Number of new diagnoses have remained stubbornly level over past decade, but campaigners think PrEP could change that
THE DAYS of “Don’t Die of Ignorance” might be a thing of the past, but HIV has been back in the news again recently.
NHS England was recently struck down by the High Court, following its controversial refusal to accept responsibility for providing a new HIV prevention drug known as ‘PrEP’.
Following the judgment, Scottish HIV charities re-iterated their own calls for the prevention method to be rolled out, with the Terrence Higgins Trust describing it as potentially “game-changing”.
But why are these calls coming now? What is the long-term context of HIV transmission and treatment in Scotland today? In short, it’s because the number of new diagnoses of HIV has remained stubbornly level over the past 10 years, averaging around 350 per year.
“There is an opportunity for the public health minister to stand up right now and say this is an effective strategy for Scotland.” George Valiotis
George Valiotis, director of HIV Scotland, tells CommonSpace: “The numbers are complicated. Over the last 10 years there has been no drop in infection rates.”
The numbers contrast with annual figures of 150-180 in the 1990s.
Pre-exposure Prophylaxis – or PrEP for short – is a HIV prevention drug taken shortly before and after sexual activity, and can prevent the virus taking hold in the body. The drugs used – anti-retrovirals, given as a combination therapy – are exactly the same as those used for treating those who are HIV positive. Currently, the only drug licensed for use as PrEP internationally is Truvada, made by pharamceuticals giant Gilead.
HIV charities are clear that PrEP is no panacea. It would instead be part of a range of HIV prevention strategies, with condoms used as the main method, and which remain widely available in bars, NHS clinics, and through schemes like C-Card.
Valiotis is also clear that existing strategies are still effective, they are just limited: “Condoms have been an effective treatment not just for HIV but for other sexually transmitted infections as well. It’s an effective strategy, it just that it doesn’t work consistently, every time.”
People prescribed PrEP could include people who inject drugs and those in heterosexual relationships – the latter constituting 19 per cent of all new infections.
But the evidence is clear that PrEP works. At least two detailed academic studies have been carried out into PrEP’s efficacy – PROUD, in England, and IPERGAY, based in Canada and France. Both studies found that it reduced the rate of new infection by 86 per cent. The evidence for its effectiveness was so strong that the IPERGAY study was terminated early, to allow the placebo group to take the medication.
While there is strong evidence that it works, there does remain concern. The treatments are expensive – potentially £400 per month for the NHS, and as such will be competing against treatments for other illnesses. When NHS England made this argument, however, it was criticised by the National Aids Trust as “deeply unhelpful”, potentially pitting patients against each other.
There are also concerns that that it could be seen as a replacement for condoms, and potentially “increase risk-taking behaviour,” with the Daily Mail describing it as a “lifestyle” drug. Such criticisms have been described as homophobic and inaccurate by HIV charities.
A key question relates to who would be prescribed PrEP, and what the criteria for prescription would be. Valiotis explains that there can be a misconception that PrEP is only for men who have sex with men and who have many sexual partners, but in reality PrEP would be taken by at-risk people in a range of different circumstances.
He says: “Some of them might have multiple sexual partners at one point in life. Multiple might be two. And then their sexual interests might change. So they might only be on PrEP for a couple of years. So it’s not a treatment for life.”
“Over the last 10 years there has been no drop in infection rates.” George Valiotis
He added: “From HIV Scotland’s perspective, we believe that people in a sero-discordant relationships – with one person who is positive and one person is negative, and when the positive person has a detectable viral load – that is one where we’d like to see PrEP available. But also to people who are likely to have sexual partners who have detectable HIV.”
The anti-retroviral treatments for HIV positive people are now so effective that it means a person’s viral load – the measure of the amount of the virus in a person’s blood – falls to what doctors call “undetectable” levels. This comes with the added benefit that they become effectively uninfectious. The authors of the European-wide PARTNER study said of the risks associated with intercourse with an undetectable partner: “Our best estimate is it’s zero.”
It is therefore believed that most new infections come from those who do not know they have HIV. In Scotland, this constitutes around 25 per cent of the 6,600 believed to be living with the virus. This means that testing remains a key priority, and is part of the wider United Nations’ 90:90:90 strategy – to have 90 per cent of positive people tested, 90 per cent of them on treatment, and 90 percent of them undetectable.
Valiotis added that people prescribed PrEP could include people who inject drugs and those in heterosexual relationships – the latter constituting 19 per cent of all new infections.
Men and women would need to take it differently, however. “Women have to take it every day for it to work effectively. There’s another way that men can choose to take it as events driven – a couple of pills before sex, and a couple of pills after sex. The reason that works for men is that it stores in the anus very quickly, but it takes longer to store in the vagina.”
At the moment, doctors can, very occasionally, provide a private prescription for PrEP at their clinical discretion. “There can be unique circumstances in which doctors might need to prescribe a drug which has never been approved for use. Truvada is already licensed, it’s not labelled. As long as they can defend the use of why they’ve taken that choice.”
At the moment, doctors can, very occasionally, provide a private prescription for PrEP at their clinical discretion.
But a formalized process remains preferable, not least because it means people without the financial means can access the treatments. Under the current system, 30 tablets can cost £50 for a generic version, or around £400 from the NHS.
“What labelling does is streamline that process and makes sure it goes to all the right people. It also provides an extra layer of protection to the prescriber, to say that this is an agreed strategy, rather than single assessments.”
There is a strong case for saying that, long-term, PrEP could be cost saving if targeted at the most high-risk groups, since it prevents the life-time costs of anti-retroviral treatment: “There’s a study by Valentina Cambiano, which looked at cost-effectiveness across the UK.
“What this study says is you need to look at PrEP as an 80-year initiative because it will take several years to get the uptake from the people it will most benefit, and initially it’s going to take a bit of investment in the first few years, but over time the more people taking PrEP not becoming positive, then it absolutely will be cost-saving.”
“People now understand this is a really effective prevention methodology, and people really want this.” George Valiotis
Valiotis concludes by suggesting that the situation presents the SNP with an opportunity for leadership: “There is an opportunity for the public health minister to stand up right now and say this is an effective strategy for Scotland. That would get the ball rolling a lot faster.”
The Scottish Government have so far given limited indications that it would back the treatment. Nicola Sturgeon said earlier this year to Pink News that Scotland would make its own decision on PrEP, saying: “I am keen that we take our own decisions and that we debate these issues in parliament and certainly don’t take a view that we will not do things because they aren’t done in England”.
When asked if this meant Scotland could take a different approach from England on PrEP’s roll out, she said: “Absolutely.”
The Health Secretary, Shona Robison, said to The Herald: “As soon as Truvada is licenced for PrEP we will call on its manufacturer to submit an application to the Scottish Medicines Consortium, at a fair price, so its routine use in Scotland can be considered as quickly as possible.”
Parliamentary questions asking the government to clarify its position have now been submitted to the public health minister by Labour leader Kezia Dugdale,and Green MSP Patrick Harvie respectively. Answers are expected at the end of this month.
Valiotis added that progress is already being made: “The company that makes Truvada, Gilead, have applied to the European Medicines Association for licensing permission for PrEP, and they’ve had an early indication that will go ahead, and it will probably pass by the end of the year. Once that happens it will then go Scottish Medicines Consortium, and there will begin a process for its use in Scotland.”
“Community awareness is really growing about this,” he says. “People now understand this is a really effective prevention methodology, and people really want this. There’s no easy way of supplying that right now,” concluding, “there is opportunity for real leadership here.”
Picture courtesy of UN Geneva
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