“When there are potential benefits to a person participating in a study that could be health related — maybe there’s a study that’s studying a new intervention. We don’t know whether it works or not, but it really might, and the alternative is to not have access to it at all, it can be attractive,” says Dr Darrell Tan, an infectious diseases physician and investigator whose research focuses on clinical trials in HIV prevention.
Well, it just so happens that there’s a study currently recruiting in Toronto to assesses whether a relatively new drug, Emtricitabine and Tenofovir Alafenamide (F/TAF), known as Descovy, is safe and effective to use as pre-exposure prophylaxis (PrEP), even more so than Truvada — and I’m considering participating.
I had to stop taking PrEP about a year ago when I started freelancing because I lost my private drug coverage. Sure, I’ve adjusted to the fact that I’m much less protected, but it doesn’t mean I like it. Without a doubt, I’d still be on PrEP right now if I could be. When I learned that they were recruiting for this study in Toronto, I thought that it was at least worth looking into.
This isn’t that radical of an idea. My friend Greg enrolled in a clinical study for a few reasons, one of which was to access PrEP as well. At the time he didn’t know how to get it, so it seemed like the best way.
The study he was enrolled in was called, PREPARATORY-5, of which Tan was the principal investigator. It was Canada’s first PrEP demonstration project, examining issues in implementing the pill it in the real world. It was great, according to Greg. He got free access to PrEP for a year and also they paid him $25 per visit.
In Canada, PrEP is accessible to some people with private drug coverage, students, or those who are enrolled in the First Nations and Inuit Health Care plan. It is also relatively accessible for people in Quebec through the Régie de l'assurance maladie du Québec (RAMQ). The maximum cost of PrEP with this government insurance plan would be $83.33 per month.
Of course there’s also the Trillium loophole in Ontario, as discussed in Xtra’s video “PrEP Talk.”
“In Canada, although we pride ourselves on having a universal health system, a big glaring gap in that universality is pharmacare. That is just a reality that we are unfortunately faced with,” Tan tells me.
And it’s not just an issue for those seeking PrEP. It applies for those in need of HIV treatment as well.
Sometimes newcomers to Canada don’t have health care coverage or drug coverage. In such instances, physicians may look to clinical trials that they’re eligible for to provide access the drugs that they need.
Of course, this isn’t the only reason people enrol in clinical trials. Access may be an incentive, but so is interest; some may want to enjoy feeling like they’re contributing to decreasing the risk of HIV acquisition. Others may just want to know how the process works. There are many reasons.
When considering a study, Tan explains that the key thing to understand is your motivation as well as the benefits of participating. You also need to understand the risks.
Personally, I struggle with the idea of ingesting an unknown drug. Sure, I used to do recreational drugs in my 20s two to three days a week, but I seemed to have lost my nerve with age. So how do we know if these studies are safe?
“A big goal of big clinical trials is to get more data about safety. There’s no way around that problem,” Tan says. “You can’t know how safe something is in humans without first testing it in humans. It’s just not possible.”
Depending on which phase the study is in, (typically ranging from one to four), you can get an idea of how much information there is about safety. The Descovy trial that I’m considering is in its third phase, so I’m less concerned. Plus, there’s also a lot already known about the side-effects of Descovy since it’s already approved for HIV treatment.
Before a potential participant enrols in a study there are up front conversations to inform them of known and unknown risks. Tan also emphasizes that informed consent is a continuous process. Participants are asked throughout the study whether they wish to continue and can stop at any time.
Upon further investigation, I learned that participants of Descovy’s prevention trial will be randomized. They’ll receive either Truvada and a placebo that looks like Descovy, or Descovy and a placebo pill that looks like Truvada. The way I see it is if I joined, I’d either be taking Descovy or Truvada. I’d still use a condom whenever possible, so I wouldn’t be any less protected than I am now anyway. If I feel sick at any point I’d stop.
No doubt it’s a reality that some Canadians are enrolling in studies just to be able to access PrEP. However, Tan is hopeful. In August 2016, the Canadian Drug Expert Committee (CDEC) recommended that Truvada as PrEP be reimbursed in Canada under public drug plans with two conditions.
First, that it’s provided through a sexual health program by someone experienced in the treatment and prevention of HIV. Second, that Gilead provides it at a reduced price. It may not make it through the negotiation process, and even if it does, access may vary. Still, it’s a step forward.