Pharma company Gilead has confirmed it will continue to supply HIV-preventing drugs to men who took part in a study, after NHS England went back on an agreement to continue a supply.
The PROUD study assessed the use of Pre-Exposure Prophylaxis (PrEP) as a method of HIV prevention among gay and bisexual men, and found that a daily Truvada pill can reduce the rates of HIV transmission drastically.
More than 500 at-risk men who have sex with men took part in the study, which found the drugs were highly effective at lowering the chance of HIV transmission.
Despite the results, NHS England declined to make a decision on the future of PrEP – instead going to court to claim it has no legal authority to commission the drugs. After losing the court battle, NHSE is now consulting on the future of PrEP.
It had been anticipated that NHS England would continue to provide PrEP to PROUD participants until a wider roll-out decision was made, but this was abandoned as the body focussed on legal action; leaving trial participants who had been on PrEP for years deprived of their drugs from this month.
In a statement today, Gilead, which makes HIV-preventing drug Truvada, confirmed it would donate a six-month supply of the drug to bail out participants, while the NHS considers a long-term solution.
The company said: “Gilead Sciences Ltd is pleased to confirm a donation of 2,000 bottles of Truvada to the Medical Research Council Clinical Trials Unit at the University College London.
“The donation is for use as Pre-Exposure Prophylaxis (PrEP) in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection, in a population of people at high risk of infection.
“This follows a request to Gilead from the PROUD study investigators to enable them to continue to supply FTC/TDF to participants following the end of the study in September 2016.
“Due to the current lack of routine commissioning in England, this one-time donation is intended to allow sufficient treatment for the study participants to continue to access treatment for a further six-month while a final funding decision is expected.”
Sheena McCormack, Chief Investigator of the PROUD trial, said: “The PROUD team is delighted that Gilead has made this donation for PROUD participants.
“PROUD has contributed important evidence that PrEP is effective at reducing HIV. We reported the results in February 2015 and did not expect to have to wait so long for a policy decision from NHS England. We thank Gilead for helping us to support PROUD participants during this time.”
Ian Green, Chief Executive of Terrence Higgins Trust, said: “We are grateful that Gilead has taken this step to make sure those at risk of HIV who took part in the PROUD trial remain protected from HIV while NHS England sorts out this mess.
“This will come as a huge relief to the 500 men who took part in the trial, many of whom were at high risk of becoming HIV positive if their access to PrEP was removed.
“However these individuals are not the only people at risk. Every day 17 people are diagnosed with HIV, including those from at-risk groups such as trans women, black Africans and people in sero-discordant relationships, as well as men who have sex with men.
“A long-term solution is still desperately needed to make sure everyone who needs PrEP is able to access it.
“It’s now the responsibility of all players – NHS England, Gilead and the Department of Health – to work together and ensure people at risk can benefit from this groundbreaking pill that will protect them from HIV.”
Greg Owen from pro-PrEP gorup iwantPrEPnow said: “NHS England’s continued delaying tactics in commissioning PrEP meant that hundreds of PROUD trial participants were suddenly going to find they no longer had access to PrEP.
“This move by Gilead gives participants access to an HIV prevention tool that quite obviously works for them. It is also reassuring to see Gilead accept their ethical responsibility for current and future study participant’s post trial care”
Will Nutland from PrEPster said: “PrEP advocates from across the world last month called on Gilead to commit to making PrEP available to PROUD participants who wished to continue using it.
“We are delighted that Gilead have provided drug to trial participants and commend the leadership of the PROUD trial team for continuing to advocate for this to happen.”
It comes after Parliament’s influential Health Select Committee said the PrEP saga should be a “cautionary tale” for the government, following the introduction of 2012’s Health and Social Care Act, which decentralised a large number of health issues.