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AIDS Treatment News

Combination Treatment and Single Drugs: Interview with




 

AIDS Treatment News Issue #227, July 21, 1995

In Part I of this interview, in AIDS TREATMENT NEWS #226, Dr. Poscher discussed treatment strategies, including her use of combination antiretrovirals, and the role of acyclovir, ganciclovir, and some other treatments. That interview is continued, below.

AZT Plus 3TC Possible Side Effects ATN: I heard about one case -- and then I heard this morning that six cases were known -- of someone's viral load going down on treatment with AZT plus 3TC, but their total lymphocyte counts also going down, sometimes as much as 50 percent, although then they tend to rise again over the next several months. Often the CD4 and CD8 counts stay about the same, or decline only slightly. This is mostly in people who start with a very low CD4 count.

Dr. Poscher: I haven't noticed that, so I cannot comment on it. We have quite a few patients on that combination. The complication we have seen with AZT plus 3TC -- and others have often not seen, so we tell them to watch out for it -- is anemia, and it comes on very quickly. All of these patients have had very low CD4 counts, way less than 50; and they have been on the anemic side anyway, with 11 or so hemoglobin. But then they will drop down to six or seven hemoglobin in less than a month.

ATN: Do you have to discontinue the drugs? Poscher: You have to stop. I have not been able to maintain anybody with anemia on AZT plus 3TC, even with Procrit (erythropoietin) and transfusions. I'm switching these people to d4T plus 3TC, and they are doing fine.

Sudden CD4 Drop ATN: We often get calls from someone who has never been on treatment, but they have had a big, sudden drop in CD4, going down as much as half or so in a few months. What treatments do you consider for people in that situation? Dr. Poscher: It would be interesting to know what their viral load was. If they have never been on any antiretroviral, and they have been HIV-infected for a long time, then if their viral load was very high, around 500,000 or a million, I would use the triple combination AZT plus 3TC plus ddI, if at all possible. If they had only a moderate viral load, I would use AZT plus 3TC. If their CD4 count is not below 100, unfortunately, they will have trouble getting 3TC, until it's approved (because the expanded-access program is now limited to those under 100, due to limited supply of the drug). Glaxo could have facilitated expanded access for sicker patients, without cutting it off completely for those over 100. But hopefully the drug will be approved this summer, and we will not have to deal with this problem any more.

Approval; Reimbursement; Expanded Access ATN: I heard that Glaxo Wellcome will ask the FDA to approve 3TC for initial therapy in combination with AZT, for people with CD4 counts all the way from zero to 500. [Since the interview was conducted, the company has applied for this indication.] Dr. Poscher: I also heard that they might manufacture a single capsule with both drugs together. I think this combination will be the initial treatment. Then if the patient breaks through on AZT plus 3TC, the standard will probably be to add a protease to it.

ATN: For getting combination treatments paid for, what has worked and what hasn't, in your experience? Dr. Poscher: We have not had a problem. I have not yet had a patient whose insurance company refused to pay for combination therapy. And we deal with all kinds of insurance companies here -- about every HMO, and Medicare, and Medi-Cal (Medicaid).

There are a few HMOs who strictly regulate combination antivirals. But usually with a letter from the physician, documenting medical necessity, that can be overcome.

3TC is a problem. I see patients as a consultant, whose personal physicians are not part of the expanded access program, who do not want to deal with that. It is true of all these parallel-track programs. The one for growth hormone is a pain. The oral ganciclovir prophylaxis program is a big inconvenience for physicians offices. So a number of patients have trouble accessing these drugs, because the physicians they are going to are not willing to provide the staff to get these drugs for their patients. And it's hard to blame them; I have a full-time nurse who deals with growth hormone, 3TC, etc. It is a full-time job, and not every office has the volume of patients to support that.

Managed Care ATN: Concerning managed care, how do you get around the problem that many managed-care systems only want to deal with large practices, and are not interested in providing good care for AIDS, cancer, and other expensive diseases, because they do not want to attract those patients.

Dr. Poscher: Managed care is going to be a big problem for people with HIV. It's only just beginning; we are only seeing the tip of the iceberg. I see it now in my role at the University of California; I am the director of HIV managed care at Mt. Zion hospital. The University could lose a lot of money if it provides certain laboratory tests for patients; the same is true of any other managed medical group. They are being given a certain amount of money to take care of people with HIV; and if it costs more to take care of those patients, they lose money. So the outcome, eventually, is that they will make it cost less. This means, for example, that viral RNA studies will not get done for people with managed-care insurance. If a medical group can save a million dollars a year and turn that into profit, they would rather do that.

I see that happening -- and I also see patients choosing managed care insurance, when their employer offers them a choice of health coverage. They see $5 co-pay, free prescriptions, etc.; it looks appealing that they will not have to pay 20 percent, they will not have a deductible. It looks terrific. But the problem is that when they get sick, they will not be able to get the care they need. I have patients now for whom I want to get a viral load test. But because of their insurance, they cannot get that test, unless they are willing to pay $200 out of pocket, which is abhorrent.

That is one example of things to come. If growth hormone is approved, the companies will not want to pay for it. TPN (total parenteral nutrition) will become too expensive; if a patient has cryptosporidium and needs to have TPN as a lifeline, it will be not indicated because the patient is terminally ill. It will be like Oregon, where care will be rationed; but there will be no policy coming from a higher power dictating the rationing. It will come from financial decision-making within medical groups.

ATN: How have you been able to get combination treatments paid for so far? Dr. Poscher: So far the HMOs have been willing to pay. The money used to pay for hospital care, or doctors' visits, or home infusion therapies, is one pool; the money for prescription drugs is another pool. The people minding that pool are mainly looking for certain expensive drugs like itraconazole, or fluconazole, or erythropoietin, or Neupogen. There are certain trigger drugs that are carefully controlled; you have to jump through hoops of fire to get your patients on them. How do you do it? You sit on the phone for an hour, you call the utilization review person, then you have to write a letter, and send copies of lab work. Then several days later, your patient has erythropoietin. You're persistent, that's how you do it. Sometimes I have to call the medical director of the insurance company, and talk doctor to doctor, and explain the situation, that this is what the patient needs. It takes a lot of time. People don't realize this when they check off the HMO (health maintenance organization), instead of a PPO (preferred provider organization). There is a big difference between those two in what you will be able to get.

ATN: What about G-CSF (Neupogen) for treating neutropenia in HIV disease, as opposed to other neutropenia. Is it a problem getting that paid for? Dr. Poscher: It used to be a big problem. It's getting much easier now, as it becomes more accepted. Several years ago, if somebody became neutropenic from ganciclovir, you had to switch them to foscarnet. Now it is totally accepted to use G-CSF. Even though it is not FDA-approved for that indication, because everybody uses it that way, the insurance company pays for it. But they are very strict about it. If the patient's neutrophil count goes above 1,000 once, they will cut off the G-CSF; you have to hold it, get their count back below 500, and then send a copy of the lab slip, and they will authorize it again. It's a pain; and it increases the administrative load, and administrative cost. We have a full-time person just doing authorizations.

Today I had a patient who was lost to followup for six months. Meantime, his insurance changed; there are now only five doctors in the city he can see. He asked me which doctor he should choose; he read me the names, and I told him I didn't know. He told me he cannot breathe, he is coughing, he has a fever; he thought he needed to see a doctor. I told him he certainly did. He had had no pneumocystis prophylaxis, though his last CD4 count, in January, was 200; no one put him on prophylaxis. Fortunately his insurance did have the option to see any physician, with payment of a substantial fee. We did his X-ray and blood work; he probably has pneumocystis. I was ready to start treating him here, but his insurance company said no, he had to go to an in-plan provider. But nobody on that list was set up for outpatient treatment of pneumocystis. So we had to admit him to the hospital; he could easily have been treated as an outpatient [at far less expense]. But the doctors who are part of that plan don't do that; they see maybe two HIV patients a year.

If people could just go where they wanted to go, patients would generally get to the right people. They usually can choose the right provider. And when they are restricted, it can cost the system a lot more money, if they are not getting the right attention to their needs.

ATN: One expert recently was quoted as saying that managed care saves money because it doesn't pay for medical education. And it doesn't pay for research, or help with the care of the indigent.

Dr. Poscher: Exactly.

Use of Combinations ATN: For this article, I asked around for people to recommend doctors who have much experience with triple combination therapies. And the same few names keep coming up. So it seems that not many physicians are using the aggressive combination treatments.

Dr. Poscher: I would agree. Because of my role at Mt. Zion, I watch the care of many patients. The average internist who is taking care of people with HIV is not doing any combination therapy. They are barely doing what I consider to be minimal standard therapy. Many patients are not on antiretrovirals; and those who are, are either on AZT monotherapy, or on ddC monotherapy. There is lots of ddC monotherapy, which I think is useless. It is because many physicians do not want to get involved in the 3TC expanded-access program, because of the paperwork. And when general internists have only ten or twenty AIDS patients, it is hard for them to keep up with what is going on in the world of AIDS. They fall behind, even though they may be excellent physicians, and their patients suffer because of it, they are not getting state of the art care.

ATN: You mentioned triple combination treatments. One person's CD4 count went from 70 to about 500, with AZT plus 3TC plus ddC; he was also taking acyclovir.

Dr. Poscher: Was he treatment naive? ATN: Yes.

Dr. Poscher: You can see that with naive patients. I know a patient who had a similar experience with AZT plus 3TC plus ddI. He went down to the mid hundreds, and went on triple therapy, full dose with all three from day one. His T-cell count went way up, and he is doing great.

ATN: Do you have patients on triple combination therapy who were not naive, who had been on AZT already? Dr. Poscher: I have a couple such patients. The rise in CD4 is not fantastic, it is OK. One patient had dipped to 175, and got back up to 325 for about a month, and is hovering around 250 now. But his viral load dropped, almost a log.

ATN: Do you have any final comments? Dr. Poscher: More drugs and different classes of drugs (especially protease inhibitors) are close to becoming available. These will increase treatment options, improving combination therapy and hopefully increasing survival.



 


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Information in this article was accurate in July 21, 1995. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.