Immune Globulin Proves Valuable For Treating Children, Possibly Adults

Immune globulin is a concentrated and purified solution rich in antibodies from pooled human blood. It has been tested for some time in children with HIV, and some adults, as a method of bolstering their immunity to various bacterial infections. The antibody protection obtained from immune globulin is considered a short-term, passive immunity. The drug is a licensed treatment, often used as a way of conferring some measure of immunity against hepatitis and measles immediately following a perceived exposure to those viruses; it has also been used for reversing low platelet counts related to immunodeficiency.

On January 17 the National Institute of Child Health and Human Development announced results of a study of intravenous immune globulin (IVIG) involving 372 children (from two months to 12 years of age) which found significant benefits in the group receiving monthly IVIG, compared to those given a placebo. The data was gathered at 28 trial sites beginning March 1, 1988, and the recommendation to end the study was made January 10 of this year, after a Data Safety Monitoring Board discerned the study's trend.

IVIG was shown to decrease the number of bacterial infections and hospitalizations, and to increase the time between infections. These benefits were more dramatic in the children with higher T-helper cell counts. Although the children with less than 200 helper cells gained some protection compared to their counterparts in the placebo group, the improvement was not considered significant.

Other than mild brief rashes, few side effects were observed from the IVIG. The particular product used in the study was supplied by the Berkeley firm of Cutter Biological, which agreed to continue supplying free IVIG to any study participant.

Many children in both the placebo and treatment arms were at some point of the study also treated with AZT or aerosol pentamidine; neither of these appeared to influence the effect of IVIG. Physicians can obtain more details of the study, known as protocol ACTG 045, by calling 800/TRIALS-A. The press release announcing the study's results also noted that by the end of November of last year, the Centers for Disease Control had recorded 2,734 cases of AIDS in children under age 13, and that two to ten times that many more children in the U. S. may be HIV-infected; of these a disproportionate number are children of color.

For a thorough discussion of IVIG in clinical pediatric AIDS care, we refer readers to an article by E. Richard Stiehm, M. D., of the Division of Immunology at the University of California in Los Angeles, published in the December 1989 issue of AIDS Medical Report. In addition to controlling chronic bouts with bacterial infections, Dr. Stiehm suggests that IVIG might effectively be included in the treatment regimens for some serious opportunistic infections in children, such as CMV pneumonia and respiratory syncytial virus. Oral formulations of immune globulin have been used against cryptosporidial diarrhea.

Adults May Also Benefit

IVIG is receiving more notice recently for treating adults with AIDS, and not just to treat ITP, or low platelets. Paula Sparti, M. D., an experienced HIV clinician in Miami, told us that some of her adult patients who are troubled with chronic infections like sinusitis and bronchitis have improved noticeably after several months of IVIG infusions (see interview with Dr. Sparti in the last issue of AIDS TREATMENT NEWS, #119). These patients have low T-helper counts, in contrast to the lesser response associated with low T-helper counts in the children's study.

There are a number of reasons why results with adults and children may not be comparable. For example, the value of immune globulin for children comes from the contribution of antibodies to help children's inexperienced immune systems resist unfamiliar infections. In healthy adults, the immune system has already collected a larger "repertoire" of protective antibodies through years of exposure to the environment's microbes. But various kinds of immunodeficiency in adults, including AIDS, can deplete their acquired immunity, increasing susceptibility to common infectious agents.

Alan Levin, M. D., an immunologist working with adult HIV patients in San Francisco, presented related information at a recent community forum. Dr. Levin explained that a substantial value of immune globulin in treating HIV symptoms, aside from the simple transfer of antibodies, is a regulatory effect on inflammatory processes which characterize HIV infection, and on the immune dysfunction set in motion with the inflammation. He cautioned that IVIG can cause headaches, and rarely anaphylactic reactions, and is very expensive. However, the cost in many instances has been reimbursed by health insurance, especially if the therapy is prescribed for treatment of repeated infections.

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