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
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
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
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.
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
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
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
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
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?
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.