ireland and Wales. Many HIV-infected people (approximately one third in the UK) are not aware of their infection, and unfortunately people who are not aware of their HIV infection are unable to fully benefit from antiretroviral therapy either for their own health or to prevent HIV transmission to their partners. For uninfected high-risk people, having a way to prevent HIV infection through PrEP could therefore be life-saving for society as well as for the individual.