Truvada And At-Home Test Join Fight Against HIV

Truvada is a pill that's already used to treat people with HIV. A daily dose can also significantly reduce the risk of new infection. And a panel recommended the FDA approve an over-the-counter HIV test, OraQuick. Users could test and interpret their results at home in as little as 20 minutes.

NEAL CONAN, HOST:

This is TALK OF THE NATION. I'm Neal Conan in Washington. In recent days, Food and Drug Administration advisory panels backed two tools that may slow the spread of HIV. Truvada is a pill already used to treat people with HIV, but then studies found it could prevent infections among those at high risk, primarily men who have sex with men.

The second is OraSure, a home HIV swab test which would be sold over-the-counter and provide results in as little as 20 minutes. Panel members and experts raised a number of ethical and practical concerns about both OraSure and Truvada, but they concluded benefits outweigh the risks. The FDA usually follows advisory panel recommendations, but not always.

If you work in the field, what are the promises and perils of these new developments? Our phone number is 800-989-8255. Email us, talk@npr.org. You can also go to our website, that's at npr.org. Click on TALK OF THE NATION.

Later in the program, non-white births now make up a majority in the United States, so what changes? But first, NPR science correspondent Rob Stein is with us here in Studio 3A. Rob, always nice to have you with us.

ROB STEIN, BYLINE: Oh, nice to be here, Neal.

CONAN: And let's begin with Truvada. We knew retrovirals could treat HIV. This actually prevents infection?

STEIN: That's right, that's right. This would be, if the FDA goes ahead and approves Truvada for this purpose, it would be the first time any drug has been approved specifically to prevent somebody from getting infected with the AIDS virus. That would protect them from getting infected, sort of like a vaccine in a pill, if you can think of it that way.

CONAN: Not quite a vaccine, but boy, a big advance.

STEIN: That's right. This is creating a lot of excitement. People are thinking of it as one of the first really big, new, important tools to reduce the spread of the AIDS virus in the 30 years that the AIDS pandemic has been going on. Right now, really all people can do is use condoms or avoid sexual contact with people who are infected. This would give people another tool to reduce - to protect themselves and reduce the risk of getting infected with HIV.

CONAN: And it's being recommended for those, should it be approved, for those who are at high risk, men who have sex with other men, people who have partners who are infected with HIV.

STEIN: That would be the two target groups that this drug would be aimed at. One, as you said, would be gay men who have a lot of sexual partners and therefore are at high risk of getting infected because they're exposed to the virus a lot. And also people who are in relationships with somebody who is infected, you know, you have a heterosexual couple where maybe the husband is infected, and the wife isn't. The wife would be able to take the drug to reduce her risk of getting infected by her husband.

CONAN: So there are recommendations also that this does not replace condoms, it should be used in - along with them.

STEIN: Absolutely. And that's one of the big concerns, actually, about Truvada and Truvada being approved for this purpose because there's a lot of worry that this would not replace using condoms and other safe-sex precautions. And there's a fear that this could lull people sort of into a state of complacency, where they think I'm taking this drug, and so I'm protected, and so I don't need to use condoms. I don't need to take other precautions. And they absolutely would need to continue to use other precautions, because the drug is not, by any means, 100 percent effective.

CONAN: Ninety percent effective in one study, when it was taken religiously.

STEIN: Yes, when it is used properly, which means taking it every day, it can be highly effective, as you said about 90 percent. In the real world, when there have been studies where they've tested it, it has not been nearly that effective. It's been more on the level of 44 to 73 percent effective.

CONAN: And in one study, I understand, as few as 10 percent of those in the study used it every day.

STEIN: That's right, only about 10 percent, and again that's another one of the big concerns because one of the fears about this drug is that if it's not used properly, if it's only used intermittently, it could actually have some serious consequences. Most importantly, it could lead to the emergence of new strains of the AIDS virus, new strains of HIV that are harder to treat, that are resistant to the drugs that are out there.

CONAN: So just like there are, you know, bacterials that respond to drugs and become resistant to it, viruses can adapt the same way.

STEIN: And that would be a very serious development if that happened, and that's a real concern because as you pointed out earlier, it's hard to get people to take the drug properly, to take it every day like you're supposed to, and if they don't, and then the virus could mutate in certain ways to become harder to treat, and that could make the situation a lot worse.

CONAN: There's also concerns, as I understand, this could become something of a party drug, a club drug sold on the black market.

STEIN: Yeah, there's this idea that, you know, if you're going out partying, you might, you know, just try to take the drug that night or something, with the idea that that would protect you, when in fact that wouldn't protect you. And so there could be a lot of misconceptions about this drug. And so there's very mixed reactions to the possibility of this being approved.

On the one hand, it's seen as a really - possibly a really important, powerful tool, but on the other hand, there are potential some really serious downsides if it's not done right.

CONAN: And that's the reason it's being recommended only for those at high risk of infection, not for a broader population.

STEIN: Oh absolutely. Yeah, if it is approved by the agency, it would only be targeted at these very high-risk populations.

CONAN: And let's now turn to the other tool that the FDA advisory panel recommended. And again, these are advisory panels, it's not final approval, but usually the FDA follows their advisory panels. But this is a home swab HIV test, results in 20 minutes.

STEIN: That's right, the way it would work is if you are curious or wondering whether you might be infected with the AIDS virus, with HIV, you would just take a swab from the inside of your cheek, and in 20 minutes you get a result back telling you whether you are indeed infected with the AIDS virus.

And again, this is all aimed, really, at trying to reduce the spread of the virus, which is - although there's been a lot of efforts to reduce the number of new infections each year, there's still about 50,000 new infections every year in the United States, and one of the ways to reduce that is to let people who are infected know they are infected so they can, one, get treated, and two, take precautions to prevent them from spreading it to other people.

CONAN: So about 20 percent, it's estimated, 20 percent, one in five of those who have HIV, don't know it.

STEIN: They don't know it, that's right, and there's been a lot of campaigns, a lot of efforts that try to get, you know, get people to get tested. But, you know, it's not reaching everybody, and one of the thoughts is if you make a test like this available, you make it easier for people to get tested that more people might get tested.

CONAN: So the test would be a home kit, available over the counter. But again, there are concerns about this, too. One of the questions I saw raised is, wait a minute, there's no counseling for this. If you come up with a positive, and there can be false positives but for the most part not, maybe you're so scared and so frightened and so humiliated and so embarrassed you're not going to do anything about it.

STEIN: Right, it's - I mean, finding out - on either side there are some significant ramifications. If you get a test result back saying that you are infected, well, that's, you know, that can be terrible news, obviously, to people and can cause a lot of anxieties and fears and panic, and people might not know what to do, and so there's a lot of concerns that they need to get the appropriate counseling to go along with that so they know exactly what that result means, what kind of treatments are available and where to go from there.

CONAN: For one thing, go first to a doctor have a blood test to confirm.

STEIN: That's right, you have to confirm. This test is not 100 percent accurate. It's only about maybe 93 percent accurate in picking up people who are infected, and maybe 99 percent effective in finding that somebody is not infected. So they could have some false positives and false negatives, and in either case, you really need to talk to somebody so you know what it means and you know what to do to follow up on it.

CONAN: And one of the concerns I've heard about it also is that because it's so easy, it's just a swab, you could be tested without your knowledge.

STEIN: Right, that's one of the theoretical concerns, that somebody could take a sample from, say, your toothbrush or something and test you for the AIDS virus without you even knowing that's happened. Now, there's never been any reports of that happening, but that's a theoretical possibility.

CONAN: There is also the question of price. As I understand it, this would relatively affordable, what, 40 bucks is what they're assuming?

STEIN: Yeah, that's somewhere in the ballpark of there. It sells for about $60 now. There's a version of this that's available for doctors. It sells for about $60, and it would probably be a little bit less expensive than that when it's on a consumer market.

CONAN: That raises a question, though, about the price of Truvada. That is likely to be something on the order of $800 a month. That's thousands of dollars every year. That's steep.

STEIN: Truvada is a very expensive drug. It would cost about $14,000 a year for every person taking it. And if you, you know, do the numbers and calculate all the thousands and millions of people out there who could potentially be taking it, you're talking about a lot of money.

CONAN: Who would pay for it?

STEIN: Well, that's the key question. Presumably if the drug gets FDA approval, one of the big ramifications of that is that more insurance companies would start paying for it.

CONAN: 800-989-8255. Email us, talk@npr.org. If you work in the field, we'd like to hear your thoughts about the promise and perils of these two new tools. Our guest is NPR's science correspondent Rob Stein, and we'll start with Daniel(ph), Daniel with us from Chapel Hill.

DANIEL: Hi there. Yes, I just wanted - unfortunately, I was talking to your producer, so I didn't hear what your correspondent was saying exactly, about the home testing kit. So I may be redundant from some of the things that he said. Some of us were interviewed by the BBC yesterday, on this, and in fact our recent book, called "Tinderbox" on the AIDS epidemic, we have quite a bit of discussion on HIV testing.

One of the things that we point out there is although HIV testing is an extremely important tool, especially for getting people into treatment, that have the virus, there can be some inadvertent negative consequences, just from testing in general. And from this home testing kit, these issues might be exacerbated.

You know, there are a number of them, but for example, what happens if somebody, you know, goes to the pharmacy, buys the test and, you know, it's late at night, and they get the result, and they're positive? Normally when you go for testing, you're with a counselor, but here you are alone in your apartment or whatever. What are the consequences? That's certainly an issue.

Also, probably a lot of people that buy this, especially in the United States, because it costs $60, may be people who are really actually at low risk of having the virus. You know, among the middle-class, heterosexual population, the prevalence of HIV, as we talk about in the book, is extremely low.

And so in fact, there's something called false positives, which are relatively uncommon but in a low-prevalent setting, there will actually be more people who test positive who actually don't have the virus than people who actually do have the virus. So that's certainly the concern, as you can imagine. There are a number of others.

CONAN: It's interesting, we got this email from Melanie(ph) in Flagstaff: As a pharmacist, I worry about an over-the-counter HIV test. The person would rely on the pharmacist for counsel when most of us are not trained for this type of consultation. I believe consultation is very important to the diagnostic process to avoid unintended consequences.

And that reinforces what you've been saying.

DANIEL: Well, that's good. I mean, I would - it would be great if they even have the pharmacist. The idea of this is that you do it at home, alone, so that - you don't even have the pharmacist there. You know, and by the way, another issue among - especially among higher-risk populations, whether it's men who have sex with men in this country or the places in Africa that we write about in our book, there's an issue of false negative.

As much as one-third or in some cases half of all HIV infections happen during what we call the window period, and that's a period of a couple weeks to a couple months after initial infection when you have not yet developed antibodies to the virus, and you're actually, relatively speaking, extremely contagious. But if you take one of these tests, you'll test negative by definition, because you don't have the antibodies.

So imagine if you had a risky episode, you worried, you go to the pharmacy, you buy this test, and you take it home, you test negative and think oh, I'm fine. And then you go out partying again that night where actually you're extremely infectious.

CONAN: Daniel, thanks very much, we appreciate the phone call. Stay with us, we're talking about the new tools against the spread of HIV/AIDS. Stay with us. I'm Neal Conan, TALK OF THE NATION, NPR News.

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CONAN: This is TALK OF THE NATION from NPR News. I'm Neal Conan. We're talking about two tools that may help the spread of HIV, prevent the spread of HIV, Truvada, again a daily pill already used to treat those infected with HIV. Studies show it also helps prevent infection.

OraQuick is a home HIV over-the-counter test made by a company called OraSure. Both were given the green light by FDA advisory panels. A decision from the FDA itself is expected soon. If you work in the field, what are the promises and perils of these new developments? 800-989-8255. Email us, talk@npr.org. You can also join the conversation on our website. That's at npr.org. Click on TALK OF THE NATION.

Our guest is Rob Stein, NPR science correspondent and senior editor, but joining us now from the National Institutes of Health in Bethesda is Dr. Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases. Nice to have you with us again.

ANTHONY FAUCI: Good to be here.

CONAN: And are we turning a corner here on AIDS?

FAUCI: Well, certainly when you add, for example, with the pre-exposure prophylaxis, when you add another important modality of prevention to the already rather robust toolkit of combination preventions, I think that's an important advance.

As you mentioned on the show, it isn't for everyone to take who is at risk, but certainly it is an important component of the broad toolkits that we do have for prevention.

CONAN: You've heard some of the concerns, as well. Do those worry you?

FAUCI: Well, there are always downsides of making medications available. There are toxic side effects. There are what we call reverse effects, where people may practice more risky behavior because they think they're protected. That's always there when you have an intervention that works.

But I agree with the advisory committee strongly that when you balance the benefits of this - making this available to the risks that the benefits far outweigh the risks, although you must take seriously the potential downsides of it and be prudent in your use of this.

CONAN: And be prudent. People who are at high risk for infection by HIV are not necessarily among the prudent category.

FAUCI: That's correct, and this is not meant to be a substitution for other types of prevention modalities that work. This is additive. It's a powerful tool. It's not to be used in a vacuum. It should be used with all of the other types of relevant-for-a-particular-population prevention modalities like good common sense in exposing yourself to risk, the use and proper use and consistent use of condoms.

You add onto that another powerful method of prevention, and I believe that that's an important advance.

CONAN: Rob Stein, I think, has a question for you.

STEIN: Yeah, hi, Dr. Fauci. I just was wondering: Do we have any sense of how many new infections a year this might prevent if it was used properly?

FAUCI: Well, if you look at - for example it's recommended for men who have sex with men to use, and as you mentioned correctly on the show, for discordant couples, for the uninfected partner in discordant couples. If you look throughout the world and even here in the United States that, for example, men who have sex with men still are the predominant risk category of new infections each year.

Of the 50,000 new infections that you mentioned each year here in the United States, a substantial proportion of those are among men who have sex with men. If you look both in the United States but particularly in the developing world that a considerable proportion of the new infections come from discordant couples.

Now, there are two ways to approach discordant couples. One, you should I think predominately treat the person who is infected, and you'll have, you know, a double advantage there: You'll save the life of the infected person and very likely dramatically, by 96 percent, diminish the likelihood that that person will transmit the infection to their uninfected partner.

But there are circumstances in which there is a discordant couple, where one is infected and one is not, where for one reason or other the infected person is not able to or does not want to go on therapy. Then by prophylacting or preventing infection by treating the person who's uninfected, that could be a very powerful way of preventing infection that you would like to avoid, that otherwise would not be avoidable.

CONAN: Here's an email question, this is from Edward in Albemarle County in Virginia: Having been involved with HIV/AIDS prevention and care for nearly three decades in Virginia, it's alarming that just as the CDC has begun to address structural disparities, including social injustice and health injustice, as part of prevention planning, Truvada as prevention raises great risks of increasing social disparities - who has access to prevention, who does not - and the abuses related to those disparities. How do those issues of injustice - are those issues of injustice being discussed?

FAUCI: Well, I think that's a very important question, a very relevant question, and that's the reason why just a few moments ago, I said used prudently. This is not something to be widely used, but there are certain subsets of populations of people in which this would be a relevant and appropriate modality of prevention.

That does not mean that you want to neglect the other areas of prevention that are much more applicable on a broader scale to people who don't have access to these types of prevention. So it should be an all-or-none phenomenon, and I totally agree with that: We've got to be sensitive to those disparities that we see with the availability of prevention.

CONAN: Another at-risk group is intravenous drug users, by definition not a prudent group. This is going to be a concern for those who worry that they will use it sporadically, from time to time. There are also side effects, which are not pleasant sometimes, and that's another reason they may not use it regularly. And then you get that resistance building up to the drug.

FAUCI: Well, that's true. There are risks to this, and again if you look at the big picture of things, it's clear in the eyes of many, certainly in eyes of the individuals on the advisory committee, that the benefits in the big picture outweigh the risks. But that doesn't mean that the risks don't exist.

CONAN: Let's see if we can get another caller in on the conversation, and this is Al(ph), Al with us from Santa Cruz in California.

AL: Hey, thanks for taking my call, Neal.

CONAN: Sure.

AL: I have spent 20 years working HIV and prevention. I'm a heterosexual, HIV-positive man. And just two points. Your former caller was excellent in pointing out the window of opportunity, that six-month window. But I'm fully in support of this because there are so many folks who will not go in and get tested, mainly for fear of being seen going in.

We had to change some clinics' titles above their doors that said HIV tests here. A lot more people are going to test themselves because it's available in the privacy of their home. And as far as the counseling goes, you know, 20 years ago, if you received a diagnosis of positive, as I did, a lot of people would just, you know, be terribly scared.

And these days, most of the general public knows that this is to some degree treatable, and therefore I think the downside of not having counseling available is not as important as the fact that people will access this test when they wouldn't go to a regular clinic.

And my last point is that many people who do get a positive test in a clinic setting will not always agree to have counseling. So that's my points, and thank you for taking my call.

CONAN: Oh, thanks very much, and Dr. Fauci, of course he's referring to the over-the-counter OraQuick, which is again approved by the advisory council, yet to be approved by the FDA itself.

FAUCI: Right, exactly, and again, I - my comment about the test, just as we spoke of, and you did on the program already, that there are downsides to these types of things. I think the benefit of making this type of test available far outweigh the risks. If you just look at the numbers, you know, there are about 1.1 to 1.2 million people infected in this country. Twenty percent of them do not know that they are infected.

About 50 to 70 percent of the new infections that occur in this country, occur from people who do not know they are infected infecting their partner. And any way that we can get people tested to be aware of their HIV status I think would be very, very important.

We have, as you mentioned quite correctly on the program, about 50,000 new infections in this country. The only want that you are going to really get that number down is by increasing the testing one way or the other. The availability of this kit will help in that direction, and for that reason, the advisory committee to the FDA made their recommendation.

CONAN: Let's go next to Alison(ph), Alison on the line with us from Fort Wayne, Indiana.

ALISON: Hi.

CONAN: Hi.

ALISON: I am a prevention educator for the AIDS Task Force here in northeast Indiana. And one thing that we've seen here in Indiana is due to budget cuts, the health departments around the state have lost their full-time HIV tester. The man who was here in Fort Wayne was testing about 8,000 people a year. And we lost him. And I'm hoping that these tests, maybe people will be more inclined to that because they like being, you know, being anonymous and going to the health department. So this might help.

CONAN: Rob - I just wanted to follow up just a second, Alison. Rob Stein, public health services around the country, are they the victims of budget cuts not just in Indiana?

STEIN: Oh yeah, oh yeah, that's been a real significant trend in this country. One of the side effects of the economic downturn is that it's hit a lot of state and local budgets hard, and a lot of the local state public health departments have had big cuts and lost a lot of their services that they were offering to the public, including HIV testing.

CONAN: And, Dr. Fauci, I'm not sure this replaces that, but it is something that can step into the breach.

FAUCI: Yes. It could help fill, a bit, that void. It is really unfortunate that prevention services have been decreased because of budget constraints. The availability of this type of a test would, in some respects, substitute for that, though you don't want that to be a real full substitution. You want to continue the standard of prevention availability, but this is a step in the right direction of getting more people tested. The more people you test, the more people that you can get on therapy, and we know that therapy is lifesaving, not only for the person who's infected but it can be lifesaving in preventing that person from infecting another individual. So the potential upsides to this are several.

CONAN: Did you have another question, Allison?

ALISON: Oh, I was just going to say the only thing that makes me nervous as being on the prevention side, is when I get people who come in here who want a test, they're normally within that window period. And you have to talk them down and let them know that we can't give you a guarantee 90 days from the act. And what makes me nervous is that people are going to be like, oh, man, I can't believe I did that. I can go to the pharmacy, get the test and, you know, show negative even though they could be positive.

CONAN: OK. Allison, thanks very much for the phone call.

ALISON: Thank you.

CONAN: Here's an email from Sheryl in Cornville, Arizona: I'm a medical technologist, and even for noncomplex kit testing, we provide training to all our staff before we're allowed to perform testing on patients. The security the training provides will be lacking if this test is allowed for home testing. We still see erroneous results with home kit testing for pregnancy. I believe great caution should be used before making this change. And, Dr. Fauci, that's one of the concerns raised by some of those before the advisory panels that some of the false-negatives and false-positives are the result of, well, people not administrating the test properly.

FAUCI: That is correct. If you look at the results from the clinical trial, it was over 99 percent specific - namely getting the positives - and about 93 percent sensitive. That is less sensitivity using the same kit that trained personnel would get. They would get closer to 99 percent if you really knew how to use it. So that extra several points, percentage points, in specificity is very likely due to improper use. But if you look at 93, it's not a bad number. It is not the best number possible. Obviously, you'd like to see it much higher. So you're right. There will be technical reasons why the test would not be correct in any given individual, but relatively speaking, that would be a small number.

CONAN: Dr. Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases, his division sponsored the AIDS pill study, along with the Bill & Melinda Gates Foundation. Also with us, NPR science correspondent and senior editor, Rob Stein. You're listening to TALK OF THE NATION from NPR News. And, Dr. Fauci, with these two developments and we await full approval by the FDA, as you say, this could be very important. What's next?

FAUCI: Well, I think what's next is the implementation of prevention modalities. We have tools. We're implementing them reasonably well in this country. We can do considerably better. We can also do considerably better on the global front. From the standpoint of a scientific advance, obviously, the next big, as we often call it, the Holy Grail, would be the development of a vaccine. But even prior to the availability of a vaccine, testing people, getting the people who are tested and positive into care, keeping them in care, getting them on therapy, having them consistently take their therapy, would be a major step towards turning the trajectory of this pandemic worldwide. So although we have a lot of really good tools, we've got to implement them much better.

CONAN: And we - one of the tools - one of the problems we talked about was price - at an estimated $40 per test. That's relatively affordable in this country. The price of the Truvada is formidable in this country. That's going to be a major factor overseas.

FAUCI: Well, it will be, but we're hoping that we will see, was just like what the standard regimens to treat people who are already infected, which, as we know, are anywhere from 15 to $18,000 originally. And even today, in this country, for a full year of treating an infected patient with a variety of ways of getting prices down by the company themselves bringing the price down as well as generic use of drugs, we do hope that when you implement these types of prevention modalities, namely the pre-exposure prophylaxis, that in the developing world the price will be considerably lower than the 12 to $14,000 that was mentioned on the program - which is the price that it would be at this point in time at least in the United States.

CONAN: Rob Stein, we've heard about in other contexts shortages of drugs. Are people ready to ramp up the manufacture of a drug like this?

STEIN: Yeah. That does not seem to be an issue, at least at this point. You never know, down the road. You know, companies can run into problems. But right now, the availability of this drug seems to be not an issue. And this has been a big selling drug for the company that makes it. So I'm sure they're prepared to fill whatever demand there might be for it.

CONAN: And that's a concern that some people have as well that these - should the FDA approve both of these - they will be money spinners for the companies that manufacture them.

STEIN: Yes, that's true. That's true. But I think the public health benefits seem to be pretty significant. And, you know, preventing an HIV infection and the illnesses it causes, that can save a lot of money.

CONAN: And, Dr. Fauci, before we let you go, this has to be - you spent your life doing this, professionally, this has to be a moment of great satisfaction.

FAUCI: Well, it's another step in the right direction. We've had a pretty good few years now with regard to prevention. Like last year, this whole concept of treatment as prevention, which I just mentioned a while ago on the show, where if you treat an infected person, you dramatically decrease their likelihood of transmitting their infection. Circumcision, mother-to-child transmission, proper use of condoms, there's an entire combination of prevention modalities.

So this is just another important incremental step in the pre-exposure prophylaxis and an incremental step in having a home-use kit to make a diagnosis so that you can implement some of these programs. So, yes, it's pretty nice to see these implement - incremental steps occur over a long period of time.

CONAN: Dr. Fauci, thanks always for your time.

FAUCI: Good to be here.

CONAN: Anthony Fauci, director of the NIH National Institute of Allergy and Infectious Diseases, with us from NIH headquarters in Bethesda, Maryland. Rob Stein, well, he's based right here in Washington, D.C., with NPR News. Rob, always nice to have with us today.

STEIN: Oh, nice being here.

CONAN: NPR science correspondent Rob Stein with us in Studio 3A. Coming up, we're going to be talking about a development from the Census Bureau today. For the first time, whites make up less than half of those born in the past year. What does that change? Give us a call, 800-989-8255. Stay with us. It's the TALK OF THE NATION from NPR News.

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