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An NIH panel charged with setting guidelines fo r HIV treatment
seeks to chart a course fo r doctors patients and policymakers
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monitoring the effect of new therapies on the
he National Institutes of Health Panel
virus in clinical practice. The commercially avail­
to Define Principles of Therapy of
able Amplicor test by Roche is sensitive down to
HIV Infection met in an exhaustive
400-500 copies of the virus. The next generation
public meeting Nov. 13-14 in Wash­
will push the level of detection down to about 20-
ington, D.C. The 24-member group of
25 copies;
clinicians, researchers and activists is chaired
by it should be available in 1997.
Roche’s Steven Herman, Ph.D., warned against
Charles Carpenter, M.D. Their recommendations
fixating
on individual numbers, particularly at the
on how to use the new array of drugs is expected
low threshold of accuracy of the viral load test.
to be published in January.
Changes in the 5,000-10,000 range “are really the
‘noise’ and variations of labs.” What is signifi­
apping the rontiers
cant is a three- to five-fold increase in viral levels
that is sustained over time.
David Ho, M.D., of the Aaron Diamond Insti­
John Mellors, M.D., of the University of Pitts­
tute, said that the half-life of viremia, or viral
burgh Medical Center, compared HIV to menin­
presence in the blood, is only about six hours. He
gitis, where conditions can change radically in
outlined the “rapid decay of viremia during the first
10 days of therapy, then a much slower decay in the just a few hours. With changes in HIV viral loads,
he said, “nothing is going to happen overnight, in
second phase.” That suggests the virus is largely
two weeks, or in two months. We can monitor and
cleared from blood during the first phase of therapy
intervene over time.”
and only more slowly from other reservoirs of
infection, primarily lymphoid tissue.
Ashley Haase, M.D., of the University of Min­
esistance and ompliance
nesota, noted that triple combination therapy has
Emilio Emini, Ph.D., of Merck Research Labo­
had a “dramatic impact” on HIV in lymph nodes.
ratory, warned, “HIV is genetically unforgiving.
But at least six months after therapy reduced plasma
Once resistance begins to occur, there is no going
viral load below a detectable level, he still “found
back.” He expressed worries about patients’ fail­
residue of the virus in lymphoid tissue.”
ure to comply with the strict
“There are stages of infection
dosing pattern of protease in­
when it might be more profitable
hibitors, which could lead to the
to intervene,” says Haase, add­
mutation of viral strains resis­
ing that the “reservoir at early
tant to those drugs.
infection is smaller.” He joined
But panel chairman Carpen­
with Ho in suggesting “a ratio­
ter and others in clinical practice
nale for early intervention.”
believe compliance is often tied
Joseph Margolick, M.D., of
to results. He used the example
Johns Hopkins University, talked
of AZT, where compliance has
of the “inflection point” where a
been a problem primarily when
rapid decline in CD4 cells oc­
the patient has felt that the drug
curs, which generally leads about
was not working for him or her.
a year later to an AIDS-defining
People who see results continue
condition. He says there is “evi­
to take a drug on schedule.
dence of emergence of new viral strains around
That led panel member Valerie Stone, M.D.,
the inflection point” in at least half the patients
of Brown University School of Medicine, to sug­
that researchers examined. But it is unclear whether
gest that the panel will have to include “quality-
viral mutations overwhelm the immune system or
of-life issues” when formulating its recommen­
the system collapses and viral strains emerge that
dations. “For those who walk in feeling relatively
had been suppressed.
well, it is difficult to convince them to take 17 pills
Janis Giorgi, Ph.D., of the UCLA School of
a day.”
Medicine, discussed a fairly recent discovery
Activist Mark Harrington is policy director of
concerning the telomers of CD4 cells. Telomers
the
New York-based Treatment Action Group and
are the multiply-repeated end patterns of chromo­
a member of the NIH panel. He believes that the
somes that sequence the other genes in cell repli­
cation. Telomers become shorter with age, thus
panel’s recommendations will include “use of
inhibiting the cell’s ability to replicate, whereas
viral load tests as a routine part of clinical manage­
in cancer cells they become longer and hence
ment, and that protease inhibitors should be a part
of the regimen.”
“immortal,” replicating wildly.
The telomers of CD4 cells in people with
But he cautioned, “It still may be an appropri­
advanced HIV infection “reached the same length
ate response for people who are healthy to wait for
as those [which] are very old.” That suggests they
more drugs or for more research to come out.” In
have undergone accelerated replication in fight­
light of potential problems of viral mutation and
ing the virus, have rapidly aged, and have ex­
drug resistance, he said, "people might want to
hausted much of their ability to further replicate to
wait until they are really sure that they want to
fight disease.
make a treatment decision and adhere to a very
Giorgi argued for early treatment, perhaps
complicated regimen.”
even “during the period before the immune re­
Gary Rose, treatment lobbyist with the AIDS
sponse develops.” She believes that the immune
Action Council, sees “the argument for resources
system shows some ability to rebound and even
becoming easier” with the establishment of these
expel subsets of CD4 and CD8 cells that have
guidelines. “It becomes easier to say you have to
been depleted. But that requires suppressing the
have this early intervention Medicaid program
virus for at least six months. It becomes much
because you have these standards.”
more difficult to restore the cells’ subsets when
Harrington concurs: “We hope this will lead to
the CD4 level falls below 50.
more appropriate coverage” by third-party pay­
ers. “All health care programs should pay for
what is the best and most beneficial treatment
iral oad ests
regimen.”
• • • » «
Viral load tests have become indispensable in
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