A person's hand with blue pills (like Truvada which will be available in the Discover Trial) floating upwards

What You Need To Know About The DISCOVER Trial

Last Thursday a community forum was held to discuss the DISCOVER trial. Gay Switchboard Director Adam Shanley gives a run down of what you need to know from the meeting

 

Researchers in Dublin have begun recruiting participants for a new HIV prevention clinical trial. The trial, called DISCOVER, will assess whether F/TAF, an experimental a new medication also called Descovy, will be safe and effective as Pre-Exposure Prophylaxis (PrEP) for HIV.

One daily dose of Truvada has been proven to be safe and highly effective at preventing HIV-negative people from contracting HIV. The study aims to determine if Descovy protects against HIV as well as Truvada. The trial will also compare the drugs’ effects on bone mineral density and kidney function, as well as other safety data.

The trial is being conducted at 97 locations throughout North America and Europe. Dublin has two study sites—one at the Mater Hospital and another at St. James’s—and is the first European location to begin recruitment.

Reflecting similar situations internationally, community activists in Ireland have aired a number of concerns about the study. Unlike elsewhere, however, community activists had a unique opportunity on Thursday evening to meet directly with the doctors who are conducting the trial in Dublin.

Noting growing uncertainty and misunderstanding in the community about the nature of the study, Siobhan O’Dea, manager of the Gay Men’s Health Service, reached out to the principal investigators of the Dublin study sites. They, alongside the Gay Health Network, Gay Switchboard Ireland, GLEN and ACT UP, agreed to participate in a community forum to discuss the study. The meeting, held at the Outhouse community centre and chaired by the new Executive Director of GLEN, Áine Duggan, saw a frank and open exchange between the researchers and activists and community members.

 

“This Is Not a PrEP Clinic”

Community members raised a range of ethical and logistical questions about the trial’s design, enrolment criteria, and the informed consent process. Others expressed criticisms of the study’s sponsor, Gilead Sciences, or wondered how the study might impact ongoing efforts to make PrEP available in Ireland.

A key concern for many was the worry that people at risk for HIV and wanting access to PrEP might be motivated to enrol in DISCOVER for the 50% chance of getting Truvada (which is known to be effective) even at the risk of getting Descovy (with unknown effectiveness). How would research staff— under pressure to enrol participants—ensure that they would make this inherent risk as clear as it needed to be to potential participants?

One of the two Principal Investigators for the trial in Ireland, Professor Colm Bergin, put it plainly: “This is not a PrEP clinic, this is a clinical trial.” Both investigators also emphasised that they were strongly in favour of wider access to Truvada as PrEP and that they were determined that this study should not detract from the efforts to do so by the community and medical professionals.

Furthermore, people vulnerable to HIV who are being recruited into this study must be able to clearly understand that no one in the study will know if they are getting Truvada or the unproven drug. Although it is effective as treatment, there is the chance that Descovy will not be as effective as PrEP. If so, some participants in the trial who receive Descovy may contract HIV, when they would not have if they had been taking Truvada.

Although the ostensible focus of the meeting was the DISCOVER study, it was clear that the larger issue of PrEP access in Ireland was foremost on many attendees minds. At the close of the evening GLEN’s Áine Duggan noted the undeniable appetite in the community for PrEP and called for future meetings to continue that discussion on its own.

 

DISCOVER Trial in Ireland

The study is recruiting at St. James’s Hospital and The Mater Hospital. It is expected that there will be spaces for 50-100 participants in Ireland. The study is open to cisgender men who have sex with men and transgender women who have sex with men. To enrol, you must be at risk of contracting HIV – this will be determined by the research staff at a screening appointment.

There are three very important things anyone considering participating should know about this clinical trial:

This is not a PrEP access trial. Half of participants will receive a study drug of unknown effectiveness.

Participants can access Post-Exposure Prophylaxis (PEP) if they have an exposure to HIV that they are concerned about. They would switch from the trial pills to the PEP regimen, then return to the clinical trial after finishing PEP.

Any participant can leave the study at any time for any reason.
This is a double-blind randomized trial. That means three things:

 

A table explaining the three points to bear in mind from the Discover trial community forum

 

Access to PrEP in Ireland

There’s been a lot of talk recently about the plummet in new HIV infections in London, particularly from Europe’s busiest sexual health clinic – 56 Dean Street based in Soho. The use of Truvada as PrEP appears likely to have been partially responsible for a 40 percent one-year drop in HIV diagnoses at the London clinic. Back home in Ireland however, 2016 was the first time that newly recorded HIV infections in the state tipped over the 500 mark. At 516 reported cases last year, we are moving in the opposite direction to developments in London with a 6% increase on 2015 numbers.

The recent drop in new HIV infections in London is partially attributable to the advent of the website iwantPREPnow.co.uk, which instructs those who want access to PrEP on how to purchase generic forms of the drug through online pharmacies. In Ireland, importing generic forms of any drug is prohibited – so those who attempt to have PrEP delivered directly to Ireland this way may face having the drugs seized by customs.

So what is being done to ensure that we have access to PrEP in Ireland in the midst of a HIV crisis? As part of the National Sexual Health Strategy, Dr. Fiona Lyons convened a national working group to discuss plans on how best to implement PrEP to those who need it and to make recommendations to government on this. While efforts of the working group are ongoing, the community is beginning to galvanise and advocate for access to PrEP themselves. Most notably a reawakening of the Dublin chapter of ACT UP has PrEP availability as one of their top priorities for action.

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