NICE evidence review supports efficacy of Truvada as PrEP in the UK
Simon Collins, HIV i-Base
On 7th October, the National Institute for Health and Care Excellence (NICE) published its evidence review on PrEP concluding: “There is little doubt that Truvada is effective in reducing HIV acquisition in high-risk people who are HIV-negative”.
The online report has six sections: a summary, introduction and current guidance, product overview, evidence review, context and estimated impact for the NHS.
The NICE review includes results from both the UK PROUD study and the French/Canadian IPERGAY study that both reported efficacy rates of 86% for daily and event-based dosing respectively, although daily dosing is the only currently approved indication.
Importantly, the NICE review also references the Partners PrEP study in heterosexual couples where one partner was HIV positive where uses of daily PrEP reduced incidence of HIV by 75%. This is important for PrEP to be option to be available for heterosexuals in the UK at high risk of HIV.
A separate aspect of these studies that the research does not directly highlight, is that a comprehensive package of HIV prevention is provided for all participants in PrEP studies. This is likely higher level of support than the standard of care and yet participants not using PrEP in the studies, still became HIV positive.
The context notes that 2015 guidelines from both European (EACS) and World Health Organisation (WHO) already recommend PrEP.The professional medical associations BHIVA and BASHH also recommended PrEP in May 2016.
Although efficacy is clear the NICE report also notes that “issues relating to uptake, adherence, sexual behaviour, drug resistance, safety, prioritisation for prophylaxis and cost-effectiveness are also important to consider, especially at a population level”.
This positive review was expected, given the previous evidence report produced by NHS England to decide on whether PrEP would be commissioned.
Both reviews were also expected to find in favour of PrEP, given that both the US and European drug approval agencies have already approved PrEP based on results from clinical studies.
The public consultation on PrEP is now concluded but NHS England have still to announce whether PrEP will be available.
NICE. Pre-exposure prophylaxis of HIV in adults at high risk: Truvada (emtricitabine/tenofovir disoproxil). Evidence summary: new medicine (ESNM78), October 2016.