This Month in HIV: Top 10 HIV/AIDS Medical Stories of 2006
Nine, again, is another policy shift. And this is the U.S. government guidelines we talked about, that recommend to clinicians what [meds] to use to start HIV therapy. [To read the U.S. Department of Health and Human Services treatment guidelines, click here (PDF).] For HIV experts who are working in the ivory towers, this doesn't have a big impact upon them. But there are a lot of clinicians out there who don't have a whole lot of patients with HIV -- maybe 10, maybe 15 -- HIV is just one of the many things that they do. They really want to keep up, and they want to do a good job, and they rely upon the guidelines to tell them what they should do. And the guidelines have really not completely kept up with clinical practice. In HIV, we tend to do things even without the full breadth of medical evidence, because we're dealing with a really important infection that could be fatal. There are a lot of data that come out all the time that don't make it into the guidelines.
The [U.S. HIV treatment] guidelines have really caught up. The important thing about the new guidelines is [that] they've really encompassed therapies that clinicians are using now in the clinic. We mentioned it before. Besides Sustiva and Kaletra, Reyataz boosted with Norvir and Lexiva boosted with Norvir have been added to the preferred list. And any of those drugs can be taken with Truvada or Combivir. This makes the guidelines really realistic and, I think, opens the door for clinicians to have better choices and not have to justify why they are using a drug that's not on the preferred list, but that data show should work just as well as drugs that are on the preferred list.
Well, I think that's great, and I think that's to be lauded. The other thing that I really like about the guidelines are, they're really stressing that we should do resistance testing when people come into clinical care. So even though you're not on HIV therapy yet, there should be drug resistance testing done on you to make sure you didn't get infected with a resistant virus. There are increasing data that show that if you have a drug-resistant virus [HIV drug resistance] and then you start on therapy with a drug that you're resistant to, it won't work as well. So I think this is worthwhile and the guidelines are pretty clear about that.
"The [U.S. HIV treatment] guidelines have really caught up. The important thing about the new guidelines is [that] they've really encompassed therapies that clinicians are using now in the clinic."
I think the new guidelines are a breath of fresh air. They're completely revamped, as far as what they recommend for initial therapy. It's a great document, and all clinicians need to know about [it].
Do you think it helps for patients to read the guidelines?
You know, it's very technical. I think patients should be very aware of what's listed in the guidelines as preferred and not preferred; I think that is savvy. If you understand what's going on, then when a clinician tries to tell you that you should start something [about which] the guidelines say, "No way," you could ask, "Why are you starting me on this? Tell me. You may have a really good reason, but tell me why it is."
That's what you need to understand. Therapy has gotten complicated, and there are data that show that the more choices you give someone, the harder it is sometimes to make a choice. I think that people have been turned off because there are so many therapies now. Well, this makes it easy.
There's a box, and it shows Column A and Column B. If anyone's ever been to a restaurant where the menu has Column A and Column B and you have to pick two from here and one from there, you're going to get it. And that's what it takes. Look at the Column A. Look at the Column B. See what you're on. See what you're recommended to be on, and then say, "Well, that makes sense. That's what the guidelines say."
But if it doesn't show up in the guidelines, you have got to say, "Well, why not? And why am I being offered this therapy that's not listed on the preferred list?" And again, there may be a great reason; you should find it out.
We have the guidelines on The Body, so anyone can look through them. [Click here to browse through a PDF of the U.S. HIV treatment guidelines.]
Okay. Number ten.
Number ten is, again, sort of a potpourri, and it's listed just as "New Drugs." You know, in 2006, we saw the approval of Prezista [generically called darunavir or TMC114]. That's a new protease inhibitor. It has great activity against viruses that are resistant to protease inhibitors. I think that's been a really big help. The problem is, for people who have been resistant to a bunch of different medicines, Prezista alone is not going to work; you need something to add to it.
This year we're probably going to see three new drugs -- at least three new drugs -- approved. This will include the first integrase inhibitor. Integrase is an enzyme that the virus uses to get its genetic information into our DNA, so that our cells can start making virus proteins that get assembled and made into virus that then kill the T cell. It's a very important enzyme that the virus uses to replicate and make copies of itself in our cell. We don't have any drugs right now that target that enzyme. We have drugs that target other enzymes, but not that one; this is the first one. This is the Merck integrase inhibitor [MK-0518]. [To read coverage of MK-0158 from The Body, click here.]
Number two [of the new meds] is a new non-nuke [NNRTI]. Sustiva and Viramune [generically called nevirapine] are both non-nukes. When you get resistant to one of those, you blow the other one, and there's nothing else you can do as far as that class of drug. There's a new non-nuke called TMC125 [also known as etravirine], and this is in expanded access, as are the other drugs I'm going to talk about: the new drugs. This is going to be important because it works for people who do have some resistance to Sustiva or Viramune. That's going to give a new lease on life (for that drug class) to patients who have been exposed to those drugs [and] are now resistant to them. [For more information on TMC125, click here.]
The last [of the new drugs] is maraviroc. Maraviroc is a CCR5 inhibitor. This is a drug that inhibits, that blocks, the entry of the virus into the T cells by blocking another receptor besides the CD4 receptor that's on T cells. It blocks another receptor, not allowing the virus to enter T cells.
These three drugs are all in expanded access right now, meaning that there are studies going on where people can get into them and start on those therapies if they meet the right criteria. It's basically a compassionate use program. [To read more about HIV drugs in development, click here. For more on maraviroc, click here. To learn about the expanded access program for MK-0518, click here. To learn about the expanded access program for TMC125, click here. To learn about the expanded access program for maraviroc, click here and here.]
So that's free drugs.
Free drugs. [The companies providing the medications] collect information on you, but basically [they] just want to get the drug out there. Those [expanded access programs] are at major centers, and people can look it up on the Web site, and I'm sure there will be links to it on our Top Ten list. I think they are important in that they offer a critical mass of new drugs that people can craft a salvage regimen with. By that I mean people who really do have multidrug-resistant HIV now have enough drugs where they can make a new regimen that can really work.
These drugs are all proven to be effective at reducing the virus. The good thing about all three of them is they seem to be incredibly well tolerated. We don't have a lot of data on all these three drugs yet, and some of them are moving very quickly through the approval process. The Merck integrase inhibitor [is] really well tolerated, and it doesn't seem to have any negative effect on lipids. That's really reassuring. So I think that's going to be very attractive. That's one of the [drugs] that we're really looking forward to, and it's probably going to be the first one to come out.
MK-0518, is that what it is?
MK-0518 -- a spiffy name. They'll change that to something that makes a lot more sense. And then number two is TMC125. I think that's, again, going to be very useful for some patients who have been experienced with Sustiva. I think that, again, will be something that people who are on their fourth or fifth regimen might see as being useful to them. And then the maraviroc: it's just a new class of drugs. So we'll have a new integrase class and a new CCR5 inhibitor class. That will also be an important drug for certain patients. I just think that's all very positive, and worth mentioning.
Do these drugs mean that people who are treatment experienced can expect, and hope, to become undetectable?
"In studies where these [new] drugs [MK-0518, TMC 125 and maraviroc] have been studied in people who have been treatment experienced, a significant proportion of them [become] undetectable. And that's when they're using just this drug, plus whatever's out there. Imagine if you could combine these drugs!"
So it's changed expectations.
Yes, I think so. People lose effectiveness of therapy for a bunch of different reasons. But if people take these drugs and are able to adhere to them to the right way, to the right level, these drugs should work. In studies where these drugs have been studied in people who have been treatment experienced, a significant proportion of them [become] undetectable. And that's when they're using just this drug, plus whatever's out there. Imagine if you could combine these drugs! Now, more work has to be done about how to combine these [drugs] -- what makes sense; are there any drug interactions; any overlapping side effects. That's going to come. But I think it really holds a new lease on life for a lot of people.
So it's a very exciting time for HIV management.
Oh, it's incredible that new drugs are still coming out, and anyone who's complaining about the industry pipeline, I think, won't have much to say in 2007. It's really remarkable to me that there are still companies investing in HIV care when the market is really, you know ...
... crowded with very good drugs.
Exactly. It's not like the CCR5, or integrase inhibitor, is going to be offered to people in Asia and Africa. The market is here [in the U.S.], and Europe.
Could you briefly mention the things that you did not include in your top ten list?
Sort of, like, what are the runners-up?
Yes, very quickly.
Very, very quickly: I think we have to take our head out of the sand and recognize that prisons are a neglected area in our consciousness when we think about HIV. [To read more about HIV and prisons, click here.] Basically, every clinician, every doctor [and] nurse, who takes care of HIV[-positive clients] is going to see someone who either has been in prison or will be in prison. About 20 percent of all the people with HIV in our country pass through a jail or prison every year. I think we have to really start paying attention to this.
"Basically, every clinician, every doctor [and] nurse, who takes care of HIV[-positive people] is going to see someone who either has been in prison or will be in prison."
There's an article in this last issue of the New England Journal of Medicine -- that's the most read and respected medical journal on the planet, and thus, by extension, the universe -- talking all about how care for HIV, and prevention especially of HIV in prisons in the United States, is really not up to par. There's an article, as well, in the Lancet Infectious Diseases -- another very important journal, lamenting about how care for people with HIV in many countries is clearly suboptimal, and how prevention just hasn't been enforced.
I think that we have to pay attention to this. There was a very interesting report about intramural -- that means spread within a prison -- HIV in Georgia. And it's clearly demonstrating that we are not doing enough to make HIV testing available in prisons, a population that already has a [high rate] of HIV. I think we have to pay attention and start doing something about this, and not ignoring it.
I think another [idea] that is worth mentioning is that there are data that people can take HIV therapy in places where they don't wear watches. There's a famous quote from over a decade ago, from, I believe, a policymaker in the U.S. government, who said, "Well, HIV therapy: How can you give it to people in Africa? They don't even wear watches to tell what time they're supposed to take their medicines." Of course, we now know that people in sub-Saharan Africa [often] take their medicines even better than [people in] Europe and the United States do. They over take their medicines, because they want the medicine, and the benefits of the medicine. There are data from Haiti that show that scores of patients, a tremendous number of patients, are taking their medicines, are doing well, and that therapy can work when rigorously evaluated over time. So I think that's just another welcome and important report.
"People with HIV can have surgical procedures that they need, and they can come out of this well. HIV doesn't usually predispose you to get bacterial infections, and those are the problems that we see after sugery."
There was another article that I think is a runner-up that we're going to have to look a little bit more closely at. You know, clinicians, HIV docs, ask all the time: "Can my patient with a low T-cell count get a surgery?" We [researchers] waffle and say, "Well, if it's over 200, they can get the surgery. If it's under 200, they can't."
There's a neat little article that shows that people with HIV can have surgical procedures that they need, and they can come out of this well. HIV doesn't usually predispose you to get bacterial infections, and those are the problems that we see after surgery. I think we can feel a little bit more comfortable saying to patients, "Yes, if you need your carpal tunnel repair; if you need to have this elective surgery, you can have it. Go for it. It doesn't matter so much that you've got HIV."
I think those are the top [articles], those are the runners-up. It was a pretty active year, and I think 2007 will be one, too!
Well, thank you, Dr. Wohl. I'm sure we'll hear a lot after people read your article, which is also going to be coming out in the next month. Thank you very much for all your insights.
Copyright © 2007 Body Health Resources Corporation. All rights reserved. Podcast disclaimer.
This article was provided by TheBody.com. It is a part of the publication This Month in HIV.
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