WASHINGTON - Announcing a significant advance in the battle
against AIDS, federal health officials said Thursday that the
antiviral drug AZT has been shown to delay onset of the disease
in certain groups of infected patients who have not yet
"What we have learned . . . provides real hope for the millions
of people worldwide who are infected with HIV (human
immunodeficiency virus)," said Health and Human Services
Secretary Louis W. Sullivan. "We are indeed entering the period
when AIDS may become a treatable disease."
The announcement came just two weeks after another AZT study
showed that the drug arrests the progression of the disease in
individuals experiencing initial symptoms of infection.
Together, the findings could benefit about 600,000 of the
estimated 1.5 million infected individuals in this country,
health officials said.
Dr. Anthony Fauci, chief of AIDS activities for the National
Institutes of Health, said the AZT findings have "the broadest
impact" of any of the therapeutic advances shown in recent
years to prolong the lives of patients with AIDS or HIV
Fauci said the findings are an important step toward the goal
of moving AIDS from "an inevitably fatal disease" to "a disease
that can be controlled over time" through early treatment after
Moreover, Sullivan said, the latest information "underlines
anew the need for people to voluntarily undergo HIV testing and
counseling" so they can fully benefit from treatment.
"Every person who has reason to believe or suspect that he or
she has been exposed to the virus should seek testing and
counseling," Sullivan said. He also cautioned that "AZT is not
a cure and, indeed, even those who are under AZT treatment
remain capable of transmitting the disease."
AZT, or zidovudine, was approved by the Food and Drug
Administration in 1987 for the treatment of fully developed
AIDS. The two recent studies present the first real evidence
that the drug can be effective in the earliest stages of
In the latest study, infected individuals who had impaired
immune systems but no symptoms and who took AZT developed AIDS
or severe AIDS-related complex at half the rate of those who
took a medically inert placebo.
The study--the largest AIDS clinical trial ever
conducted--began two years ago and was coordinated by Paul
Volderding, an AIDS specialist at San Francisco General
The trial compared high and low doses of AZT against a placebo
in 3,200 people who were infected with the virus but had not
Of the 3,200 volunteers, 1,300 initially had abnormally low
counts of T4 cells in their blood, indicating that their immune
systems had been damaged. Those participants had fewer than 500
T4 cells per cubic millimeter of blood, contrasted with a
normal range of 800 to 1,200. T4 cells are the primary targets
of the AIDS virus.
The 1,300 participants with low T4 cell counts were divided
equally into three groups. One group received a medically
worthless placebo; a second group received a high dose of AZT,
and the third group was given a low dose of the drug.
In the placebo group, 38 individuals developed AIDS or severe
AIDS-related complex, contrasted with only 17 in the low-dose
AZT group and 19 in the high-dose AZT group.
On Wednesday, an independent board of scientists monitoring the
study decided that the placebo arm of the trials should be
halted for participants with low T4 cell counts and that those
people should be offered AZT because of its potentially
Officials said the three-group approach will continue for
participants whose T4 counts are above 500, "since the study
has shown that short-term risk of developing AIDS is negligible
in persons with higher T4 counts."
Officials said progression of the disease was about the same in
patients receiving the low dose of 500 milligrams of AZT per
day or the higher dose of 1,500 milligrams per day.
Reinforcing the study results of two weeks ago, they said that
side effects associated with AZT were minimal, indicating that
the drug can be better tolerated early in the disease. AZT has
proved to be extremely toxic in many people with fully
Although the results of both studies were dramatic, officials
emphasized that AZT is not considered an AIDS cure and it
remains unclear how long the disease can be slowed or delayed.
Although AIDS organizations, lawmakers and others cheered the
results of the latest study, many expressed concern that
AZT--which can cost a patient from $8,000 to $12,000 a
year--will be inaccessible to many who need it.
"This announcement is great news for those people with good
insurance," said Rep. Henry A. Waxman (D-Los Angeles), chairman
of the House Energy and Commerce subcommittee on health. "We
have to find a way to get this drug to all who need it."
Sullivan said he ordered the Medicare system Thursday to begin
reimbursing for AZT, although it is unclear who would benefit
from the directive. Medicare is available only to individuals
older than 65, final-stage kidney disease patients and those
who have been disabled for 29 months under Social Security
regulations. Fully developed AIDS is considered a disability,
but AIDS infection is not.
The administration of AZT, which is manufactured by Burroughs
Wellcome Co. of Research Triangle Park, N.C., is not covered by
all private health insurance programs and is covered by
Medicaid only under certain circumstances.
"This research news is tremendously encouraging," said Sen.
Edward M. Kennedy (D-Mass.), chairman of the Senate Labor and
Human Resources Committee.
Jean McGuire, executive director of the AIDS Action Council,
said the news "marks a major turning point in the AIDS
epidemic. For the first time, there is hope at the asymptomatic
stage that progression to serious AIDS manifestations may be
CAPTION: Photo: Dr. Anthony Fauci speaks at press conference;
behind him is Louis Sullivan, health and human services
DE AZIDOTHYMIDINE (DRUG); ACQUIRED IMMUNE DEFICIENCY SYNDROME;
HUMAN IMMUNO DEFICIENCY VIRUS; FAUCI, ANTHONY S; MEDICAL COSTS;
MEDICAL RESEARCH; HEALTH STATISTICS; MEDICAL TREATMENTS