A two-year study into whether pre-exposure prophylaxis (PrEP) should be routinely made available on the UK NHS for gay and bisexual men is being fast-tracked after interim results show it highly protective against HIV.
The trial study of a two year research project entitled PROUD recruited 545 gay men at high risk of HIV infection through 13 sexual health clinics in London, Brighton, Manchester, Birmingham, Sheffield and York.
The trial involved two randomised groups: one taking Truvada immediately, while the other would be given the drug after the study had been running for 12 months.
Initial analysis showed a far better than expected results which had PROUD’s medical staff to have participants of the second group start taking Truvada immediately.
Results also showed that placebo controlled trial PrEP works to protect against acquiring HIV with the consistent one daily tablet dosage.
In addition PROUD participants are offered regular testing for HIV and sexually transmitted infections, condoms and safer sex support and counselling.
The exact number of HIV infections prevented by PrEP is yet unknown, but results will be available in early 2015.
PROUD’s Independent Data Monitoring Committee, who reviewed the interim results, are confident that the follow-up will not change the over conclusion of the trial but provide greater accuracy and answer further questions about longer-term adherence, changes to risk behaviour and drug resistance.
The results shows that PrEP is highly effective at protecting against HIV. The final results will provide evidence to support making PrEP available in the NHS. It also paves the way for future research to identify other PrEP regimens that may be even easier to adhere to or have even fewer side-effects.
Commenting on the results, Waverley Care’s Chief Executive Grant Sugden, told KaleidoScot: “The findings so far from the PROUD study are very encouraging. In 2013, 49% of people diagnosed with HIV in Scotland, where the probable route of transmission was reported, were men who have sex with men. This speaks of the continuing challenge we are faced with around HIV and men who have sex with men in Scotland and the UK.”
He added: “This latest positive report on the use of PrEP as an option for HIV prevention provides real hope for the future. We look forward to hearing more as the study continues and, if the final results advocate it, seeing PrEP promoted as a prevention tool alongside those we already endorse including the use of condoms and lube and safer sex practices.”