The UK based PROUD Study presented the results of its ongoing study at the CROI conference in Seattle this week and the findings are very positive indeed
The PROUD Study, run by the Medical Research Council (MRC) here in the UK, has presented its findings on the efficacy of Truvada as PrEP (Pre-Exposure Prophylaxis) as part of an ongoing two-year study. The trial, composed of 545 men who have sex of men (MSM) found a “real world” efficacy of 86% of preventing HIV infection.
The trial was run in two groups, the first group were randomly allocated to get Truvada immediately, while the second group were given it after one year. Among the men who started the drug straight away, there were three HIV infections, but among the other group who did not have the drug, there were 19.
Researchers at the MRC said that PrEP “offers a major opportunity to curb new HIV infections in men who have sex with men in the UK.”
Concerns have previously been raised that the offer of PrEP will lead to a fall in condom use and a rise in other STIs. However the PROUD Study found condom usage and STI rates remained the same between those in offered the drug and those who were not.
The drug on trial is Gilead’s Truvada, a single pill co-forumulation of Tenofovir and Emtricitabine, which forms the backbone of many existing HIV treatments. The cost of Truvada is currently around £360 per month although this could fall by almost 90% when the patents on both drugs expire in 2017.
Sheena McCormack, Professor of Clinical Epidemiology at the MRC Clinical Trials Unit at University College London, and Chief Investigator of the study said:
“These results are extremely exciting and show PrEP is highly effective at preventing HIV infection in the real world,”
“Concerns that PrEP would not work so well in the real world were unfounded. These results show there is a need for PrEP, and offer hope of reversing the epidemic among men who have sex with men in this country. The findings we’ve presented today are going to be invaluable in informing discussions about making PrEP available through the NHS.”
The National Aids Trust is calling for PrEP to be available via the NHS. Deborah Gold, chief executive, said:
“Over the course of their lifetime the treatment of those 19 men will cost the NHS nearly £7m,” she said. “So the financial argument is clear, as is the ethical one. PrEP needs to be available on the NHS as soon as possible for all those who need it.”
Dr Michael Brady, medical director at Terrence Higgins Trust, said:
“PrEP is, quite simply, a game-changer. We know that most gay men use condoms most of the time, and that this has prevented tens of thousands of HIV infections since the epidemic began in the UK. However, we also know that condomless sex vastly increases the risk of HIV being transmitted.”
“It is not a vaccine and it won’t be for everyone, but once approved, we expect it to significantly increase the momentum in our fight against the virus,” he said.
Tom Hayes, Editor-in-Chief of beyondpositive, said:
“PrEP has proven itself to be effective time and time again – we know this now. It’s time for us to work out how we fit this valuable tool into our prevention programmes. PrEP won’t be for everyone, the NHS won’t be prescribing it to tens of thousands of people, but for those who are at constant high risk this could be a real life saver.”
“As well as the bio-medical intervention the prescribing for, an monitoring of, those receiving PrEP will give us invaluable on-one-on time with these high-risk people which will allow us to help them make changes to their lives and hopefully in the long term reduce any risk taking behaviour.”
NHS England will now study the results to determine whether it is cost effective to provide it for men at risk of infection.
External link: PROUD Study (http://www.proud.mrc.ac.uk)