RAY SUAREZ: Now a two-part look at advances in AIDS medicine and the ethical and financial considerations that loom.
We begin with a major finding this week about preventing AIDS. I spoke with my guests yesterday.
RAY SUAREZ: For years, people with AIDS had taken a cocktail of medicines to treat the disease, but for the first time there’s new hope about using some of those drugs to prevent HIV.
A study published in “The New England Journal of Medicine” found that healthy gay men who took regular doses of a drug combination called Truvada reduced infections by more than 40 percent. Among men who took it every day, the pill was more than 90 percent effective in preventing them from contracting HIV. But the findings raise a number of questions, as well.
For more, we turn to two people closely following this, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which funded the study, and Chris Collins, the vice president of amfAR, the Foundation for AIDS Research.
And Dr. Fauci, 90 percent sounds like a pretty important breakthrough.
DR. ANTHONY FAUCI, NIH: Well, it is. The idea that you can give a drug that’s commonly used for the treatment of HIV to individuals who are risk because of behavior in certain respects, you can block that possibility of infection and decrease risks by a substantial amount, is really an important advance in giving us another potential tool in prevention.
And one of the things that we’re all emphasizing about this is that no one preventive intervention in and of itself should be considered in a vacuum. You have to do combinations of things, including consistent and correct use of condoms and decreasing the numbers of sexual partners.
But for the study as a concept, this is a very important advance.
RAY SUAREZ: Who was in the test group? Was it a group of people who were considered at high risk for contracting HIV?
ANTHONY FAUCI: They were men who had sex with men who put themselves intermittently at risk for HIV infection. The important aspect of the study that people need to appreciate is that it was a randomized, controlled study, double blind. They didn’t know if they got the drug or the placebo.
But there were 2,500 people in the trial, and they were equally divided into two groups, one of which got the Truvada and one of which got the placebo. But they were also educated equally about counseling for using condoms, decreasing the numbers of sexual partners, getting tested for HIV frequently, and treatment for other sexually transmitted diseases.
So, for all other things being equal, the two groups were essentially the same, except one got the drug and one got the placebo. That’s why the results are so compelling, because it was a randomized trial. But these were men who have sex with men.
RAY SUAREZ: Chris Collins, is it important that this wasn’t just a pill, but also, as Dr. Fauci mentions, a bunch of other interventions going on at the same time?
CHRIS COLLINS, The Foundation for AIDS Research: It’s very important to recognize that what the people in the study got was a package of interventions, including regular behavioral counseling and condoms, and they were encouraged to use those.
And as we move forward and take the next step between the demonstration projects to see how we can use PrEP in the field, we’ve got to keep that in mind, providing people with other behavioral interventions that we know work is going to be a critical part of making this work.
RAY SUAREZ: In the recent past, when there’s been this kind of a breakthrough, and we saw it with the morning after pill, there are those who say, well, I’m not really sure this is the kind of thing we want to find because it will encourage people to be irresponsible, because they’ll know there’s now a defense against it.
Is that a problem?
CHRIS COLLINS: Well, I think it’s something we need to be aware of.
People’s behavior may change. One thing to point out is that in the trial, people actually got safer in terms of their behavior over the life of the trial. So, we don’t see any initial worries there.
How that will play out if this were delivered in the real world is something we’re going to have to look at. That again is why I think one of the next steps, in addition to continuing with all the research trials we’re doing now, is demonstration project that can look at how do we deliver this as part of the package with behavior change messages and then monitor whether there is behavior change.
RAY SUAREZ: Dr. Fauci, what changes in medicine when you move it from being a treatment for a chronic condition as people taking antiretrovirals now, if they already are HIV positive use, to moving — to using it as preventive medicine?
DR. ANTHONY FAUCI, NIH: Well, there are a number of questions that come up, Ray, that are important. And I want to point out, just like when you are HIV infected, you should be taking these medications every day.
If you’re talking about adding this as a truly effective prevention modality, the study already has told us that when you are taking the pill, you should take the pill, because there was a discrepancy between what people reported taking the pill, and whether they did or not, and that’s the reason why the results of the decrease in risks varied.
If you look at the entire study, it was a 44 percent decrease in risk. If you looked at people who took it or said they took, 90 percent of the days when they were supposed to take it, the decrease in risk was
72 percent. If you looked at people who actually had blood levels versus no blood levels, the efficacy was 90 percent.
So, the first thing you have to do is make sure you take the drug. The other more policy-related issue is that if, in fact, after the demonstration projects and the analysis of the data and the discussion of whether or not this would be a feasible thing to actually recommend or make as part of the guidelines, if you look globally, people are going to ask the question: how can you be giving a drug to prevent infection in an individual who might be getting infected with HIV when we don’t even have the resources to treat people who are already infected?
And those kind of cost-benefit analysis are going to have to be done country to country because the situations will be very different in one country versus another, in the developing world versus the developed world.
So, although they’re the same drug used in essentially the same way, given every day, there are a lot of implications that go along with using it as prevention versus using it as treatment.
RAY SUAREZ: Well, let’s talk about cost, Chris Collins, because one quote as this at about $12,000 a year as a therapy. That’s an expensive drug regimen, isn’t it?
CHRIS COLLINS: Well, in the developing world already, it much, much cheaper because it’s available, it’s licensed for generic production. I think cost is absolutely something we need to be looking at. I think one thing to really keep in mind here, something that study is telling is that our investments in AIDS research are really paying off. And we now have the tools to really change the trajectory of this epidemic.
So, it’s important on a policy level to realize that even in tough budget times, tools like this used in combination can really bring HIV infections down.
The other thing we have to remember is, as Dr. Fauci was alluding to, there’s 10 million people in the world who should be on AIDS treatment right now and aren’t. And every year, there’s more than
2 million new infections. So, we have a long road ahead. But PrEP is going to be one important element probably in doing that. We need to find out how powerful it can be.
RAY SUAREZ: But, Dr. Fauci also brought up how you figure out to whom to give this drug. If it’s people who indulge in high risk behaviors, and it’s an expensive drug, isn’t it just cheaper to make them stop doing the high risk behaviors?
RAY COLLINS: Well, I think that we — it’s going to be different for every individual. One that’s clear is PrEP isn’t for everybody. As Dr. Fauci said, you know, we saw in the trial that many people didn’t use the study drug. Many people don’t want to take an ARV every day, and that makes sense particularly if you’re HIV un-infected.
So, what we need to do is think about who would really benefit from this most, who’s really at elevated risk, who may be in position not be able to insist on using a condom every time they have sex, who’s at elevated risk can benefit, who wants to be part of this? Because, again, not everybody will want to comply, who can we — you know, and I think in the beginning we’re going to need to be monitoring, how people use it, who can be involved in those kinds of projects where it can really follow the effect of using the drug.
RAY SUAREZ: And very quickly, Dr. Fauci, what has to happen between now and this becoming a readily available therapy?
ANTHONY FAUCI: Well, what will happen is that there will be intensive meetings with stakeholders, the CDC will get involved because they will likely be involved in making guidelines or recommendations, medical societies, constituency, individuals, community physicians, the FDA will have to get involved. And, in fact, if it does become a recommendation, Ray, that people use it under certain circumstances for prevention, then we’re going to have to see whether or not it will be paid for by insurance, just the same way that when people are infected and they get treated that their medications are paid for.
There are a lot of policy issues, and we’re going to see these unroll over the next weeks to months, and probably even longer. There’s a lot of good important discussions involving a lot of stakeholders that have to go on over the next several months.
RAY SUAREZ: Dr. Fauci and Chris Collins — gentlemen, thank you both.
RAY COLLINS: Thank you
ANTHONY FAUCI: Thank you.