“Intensive Combination Prevention” proposal for gay men in England would include PrEP

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A pilot rollout in England of a new, standardised intensive HIV prevention package for gay men at high risk of HIV infection would include a substudy in which half of them will be offered pre-exposure prophylaxis (PrEP), the 17th British HIV Association (BHIVA) Conference heard in Bournemouth last week.

The proposal, which has been drafted by the Health Protection Agency (HPA) and members of BHIVA, is at an early stage and would need to secure funding from a variety of sources, including local authorities who will now be in charge of public health, to be viable.

The “Intensified Combination Prevention” (ICP) is a package which will involve:

  • regular, rather than ad-hoc, attendance at GUM clinics by the target population
  • a standardised counselling intervention at each attendance based on motivational interviewing
  • and, at 50% of the ten GUM clinics involved, daily oral PrEP using open-label tenofovir/FTC (Truvada).

Glossary

pilot study

Small-scale, preliminary study, conducted to evaluate feasibility, time, cost, adverse events, and improve upon the design of a future full-scale research project.

 

acute infection

The very first few weeks of infection, until the body has created antibodies against the infection. During acute HIV infection, HIV is highly infectious because the virus is multiplying at a very rapid rate. The symptoms of acute HIV infection can include fever, rash, chills, headache, fatigue, nausea, diarrhoea, sore throat, night sweats, appetite loss, mouth ulcers, swollen lymph nodes, muscle and joint aches – all of them symptoms of an acute inflammation (immune reaction).

open-label

A clinical trial where both the researcher and participants know who is taking the experimental treatment. 

oral

Refers to the mouth, for example a medicine taken by mouth.

treatment as prevention (TasP)

A public health strategy involving the prompt provision of antiretroviral treatment in people with HIV in order to reduce their risk of transmitting the virus to others through sex.

The pilot phase would last two years.

Background: increasing diagnoses in gay men

Professor Noel Gill, chief epidemiologist of the HPA, spoke of a sense of new urgency in the need to bring down the number of HIV infections diagnosed in gay men and men who have sex with men (MSM) in the UK.

Last year the number of MSM diagnosed with HIV exceeded 3,000 for the first time ever. This represented an 11% jump in the number of new diagnoses in one year, after a couple of years in which infections stayed relatively static, and for the second year running they represented the risk group with the highest number of diagnoses, after a decade in which there were more new diagnoses amongst Africans living in the UK than gay men.

The annual number of new diagnoses in gay men has increased by 41% since 2001. Gay men represent nearly half of all those infected in the UK.

Infections among heterosexuals within the UK also continues to increase and has tripled since 2001; last year's annual total of 1150 represents one-sixth of new diagnoses.

Professor Gill said he had initially hoped that the continuing increase of diagnoses in gay men was due to more coming forward for tests. He had also anticipated that lack of increase in diagnoses seen in 2008 and 2009 might signal that antiretroviral therapy in HIV-positive people was starting to have an effect by bringing down their infectiousness, as has been observed elsewhere. This year’s increase, however, sent a warning signal that so far this did not seem to be the case in the UK.

“I’ve spent eight years expecting diagnoses to go down,” he said, “and it’s clear that we need to do something new”. He estimated that 3,000 new diagnoses represented an additional cost to the NHS of £38 million a year.

Intensified combination prevention

Gill said that the UK’s network of open-access, STI-specific GUM clinics represented a unique environment in which to test both Intensified Combination Prevention (ICP) and PrEP. 

There are 204 GUM clinics in England of which 29 – most of them larger clinics representing nearly half of all patients - are involved in an existing surveillance and research collaboration with the HPA called GUMNET. The cost of involving all 29 clinics in the pilot ICP-and-PrEP intervention would be well in excess of £50 million so the proposal is that ten clinics pilot ICP and that five of them include PrEP as part of the package.

The sole criterion for offering ICP and PrEP is that the patient be a ‘high risk gay man. ‘High risk’ is defined as

  • attending with an acute sexually transmitted infection (STI) and/or
  • having had unprotected anal sex with a regular partner of positive or unknown status in the last six months and/or
  • having had unprotected anal sex with at least one casual partner in the last six months.

Gill said that to roll out this prevention initiative, even in ten clinics, would involve an unprecedented collaboration and pooling of funds between STI and HIV clinicians, the at-risk communities, the new commissioners of public health, medical research groups, and the pharmaceutical industry.

He hoped that pharmaceutical companies would appreciate that this proposal potentially had international implications when it came to demonstrating the feasibility of rolling out PrEP in the real world.

Dr Tony Nardone, the HPA’s specialist in virology, put some more figures on the proposal. The idea is to recall all ‘high risk’ gay men as defined above for routine appointments three and six months after first attendance and then every six months. Men offered PrEP would also attend at months one and nine, requiring two more attendances per year. This is because men taking PrEP would be tested for HIV every three instead of every six months, due to the need to avoid taking PrEP while seroconverting for HIV, and also to discuss any adherence difficulties at an early stage.

As well as the basic testing, counselling and PrEP package, ICP would also offer net-based health promotion and behavioural monitoring and accelerated partner notification.

Nardone said that about 9000 MSM turn up with an acute STI at the GUMNET clinics every year and that if the larger clinics are involved 3600 to 6000 MSM could be enrolled in the two-year pilot of ICP, of which half would be offered PrEP. Annual HIV incidence amongst repeat visitors to GUMNET clinics – excluding those diagnosed with HIV on their first visit - was 1.1%. This should be enough to be able to prove establish efficacy for PrEP if the reduction in infections was the same as in the iPrEx study (43%).

The BHIVA/BASHH position statement

BHIVA and the British Association for Sexual Health and HIV (BASHH), which represents GUM clinicians, are collaborating on writing a Position Statement on PrEP including:

  • a review of the PrEP data so far
  • appraisal of which populations might benefit from it
  • a review of cost-effectiveness models
  • the identification of research gaps.

This will be available for community consultation and comment this summer, with the aim of publication at the autumn BHIVA conference in October.

BHIVA’s Sheena McCormack, who is co-ordinating the Position Statement, emphasised that this project would cover all possible populations who might benefit from PrEP and was not restricted to the gay community.

Audience members in the meeting announcing the ICP/PrEP proposal had several comments and queries. Some questioned that ‘treatment as prevention’ was failing to work in the UK. Others emphasised that as much thought and effort needed to be involved in the counselling intervention as PrEP and that psychologists and social researchers must be involved. Finally, the PrEP proposal as it stands is dependent on Truvada being available at no or reduced cost and it was questioned if this would be forthcoming.

NAM is the community partner in the BHIVA/BASHH Position Statement project. To find out more, email info@nam.org.uk with the subject line ‘PrEP’.