Raltegravir Racial Analysis Marks an Evolution in HIV Drug Studies
November 5, 2014
Why did you choose raltegravir as the drug you wanted to explore?
Raltegravir, as you know, is the first of the integrase inhibitors that has been approved. I had worked with the drug from the beginning, [and] I've always been very interested in the gender effects, or differences. Gender and race are very tightly aligned, at least in my patient population, because I deal with HIV infection in women.
So, I've been using this drug. I've been working on these clinical trials. And I think for any of the drugs that come into the marketplace, we really want to be able to explain to the patients that we're taking care of what we know about safety and efficacy in that patient population. So that led me to do this.
To what extent do you feel a study like this can serve as a good model for other HIV drugs that are either out or soon to be coming out?
I think doing a study like this is a good model for all of the drugs that are in the clinical marketplace right now, in terms of going back and mining the data that you have from drug studies. But going forward, in terms of drug development, I think the most important thing to do is to make sure that patients who are in clinical trials are very representative of individuals who are most affected -- which would certainly mean that you would want to see a high proportion of black patients in trials in the United States. [In] different regions of the world, you might want to see something different. Then, for women, you certainly want to see -- since 50% of the [HIV-positive] population globally are women -- you want to at least have a representation so that you can do these kinds of analyses and really understand something.
Traditionally, the pushback against those suggestions has been, "Well, it's really hard to get those people involved in clinical trials in the first place." Is that still true?
We do have some models for that. There's the so-called GRACE study model.
First and foremost, I think you have to think carefully about the patient population that you're trying to reach. You have to understand what their challenges may be -- not your challenges, but their challenges -- so that you can try and make it easier for them to be able to participate, to access these trials and to stay in the trials.
Trying to help women and gay men are two very different things, in terms of the kinds of barriers and challenges in both of those groups. And they do, each of them, have barriers or challenges. So you, as a clinical trialist, have to think: What can I do to make it easier for them to access, and to stay on trials?
For women, for instance, it would be looking at things like extending hours, in terms of work; thinking about things like childcare; for people who are living in poverty, helping them out with transportation costs; for all patients in clinical trials, trying to defray the cost for them to be in a clinical trial, in terms of things like helping them out with lunch vouchers.
You really have to look at the milieu in which these people live and try and help them if they want to be participating. You don't want to entice people; you want to help them to access something that they're interested in doing.
Do you feel there's been movement?
I do. I think there's been a lot more talk about it. I think that the FDA [U.S. Food and Drug Administration] has made it explicit to companies -- because it's mostly companies who are developing their own agents -- that there is an expectation that the results they're bringing to them are performed in populations that are representative of the disease state. I think for drugs that have already been approved, as part of the approval process the FDA has said to these companies, "You need to go back and do studies in populations that are underrepresented in these clinical trials."
That's a ground shift.
Yes. For the two other integrase inhibitors, elvitegravir [Vitekta] and dolutegravir [Tivicay, DTG], Gilead Sciences and ViiV are both doing large studies in women, for instance.
It's about time.
Myles Helfand is the editorial director of TheBody.com and TheBodyPRO.com.
Follow Myles on Twitter: @MylesatTheBody.
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This article was provided by TheBodyPRO. It is a part of the publication The 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2014).
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