5th December 2016
Response to NHS England announcement
England yesterday announced that they will not be rolling out PrEP as a new
specialised service. Instead, they will make up to £10 million available to Public
Health England to enrol at least 10,000 participants over the next 3 years in a
clinical trial of PrEP (https://www.england.nhs.uk/2016/12/hiv-prevention-pregramme/).
are disappointed that PrEP will not be available on the NHS in the near future.
Nonetheless, we are glad that at least 10,000 people will be offered PrEP, as even this limited availability has the
potential to dramatically reduce the number of new HIV infections reported each
year, when delivered as part of a comprehensive HIV prevention package.
The PROUD trial demonstrated that
the offer of PrEP:
can attract individuals at high risk of HIV
can be delivered through sexual health clinics
dramatically reduces the risk of HIV infection
is cost effective when efficiently targeted towards
people at risk of HIV.
Early next year we will release
new evidence on long-term use of PrEP collected over the 4 years of the PROUD trial,
which will provide additional insights for PrEP implementation.
The NHS England announcement
claims that an additional clinical trial is necessary in order to address
“significant outstanding implementation questions” around uptake, preferred
dosing methods, duration of use, HIV
incidence and STI incidence. We look forward to further details about the trial
design including the control group, and how these research questions will be
measured. We hope that the plan is to
build on evidence from PROUD, instead of merely repeating the important work
that has already been completed, and the PROUD team are willing to support the
Public Health England trial team to achieve this.
There are important outstanding
questions about uptake, adherence and duration of use PrEP among populations
who were not included in PROUD, and we look forward to hearing about plans to
actively include heterosexual women and
men, BAME communities, and trans women and trans men in the new clinical trial.
We remain eager to hear from NHS England how they will
partner with Local Authorities to commission PrEP as part of a
comprehensive prevention package in the near future.
10th November 2016
Today we welcome the judgement from the Court of Appeal that
confirms that NHS England has the ability to fund PrEP. The clinical evidence
for PrEP is indisputable. We are confident this will result in NHS England
deciding to fund PrEP and a successful discussion with local authorities
about administering PrEP. We recognise that there will be short-term cost
implications until the patent for the drug ends in 2017, but this should not
deter the offer of this game-changing HIV prevention option.
NHS England statement: https://www.england.nhs.uk/2016/11/update-on-prep/
3rd November 2016
PROUD participants: The extra drug donated by Gilead is now in your clinics, please contact your clinic for further information.
3rd October 2016
PROUD participants: the extra drug donated by Gilead is NOT yet in clinics. Keep in touch with your clinic to find out when it will be available.
29 July 2016
We are sorry to announce that PROUD has to close according to the plan agreed in January, which allowed for one visit after the anticipated NHS England decision in June. This decision never took place. The NHS England announcement of 21 March 2016 implied a commitment to PROUD participants that continue to need PrEP. However, it transpires that this commitment is contained within the £2M set aside for early implementer sites. Public Health England (PHE) is working, with partners, on the design of the early implementer sites but these will not be launched until 2017. Gilead is also planning a study to compare Truvada (the drug used in PROUD) to F/TAF (a new version of Truvada). The study is called DISCOVER and everyone in the study will get PrEP. DISCOVER is likely to start in the next 6 months.
In June this year we found out that NHS England had no separate plan for PROUD participants.
We wrote to Gilead with a request for a donation of drug for PROUD participants to bridge the gap between PROUD closing and the PHE/DISCOVER studies starting. Gilead is considering this request, but could not activate it until October as they won’t have approval for Truvada as PrEP in Europe until then.
It is legal in the UK to purchase drug for personal use and you can find out more about how to do this on the following websites:
If you decide to do this, please read the following article and order drug in plenty of time so that you don’t run out.
Prepster also has information on what you can do to call for increased access to PreP in the UK.
We thank the PROUD participants for taking part in a study that has accelerated access to PrEP globally, if not yet at home.
3 June 2016
In March, NHS England announced: “In addition, NHS England is keen to explore how a period of further support can be offered to the participants enrolled in the PROUD study and is committed to making funding available where there is a clinical need for additional help.”
Sheena McCormack wrote to Simon Stevens for an update on how NHS England are planning to support PROUD participants access to PrEP and to date have only received the following unhelpful letter. We will continue to pursue this!
31 May 2016
Here is a further disappointing update from NHS England on commissioning and provision of Prophylaxis (PrEP) for HIV prevention:
BHIVA-BASHH Position Statement on PrEP in the UK (second update May 2016)
The Position Statement was revised following an NHS England update on the commissioning and provision of pre-exposure prophylaxis (PrEP) for HIV prevention (https://www.england.nhs.uk/2016/03/prep)
World AIDS Day announcement
1 December 2015
On this World AIDS Day of 2015 we can celebrate a year of major successes in HIV prevention.
Last week the French Ministry of Health was the first in Europe to authorise access to PrEP for populations most at risk of HIV infection. This decision was largely based on the results of the IPERGAY study who released their results in the New England Journal of Medicine today.
PROUD results published showing pre-exposure prophylaxis effectively prevents HIV
10 September 2015
Results from the PROUD study, showing a daily pill can effectively protect people from HIV infection, were published today in The Lancet. PROUD is the first study of the pre-exposure prophylaxis approach to preventing HIV to be carried out in the UK. The results show the approach could play a major role in reducing the number of new infections among men who have sex with men.
Pre-exposure prophylaxis (PrEP) is a HIV prevention strategy that involves HIV-negative people taking antiretroviral drugs to reduce the risk of becoming infected if they are exposed to the virus. The PROUD study looked at whether offering daily PrEP to men who have sex with men was an effective way to prevent HIV infection. The results show that PrEP is highly protective, reducing the risk of infection for this group by 86%.
24 February 2015
The PROUD study today reported that PrEP reduced the risk of HIV infection by 86% for gay and other men who have sex with men when delivered in sexual health clinics in England.
The PROUD study measured the effectiveness of daily PrEP for gay and other men who have sex with men in England. The results released at the Conference on Retroviruses and Opportunistic Infections today indicate that PrEP is highly protective for this group, reducing the risk of infection by 86%. The researchers concluded that PrEP offers a major opportunity to curb new HIV infections in men who have sex with men in the UK.
The PROUD Study
Examining the impact on gay men of using Pre-Exposure Prophylaxis (PrEP)
What is PrEP?
PrEP (Pre-Exposure Prophylaxis) is a new way to reduce the risk of getting HIV. It involves HIV negative people taking a daily tablet that contains drugs commonly used to treat HIV.
PROUD is a two-year study to recruit volunteers across England, who will be placed at random into one of two groups. One group will use PrEP from the start of the study, and the other group will receive PrEP after 12 months.
Truvada (which contains tenofovir and emtricitabine, also called FTC) is used in this study. Truvada is already widely used and any side effects are usually mild.
Previous studies with gay men found that using PrEP almost halved HIV infections – and there were even fewer infections amongst men who took their pill every day.