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Published on 27 September 2016

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BLOG: Pre-exposure prophylaxis – the anti-HIV drug at the centre of an ongoing funding battle

For over a decade, every year in the UK more than 6000 people are newly diagnosed with HIV. In 2014, the year for which we have the most recent data, more than half of those patients were Men who have Sex with Men (MSM).

 

For over a decade, every year in the UK more than 6000 people are newly diagnosed with HIV. In 2014, the year for which we have the most recent data, more than half of those patients were Men who have Sex with Men (MSM).

 

The mainstay of HIV prevention in this country has long focused on awareness, education, condom promotion and – more recently – “test and treat”, based on increasing evidence of Treatment as Prevention (TasP). This latter principle was confirmed last month when a large study reported that HIV positive patients with an undetectable viral load are uninfectious to their sexual partners. Hence the emphasis of the London HIV Prevention Programme public campaigns, known as “Do It London”, on promoting HIV testing and safer sex as important, combined methods to reduce the risk of viral transmission.

 

Another major breakthrough in recent years has been the discovery of the efficacy of Pre-Exposure Prophylaxis (PrEP): the provision of antiretroviral medication to confirmed HIV negative people at high risk of exposure to HIV. This drug called Truvada (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) is manufactured by Gilead Sciences and has long been used to treat HIV positive patients.

 

Numerous trials across the world have demonstrated Truvada to be highly effective at preventing HIV transmission, representing a huge breakthrough in HIV science, and it is now prescribed in the USA, France, Canada and Israel for MSM at high risk of HIV infection. In the UK, the PROUD study revealed an extremely high rate of effectiveness in preventing HIV transmission for gay men and, earlier this year, the European Medicines Agency changed and extended the licence for Truvada to be used as a preventative drug. Yet, in the UK, it remains unavailable on the NHS; some patients are now buying versions of the drug online, from unlicensed manufacturers abroad.

 

Many commentators have publicly called Truvada a “game-changer” in the stubborn battle to prevent ongoing (and increasing) rates of HIV diagnoses, especially in MSM, whilst recognising that it must be used in combination with time-honoured prevention methods such as condoms and regular testing to be fully effective at population level – and to prevent other sexually transmitted infections. Yet PrEP has equally garnered front page media coverage and, over the summer, has become the subject of a pitched battle between HIV activists and NHS England.

 

On one hand, the science is clear: PrEP is a new, powerful addition to our “menu” of preventative options. That is especially true for some gay men who, for various reasons, find consistent condom use difficult and for whom regular testing is not offering enough protection. However, as with many new medications, the battle over cost – and who is responsible for bearing that cost (about £400 per month for the current drug, although it comes off patent in 2018) – has been played out in both the public domain and in the courts, with increasingly inflammatory rhetoric.

 

In August 2016, the High Court rejected NHS England’s contention that it was not responsible for commissioning PrEP, although (at the time of writing) NHS England is appealing that Judicial Review. Meanwhile, media coverage of the court case revealed something deeper about British attitudes towards sex, HIV and gay men. This was arguably triggered by NHS England’s press release about the case, which used unhelpful, simplistic language to describe the complexity of PrEP use. Referring to ‘men who have high risk condomless sex with multiple male partners’, it failed to recognise that, for most MSM, PrEP would likely be used either intermittently or for relatively short periods of time, such as at the end of a relationship, or when having sex with a new partner before confirming their HIV status within a testing window period, or especially in a serodiscordant relationship before confirmation of the HIV positive partner’s undetectable viral load.

 

Perhaps unsurprisingly, the “moralistic” line was taken up by some sections of the British press, which ignored the weight of medical evidence (and the widespread cross-party political support) and sought to blame gay men for their own sexual behaviour and HIV risk, echoing the media coverage of the mid 1980s when the victims of AIDS were often blamed for bringing the illness on themselves. The Daily Mail called Truvada a “promiscuity pill”, accusing the judge of “a skewed set of values” and contending that the NHS should “fight back” against a drug that, it claimed, would deny funding to treat other specialist conditions whilst causing “immoral behaviour”.

 

Much of this commentary ignored the life-changing health benefits of PrEP in favour of a kind of moral panic that pitted other illnesses against HIV prevention and stereotyped gay men, despite numerous experts insisting the drugs were regarded as a welcome game-changer, but not a magic cure.

 

At the time of writing, NHS England is appealing the Judicial Review on the grounds that local authorities have the legal responsibility to commission services to “prevent” HIV whilst, it argues, its own responsibilities are limited to treating those already assumed to be infected. This principle is contested on numerous grounds – including the complicated wording of the Health and Social Care Act 2012 which made councils responsible for public health, but left HIV treatment in the hands of the NHS – and supported by the fact that NHS England has long accepted the principle that it is responsible to fund the drugs used for Post-Exposure Prophylaxis (PEP) for HIV.

 

NHS England is running a public consultation (closing 23 September) on PrEP and has set out its plans if the appeal fails. Were it to be provided, PrEP would be funded from the NHS England Specialist Commissioning budget – currently over £15bn per year. But with almost 150 different services competing for that budget, the decision will be a difficult one for NHS commissioners and is symptomatic of the pressures placed on the NHS by highly effective – but expensive – drugs.

 

Meanwhile, the battle against HIV continues, which is why the London HIV Prevention Programme – funded by all 33 local authorities – will continue to educate the public about HIV, promote testing and safer sex, address ongoing HIV-related stigma and get the right information to those who need it most. Adding PrEP to that mix would arm us with a hugely effective tool to turn around this growing and intractable epidemic 35 years since it first began.



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