Dr. Fauci Optimisitic About HIV Drug Truvada
NEAL CONAN, host:
AIDS researchers and activists celebrated this week after news that a daily pill can do a lot to prevent HIV-AIDS. A study published in the New England Journal of Medicine reported that healthy gay men who took an antiretroviral pill called Truvada were up to 73 percent less likely to become infected than those who took a placebo.
In a moment: Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health, which sponsored the study. If you have questions for him about these results, give us a call. 800-989-8255. Email us, email@example.com. You could also join the conversation at our website. That's at npr.org. Click on TALK OF THE NATION.
Dr. Fauci joins us from NIH headquarters in Bethesda, Maryland. Nice to have you on the program again.
Dr. ANTHONY FAUCI (National Institutes of Health): Good to be here.
CONAN: And this is, this is great news.
Dr. FAUCI: It is. It's a very important finding. As you mentioned, a study was just published yesterday in the New England Journal of Medicine in men who have sex with men, which asked the question: If you divided into two groups one that receives this drug, Truvada, as a single pill every day versus a placebo, could you decrease the risk of acquiring HIV-infected in these uninfected men who have sex with men? And the results are really quite significant.
Overall in the entire study, people who took the - who were in the limb(ph) of the study that was the drug itself - had a 44 percent decrease in the risk of acquisition of infection. But importantly, if you look at the people who actually took their pills for 90 percent of the days that they should have taken it, they had a 73 percent decrease in risk, which is highly significant and a very impressive result, meaning that we now have a potentially new tool in our armamentarium of preventive measures, which must be always considered as a multifaceted, comprehensive approach to prevention. But this is a very important weapon now we have in that approach to prevention.
CONAN: And also part of the good news, Truvada is not a new drug. It's been around a while, and it's used as, in fact, as part of the treatment by a lot of people who already have the infection.
Dr. FAUCI: That is absolutely correct. Truvada is two-thirds of one of the most popular regimens for the treatment of infected individuals, usually with a triple combination of drugs. Many of the regimens that are used in the United States and in other parts of the world include Truvada as two of those three drugs, the third one being either Efavirenz or a protease inhibitor or some other such drug. But Truvada is very extensively used for the treatment of HIV infection.
CONAN: So would you recommend at this point for people who are - see themselves at risk, that they go to their doctor and get a prescription?
Dr. FAUCI: No, I wouldn't, for the following reason, that this is still just a study in men who have sex with men. We still need to confirm this in women and in heterosexual men. But importantly, before you change recommendations or create guidelines, you've got to get various bodies together, such as the Centers for Disease Control and Prevention, the FDA, community physicians, community input, to take a look at whether or not this should be part of a general recommendation, which would have important implications for the use of the drug, either off label or perhaps having the company apply to have the advertised usage of the drug be extended beyond just treatment.
These are things that are going to take weeks to months to hash out. So at this particular point in time, although I'm quite excited about the data, I think it would be premature to make any official recommendation of what people would do.
CONAN: Why wait? What danger would there be?
Dr. FAUCI: Well, because there are certain things that you really want to make sure that are firm. For example, the people in the study were in there for a median of 1.2 years, with a max of 2.8 years. There did not seem to be any significant toxicities, except for a bit of transient nausea in the people who were taking the pill. But we don't know what the long range effect is going to be.
We also have to be very careful concerning this issue, what I call adherence, because many people in the study, when you question them, said that they were taking the pill but, in fact, they did not. Because when you do pill counts and bottle counts and even blood levels of the drug, they were not taking it. So as important as the effect of the drug, is people making sure that when they get on a program such as this, that they faithfully take the drug. Otherwise, they will be actually fooling themselves into think that the drug is protecting them when they're not taking it.
The other thing is, you have to counsel them very, very carefully, that this is not a substitute for other prevention measures. This is additive. This is an additional tool that we have in our armamentarium for prevention. That message has to be very firmly given before you can any make any kinds of recommendations. So there's still a lot of work to do before we make an announcement on NPR, go ahead and do it.
Dr. FAUCI: I don't think that that would be appropriate right now.
CONAN: Well, when you're ready for the announcement, we'll be ready...
(Soundbite of laughter)
CONAN: ...to accommodate you.
Dr. FAUCI: Yes indeed. Okay, thanks.
CONAN: We're talking with Dr. Anthony Fauci from NIH. If you've got questions for him about the AIDS pills, as it's being called, 800-989-8255. Email: firstname.lastname@example.org.
Let's begin with James(ph), James calling us from Tennessee.
JAMES (Caller): Yes. I guess the nature of my question is, just how ethical is a study like this? And the reason I say this is because, in a trial study like this you are basically putting, in a way - and I know you talked about counseling them. But in a way, it's you're putting peoples' lives at risk for a study like this, by administering the placebo. And because, you know, the very nature of the placebo, they don't know what it is, if it is the real thing or not. And the second part of that, is that how exact, as far as the statistical numbers, can they be when it is it's not like a lab where you test with, say, animals or something where you know you are infecting them or trying to infect them with HIV or AIDS.
I mean, those the statistical numbers would seemed like something that would be very, very inexact as far as how successful the rates are. And I'll take my answer off the air.
CONAN: All right, James. Thanks.
Dr. FAUCI: Okay, very good. A reasonable question. But I have to say, with all due respect, I disagree with you completely about the ethical aspects of it. And I'll explain, precisely, why. First of all, it was a randomized, double blind, controlled study. So the people who got the placebo and the people who got the drug, were instructed equally as well as for the use of condoms, the decrease and the number of sexual partners, testing for HIV and treatment for other sexually transmitted diseases.
When you talk about the ethics of giving one a placebo and another with drug, that would only be an ethical issue if you knew that the drugs that you were testing worked. This is not standard of care and we did not know whether it was going to work or not. Therefore, we are not putting one versus the other of the groups of people in the study at any disadvantage, or with any ethical consideration. Only if you know a treatment works and you withhold it from someone, is there an ethical consideration there.
CONAN: Once you found out it was effective, did you put the other half of the people well, you weren't conducting the survey - the study - but did they put the other half...
Dr. FAUCI: That...
CONAN: ...on the pill?
Dr. FAUCI: A very good question. That is exactly what happened. The study was terminated because the results were so impressive. And that it's going to continue on what we call a carry-on study for an additional 18 months, where the participants in the study will be offered the drug if they want it so that we can test in the longer range: toxicities, adherence, other aspects that we need more information on. So that's an excellent question. They are offered the drug.
CONAN: All right. Let's go to Jay(ph), Jay calling us from Phoenix.
JAY (Caller): Yes. Hi.
CONAN: Go ahead.
JAY: Yes. My question is, was the company that manufactures the drug in any way involved in paying for the study?
Dr. FAUCI: The company donated the drug free. They played no role in the development of the protocol, nor did they play any role in the analysis and interpretation of the data.
JAY: Okay. Thank you.
CONAN: Thanks, Jay. Let's go next to this is Brian(ph), Brian with us from Wilmington, Delaware.
BRIAN (Caller): Hi. I worked for DuPont Pharma when we came up with Sustiva. And one of the things that's always been a problem with HIV drug is that how quickly the drug could adapt to, you know, regimens. And I was wondering if there is a concern about prophylactic use of antiviral, like in this case.
CONAN: I think you meant how quickly the disease can adapt to drugs. But anyway, go ahead.
Dr. FAUCI: Well, the question really relates to the question about the development of resistance. Resistance can only develop if you are infected and you give the person a drug. There is a possibility that someone would come into the study and not know that they are infected and then get put on the drug, which would be essentially inadequate therapy because you really need three drugs and not just two. And Truvada is a combination of two drugs. But there is some information that might be useful to the caller as well as the people in general in that there was no development of resistance in people who were on the drug limb of the protocol, who ultimately actually did become infected.
There were 100 infections in the whole study, 36 among the group that were taking the Truvada, and 64 among the people who were taking the placebo. And the people in the Truvada group, who were infected, there was not the development of the resistance to the drug by HIV. The only resistance that occurred, were among three people who actually didn't know it but were infected before they even started on the drug or on the placebo. So far, in the length of time that we've been doing the study and following people, resistance to the drug has not been a problem.
CONAN: Okay. Thank you, Brian. If antiretrovirals like Truvada work, might it suggest that others would work?
Dr. FAUCI: There's no doubt that there will be likelihood that others will work. Truvada, which contains two drugs, emtricitabine and tenofovir, were chosen for several reasons. They had what we call favorable pharmacokinetics, namely that the levels of drug hung around for a while to give you rather a smooth level if you took a pill a day. Number two, it was shown in the non-human primate model to be quite effective in blocking infection in the challenge model in a non-human primate.
And third, there is extensive experience, as we said in the beginning of the show, with Truvada being used as a treatment for HIV infections. So there were three good reasons to go with Truvada. That does not mean that there would not be other drugs that would be equally as effective if used as pre-exposure prophylaxis.
CONAN: Dr. Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases. We're talking about the so-called AIDS pill. You're listening to TALK OF THE NATION from NPR News.
Tim is on the line calling from San Francisco.
TIM (Caller): Hi, it is - good afternoon now. I have a couple of questions about this study. How many of the - how many gay men - I'm a gay man. I've been out since 1989, and I've lived as a gay man for that amount of time as negative. And I was wondering how many of those men were screened for crystal meth use, how many of them were screened for popper use, and how much screening was done as far as alcohol - because those are extremely high...
Dr. FAUCI: Yeah.
TIM: ...factors as far as contracting HIV. And if there were no men who were using those in your study, then theyre more likely to take the pill everyday and they're more likely not to become infected by the disease. Now, the other part of my question - and this gets to an ethical part of you selling - or Truvada selling their drug to gay men - is, okay, if 70 percent of the people who are negative, or 75 percent, do not contract the disease when they're taking this drug - and I as a gay man refuse to take that because they're potential harmful to my liver. And since I am not going to take the drug as an HIV-negative man, am I going to be held responsible by - or will I be taken to task by the drug company as contributing to the spread of HIV in my community? Now - so if you're a non-HIV positive man, it just gets into a huge ethical problem because...
CONAN: Why don't you give Dr. Fauci a chance to address it, Tim. Hold on.
TIM: ...of taking the drug or not taking the drug?
CONAN: Tim, can we hear an answer?
Dr. FAUCI: Okay. So this - at least two parts to your question. The first has to do with the valence of use of other drugs, alcohol or what have you. The individuals were not screened with regard to looking for blood levels of crystal meth or other drugs, but they were questioned as to a number of habits and behavior vis-a-vis alcohol use and other substance use.
But it was a randomized study, so that the individuals who were in the group that receive the placebo compare to the individuals who are in the Truvada group, were completely balanced in every single respect. So that's the beauty of a randomized trial, that both of the components of your study groups are essentially identical in every other way, except that one is getting a placebo and one is getting the drug.
I don't think - with all due respect to the call, I think it's a little bit farfetched to think that if you don't want to take a drug for prophylaxis, that anybody is going to hold you to task if you get infected. I think your safety and your ability to protect yourself against HIV is your business and no one else's.
If you don't take the pill, which is not yet recommended at all, it's just the results of a study, that will serve as the basis for some considerable consideration that you can avoid infection by well-proven preventive measures -the consistent and correct use of condoms, decreasing the numbers of sexual partners, et cetera. So you have a very good prevention modality that you can use without even considering drugs.
CONAN: And we just have a few seconds left, but there are also questions about the cost of this drug, which is, at a pill a day, what, 12 to $15,000 a year.
Dr. FAUCI: Yeah. Well, if you go to a drugstore, for example, go to a drugstore here in the Washington, D.C. area, it'll cost you about 12 to $13,000 a year. Here at the NIH pharmacy, where we get drugs much more inexpensive because we get them wholesale, practically - that's about 5,000 a year.
The price varies in certain countries. These formulations are available as generic preparations, which might actually decrease the price considerably.
CONAN: Well, Dr. Fauci, again, good news. Congratulations.
Dr. FAUCI: Thank you very much.
CONAN: Happy Thanksgiving to you.
Dr. FAUCI: Same to you, thanks.
CONAN: Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. He joined us from the NIH headquarters in Bethesda, Maryland.
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