European demonstration projects and opinions on PrEP
A meeting a month ago at the European Centre for Disease Control (ECDC) in Stockholm found that cost was regarded as the biggest barrier to the adoption of HIV pre-exposure prophylaxis (PrEP) by European countries. Many regarded significant price reductions in the drugs used as a pre-condition for adopting PrEP.
The ECDC held the meeting to discuss considerations for PrEP implementation throughout Europe and invited clinicians, researchers, epidemiologists, community advocates and, significantly, a high proportion of representatives from various countries’ Ministries of Health – the people who would actually make recommendations on PrEP to their governments.
The ECDC conducted a survey of 31 European countries as part of the monitoring work it does on the implementation of the 2004 Dublin Declaration on fighting HIV in Europe and Central Asia. It found that 17 countries ranging from Portugal to Azerbaijan had demonstration projects of PrEP either in progress or planned.
It also asked: “What issues are limiting or preventing the implementation of PrEP in your country?” By far the most common issue cited was cost. Twenty-one out of the 31 countries considered the cost of PrEP drugs as a highly important limiting factor and only two considered it of low importance; the second most important limiting factor was the cost of service delivery, which 11 countries considered as highly important and again only two of low importance.
Compared with these, the medical or moral objections often used against PrEP were less often cited. While lower condom use as a possible consequence of PrEP was cited by 20 countries as of some importance only five thought it was of high importance and increases in sexually transmitted infections (STIs) were cited by seven countries as a possibly highly-important consequence.
Other cost issues that the ECDC meeting highlighted as important included the fact that only in the UK and the Netherlands have thorough cost-effectiveness studies of PrEP been done and that even if models do show PrEP to be cost-effective, PrEP programmes will require a considerable initial spend before they start achieving significant-enough reductions in infections. There was general consensus that the barriers to rolling out PrEP would be considerably lower once drugs come off-patent and are available at generic prices.
The meeting looked at a number of other issues that might need to be addressed in order to make accessing PrEP easier in Europe.
One particularly important consideration is the sheer difference in healthcare systems from one country to another. This makes a standard European ‘template’ for adopting PrEP impossible, and requires each country to come up with its own answers.
Who, for instance, will provide PrEP? STI clinics? Community testing sites? Infectious disease physicians? Primary care physicians? Through online order schemes? Different arrangements and even laws already exist in different countries on who can conduct an HIV test and these are likely to affect PrEP provision too.
Hornet study: 10% of respondents ‘are taking PrEP’
As part of the preparation for the meeting, the ECDC also collaborated with the gay social network site Hornet on a rapid survey about PrEP. Despite the survey only being online for three days (23-25 April), 8543 men answered the survey. A quarter of these were from France, 22% from the UK, and, interestingly, 10% were from Russia, where Hornet is the most widely used gay social app.
Eleven per cent of respondents were HIV-positive and 10% did not know their status, leaving 79% (7519) of respondents who were HIV negative. Of them, an extraordinarily high proportion – one in ten – said they were taking PrEP, and 69% said their health provider was aware of this fact.
People were asked where they got PrEP. Only 528 men actually answered this question. Excluding France, where PrEP is available through the healthcare system, 47% of respondents said they sourced PrEP through the internet; 24% through their physician; 15% from a friend; and 14% because they were in a study. A tiny proportion (1%) were sourcing PrEP through making repeat requests for post-exposure prophylaxis (PEP).
Thirty-one per cent said they were ‘very likely’ to use PrEP at some point in the next six months, though an equal proportion said they very unlikely to.
In France, 63% of respondents said they were acquiring PrEP through their doctor and 22% through a research study (presumably Ipergay). Only 8% were buying it online and 6% getting it from friends – a completely different pattern, and the first evidence showing the difference in acquisition being made by providing it through the healthcare system.
First data on PrEP programme in France
In the case of France, Ipergay’s principal investigator, Jean-Michel Molina, provided the first data on the PrEP programme in France since it started in January. This is based on a measure available in French law called a Temporary Recommendation for Use (RTU), which was issued in November and lasts for three years, though it is renewable.
Sixty clinics are now offering PrEP, starting with clinics in the Ipergay sites in Paris, Lyon, Nice, Lille and Nantes. In the first three months of the programme’s operation, 437 people had started PrEP through the healthcare system. This might be something like 2% of the people in France who need it, as it is estimated that between 10,000 and 20,000 people in France are in the high-risk categories who would benefit from PrEP.
PrEP is on offer to gay men and trans men or women who have had anal sex without a condom with at least two partners in the last six months, or had an acute STI in the last year, or who had more than one course of PEP, or who reported frequent use of drugs during sex. PrEP for other groups was considered on a case-by-case basis but could include people with acute STIs, who had had condomless sex with someone from a high prevalence area or who injected drugs, or female sex workers who reported condomless sex.
Contrary to previous reports, PrEP is not solely being offered on an intermittent or on-demand basis; people are offered daily PrEP with an option to take it intermittently, as per the Ipergay protocol.
The way the French healthcare system works means that PrEP is not entirely free. The €500 monthly cost of the drug is borne by the healthcare system, but people pay their doctor €23 upfront, 70% of which is reimbursable; baseline tests for HIV, hepatitis B and C, STIs, creatinine and liver enzymes cost €190, of which a minimum of 60% is reimbursable; and the one-month and quarterly monitoring tests cost €23 of which all but €2 is reimbursible.
This means that the upfront cost post-reimbursement of starting PrEP could be €91, though patients with additional insurance or on social security would pay a lot less.
Data on patient characteristics, whether daily or intermittent PrEP is being prescribed, adverse events and HIV infections are reported to a website at https://www.rtutruvada.fr which Truvada manufacturers Gilead were required to set up as part of the RTU agreement.
Molina presented an analysis of the first 249 PrEP users at the Paris St Louis clinic, up to mid-April 2016, which represented 40% of PrEP users in the RTU up to that point. All but one were gay men, 86% were French nationals, most were employed and had completed secondary education and 72% were single. Over a third (37%) had been told about PrEP by a friend, 26% by looking it up online, and 19% by the main French HIV NGO, AIDES.
About 75% chose intermittent PrEP and 25% daily, though Molina commented that these proportions may change as other clinics get more involved.
One in six had used PrEP before going to the clinic and over half had a history of using PEP. A third had had sex with a partner they knew to have HIV. Two PrEP-seekers at screening turned out to have HIV (0.8%). The average number of sexual partners they had had in the previous three months was 18 and the number of occasions of condomless anal sex in the last four weeks was five. Forty-four per cent had used psychoactive drugs (ecstasy, crack cocaine, methamphetamine, amphetamine, GHB/GBL) in the last four weeks. One in five users were referred to psychiatric follow-up for mental health support.
Eighty-six per cent started PrEP at their first visit. There were two HIV infections detected in the 249 patients; neither had actually started taking PrEP.
Jean-Michel Molina said that remaining scepticism about PrEP in physicians, the gay community, funders and the general population needed to be addressed, and that there needed to be more awareness of PrEP among doctors and people at risk (MSM, transgender, and, especially, heterosexual migrants).
The full meeting report can be read online at http://www.eatg.org/gallery/174250/PrEP%20in%20the%20EU-EEA%20-%20challenges%20and%20opportunities.pdf