The PROUD study (Pre-exposure
Option for reducing HIV in the UK: immediate or Deferred),
led by the MRC CTU at UCL and Public Health England in partnership with 12 NHS
trusts in England, looked at whether offering daily HIV Pre-Exposure
Prophylaxis (PrEP) to men who have sex with men (MSM) was a reliable way to
prevent them from becoming infected if exposed to the virus. The results
released at the Conference on Retroviruses and Opportunistic Infections (CROI)
held this week indicate that PrEP is highly protective for this group, reducing
the risk of infection by 86%.
The results will be submitted
to a peer reviewed journal this April.
The researchers highlighted
that MSM who took part in the trial were at very high risk of HIV and that PrEP
is highly effective in a real world setting. The sexual health research clinics
that took part in the PROUD study were able to integrate PrEP into their
routine HIV risk reduction package with ease. Participants incorporated PrEP
into existing risk reduction strategies, which included condom use. There was
no difference in the number of men diagnosed with other STIs between those on
PrEP and those not on PrEP.
The researchers concluded that
PrEP offers a major new opportunity to curb newly acquired HIV infections in
MSM in the UK, of which there were an estimated 2,800 in 2013.
The drug used in the trial, the
anti-retroviral Truvada usually used to treat HIV, was already known to reduce
the incidence of HIV infection in placebo controlled trials. The PROUD study
was designed to see if the same effect would be found in a real world situation
where participants knew they were taking an active drug. It aimed to address
outstanding questions such as whether taking PrEP would change sexual risk
behaviour – for example increasing the number of partners they did not use
condoms with and increasing the rate of other sexually transmitted infections
(STIs) – and whether or not it would be cost-effective to make it available on
the NHS.
The study was launched in 2012,
enrolling 545 participants at 13 sexual health clinics in England. The study
randomised participants to receive PrEP immediately or to receive PrEP after a
period of 12 months, allowing researchers to compare those on PrEP versus those
not yet on PrEP.
In October of last year, the
PROUD Trial Steering Committee announced that participants currently in the
deferred group, who had not yet started PrEP, should be offered PrEP ahead of
schedule. This followed a recommendation from the Independent Data Monitoring
Committee (IDMC), based on an interim analysis of the data that showed that
PrEP was highly protective against acquiring HIV in this study population.
Of the 545 participants who
joined the study, 276 were randomised to the group who received PrEP
immediately and 269 to the group who received PrEP after a deferred period of
12 months. There were 22 HIV infections among participants in their first year
in the study, with 3 in the immediate group giving an HIV incidence of 1.3 per
100 person-years, and 19 in the deferred group giving an incidence of 8.9 per
100 person-years. The 86% protection from daily (Truvada) PrEP reported by the
study, is the highest reported from a randomised controlled trial of PrEP to
date.
Adherence to the daily drug
regimen appears high in the study.
The research team presented
preliminary behavioural data at the conference, and plan to expand on this
analysis. At this stage the reported condom use in the study looks similar to
the condom use reported at enrolment in the immediate and deferred groups in
terms of the median numbers of partners with whom participants reported having
anal sex without a condom. There were no significant differences in the
proportion of participants who had an STI infection between the groups.
The study results are in line
with previous evidence showing Truvada is well tolerated with minimal concerns
about resistance. The PROUD study results, and subsequent cost effectiveness
analyses, are to be included in the review underway by the PrEP Policy
sub-group of the NHS England HIV Clinical Reference Group. This group is
considering whether use of anti-retrovirals for PrEP should be commissioned,
and is working with a range of stakeholders on how PrEP service could be
commissioned across NHS and local authority responsibilities.
Sheena
McCormack, Professor of Clinical Epidemiology at the MRC Clinical Trials Unit
at UCL, and Chief Investigator of the PROUD study, said: “These results are extremely exciting and show PrEP is highly
effective at preventing HIV infection in the real world. Concerns that PrEP
would not work so well in the real world were unfounded. These results show
there is a need for PrEP, and offer hope of reversing the epidemic among men
who have sex with men in this country. The findings we’ve presented today are
going to be invaluable in informing discussions about making PrEP available
through the NHS.”
Professor
Noel Gill, Head of HIV & STIs in PHE and PHE Lead for the PROUD study, said: “PHE estimates there are around 2,600 new HIV
infections annually in gay men in the UK, a number that has not fallen over the
past decade. If pre-exposure prophylaxis (PrEP) can be delivered
cost-effectively as a component of the HIV prevention toolkit this could be a
major step towards reducing the numbers of men acquiring HIV within this
community.“Building on its co-sponsorship of the PROUD Trial, PHE is
collaborating with UCL on further economic analyses to provide vital data to
inform the decisions about next steps for PrEP in England."
Dr
Des Walsh, Head of Infections and Immunity at the Medical Research Council
which co-funded the study, said:
“HIV remains a serious public health concern - in 2013 alone, around 2,800
gay, bisexual and other men who have sex with men became infected. So clearly,
additional approaches are needed to tackle the HIV epidemic, particularly for
populations at higher risk. The PROUD study addresses this very important issue
and shows promising results that a relatively straightforward intervention
based on existing therapy – PrEP – could have a major impact in preventing HIV
infection.”
The PROUD study was implemented
in partnership with a number of organisations. The Community Engagement Group
comprised: Terrence Higgins Trust; NAT; GMFA; MESMAC; NAZ; NAM; The Lesbian and
Gay Foundation.
- See more at:
http://www.ucl.ac.uk/news/news-articles/0215/250215-PROUD-pre-exposure-prophylaxis-protects-against-HIV#sthash.ESOwT71y.dpuf