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News
Briefs
by
Enid Vázquez
Subjects:
Expanded access
for kids
Neuropathy
drug
Agenerase warning
Vaginal thrush
Children’s immune response
HIV drugs and diabetes
Transgender TB
Bottled water
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Expanded access for kids
The liquid formula of Sustiva
(efavirenz) non-nucleoside analog is now available through
an expanded access program for HIV positive children and adolescents
(ages 3 to16). The clear, strawberry/mint-flavored solution
is taken once daily with or without food. Children have the
same side effects as adults (primarily in the central nervous
system), but experience more rash (40% in pediatric trial).
Children also experienced diarrhea/loose stools (39%), fever
(26%), cough (25%) and nausea/vomiting (16%). For more information,
call (800) 334-4486 or visit www.sustiva.com.
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Neuropathy drug
The AIDS Clinical Trials
Group (ACTG) reported improvement in pain from HIV-related
peripheral neuropathy with injections of recombinant human
nerve growth factor (rhNGF). Peripheral neuropathy, damage
to the nerves of the hands and feet, frequently begins as
numbness or a sense of pins-and-needles, but then commonly
becomes painful and permanently disabling. In a March Neurology
report, the researchers noted that after 18 weeks of treatment,
“17% of placebo recipients rated their neuropathy as
‘improved’ or ‘much improved’ compared
to 33% of lower dose and 36% of higher dose patients.”
Current treatments for peripheral neuropathy are generally
hit-and-miss, and sufferers are hard pressed to find relief.
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Agenerase warning
Because of the potential
for toxicity due to its content of propylene glycol, the liquid
formula of Agenerase (amprenavir) protease inhibitor should
not be used by infants and children, pregnant women, people
with liver or kidney failure, and people who take Antabuse
or metronidazole (including Flagyl), according to a new drug
warning on the package insert. Signs of toxicity include seizures,
stupor, tachycardia (rapid heart beat), hyperosmolality (an
abnormally acute sense of smell), lactic acidosis, renal toxicity,
and hemolysis (loss of red blood cells). Alcohol should be
avoided during dosing. The manufacturer also reported that,
“Certain ethnic populations (Asians, Eskimos, Native
Americans) and women may be at increased risk of propylene
glycol-associated adverse events due to diminished ability
to metabolize propylene glycol; no data are available on propylene
glycol metabolism in these groups.” The warning does
not apply to Agenerase capsules. For more information, visit
www.fda.gov/medwatch/safety/2000/agener.pdf
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Vaginal thrush
Both clotrimazole (Lotrimin
or Mycelex) antifungal tablets and lactobacillus acidophilus
gelatin capsules reduced outbreaks of vaginal candidiasis
by half, according to a conference abstract (summary) presented
earlier this year. “This demonstrates that simple topical
vaginal prophylaxis may be effective in preventing yeast infections
and may be associated with a lower risk of fluconazole [Diflucan]
resistance than systemic prophylaxis [prevention therapy],”
noted Dr. Jean R. Anderson in The Hopkins HIV Report for May
2000. Visit http://www.aegis.org/pubs/jhopkins.
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Children’s immune
response
A small study of 25
HIV positive children taking antiviral drugs for the first
time found a 3-log drop in viral load (for example, from 100,000
to 1,000) for up to a year on Viracept (nelfinavir) protease
inhibitor with two nucleoside analogs. Their CD4 percentage
also doubled. The researchers reported better immune system
restoration with the children than is seen in adults. The
study was published in The Lancet.
In a separate study
from the Children’s Hospital of Philadelphia, researchers
also reported a better immune response from youngsters, this
time adolescents on strong HIV drug combinations. In a press
release, the hospital reported that researchers “found
an unexpectedly higher number of CD8 naive T-lymphocytes in
adolescents who had been infected with HIV, compared to uninfected
adolescents.” Naive T-lymphocytes are cells that have
not been previously exposed to invading microorganisms, including
HIV. ‘The high levels of naive CD8 cells that we found
suggests that these cells may be capable of mounting an immune
response,’ said the study’s lead author, Steven
D. Douglas, M.D., Chief of Immunology at Children’s Hospital,
who added, ‘CD8 cells are major players in killing the
virus.’ T-lymphocytes are produced by the thymus gland,
which gradually shrinks after puberty, becoming less active
in immune function during adulthood. ‘If the thymus continues
to produce immune system cells in HIV- infected adolescents,
the adolescent immune system may be stronger than previously
thought,’ said Dr. Douglas.” The findings were published
in the April issue of Archives of Pediatric and Adolescent
Medicine.
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HIV drugs and diabetes
Using studies in mice, researchers
report that the HIV protease inhibitors Crixivan, Norvir and
Agenerase block the body’s ability to store sugar. This
malfunction leads to diabetes. They expected the mechanism
to be true of other HIV protease inhibitors. The development
of diabetes has been noted in many people on HIV drug combinations,
but the reason remains unknown. Excess abdominal fat, impaired
glucose (sugar) tolerance and insulin resistance, all risk
factors for diabetes, are also being seen. Washington University
School of Medicine in St. Louis, where the research took place,
noted in a press release that in one pilot study, 46% of people
on a protease inhibitor had glucose intolerance and that an
additional 13% of them developed diabetes within a year and
a half, compared to 6% of the general U.S. population that
develops diabetes during adulthood after years of problems
with their glucose. The researchers reported that, “if
our hypothesis is correct, insulin resistance should be maximal
when in vivo protease inhibitor concentrations are maximal.
Thus, depending on the dosing regimen and the pharmacokinetic
characteristic of the protease inhibitor used, simple measurements
of fasting glucose and insulin levels may be underestimating
the true extent of insulin resistance that actually occurs.”
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Transgender TB
The U.S. Centers for Disease
Control and Prevention (CDC) reported an outbreak of tuberculosis
among young transgender persons in Baltimore and New York
City, 62% of whom were also HIV positive. The CDC reported
that, “Frequent travel and social network links identified
among the Baltimore and NYC cases have raised concern that
this strain of M tuberculosis may be circulating in other
cities among young, mobile, transgender persons with HIV infection.”
For technical assistance in controlling this outbreak, health
departments were asked to call (404) 639-8117.
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Bottled water
The American Water Works Association
(AWWA), the people who clean the water coming from your tap,
has asked the Food and Drug Administration (FDA) to improve
the information consumers get about bottled water. The FDA
should require better labeling, the association says, so that
instead of just a toll-free number, buyers can also see the
source of the water and the methods used to make it safe.
People with AIDS, for example, need to drink water free of
the parasite cryptosporidium. This requires a filtering method
using a 1 mm microfilter.
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