AIDS Treatment News #152, June 5, 1992
John S. James
Gamma globulin is the component of human blood which contains antibodies -- certain proteins which are specially made by the body to fight particular infections. A number of gamma globulin preparations are available as prescription drugs; when injected, the antibodies provide temporary protection against certain infections, for up to several weeks. They provide a passive immunity (unlike vaccines, which stimulate the body's own immune system to produce antibodies and/or infection-fighting cells).
Unfortunately, the more recently available intravenous gamma globulin preparations are too expensive for widespread use (except for infants and children with HIV, who probably have a greater need for this protection than adults do). But intramuscular gamma globulin, which has been available for decades, costs very little; it is safe, FDA approved, and is routinely used to protect against various infections. It has not been formally tested for persons with HIV, and there might never be such a trial. But the safety and cost "downside" of this treatment -- a sterile preparation made from HIV-negative blood -- is low enough that patients and physicians may want to try it, despite the lack of formal trials.
This potential treatment was brought to our attention by Joseph A. Hertell, M. D., an internist in private practice in Atlanta, who was involved in developing intramuscular gamma globulin in the 1950s. We asked several other physicians what they thought about using this treatment for persons with HIV. Our impression is that while few HIV physicians have used it, most do not dismiss the possibility; they recognize that it does have a scientific rationale. (There is more interest among physicians in the much more expensive intravenous gamma globulin, but little use of it for adults because of the cost. Physicians can often get insurance reimbursement, however, by being very familiar with the FDA-approved non-HIV indications for this treatment; patients who are candidates can often be fit into one of those.) We suspect that the low- cost intramuscular gamma globulin may be underused, since there is no commercial incentive for any company to promote it.
Dr. Hertell has had little problem getting insurance companies to pay for the intramuscular gamma globulin -- which is not surprising, since this treatment costs very little and might prevent hospitalization or other expensive care. But reimbursement is not critical, since the cost is so low that most patients could pay it themselves if necessary.
Interview with Joseph Hertell, M. D.
JJ: How did you decide to try gamma globulin?
JH: "I was medical director of the American National Red Cross in the early 1950s when we started fractionation of plasma proteins. At that time we brought out gamma globulin, fibrinogen, and the other proteins. My interest was in gamma globulin. We first used it to prevent hepatitis.
"I'm a general internist; for a while, we in Atlanta depended on the infectious disease physicians to treat HIV patients. But with the rising number of cases it became impossible for them to carry the load. So I became more involved in taking care of AIDS patients as their counts began to drop. I first tried gamma globulin because I did not see any hazard to the patient; and on the positive side, it has a number of antibodies, and might be of value in preventing infections in immune-deficient persons.
"We started using gamma globulin over two years ago. I usually began the treatment when patients' T-helper counts fell below 400. We have followed 14 patients using gamma globulin; only one of them has discontinued the treatment. Of the 14, three started with T-helper counts under 100, two between 100 and 200, three between 200 and 300, five between 300 and 400, and one with over 400.
"This treatment does not seem to make much difference in the drop of the T-helper cells. What has impressed me is that none of these people has had any serious AIDS-related illnesses; in fact some of them have been able to resume activities. One with a count of 33 has gone back to work, and one with a count of 52 has taken a long vacation overseas. They're all active, and they have not had the AIDS-related illnesses I see in other patients.
"We also start patients on vitamin B-12 injections after they go below 100, because they might not absorb B-12 easily from the gastrointestinal tract. This is based on studies in the very elderly, who have a compromised immune system.
"Now I routinely start gamma globulin when patients go below 500 T-helper cells. We give 2 cc of gamma globulin weekly. That seems to be working well. I have not gone to the IV gamma globulin; that is very expensive. We do use it in pediatric HIV cases, especially when they have AIDS-related problems. But for adults it is expensive, and I see no reason for it, since the intramuscular form is rapidly taken up in the blood.
"The gamma globulin we use (brand name Gammar) costs about $30 for a multiple-dose vial. The patient buys it; most of the insurance companies will pay for it. The patients bring the vial to us, and we put their name on it. We don't have to charge them for the drug, and we give them the injections once a week.
"What I notice is the lack of AIDS-related opportunistic infections. We do use aggressive prophylaxis. We often start Bactrim three times a week when the T-helper count goes below 500; when it drops below 200, we add fluconazole to avoid cryptococcal meningitis, clarithromycin to avoid MAC, and sometimes acyclovir. But the difference seems to be the gamma globulin."
JJ: What dose do you use (for adults)?
JH: "We give 2 cc of Gammar every week.
"I am pleased with the results, and expect to use it increasingly for patients with T-helper counts below 500. We seem to be holding off infections in these patients, by using other peoples' antibodies, from a pool of people. [Blood is pooled from a number of people to make each batch of Gammar; therefore, many different antibodies are likely to be present.] By repeating the treatment weekly, I believe that we are giving immunity to a host of perhaps minor infections, which would not be good for persons with compromised immune systems. While this treatment is not affecting the basic course of the illness, at least these people are able to do activities, to work and take vacations, that otherwise they might not be able to do because of numerous minor infections. The number of patients treated so far is small, but we have seen them in good health month after month."
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