NEW AIDS POLICY WAITS WITH DRUG USAGE
By Robin Eisner
ABCNEWS.com 31 January 2001
"Hitting early, and hitting hard" with the AIDS cocktail is no longer
the best approach for HIV-infected people, the government says,
because side effects, such as high cholesterol and liver problems,
outweigh any benefits of treatment.
Five years ago, Time magazine named AIDS researcher David Ho "Man of
the Year" for his idea that new AIDS drug "cocktail" might eliminate
the virus and potentially cure both very sick AIDS patients and those
who had been infected with HIV.
Doctors, AIDS activists, the pharmaceutical companies all jumped on
the bandwagon touting these drugs for AIDS patients, and for the tens
of thousands of people infected with HIV but not yet showing signs of
the devastating related infections, such as pneumonia.
So with this "hit early, hit hard," approach, physicians began to
prescribe the combination therapy of drugs to relatively healthy HIV-
infected people. The drug mixture included the newly approved anti-
HIV protease inhibitor drugs and the old standbys, like AZT.
Fast-forward to 2001: For AIDS patients, the drugs have been a
godsend, reducing the number of deaths each year by 50 percent. For
HIV-infected people, though, the promise has not lived up to the
reality. At a conference next week on human retroviruses in Chicago,
the federal government will now say infected people should wait for
awhile before they begin to take these powerful drugs, citing
dangerous side effects and drug resistance outweighing any benefits
The announcement comes as another blow for the AIDS community, which
is starting to see an increase in infection rates in San Francisco
and New York City. Forty-seven million people worldwide have been
infected with HIV since the beginning of the epidemic 15 years ago,
with 2 million dying each year. Some 311,000 Americans currently have
AIDS; another 120,000 are infected with HIV. Vaccines remain in
More Conservative Treatment Approach
"We are now being a little more conservative in treatment," the
director of the National Institute of Allergy and Infectious Diseases
Dr. Anthony Fauci told ABCNEWS.com. NIAIDS is a federal agency that
helps set AIDS policy in this country. "Although the therapy is
beneficial, it is better later in the course of infection."
While people with more advanced AIDS might more willing to face the
side effects of the drugs rather than the devastating AIDS-related
conditions - such as infections, wasting and lymphoma - less ill
people can delay their potential exposure to side effects. To stay
healthy, people probably need to take the medications, which are
expensive and require following a rigorous regimen, for the rest of
Side effects of the drugs include unusual body fat redistribution,
high cholesterol levels, sugar metabolism problems, hip bone tissue
death, kidney failure, liver metabolism alterations and loss of nerve
"I have had to change drugs a few times," says Michael Harrington,
senior policy director for the Treatment Action Group, an
organization founded in 1992 dedicated to advocating for larger and
more efficient AIDS research efforts. He experienced kidney stones
twice, high cholesterol and liver and peripheral nerve problems.
Many patients also fail to properly take what can amount to a dozen
pills in some treatment plans, a practice that can lead to drug
resistance to the virus. During the time of a missed dose, a mutant
virus can grow within the person's body that no longer responds to
"I take a dozen pills a day," explains Greg Gonsalves, director of
treatment advocacy for the Gay Men's Health Crisis, a group founded
in 1981 dedicated to treatment of New Yorkers with AIDS. "It's a
rigorous process. You have to take some with food and some without.
It is not a trivial task to take these drugs."
Treatment With a Theory, Not Data
The drugs had been prescribed despite the fact that there is no long-
term clinical testing showing at what point during HIV infection they
could help. The doctors made their recommendations based on the
success of using the drugs with a small group of patients who had
"In 1996, we had no data that hitting hard was either bad or good,"
says David Barr, director of the Forum for Collaborative HIV research.
"The general approach to infectious diseases was that the sooner you
get rid of them the better to eliminate infection?"
"There was excitement from everyone, from doctors, from the drug
companies from the AIDS community," Barr adds. "Everyone got on the
The hoopla has, indeed, paid off for those with more serious disease.
"Even in advanced disease, people now are able to go back to work,"
says Dr. Oren Cohen, assistant director of medicine at NIAID. "There
have been very dramatic changes with these drugs. We shouldn't lose
sight of this."
"I would much rather be dealing with side effects of these
medications than patients dying," says Dr. Robert Schooley, head of
infectious diseases at the University of Colorado Health Sciences
Center and chair of the Adult AIDS Clinical Trials Group, an
international group of investigators studying AIDS treatments.
Referring to the policy change, Schooley says: "It won't be the last
time the pendulum swings in AIDS treatment. It is a constantly
Unlike antibiotics that can eliminate bacteria from people, research
has shown that high levels and early dispensing of these drugs cannot
eradicate the virus in HIV-infected individuals.
The new guidelines will suggest that HIV-infected people should delay
starting the cocktail until their CD4 immune cell count falls below
350; the current recommendations say people might consider the
cocktail at 500 CD4 cells or less. CD4 cells decrease as infection
proceeds to AIDS. Healthy individuals have around 800 to 1,300 cells.
Activists: Time to Test When To Use Drugs
Since no clinical trials have been done to determine when is the best
time to take the cocktail of AIDS drugs, AIDS activists are calling
on the government to begin doing so.
"This is one of the most important questions in AIDS research," says
Treatment Action Group's Harrington. "I am angry and disappointed
they didn't do such a study. They are more interested in a high tech
treatment or a new drug, not in answering questions important to the
public and to people with HIV."
NIAID's Fauci says such a study would be "logistically impossible" to
do, because of the complexity of the different treatments in the
United States. "No one has yet been able to come up with a protocol,"
Doctors are urging caution for those HIV-infected people who started
the cocktail a few years ago and may wonder whether they should stop
taking the medications.
Talk to Doctor Before Stopping Drugs
NIAID's Cohen says patients should talk to their doctors about how to
proceed. "If the decision is to discontinue treatment," Cohen says,
"the patient should be monitored very carefully."
While AIDS activists are used to changes in AIDS treatments, infected
people may still get upset about the new policy. "Some people will be
confused, some will be mad, yet others will be relieved that they can
wait longer," Gonsalves says.
Barr says those people who may have died or who have developed drug
resistance because they took the drugs early saddens him. "Had they
waited," Barr says. "They might still be OK."