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Study: Drug

NEW YORK CITY,NY (February 17, 2004) -- Women with advanced-stage HIV can benefit greatly from treatment with a standard “cocktail” of drugs known as HAART (highly-active antiretroviral therapy), according to a new national study of 1,132 HIV-infected women, which appeared in the February, 2004 issue of the Annals of Internal Medicine.

“Prior to this study, it was believed that many patients with advanced-stage HIV would not do very well with HAART,” said Kathryn Anastos, MD, principal investigator in the six-year, NIH-sponsored study, and an attending physician and associate professor of medicine and epidemiology at Montefiore Medical Center.  “Our study shows that is not the case. It is tremendously exciting news for patients who, for a variety of reasons, do not start HIV therapy early.”

The importance of the study was underscored in an accompanying editorial, which noted that many patients with HIV infection in the United States are not receiving treatment until after they become sick with AIDS. For these patients, the editorial said, the study is “encouraging because it shows them that most patients with very late-stage illness benefit from antiretroviral therapy.”

To determine the effectiveness of therapy, researchers measured HIV “markers” in the blood of patients..  For example, the number of CD4+ cells is a measure of the volume of “helper” T-lymphocytes, “good” cells which fight the disease.  HIV-1 RNA level, on the other hand, also called “viral load”, measures the number of HIV viruses present in each drop of blood (higher numbers are “worse”). Combined, these two counts are used to predict whether a patient will remain well with HIV/AIDS as a chronic disease, or get sick or die.  

 “We found that low CD4+ counts and high viral load prior to treatment do not matter in determining the outcome for HIV-infected patients, as long as those numbers improved,” said Anastos.“Only post-HAART treatment levels of these markers matter in determining a patient’s chances of survival.” 

 The study found that “even in women with advanced immunologic abnormalities, HAART that raises the CD4+ cell count to greater than 200 cells/µl and reduces HIV-1 RNA levels to less than 10,000 copies/mL effectively mitigates the negative prognosis associated with low CD4+ cell counts and high HIV-1 RNA prior to therapy.” 

This does not mean that HAART is a cure-all for AIDS. “There are still some patients who do not respond to therapy with improved laboratory values of CD4+ count and viral load, and thus may not do well clinically,” said Dr. Anastos.

The study used data from the Women’s Interagency HIV Study, the nation’s largest ongoing study of women and AIDS, now in its 11th year.

Montefiore Medical Center, The University Hospital and Academic Medical Center for the Albert Einstein College of Medicine, is an internationally recognized leader in patient care, education, research and community services.

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