NHS trial of HIV-preventing drugs for gay men begins
A large-scale trial of HIV-preventing drugs has launched in England.
Pre-Exposure Prophylaxis (PrEP) drug Truvada, which can drastically reduce people’s chances of being infected with HIV, will be made available for free on the NHS next month as part of a three-year trial.
The drug is recommended for groups considered to be at high risk of exposure to HIV, most significantly men who have sex with men.
A three-year trial of the drug launches this week, with 10,000 places available to the IMPACT trial via participating sexual health clinics across England.
The first clinics taking part in the trial have now come online, with London’s 10 Hammersmith Broadway beginning enrolment today, with 56 Dean Street expected to start enrolment on Friday.
A list of clinics taking part in the trial has been published on the IMPACT website, and most are expected to come online by the end of October.
The website says: “The PrEP Impact Trial aims to answer key questions about the use of PrEP by groups at a higher need in England. The trial is planned to last three years and enrol 10,000 participants at high risk of acquiring HIV.
“Whilst the efficacy of PrEP has been established in multiple trials across the world, including the PROUD trial that was conducted in England, the relatively small sample prevented the results being generalised to all sexually transmitted infection (STI) clinic attendees and left unanswered key questions about large-scale use of PrEP.
“The PrEP Impact Trial aims to address the outstanding questions about eligibility, uptake and length of use through expanding the assessment to the scale required to obtain sufficient data.
“The trial is a pragmatic health technology assessment of PrEP and its implementation, that is, it aims to answer the key questions under real world conditions and at sufficient scale.
“In addition, the new trial will assess the impact of PrEP on new HIV diagnoses and sexually transmitted infections. The results will inform service commissioners (funders) on how to support clinical and cost effective PrEP access in the future.”
It adds: “We had hoped everything would be in place for the trial to launch in early September.
“Unfortunately, it has not quite been possible to complete all the necessary steps to achieve this which we know will be disappointing for all those eager to participate in this important research.
“All partner organisations are working hard to put the remaining pieces of the jigsaw into place and whilst we hope the first clinics will open their doors in the next couple of weeks we are confident that the trial will be up and running by the end of October.”
With just 10,000 places available, campaigners have warned that capacity on the trial could be full in just a matter of weeks.
Sexual health campaigners estimate that there are already around 8,000 people who are on PrEP in the country using drugs bought privately online.
A survey carried out by PrEP advocacy sites iwantPrEPnow and PrEPster found that nearly all of those already taking PrEP are planning to transfer to the trial scheme when it launches.
Campaigners have warned that the trial reaching capacity could end up being turned away and left at risk.
Matthew Hodson, Executive Director of NAM said: “The effectiveness of PrEP in preventing new HIV infections has been well-established, both in trials and in practice.
“I welcome that we now have a timeline for this major trial to begin in England but remain concerned that the ambition is set too low.
“The demand for PrEP, particularly from gay and bisexual men who are well-informed about it, means that the limited number of places on the trial are likely to go rapidly.
“Unless the scope of the trial is increased, we will see people turned away, many of whom may become HIV positive as a result.”
Greg Owen, co-founder of iwantPrEPnow said: “This survey for the first time gives us a much clearer picture about the number of PrEP users in England.
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“Now we know where people are buying their PrEP from, we can extrapolate from the sales of Dynamix – the only supplier that provides us with sales data to the UK.
“We’ve been estimating for the past few months that between 6-8,000 people are buying PrEP online in the UK and that figure is substantiated by the data from the survey.”
PrEPster, which has helped people privately access drugs for PrEP prior to the NHS trial, says it will remain in operation despite the IMPACT announcement.
Will Nutland, co-founder of PrEPster said, “Not everyone who currently self-sources PrEP will meet the criteria for enrolment on to the trial.
“As such, we’ll continue to provide information about how to obtain PrEP safely and legally online, and work with clinical colleagues to ensure that PrEP support continues to be provided to PrEP users who are not on the trial.”