Multi center study finds "AIDS cocktail" therapy effective in advanced AIDS cases

Highly active anti-retroviral therapy (HAART), also known as “AIDS cocktail”
therapy, is saving lives and preventing infections even in the most advanced
AIDS patients, according to a new study.

The authors of a multi center study published in the July 3, 2001 issue of
Annals of Internal Medicine calculated the exact reduction in death and
opportunistic infections attributable to HAART. Researchers at 11 university
medical centers across the country followed 528 advanced AIDS patients for an
average of 15 months during the period from August 1995 through June 1999. The
researchers found that HAART decreased the HIV death rate to 38 percent of
pre-HAART levels, and decreased the rate of most opportunistic infections to 66
percent of pre-HAART levels.
“In general, other studies were based on healthier populations,” said Edward
Murphy, MD, MPH, professor of laboratory medicine at the University of
California, San Francisco and principal investigator for the study at the UCSF
site. “This study supports the clinical experience of doctors, that HAART does
work in these advanced patients.”

Patients entering the study had a median CD4+ lymphocyte count of 15. Healthy
adults usually have CD4+ counts between 600 and 1,000. Patients with counts
below 200 have severely suppressed immune systems. “Untreated, someone with a
count of 10 or 20 has a life expectancy of about a year,” said Murphy.

The study analyzed data from the Viral Activation Transfusion Study (VATS)
which followed AIDS patients with anemia who also tested positive for
cytomegalovirus (CMV), a herpes virus that is a common cause of opportunistic
diseases in persons with AIDS. Researchers used VATS data because the study
spanned the introduction of HAART. In January of 1996 only 1 percent of study
participants were using HAART, but by January of 1999 that number rose to 79
percent. Because of the timing of the study, researchers were able to track the
effects of HAART on individual patients. “Our study was able to determine each
patient’s HAART history,” said Murphy. “Therefore, we could figure out more
precisely what the benefit of HAART was.”

Researchers also found that HAART decreased opportunistic infections (not
including CMV) to 66 percent of pre-HAART levels, but HAART did not decrease
instances of CMV disease.

HAART suppresses the replication of HIV particles in the blood stream, allowing
a patient’s immune system to recover. For this study, HAART was defined as use
of at least three HIV antiretroviral medications, at least one of which was an
HIV protease inhibitor or a non-nucleoside HIV reverse transcriptase inhibitor.

Co-investigators on the study include Edward Murphy, MD, MPH, UCSF; Ann
Collier, MD, University of Washington; Leslie Kalish, ScD, New England Research
Institute; Susan Assmann, PhD, New England Research Institute; Michael Para,
MD, Ohio State University; Timothy Flanigan, MD, Brown University Medical
School; Princy Kumar, MD, Georgetown University Medical Center;  Letty Mintz,
ANP, Mount Sinai Medical Center; Frances Wallach, MD, Mount Sinai Medical
Center; and George Nemo, PhD, National Heart, Lung, and Blood Institute.

The study was funded by the National Heart, Lung and Blood Institute.