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Edurant (Rilpivirine): The HIV Treatment Dating Game Just Got More Interesting

An Interview With Cal Cohen, M.D.

May 26, 2011

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The Future of First-Line HIV Treatment

So then, when you pull all that together -- the resistance, the baseline viral load, the ability to tolerate specific kinds of side effects or not, potential issues with drug interactions -- how does the average HIV clinician and HIV-positive person start to come to a decision about what to take first when the number of options just continues to grow?

"I think it's a great problem to have, isn't it? We have many competing options, all of which have something good to offer. So it's a wonderful conundrum to have in our field."

Well, let me start by saying I think it's a great problem to have, isn't it? We have many competing options, all of which have something good to offer. So it's a wonderful conundrum to have in our field.

The second is to probably just note for a moment that while Edurant is now available as a single, stand-alone tablet, it is widely expected that in a few months we'll also have a single-tablet regimen combining Edurant with tenofovir and FTC, which was one of the most-studied combinations in the ECHO and THRIVE studies [that led to Edurant's approval]. The single-tablet piece of it, while not approved simultaneously, is expected in a few months.

Edurant certainly provides some important attributes now -- the ability to take it once-daily with something to eat and have very few expected toxicities, as well as the virologic suppression rates, albeit with differences based on the pre-treatment viral load that we talked about -- that combination of factors for the right person is overall a useful addition. With two pills a day -- a single combination nucleoside pill [e.g., Truvada] and an Edurant -- we could do very good work.

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But when this becomes a single tablet, I think there's an additional reason for enthusiasm, because I think many of us have experienced that when we put all the factors together, many people are just drawn to the simplicity of a single tablet.

It isn't the only factor, of course. But when all those attributes line up -- when you have confidence that the drug can work in the right population; when you gave a drug with few expected side effects; and you have the simplicity of a single tablet -- I think that there'll be enough patients who are glad to have yet another combination in a single tablet, one with a different toxicity profile than the current one available [i.e., Sustiva], and one that some patients may prefer to be on.

So is this really just a case-by-case type decision in which the patient and the clinician need to take into account all of the different pluses and minuses of each of the different options? Right now, the U.S. treatment guidelines already recommend four options: Atripla, which is Sustiva plus Truvada (tenofovir/FTC) ; Reyataz with Norvir (ritonavir) and Truvada; Prezista (darunavir, TMC114) with Norvir and Truvada; and Isentress (raltegravir) with Truvada.

Obviously, it's a little bit too soon to conjecture what's going to happen the next time the guidelines are updated in regards to Edurant. But that's potentially a handful, literally, of different options to choose between, and a lot of things to weigh. Which can get pretty complex, I would imagine, for some clinicians and patients.

Well, how complex it is, or how reassuring it is, is perhaps at the center of your question. It's complex if you feel overwhelmed by choice and don't know the data, and don't know what makes these distinct. On the other hand, I find it wonderfully reassuring that, in the current era, I can sit with a patient who is facing starting therapy and describe five different combinations -- amongst others, I can describe the five you just mentioned -- and say, "Here's what makes this great, and here's its asterisk -- here's the issue with this drug."

So, with Edurant, I would consider the viral load, and if it was below 100,000, I could say, "You have to take it with food, and do you have heartburn? Because if you take certain heartburn medicines, this is not the right drug." And that would allow me to decide whether Reyataz or Edurant is on or off their list.

Raltegravir is twice-daily. Some people say, "Sure, I could do twice-daily, no problem," and other people say, "Ooh, I might forget. I'll stick with the once-dailies."

We individualize this through a number of questions that all of us, I think, routinely ask. And as a result of those questions, I think we go from having a field of five that are all perhaps competing for attention to feeling like we can match somebody up with the right drug.

"It's kind of like the Dating Game, if that's even still on TV anymore. It's really a question of 'Bachelor Number One, do you have heartburn? Bachelor Number Two, can I take you with food, or without, or does that matter?'"

My sense of it, to risk dating myself, is it's kind of like the Dating Game, if that's even still on TV anymore. It's really a question of "Bachelor Number One, do you have heartburn? Bachelor Number Two, can I take you with food, or without, or does that matter?"

The way we go through it is a series of questions, and I ask the people I see, "What's the most important thing to you? Are the number of pills important to you? If I said the combination was one pill or four pills a day, does that matter?" Some people say, "Wow, that matters a lot! Four pills, yikes, that's scary!" And other people say, "Four pills? I'm already taking five vitamins; why would four pills matter?"

So everybody is different, and these regimens have ways in which they're distinct. I don't think it's all that complicated to review the options and match somebody up with a drug that meets that person's criteria with the most check boxes.

You mentioned that a few months down the road, hopefully, there will be a single combination pill that includes Edurant and Truvada together.

That's now up to the FDA. There is one in development, and now it's up to the FDA to agree.

What else is on the horizon as far as drugs in development?

Probably the next drug that's closest to completing its phase 3 work is what's affectionately known as "the Quad," the Quad being the same two nucleosides, tenofovir and FTC, and then Gilead has two new drugs in development, one is an integrase inhibitor and one is a booster. That drug is being now studied in phase 3 as a single combination. How successful it will be is not something we yet know, because the phase 3 studies aren't done.

Behind that is an integrase inhibitor that ViiV is developing, and that's entering phase 3 studies now, so we've got a little while before we're gonna know that data. But we do have a pipeline, and it's great that the industry is still finding drugs that it wants to develop with us.

And it sounds like, within the course of a year, options for first-line therapy are gonna get even more diverse and interesting than they already are.

Well, I hope so. I want more options, because the more we have, the more I can be confident that I can pair this person with what seems to be the best choice for him or her. Because, again, this person might be on this pill the rest of his or her life. So because people differ, I would like to have more options and start somebody on something that has as many of the right attributes for him or her as possible -- and if, after a week or two, it's not the right one, to be able to switch to something that is equally attractive and should work as well, and address some of the limitations of wherever we started. So I think the more options the better.

Now, just to clarify, you say a week or two -- that's usually because of side effects you can't handle, right?

Correct. The most common experience, for example, on efavirenz is that some people in the first week or two experience either a rash or some of the well-known neuropsychiatric toxicities, and in that first month some people find that it's just not going away, and they need to switch.

Thank you, Dr. Cohen.

Myles Helfand is the editorial director of TheBody.com and TheBodyPRO.com.


Copyright © 2011 The HealthCentral Network, Inc. All rights reserved.

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This article was provided by TheBody.com.
 
See Also
FDA Approves Complera (Edurant + Truvada), the Second "All-in-One" Pill for First-Line HIV Treatment
Next Single-Pill HIV Treatment Approved, and It's Not Called "B-Tripla"
Approval of Complera: Emtricitabine/Rilpivirine/Tenofovir DF Fixed-Dose Combination (Official FDA Announcement)
More on Edurant (Rilpivirine, TMC278)

 

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