E-DRUG: ARV drug holidays?
-----------------------------------
[One week on, one week off? If this research is confirmed in bigger
groups, it could
be an important breakthrough for developing countries, especially if
we get access to
the three-in-one tablets which can be taken twice daily (in the
morning and evening).
But, don't try this at home (yet)! AP message and NIAID report. Copied
as fair use. NN]
http://www.nytimes.com/aponline/health/AP-AIDS-Drug-Timing.html
December 4, 2001
Study: Cycling Drugs May Curb AIDS
By THE ASSOCIATED PRESS
WASHINGTON (AP) -- It may be possible for AIDS patients on a powerful
drug combination to take weeklong medication vacations and still
control
HIV, while cutting costs by half and reducing serious side effects, a
study
suggests. Federal researchers, whose findings appeared Tuesday in the
Proceedings of the National Academy of Sciences, said a small group of
patients in their study was able to successfully follow a drug regimen
of
one week on and one week off the antiretroviral medications. ``If
further
studies bear out what we've seen so far, it will mean that you can
reduce
the cost of therapy by 50 percent,'' said Dr. Mark Dybul, a clinical
researcher at the National Institute of Allergy and Infectious
Diseases,
which is one of the National Institutes of Health. He said the study
also
suggests the on-again, off-again approach may lower the toxicity of
the
drugs enough to give ``a dramatic improvement in a patient's quality
of life.''
This effect is less certain than is the reduction in costs, said
Dybul, ``but it
is very promising.'' International AIDS experts said if the
intermittent drug
therapy approach proves successful in studies with more patients, it
could
have a dramatic effect on the HIV epidemic in third world countries,
where
the expense of the drugs often prevents patients from being treated.
Jose
M. Zuniga, president of the International Association of Physicians in
AIDS
Care, said that results of the NIAID study ``are extremely
encouraging'' and
should be expanded into studies involving many more patients. ``They
merit
increased studies because of the potential revolution of this type of
medical
management'' in countries with limited resources, said Zuniga, whose
organization represents 10,800 doctors and health care workers in 83
countries. ``This is a very welcome development,'' said Hans P.
Binswanger
of the World Bank. He said international agreements have helped reduce
the cost of HIV drugs in some African countries to about $500 per
patient,
per year, but even this is too much for many patients. By cutting the
cost
in half, Binswanger said, many more patients would be able to receive
the
drugs. Dr. Jeffrey Laurence of the American Foundation for AIDS
Research
said the study is ``good news'' for the AIDS community, but cautioned
that
the cycling therapy has only been used experimentally in a small group
of
select patients. He said it should not be followed by the 1 million
Americans infected with HIV except under the direction of a doctor in
a
controlled trial. ``I don't recommend that patients try this at
home,'' said
Laurence. Dybul agreed, noting that it will take a much larger
clinical trial to
prove that the intermittent therapy is appropriate and safe for all
HIV
patients. In the study, Dybul and his NIAID colleagues selected 10 HIV
patients whose disease was being controlled by highly active
antiretroviral
therapy, or HAART. This involves a rigid daily schedule of taking a
cocktail
of drugs which inhibit the reproduction in their bodies of the HIV
virus. The
drugs were working well in all the selected patients -- the level of
virus in
their blood was depressed, while the number of CD4 cells in their
blood
was at a good level. CD4 cells, which are crucial to a healthy immune
system, are the main targets of the HIV virus and can quickly become
depleted by the infection. Dybul said the 10 patients were put into a
program where they took the drugs as before for seven days and then
stopped for seven days. The experiment continued for up to 88 weeks.
Blood tests showed the virus infection continued to be suppressed in
all the
patients who maintained the schedule, he said. Two patients were
dropped
from the study because they failed to take their drugs as required,
said
Dybul. As for side effects, Dybul said cholesterol levels in the
patients
dropped by an average of 22 percent, while triglyceride levels were
halved.
High cholesterol and triglyceride levels, along with a shift of fat
deposits in
the body, is a major side effect of the HIV therapy. Some patients
develop
thick fat pads in the back and around the abdomen. Other side effects
include diabetes, hepatitis and lethal levels in the blood of lactate
acid.
Learning how to combat these side effects and lower the drug cost are
important, said Dybul, because it is clear that the current group of
antiviral
drugs can control HIV infection, but not cure the virus. Once the
drugs are
halted for more than a week, the infection can come roaring back, he
said.
``This means that these patients will be on the drugs for the rest of
their
lives,'' said Dybul. As a result, he said, researchers are trying to
find ways
to maintain the good effects of the drugs, while eliminating the toxic
effects
and lowering the costs.