Living + Magazine Issue 1 - Positive Living BC

WOMEN’S TREATMENT
LADIES FIRST
Women’s bodies pose
challenges for HIV treatment
by EMILY BASS
Women represent the fastest rising
group of new HIV infections in the
United States, making up 22 percent of
reported AIDS cases in 1997. In spite of
these rising numbers, female participation
in clinical trials of anti-HIV drugs
hovers at around 10 percent. This
means more and more women are taking
drugs whose side effects and
toxicities in the female body are largely
unknown. While short-term studies to
date suggest that most HIV antiretroviral
drugs are effective and well-tolerated
in women, emerging data reveal
potential gender-specific side effects,
including fat-related disorders and pregnancy-related
toxicities. This has
prompted advocates to intensify their
demand that drug companies consider
the effects of new drugs on women’s
bodies before they reach the market.
Until recently, women with HIV, particularly
pregnant women, were excluded
from many drug trials on the
grounds that experimental compounds
could cause birth defects, and that women’s
hormonal cycling might interfere
with data collection. Drug companies
fear expensive lawsuits related to birth
defects, and often require women of
child-bearing age seeking entry into a
drug trial to take birth control. They’ve
also been reluctant to pay for day care
or transportation, factors that limit
womens’ participation in drug trials.
As it stands, much of the information
we have gleaned about HIV drugs is
based on how they affect adult male
bodies. Women’s body composition can
impact drug potency and side effects.
Women generally weigh less than men
and have a higher fat and water content
in their bodies. Their reproductive systems
are also different. Menstrual peri-
ods, menopause, and pregnancy all
cause major changes in women’s body
chemistry that can affect how drugs are
absorbed and where they are distributed.
In spite of these differences, anti-
HIV drugs-and most medications in general-are
dosed according to average
male weight and volume.
“Yes, drugs are working, which is extremely
important and saving lives,” says
Dr. Kathryn Anastos, a principal investigator
from the Women’s Interagency
Health Study (WIHS), the largest study
of women and HIV in the country. “But
we may be blasting women
with higher doses than we
need to.” It is also likely that
women have different side
effects. Gender-based studies
of safety, dosing, and efficacy
are complicated to do-which
spells dollars-and some drug
companies avoid the issue
altogether, saying that preand
postmenopausal women with HIV
have no apparent hormone-related
problems. Experts and women’s health
advocates remain unconvinced. “It’s a
moot point,” says Dr. Kathleen Squires,
an AIDS researcher at the University of
Alabama at Birmingham. “We need to
do well-controlled pilot studies (of hormonal
influences) even if the drugs appear
to be working.”
Researchers are already puzzling
over gender differences in lipodystrophy,
a disfiguring side effect marked by
unusual fat deposits, facial and truncal
wasting in people taking HIV combination
therapies-notably protease inhibitors.
While men tend to develop big
bellies and “buffalo humps” or large fat
deposits in their necks, women may experience
increases in their breast size
and lose body fat in their thighs and
buttocks (see “Side Effects”). Other
pressing issues that demand a genderbased
focus include HIV viral load,
which may be lower in women than men
(see “Viral Load”). Since viral load levels
are used to determine when to start,
switch, or stop treatment, the issue is
critical for women considering therapy.
Given the escalating rates of HIV infection
among women, including teenage
girls, there’s increased pressure on
the Food and Drug Administration to
update its drug-testing guidelines. Even
so, the response has been slow. The
agency waited until 1995 to start requiring
drug sponsors to provide a gender
breakdown of trial data: if women are
included in the study, their data are
analyzed separately. However, there’s no
requirement to enroll women (let alone
As it stands, much of the
information we have gleaned about HIV
drugs is based on how they affect adult
male bodies. Women’s body composition
can impact drug potency and side effects.
study hormonal influences), so sample
sizes continue to be small or non-existent.
A 1997 FDA attempt to enact a
“clinical hold” rule that would prevent
trials of drugs for life-threatening illnesses
from excluding women is languishing
in the proposal stage.
The research now taking place is a
curious mixture of underenrolled clinical
trials and high-profile “women-only”
studies like Agouron’s Women First, a
trial that treats participants to support
groups, customized pill boxes, and calendars
with daily inspirational messages.
These adherence tools have helped
women stick with the study’s demanding
four-drug regimen. That’s good
news for women who get access to fancy
planners-but even better news for
continued on next page
JULY/AUGUST 1999 • LIVING + 29