Kaiser Daily HIV/AIDS Report: Feb 16, 2001
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Opinion:
1. Oxfam, Doctors Without Borders Respond to Glaxo SmithKline CEO in
Continuing Drug Patent Dialogue [Feb 16, 2001]
"According to Jean-Pierre Garnier ... patents do not have the effect
of increasing prices," Phil Bloomer, head of advocacy for Oxfam In-
ternational, writes in a Guardian op-ed in response to an op-ed by
the GlaxoSmithKline CEO that appeared in the Guardian on Wednesday.
If this is so, "why until recently was his company selling the an-
tiAIDS drug Combivir in developing countries at twice the price of a
generic equivalent?," he continues. "Does Mr. Garnier believe the
central laws of economics (i.e. higher price produces less demand)
are suspended in markets for drugs?" Bloomer asks. "For poor house-
holds, the difference in price between patented and generic drugs is
often -- quite literally -- the difference between life and death,"
he writes. "As a global leader, Mr. Garnier recognizes that GSK has
global responsibilities. He has made welcome pledges to make GSK's
medicines more available to poor people," Bloomer continues, conclud-
ing, "We appeal to him to discharge those responsibilities in a posi-
tive way by withdrawing from the case against the South African gov-
ernment, and waiving patent claims on life-saving drugs in poor coun-
tries."
2. Question Not Whether, But How to Provide Drugs
Dr. Eric Goemaere of the Doctors Without Borders AIDS program in
South Africa writes that the argument that expensive AIDS drugs would
be a "misuse of a poor country's health resources" is not valid. "In-
stead of reducing the cost, western standards and prices have been
used to conclude that the 'developing world' isn't developed enough
for AIDS drugs," he states, adding that now that "international pub-
lic pressure has finally started to drive drug prices down, the in-
ternational community must start to look seriously at how we can
practically support the efforts of third world governments." Goemaere
concludes, "It is no longer morally acceptable to debate whether or
not antiretrovirals should be provided. We must concentrate now on
finding, quickly, ways to make sure they are" (Guardian, 2/15).
Science & Medicine:
3. Antiretroviral Therapy Still Effective in Patients Who Develop
Drug-Resistant Viruses, Study Says [Feb 16, 2001]
Patients harboring drug-resistant HIV strains may still benefit from
antiretroviral therapy, according to new research published in this
week's New England Journal of Medicine. The study, conducted by Uni-
versity of California-San Francisco researchers, indicates that muta-
tions that allow HIV to become resistant to standard antiretroviral
therapy may also reduce the virus' "fitness" -- its ability to repli-
cate and cause disease. The study involved HIV-positive male patients
who had drug-resistant HIV circulating in their blood for at least
one year. Sixteen of these patients were "randomly assigned to con-
tinue or discontinue antiretroviral therapy" -- 11 patients stopped
therapy and five continued therapy. The remaining seven patients were
enrolled in a non-randomized component, and all of them discontinued
therapy. Researchers each week measured viral loads, CD4+ cell counts
and level of drug resistance; viral fitness was measured at the be-
ginning of the study and 12 weeks after therapy was discontinued.
4. Drugs Keep Working in Face of Resistance
Researchers found that the five patients who continued antiretroviral
therapy had a median increase in viral load counts of 0.31 log copies
per milliliter, a median decrease in CD4+ cell counts of 15 cells per
cubic millimeter and maintained stable drug resistance levels. These
patients also exhibited "markedly reduced" viral fitness throughout
the study. Among the 18 patients who discontinued therapy, viral
loads increased and CD4+ cell counts decreased "immediately" after
therapy was stopped. This finding showed that the drugs "were exert-
ing a moderate antiviral effect against the resistant virus." In ad-
dition, eight weeks after therapy was discontinued, "drug susceptible
'wild-type'" virus emerged among study subjects, and replicated at
"much higher levels" than the drug-resistant virus. Researchers found
that as the wild-type virus emerged in patients' blood, CD4+ cell
counts decreased "dramatically," and several patients developed
clinical disease "soon after treatment was discontinued." Lead study
investigator Dr. Steven Deeks, UCSF assistant professor of medicine
in the Positive Health Program at San Francisco General Medical Cen-
ter, said, "The observation that antiretroviral therapy can select
for a poorly fit virus has important clinical implications. Many pa-
tients with drug-resistant virus will likely continue to benefit from
therapy for several years after the emergence of a drug-resistant vi-
rus. Hopefully these patients will remain stable until drugs that are
able to suppress resistant virus become available."
5. Drug-Resistant Virus in Hiding
Researchers also measured drug-resistant viral levels in cellular
reservoirs from nine patients, and were able to detect resistant vi-
rus in five of these patients "long after resistant virus could no
longer be detected using standard tests." Deeks said of this finding,
"Based on these observations, we believe that drug-resistant virus
will re-emerge once therapy is restarted. This suggests that for pa-
tients with drug resistant virus, a strategy of stopping therapy, al-
lowing drug susceptible virus to re-emerge, and then restarting ther-
apy may not necessarily give them a second chance" (UCSF release,
2/13). The study concludes, "Although the long term clinical implica-
tions of our findings remain to be determined, continued treatment
with a regimen containing protease inhibitors in patients with lim-
ited therapeutic options may be associated with sustained clinical
benefit" (New England Journal of Medicine, 2/15).
6. A Temporary Impairment of Viral Fitness?
An accompanying NEJM editorial states, "[W]e believe that the benefit
of continued drug therapy in patients with drug-resistant viruses may
in large measure be due to the continued suppression of drug-
sensitive viruses, as well as to the appreciable time required for
the selection of drug-resistant viruses that are as pathogenic as the
drug-sensitive viruses." The editorial notes that the "slow but con-
sistent increase in the viral load and decrease in the CD4+ cell
count observed by Deeks et al. in the small group of patients who
continued therapy suggest that viral adaptation is indeed continu-
ing," speculating that "although it is certainly true that drug re-
sistance develops at a cost to viral fitness, the impairment in viral
replication may be temporary." The NEJM editorial concludes, "The
strategy of continuing treatment despite the ongoing replication and
selection of drug-resistant variants will need to be compared with
other strategies, such as those aimed at detecting drug resistance
early, at a time when a change of therapy might suppress replication
to an undetectable level" (Frankel/Mullins, NEJM, 2/15).
The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org,
a free service of The Henry J. Kaiser Family Foundation, by National
Journal Group Inc. c 2001 by National Journal Group Inc. and Kaiser
Family Foundation. All rights reserved Please contact
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