European Centre for Disease Prevention and Control (ECDC) has issued a paper saying that it
cannot make a clear Europe-wide recommendation on the use of pre-exposure
prophylaxis (PrEP), and that it would require clearer data on efficacy,
cost-effectiveness, side-effects, resistance and its impact on condom use
before making a recommendation.
two important public health organisations have recommended pre-exposure
prophylaxis (PrEP) as an additional prevention strategy, especially for gay
is already licensed for use in the US and in May 2014 the
US Centers for Disease Control and Prevention (CDC) recommended its use for anyone
HIV-negative with an HIV-positive partner, for gay men who haven’t used condoms
consistently or who have had a sexually transmitted infection (STI) in the last six months, for people who
inject drugs who have shared needles, and for heterosexuals who have had
condomless sex with a high-risk partner.
month, the World Health Organization (WHO) issued a comprehensive
set of prevention guidelines which continued to recommend “the correct and
consistent use of condoms” as a highly effective HIV prevention strategy, but
which also included the new recommendation that “Among men who have sex with men, PrEP is recommended as an additional HIV
prevention choice within a comprehensive HIV prevention package”. This
was widely misreported as WHO wanting all gay men to take PrEP.
European agency has issued a public statement on PrEP since March 2012, when the
European Medicines Agency (EMA) published a consultation paper on PrEP. In
the end this consultation was never completed. European agencies may therefore
have felt under some pressure to make a statement on PrEP.
ECDC has now issued a paper taking a much more cautious line on PrEP. It
comments that “PrEP is an antiretroviral therapy-based HIV prevention strategy
which merits some mention” and in an accompanying presentation says that it “shows
promising prospects for inclusion in the ‘HIV prevention toolbox’ in Europe”.
is no common approach on PrEP across Europe, the ECDC comments. Apart from the
never-completed EMA paper, the British HIV Association/British Association for
Sexual Health and HIV issued a
statement on PrEP in which they said they wanted to see more European research
before making a decision on PrEP. There are two scientific studies of PrEP
currently underway in the UK and France, PROUD and IPERGAY, (PROUD’s principal
investigator, Professor Sheena McCormack, was also an author of the BHIVA/BASHH
statement) but they will not report efficacy data for a couple of years. Because of
this, the ECDC says that “This makes it difficult to provide a clear
recommendation at present that would apply to the entire European Union”.
ECDC says that “despite some encouraging results, a number of questions remain
unanswered regarding PrEP. For example, the cost-effectiveness of PrEP in the
long term requires further investigation, as it is likely to depend on high
levels of adherence to the treatment.”
have been many papers modelling the cost-effectiveness of PrEP. The ECDC
mentions one based
on the US setting that computes that PrEP could be cost-effective in terms
of preventing HIV infections, but would still be very expensive. If 50% of
high-risk gay men used PrEP (taking the CDC’s definition of unprotected sex in the last
six months), this would prevent 30% of HIV infections over the next 20 years that would otherwise have occurred,
and reduce HIV prevalence in high-risk gay men from 31% to 23% – a 26% relative reduction. This PrEP
programme would cost $2.1 billion every year for the next 20 years; taking HIV
infections avoided into account, it would still cost $1.8 billion. The paper cited found that PrEP would be
cost-effective by US standards only if it cost less than $5475 per person per
year or if its efficacy was more than 75%.
number of other modelling papers on PrEP’s cost-effectiveness have found that,
in various global settings, it could be everything from cost-saving to completely
unaffordable, depending on two crucial factors: the price paid for PrEP drugs
and how tightly it is targeted at people whose risk of HIV, to quote an early
paper on the iPrEx trial is not just “high, but imminent”.
acknowledges PrEP “could be particularly effective for persons at very high
risk of HIV acquisition, such as sexual or injecting partners of people living
with HIV” but says a number of questions need to be answered before a
Europe-wide recommendation is possible.
- Can countries afford to invest in PrEP? HIV treatment costs
are only going to increase.
- Is it justifiable to provide ART to HIV-negative individuals
before having reached sufficient ART coverage for people who are HIV positive?
- Will PrEP divert resources away from other prevention
- Given the high costs of PrEP, how do we determine who will be
- How will we ensure that adherence is maximised?
- Will the use of PrEP impact on condom use? If so, will
overall transmission risk increase or decrease as a result of PrEP?
The ECDC concludes by saying that “Future
research needs in the use of ART for prevention of HIV transmission should
focus on obtaining the evidence on the efficacy of ART in reducing onward
sexual transmission in the wider population” – in other words, that the
public-health effectiveness of ARV-based prevention strategies in general, and
not just PrEP, needs more research and evaluation in Europe.