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NHS England PrEP Implementation Study

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Paul Clift
Member
Posts: 467
NHS England PrEP Implementation Study
Posted on: December 7 2016, 10:42 am

Colleagues at the PROUD website have posted their response to NHS England news of a PrEP implementation trial, to start next year:

5th December 2016

Response to NHS England announcement

NHS 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/).

We 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.
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Simon Collins
Global Moderator
Posts: 651
Re: NHS England PrEP Implementation Study
Reply #1 on: December 7 2016, 03:11 pm

They key sentence is "We are disappointed that PrEP will not be available on the NHS in the near future."

No amount of spin for potential numbers getting PrEP in a future trial - at least six months away - get past the FACT that no doctor can prescribe PrEP to anyone, no matter how high their risk.

That this trial is planned to last at least three years indicates how long NHE England think they have postponed access.

This is terrible news and the community response should be furious.

The i-Base report is below.
http://i-base.info/htb/31078

NHS England fudges PrEP access and delays on-demand access to PrEP by years; blocks doctors from prescribing PrEP now   | Edit
Simon Collins, HIV i-Base

After almost a year of turmoil, requiring NHS England to face court challenges for what has now been proven to be an illegal decision to block access to PrEP, a new press statement still fails to allow a single doctor to protect the health of their patients by prescribing PrEP based on clinical need. [1]

Instead, a press release issued at one minute past midnight on Sunday 4th December, detailed plans for further delays. Foremost of these is a promise of funding for a study that is dependent on drug manufacturers meeting unspecified prices for their products, and speculation that this may or may not be possible.

It is difficult to be impressed with this compromise. Rather than meet the real need of people currently at highest risk, it will further delay access to an option to prevent HIV transmission that has clearly passed the criteria for safety, efficacy and effectiveness laid out for other NHS treatments. PrEP has not only been available in the US since July 2012, but has been part of a strategy to overcome the HIV pandemic recommended in guidelines from the World Health Organization since 2015. [2]

By deferring to a need for further research, but without being able to identify key scientific questions that remain unanswered, the plans are intellectually dishonest.

Instead, in addition to any research, the proposals should have included the ability for doctors (who are already experts in managing sexual health to assess individual risk) to prescribe PrEP, even if access remains capped or restricted. For example, after many delays, the NHS eventually approved access to the latest effective treatments for hepatitis C, though later capping access.

Two examples that have previously been used to explain the urgency of access to PrEP are worth repeating. [3]

A woman who explains to her doctor that her husband refuses to use condoms and that this has led to her needing treatment for STIs will hear her doctor say “come back when you are HIV positive and then I can prescribe HIV drugs for the rest of your life, two of which would have kept you negative if I could have prescribed them today”.
A 17-year-old man with low self-esteem related to a history of childhood abuse and who has transactional sex with clients who take off condoms will be told that he can’t be prescribed the same drugs that he has already accessed five times this year as PEP to help him stay HIV negative.
In the two examples above, based on the new NHS plans, a doctor can say: “you might be able to join a study in six months, but only if you access care at one of a limited number of research centres and if you feel sufficiently engaged and supported to attend additional clinic visits and fill in questionnaires about your sex life and risk”.

If someone has a life that is more chaotic, for example if they have issues relating to substance use, or if they have limited free time due to restrictions at work, they will likely be excluded from the research anyway. This is despite these very issues increasing the need to have alternative options to protect against HIV.

The clinical research that is essential for proving safety and efficacy has already been sufficiently rigorous for both the US and European regulatory agencies to approve PrEP.

The UK PROUD study also contributed to a large body of growing research showing that PrEP often also leads to behavioural changes that lower a person’s risk of HIV. PrEP therefore achieves a double effect: it directly protects against HIV when at risk and also helps people be more confident in negotiation risk.

Proposing further research raises a major limitation that studies generally recruit participants who not reflective of either the general population or the population at highest need.

For example, the circumstances needed to take part in a research study rarely ensures that trial participants reflect the diversity of gender, class, race, education, geographical proximity to a large city and economic status. By definition, research studies therefore usually underrepresent communities for whom equity of health care should instead be paramount. And risks of HIV transmission often directly correlate with issues of social exclusion listed above.

So the hush-hush “important new plans” released in the early hours of Sunday morning are not an optimistic advance. These proposals fudge the clear community demand for immediate access to effective treatment.
Instead, they create additional hurdles to access based on spurious claims for a need for further evidence, that in turn effectively blocks access for many of the people most in need. It is also extremely strange that NHS England tactfully choses to release this news in the early hours of Sunday morning when many people are likely to be at highest risk.

COMMENT

Instead of gratitude for crumbs from the table we should be furious that the health of gay men, transgender people and others at high risk is dependent on jumping through further hoops and over further hurdles.

This NHS “pregramme” [sic] – the title of this middle-of-the-night press release is not even proofed – just delays real access for years – well past the availability of generic PrEP which will be cost effective by any analysis.


Notes

PrEP stands for Pre-Exposure Prophylaxis. In the context of HIV this currently involves using a co-formulation of two widely used HIV drugs to protect against HIV transmission. If taken when needed – either daily, or in some circumstances only when at risk – PrEP reduces the risk of transmission by more than 99%. More information about PrEP is included in an online UK guide to PrEP. [4]

References

1.  NHS England announces major extension of national HIV prevention pregramme [sic] with public health england and funding for ten new specialised treatments. 4 December 2016: 00:01 am).
https://www.england.nhs.uk/2016/12/hiv-prevention-pregramme

2.  World Health Organization. WHO guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV, September 2015.
http://www.who.int/hiv/pub/guidelines/earlyrelease-arv/en
3.  Collins S. NHS England confuses arse and elbow: block to PrEP ignores UK HIV crisis and will send PEP services into chaos. HIV Treatment Bulletin, May/June 2016. (02 June 2016).
http://i-base.info/htb/29979
4.  BASHH and HIV i-Base on behalf of multiple authors. UK Guide to PrEP. June 2016, reprinted November 2016.
http://i-base.info/uk-guide-to-prep
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