AEGiS-PRn: Interleukin-2 Therapy Significantly Benefits Patients With AIDS Data to Be Presented at World AIDS Conference Suggest Additional Immune Reconstitution Beyond Antiretroviral Therapy in Patients With Less Than 200 CD4 Cells

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Interleukin-2 Therapy Significantly Benefits Patients With AIDS Data to Be Presented at World AIDS Conference Suggest Additional Immune Reconstitution Beyond Antiretroviral Therapy in Patients With Less Than 200 CD4 Cells

PR Newswire; Monday June 22, 8:30 am EST

CHICAGO, June 22 /PRNewswire/ -- Interleukin-2 (IL-2) therapy significantly increased CD4 cell counts and other key immune markers in patients with AIDS without increasing HIV viral levels, according to a new study to be presented by Daniel S. Berger, M.D. at the upcoming 12th World AIDS Conference in Geneva, Switzerland. The study also highlights that treatment with IL-2 was safe and tolerated by patients with advanced HIV on stable antiretroviral therapy.

"Our findings demonstrate that IL-2 therapy is a viable option for people with AIDS," said presenting author Daniel S. Berger, M.D., medical director of NorthStar Medical Center in Chicago, Illinois. "While it was previously believed that IL-2 therapy had limited benefit for patients with advanced HIV, we have found that IL-2 induces significant immune recovery in this population."

IL-2 is a natural cytokine produced by the human body in response to viral infection. Chiron Therapeutics currently markets a recombinant version, called Proleukin(R), to treat certain forms of kidney cancer. Studies published in the New England Journal of Medicine have concluded that IL-2 significantly raises CD4 cell counts in patients with early-to-moderate stage HIV infection. However, the role of IL-2 in patients with late-stage disease has not been clearly defined.

The study examined 15 patients with AIDS who were on stable protease inhibitor-containing regimens. Patients were subsequently placed on IL-2 therapy with dosages ranging from 9-18 million units once daily for five days in cycles delivered approximately every eight weeks. The results showed that IL-2 therapy significantly increased absolute CD4 counts, CD4 percentages, as well as naive (CD45+RA) and memory (CD45+RO+) cells. The results also revealed no statistically significant increase in HIV RNA levels after long-term therapy with IL-2.

The study compares laboratory values of patients on highly active antiretroviral therapy

(HAART): Pre IL-2 Post IL-2 P value

CD4 cells 249 470 <.001

CD4 percentage 17.2 23.6 <.05

CD8 cells 787 1,127 <.05

Naive CD4 cells 98 189 <.05

Memory CD4 cells 142 242 <.01

Note: The mean duration of HAART before initiation of IL-2 was 12.2 months.

The most common clinical side effects of IL-2 therapy included fever, chills, fatigue, malaise, sinus congestion, headache and nausea. Generally, fever was the most severe side effect, with temperatures rising to 103 degrees. Side effects were managed with symptomatic treatment. Side effects tended to be most severe on the 4th and 5th day of cycles, but generally resolved within 24 hours after therapy.

The results of the study will be presented on July 1st at the upcoming World AIDS Conference in Geneva, Switzerland. At an oral presentation to begin at 11:00 in Session Hall VII, Daniel S. Berger, M.D., will detail the study in a session entitled Clinical Immunology in HIV-1 Infection. Also, Dr. Berger will display results during a poster session on June 30th from 8:00-8:50, 12:00-13:00, and 17:00-18:00 in Hall 7.

SOURCE: Daniel S. Berger, M.D.

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