Today’s decision by the Scottish Medicines Consortium (SMC) to approve medication to prevent HIV infection has been widely welcomed by patient groups, sexual health executives and clinicians from Health Protection Scotland and NHS health boards.
The SMC has approved Tenofovir disoproxil fumarate/Emtricitabine (known as TDF/FTC and commercially as Truvada™) for use as a prevention drug in combination with safer sex practices across NHS Scotland.
This prevention method is known as HIV ‘pre-exposure prophylaxis’ or ‘PrEP’ and provides an additional way to prevent HIV being passed on. TDF/FTC has been used with other medications to treat people already infected with HIV in Scotland since 2006.
This latest development is supported by the Sexual Health and Blood Borne Virus (SHBBV) Executive Leads Network. Ann Eriksen, Co-Chair, said: “PrEP is for specific HIV negative individuals at the time in their life when they are at highest risk of sexually acquired HIV infection. The drug is intended to be used in combination with existing interventions to promote safer sex and as part of a comprehensive approach to HIV prevention. PrEP will not be a replacement for condom use and it will continue to be important for individuals to test regularly for HIV and other sexually transmitted infections.”
Dr Rak Nandwani, Chair of the Scottish Short Life Working Group on PrEP, said: “Despite advances in treatment and care, HIV changes the life of people who become infected, not just in terms of health, but also relationships and well-being. International randomised controlled trials have demonstrated a substantial reduction in HIV transmission using pre-exposure prophylaxis (PrEP). The provision of NHS-funded PrEP, combined with other prevention interventions, is a total game-changer that will lead to a drop in the number of HIV infections in the UK.”
Professor David Goldberg, Consultant Epidemiologist, Health Protection Scotland, added: “We will now work together to ensure that PrEP can be made available through sexual health services within the usual 90 days following a decision by the SMC.”
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Notes to Editor
- The Sexual Health and Blood Borne Virus (SHBBV) Executive Leads Network consists of Executive Leads and Lead Clinicians representatives for Sexual Health and HIV from Health Protection Scotland and the 14 health boards across Scotland.
- There are currently 4,575 people who are living with HIV in Scotland and are in specialist care. Of these, 95% are taking HIV therapy: http://www.hps.scot.nhs.uk/documents/ewr/pdf2017/1711.pdf
- Health Protection Scotland estimates that between 50 and 150 men who have sex with men (MSM) have become infected with HIV within Scotland each year over the last 20 years.
- PrEP involves HIV-negative people taking antiretroviral medication as an additional prevention measure to reduce the risk of becoming infected. PrEP is cost effective in preventing HIV infection (a key aspect of what SMC consider for any new drug) and, over time may save money for the NHS.
- International randomised trials have found PrEP medication to be highly effective in MSM. The risk of sexually acquiring HIV was reduced by 86% in uninfected adults in two clinical trials PROUD1 and IPERGAY2. Importantly, PROUD found no difference in the incidence of STIs in the intervention and the deferred arm of the study. The PROUD study was conducted in sexual health clinics in the UK.
- In Scotland, the Executive Leads for Sexual Health and Blood Borne Virus convened an expert Short Life Working Group (SLWG) to review the evidence and provide recommendations on initiatives and strategies relating to PrEP in Scotland. The recommendations made by the expert Short Life Working Group in the report PrEP in Scotland provided guidance on how a PrEP programme could be delivered. Read the report: http://www.hivscotland.com/news-and-events/latest-news/article/report-recommending-prep-use-in-scotland-published/
- PrEP will be provided by specialist sexual health services, or in the Island Boards through locally agreed arrangements. To support Boards with local implementation and ensure that there is a consistent, coordinated approach, an HIV PrEP Implementation and Monitoring Group chaired by Professor David Goldberg of Health Protection Scotland will be established.
- Further information about PrEP is available on sexual health websites of local health boards and at HIV Scotland’s website at www.hivscotland.com
- McCormack et al, Pre-exposure prophylaxis to prevent the acquisition of hiv-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial, The Lancet, 2016;387(10013): 53-60
- Molina JM et al, On-demand pre-exposure prophylaxis in men at high risk for HIV-1 infection. New England Journal of Medicine, 2015 Dec 3;373(23): 2237-46