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AIDS PROGRESS REPORT

January 27, 1997

TRANSCRIPT

Margaret Warner looks at the latest progress in the fight against AIDS.

MARGARET WARNER: Are scientists on the verge of making AIDS a manageable disease? There was positive news on that issue but some caution too at the fourth Annual Conference on Retro-viruses and Opportunistic Infections that ended in Washington yesterday. Last year's conference had reported dramatic advances in treating the disease using a new class of drugs called protease inhibitors. For an assessment of the latest developments we turn to Dr. Anthony Fauci, Director of the National Institute of Allergy & Infectious Diseases, and reporter Laurie Garrett of "Newsday." She's followed the AIDS epidemic from the beginning and wrote a book about infectious diseases called "The Coming Plague." Welcome, both of you.

DR. ANTHONY FAUCI, National Institute of Allergy & Infectious Diseases: Good to be here.

MARGARET WARNER: And Dr. Fauci, starting with you, what do you think has been the most important progress in fighting the disease that's been made in the last year?

DR. ANTHONY FAUCI: Well, in the last year we've taken that next step. Last year at this time it was shown that these combinations of drugs, including protease inhibitors, could drop the level of virus in the blood to below detectable levels. That has been sustained in a proportion of patients--not all patients by any means. Now, for a year, a year later, we're starting to look at the lymphoid tissue, or what we would consider the sanctuaries or hiding places and reservoirs for the virus. And what has been found is that the level of virus replication in many, not all of these--

MARGARET WARNER: Explain that--level of virus replication.

DR. ANTHONY FAUCI: Virus replication means the virus's ability to reproduce itself is markedly depressed, if not absent; however, there are remnants of the virus there. If you look at the virus's gene that inserts itself into the cell, in many of the cells it's still there. What we don't know is whether or not it is able to be reborn, as it were, to start replicating again. The hope is that if you continue the therapy for a period of time, over a period of time, those cells will actually, themselves, die off. So there's virus that's still there. The proof of the pudding will always be when you stop the therapy, will the virus then come back? There are people that have had the therapy, stopped in them for one or another reason, and we've seen the virus come back, which means in the short range we still haven't had enough time to be able to completely suppress it without it coming back. It's good news though, good news.

MARGARET WARNER: And, Laurie Garrett, based on the past year's clinical experience, is a consensus emerging about when to use these drugs, with which patients, at what stage in the disease?

LAURIE GARRETT, Newsday: I wouldn't say a consensus but certainly at this meeting the overwhelming message I came away with was the earlier you start, the better, and if you have never taken any of the anti-HIV drugs before, your chances of having a powerful response to a combination of three or more of these drugs are far better than the odds for people who have already tried and failed AZT, already tried and failed--

MARGARET WARNER: That being one of the older anti-AIDS drugs.

LAURIE GARRETT: --EDI--yeah. These are all, you know, various drugs that are out there, and I should say, though, that there are some patients that have been described at this meeting and at a few previous meetings in the last couple of months who had as many, you know, tens of billions of viruses in their bodies, from the highest viral load, as it's called, count that one could imagine, and when they've gone on these triple combination therapies, their virus levels have gone down to below the limits of what current technology can detect, which the best current technology detects down to the level of 20 viruses were milliliter, or tiny droplet of blood.

MARGARET WARNER: That's amazing. And when you say go in early right away with this full treatment, are you talking about when someone is diagnosed with HIV positive, or do you wait till they have full blown AIDS?

LAURIE GARRETT: Well, I can only tell you what the scientists are saying and what the physicians are saying. And all the evidence seems to indicate that your immune system, your own body's ability to fight off disease and fight off this virus really severely deteriorate quickly, and that after the sixth month point of infection--

MARGARET WARNER: And you're talking about just HIV?

LAURIE GARRETT: Right. Long before most people have any idea they're infected. After that six-month point you've already got some pretty serious damage, irreparable damage, as far as we can tell at this point, done to your immune system. So if you can get in there and treat before that damage occurs, logic dictates you're going to have a better response.

MARGARET WARNER: All right. So, Dr. Fauci, are we at the point or what stands between getting to the point of calling this say a manageable disease, something like say diabetes, which someone may have to stay on treatment all their lives, but they can live with it?

DR. ANTHONY FAUCI: Well, you know, we don't know that right now. We know in the short run that it appears that we're getting towards that point of making it manageable. We certainly are able to manage patients better by our ability to decrease that virus very, very low, sometimes to below detectable level. We know there's a correlation between the level of virus and the prognosis of a person, so it makes sense by extrapolation that if you bring it down as low as possible, the person will do better. What we don't know is in the long range whether the other confounding issues, like cumulative toxicities or the emergence of resistance might overcome that positive beneficial effect. We think not, but we can't say right now in the beginning of 1997 what the long-term and the long-range clinical benefits would be. Were we to predict, it looks good because of that correlation between virus and prognosis, but our experiences with viruses, particularly with this virus, causes us to be optimistic but very cautiously optimistic. The ball game is certainly not over yet.

MARGARET WARNER: And what does it cost for a patient to be on this?

DR. ANTHONY FAUCI: Well, it's quite expensive. If you talk about a standard--and it varies by a few thousand dollars, depending on the drug--the standard triple combination, it's anywhere between fifteen and twenty thousand dollars, if you consider the protease inhibitors plus two of the standard first generation drugs. And then you add on to that the other drugs that some patients who have very suppressed immune systems need to be on to prevent the occurrence of the complicating infections, you put that altogether, it becomes a very expensive proposition, usually above $20,000 a year.

MARGARET WARNER: So, Laurie Garrett, how are patients that are taking these, how are they paying for this?

LAURIE GARRETT: With great difficulty, unless they have excellent insurance or they live in a state that has state-subsidized access to the drugs, and certainly many people who ought to be on these drugs aren't on them, if you follow the current logic. I think one of the most shocking little factoids I heard in the whole meeting came from Dr. Peter Piat, who's head of the United Nations' global effort to control AIDS. He noted that current costs, the costs that Dr. Fauci just described, are 5,000 times the per capita annual spending on all health care combined for the nation of Zimbabwe, where the HIV rate is so high that 40 percent of all the women of pregnancy age, child-bearing age, are already infected. So you can see that we have a tremendous skewing occurring globally. In the wealthy countries where HIV rates are comparatively low it's already a burden to try and pay for this.

In the poor countries, it's impossible. But there is one positive note, and, again, it's only relevant to the wealthy countries of the world. There were several papers presented at this meeting where they attempted to compare on the one hand this horrendous cost for the drug, but on the other hand the savings that you may accrue in hospitalization and acute care costs because the drugs are keeping people from having to be hospitalized. And the most striking such study I saw came from Northern France, where they compared hospitals that aggressively promote triple combination protease inhibitor therapy to their patients to ones that don't, and found that the aggressive hospitals are saving a quarter of a million dollars a month on average in hospitalization costs over and above the costs of the drugs, while the hospitals that haven't been promoting these combination therapies are losing a hundred thousand a month.

MARGARET WARNER: So, in other words, it was really cost efficient to go ahead for the hospitals, pay for these drugs, because they were going to make it back.

LAURIE GARRETT: Indeed, the government of France pays for everybody's drugs.

MARGARET WARNER: Do you see the costs coming down anytime soon, Dr. Fauci, here?

DR. ANTHONY FAUCI: No. It's very tough to say. The good thing about the protease inhibitor is that unlike the situation that we had very early on in the epidemic, where you had one drug and only one drug for several years, there are--we have three already approved--one that's in expanded access and a few more coming along. Whenever you have a situation where you have more than one company who's making a drug of the same class, there's that internal among the companies competition that would hopefully drive the cost down.

MARGARET WARNER: The good old market.

DR. ANTHONY FAUCI: I hope so, right.

MARGARET WARNER: And Laurie Garrett, what's been the practical effect of the use of these drugs, that is, on death rates? I saw that New York City's death rate dropped from AIDS 30 percent last year. Is that elsewhere? What about infection rates?

LAURIE GARRETT: Well, let's back up a second. I don't think there's any evidence that anyone would argue the drop--the very striking drop in AIDS deaths in New York City is due to protease inhibitors, and these drug combinations, because it preceded the availability of these drugs; it's due to other factors having to do with congressional support for a variety of medical care access programs for people who don't have health insurance and can't qualify for Medicaid, but we are seeing a dramatic decrease in hospitalization in all the major cities that have large populations of people with HIV disease. And that's clearly very powerful. I think--

MARGARET WARNER: Yet, you think that is, you can tie that to the drugs?

DR. ANTHONY FAUCI: You can tie it to the combinations drug. What Laurie is saying that the proteases weren't readily available when the trend--the protease inhibitors--when the trend started, but prior to that and for a considerable period of time, the concept of combination therapies were in vogue then, so it was a combination, as Laurie said, not only of having drugs that we use in combination, even though we just anti-dated the protease inhibitor availability, but it was the ability to get access to the people of New York City because the Ryan White funds were increased greatly from one year to the other. So people who the previous year wouldn't have been able to afford drugs now had the ability to pay for the drugs.

LAURIE GARRETT: Margaret, I think that points up a crucial point here. What I came away hearing from most of the physicians who were at this meeting and the physicians I deal with here in New York City and the patient population I deal with is that we've reached the stage where the real obstacles day to day have less to do with biology in conquering this problem than with the sort of social context, the economic context of people's lives. These drugs are not easy to take, and let's not make this sound like this as cough syrup. This stuff is tough to tolerate. There are a lot of side effects. You have to take them on special schedules, some with food of certain kinds, some without food of certain kinds. One of the drugs requires a massive amount of water in order to avoid kidney stones. We can go on and on and on. Some of them have to be taken on scheduled that would interfere with people's work lives.

MARGARET WARNER: We're just about out of time but go, just finish.

LAURIE GARRETT: Well, the point is that the real barriers are social barriers, getting them out for the people who need them, get people in early to get tested, and finding ways to make it easier for people to tolerate and take these drugs.

MARGARET WARNER: All right. Well, Laurie Garrett and Dr. Fauci, thank you both very much.

DR. ANTHONY FAUCI: Good to be here.

LAURIE GARRETT: Thank you.


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