Hundreds of gay men lose access to HIV-preventing drugs as study concludes without NHS decision

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Hundreds of men who have sex with men are set to lose their supply of HIV-preventing drugs, after a large-scale study concluded without an NHS England decision.

The PROUD study had assessed the use of Pre-Exposure Prophylaxis 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.

Hundreds of men took part in the initial study – but though it was deemed hugely successful, health body NHS England declined to make a decision on the future of PrEP – claiming legal authority rests with local councils in an abrupt reversal of its previous stance.

The decision means that hundreds of men will now imminently lose their access to PrEP as the PROUD study concludes.

Under the previous agreement it was anticipated that NHS England would continue to provide PrEP to PROUD participants, but this will now no longer take place.

A statement via Medical Research Council says: “We are sorry to announce that PROUD has to close according to the plan agreed in January, which allowed for one visit after the anticipated NHS England decision in June. This decision never took place.

“The NHS England announcement of 21 March 2016 implied a commitment to PROUD participants that continue to need PrEP.

“However, it transpires that this commitment is contained within the £2M set aside for early implementer sites. Public Health England (PHE) is working, with partners, on the design of the early implementer sites but these will not be launched until 2017.

“Gilead is also planning a study to compare Truvada (the drug used in PROUD) to F/TAF (a new version of Truvada). The study is called DISCOVER and everyone in the study will get PrEP. DISCOVER is likely to start in the next 6 months.

“In June this year we found out that NHS England had no separate plan for PROUD participants.

“We wrote to Gilead with a request for a donation of drug for PROUD participants to bridge the gap between PROUD closing and the PHE/DICOVER studies starting. Gilead is considering this request, but could not activate it until October as they won’t have approval for Truvada as PrEP in Europe until then.

“We thank the PROUD participants for taking part in a study that has accelerated access to PrEP globally, if not yet at home.”

The statement notes that it is legal to buy PrEP drugs privately, but the cheapest option amounts to £44 per month – which is unlikely to help the most disadvantaged groups.

Though PrEP is prohibitively expensive for individual consumers, it is economically viable for large-scale healthcare providers compared to the cost of treating a higher number of HIV infections.

Pro-PrEP campaigners slammed NHS England for failing to honour its previous commitment to trial participants.

Will Nutland from PrEPster said: “PROUD participants put drugs in their bodies on a research trial that has accelerated access to PrEP globally.

“Hundreds of gay men and trans* women signed up to volunteer on this trial and trusted the promise from NHS England that PrEP would continue to be provided. This is one of many broken promises from government and bureaucrats on PrEP.

“With new PrEP trials on the horizon, steps need to be taken immediately to restore confidence in those considering participation in future trials. Gilead, NHS England and Public Health England have a responsibility to look after PROUD participants.”

Greg Owen from I Want PrEP Now said: “There is enough remaining trial drug to provide all PROUD participants with a further 3 months supply each.

“Our understanding is that ‘trial drug’ cannot be issued outside of a trial setting and because funding for the trial has ended this trial drug sits unused.

“We are calling on Public Health England and NHS England to rectify this senseless situation.

“We demand that while free drug is still available that all PROUD study participants be recalled and supported until such times as these participants can be enrolled in a new PrEP study or until there is alternative PrEP provision in place for this group of people.”