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Truvada and Access: A Further Update

Posted in: Health & HIV
By Craig Young - 15th September 2016

The ongoing saga of Truvada/Post-Exposure Prophylaxis (PrEP) regulation and access concerns within the United Kingdom and Australia continues to unfold. So, what new information has become available since August's review of HIV prevention group headaches with access in both countries?

At the time the previous article was compiled, I didn't have access to further information about the regulatory quagmire that has beset PrEP related to NHS England's confusion about the extent of its ability to approve and fund access to the medication. On August 8, solicitor Mark Hendron shared withPinkNewsand other UK LGBT media outlets that he was using to PrEP/Truvada to prevent HIV exposure. He slammed cheap tabloid victim-blaming tactics as the consequence of homophobic stigma and profound ignorance about the contemporary context of HIV transmission in the contemporary United Kingdom. He also acknowledged that he had been on PrEP for the last six months, concerned about precisely the current turmoil that resulted from the UK High Court decision to strike down NHS England's obstruction of access and approval of the medication. Hendron argued that narratives about condom use alone are simplistic and do not take due notice of the contexts behind decisions to undertake unsafe gay sex and risk HIV exposure. In his case, it was the end of a long-term relationship and re-entry into the gay single scene. It was useful to have a personal narrative about what personal factors might lead to unsafe sex, HIV risk and PrEP use, and Hendron's candour provides that much-needed element to the PrEP debate within the United Kingdom and elsewhere.

The House of Commons Health select committee weighed in on the issue in early September 2016. The committee backed rollout of PrEP across the United Kingdom, as ongoing costs of HIV treatment can reach three hundred and eighty thousand pounds per individual. However, the Cameron and May administrations tended to restrict such access through local authorities and their attendant health boards, co-ordinated by NHS England, which had initially obstructed further PrEP access through the claim that it had 'no direct authority' to distribute and facilitate the use of PrEP until it was sanctioned by Parliament or judicial authority. The Health Select Committee strongly criticised NHS England snioer management for its absence of clarity about commissioning and further distribution of PrEP, currently available only on a user-pays basis. The culprit appears to be the Cameron administration's Health and Social Care Act 2012, which devolved many medical service provision decisions to local authorities, trusts and service providers, without any related clarification of attendant responsibilities involved.

At the same time, Truvada manufacturer Gilead stepped in to facilitate a discontinued clinical trial within the United Kingdom. As with mass provision and distribution, NHS England also proved obstructionist when it came to continuing to provide PrEP to participants within the PROUD clinical trial as well. The PROUD trial had enlisted 500 'at risk' gay men, and had tentatively found that taken once a day, PrEP seriously reduced the risk of HIV exposure amongst trial participants. In August 2016, the PROUD trial participants had suddenly lost their PrEP access as the PROUD trial concluded and NHS England was engaged in preparing for its High Court legal action. One month later, Gilead announced that it would distribute a further 2000 Truvada/PrEP bottles to the Medical Research Council Clinical Trials Unit at University College London, which was running the PROUD study. It was hoped that there would be a final commissioning decision made before this supply also ran out. PrEP support groups "iwantPrEPnow" and "PrEPster" applauded the decision and called for a co-ordinated response on the matter.

At the same time, the AIDS Epidemiology Annual Report in San Francisco sounded a warning note. While white gay men had indeed benefited from conscientious use of PrEP and condoms in that city, the decreased rate of infection was not universal, indicating that African-American, Latino and older (50+) gay, bisexual and men who had sex with men had not experienced the same decrease in HIV diagnosis, estimated to be down by a third amongst younger white gay men. Institutional racism and poverty also affected access in the United States, which did not have a co-ordinated public health system until the advent of Obamacare (the Affordable Health Act).

As for Australia, in July 2016, Alfred Health, the Victorian AIDS Council and Victorian State Government announced PrEPX, a 2600-participant clinical trial scheduled to take place within the metropolitan Melbourne area, with information about trial participation within Australian LGBT media outlets such as theSydney Star Observer(06.07.2016). On August 17, the Queensland AIDS Council ran a seminar on PrEP at the Sportsmen Hotel in Brisbane about this HIV treatment option, while PrEPX launched in Melbourne (01.09.2016) earlier this month, with 1300 participants. Victorian ALP Health Minister Jill Hennessey was onhand, and condemned the federal Pharmaceutical Benefit Advisory Committee's refusal to list Truvada/PrEP as a Medicaid-subsidised treatment. Initially, the Victoria trial will centre in Melbourne at its Alfred Hospital and Melbourne Sexual Health Centre, but it is planned to spread to Geelong and Wodonga, other large Victorian urban centres, as the trial continues.

Recommended:

Mark Hendron: "I am on PrEP: Here's why it's vital to help stop HIV"Pinknews: 03.09.2016:http://www. pinknews.co.uk/2016/08/08/ comment-i-am-on-prep-heres- why-its-vital-to-helping-to- stop-hiv/

Nick Duffy: "Hundreds of gay men lose access to HIV-preventing drugs as study concludes without NHS decision"Pinknews:01.08.2016:http://www. pinknews.co.uk/2016/08/01/ hundreds-of-gay-men-lose- access-to-hiv-preventing- drugs-as-study-concludes- without-nhs-decision/

Nick Duffy: "Pharma company donates PrEP drugs to trial participants abandoned by NHS" Pinknews: 01.09.2016:http://www. pinknews.co.uk/2016/09/01/ pharma-company-donates-prep- drugs-to-trial-participants- abandoned-by-nhs/

Nick Duffy: "MPs say NHS dispute over HIV-preventing PrEP drugs exposes flaws in health legislation"Pinknews:01.09.2016:http://www. pinknews.co.uk/2016/09/01/mps- say-nhs-dispute-over-hiv- preventing-prep-drugs-exposes- flaws-in-health-legislation/

Jack Flanagan: "HIV infections down by a third in San Francisco, but race is still a factor" Gaystarnews: 03.09.2016:http://www. gaystarnews.com/article/hiv- infections-third-san- francisco/#gs.x1JcN_g

"Study gives 2600 access to PrEP"Sydney Star Observer:06.07.2016:http://www. starobserver.com.au/news/vic- study-gives-2600-access-to- prep/150501

PrEPX Study (Alfred Health):https://www. alfredhealth.org.au/research/ research-areas/infectious- diseases-research/prepx-study

"Brisbane: PrEP at the Pub"Sydney Star Observer:05.08.2016:http://www. starobserver.com.au/news/ national-news/queensland-news/ brisbane-prep-at-the-pub/ 151641

"PrEP trial launched in Victoria" Sydney Star Observer: 01.09.2016:
http://www.starobserver.com. au/news/national-news/ victoria-news/prepx-trial- launched/152436



Craig Young - 15th September 2016

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