Gay Men's Health Crisis "Treatment Issues", Vol 8, No. 10, November, 1994
Dave Gilden

What is Passive Immunotherapy?

PIT involves the transfer of plasma (the fluid portion of the blood without the cells) from asymptomatic HIV-infected donors with high HIV antibody levels to individuals with advanced HIV infection or AIDS and low levels of HIV antibodies. The hope is that the HIV antibodies in the transferred plasma will help preserve the recipient's health. PIT's originator and chief promoter is Abraham Karpas, Sc.D., an AIDS researcher from the University of Cambridge in Britain. Dr. Karpas published his first paper on PIT in 1988.1

No New News

There is actually little new to report on PIT at the moment. The occasion of the conference was the publication in Blood2 of the results of a PIT study conducted by a small California company known as HemaCare. (HemaCare is not a research company. Its main business is blood tests.) The study was originally released two years ago, at the 1992 National AIDS Update Conference in San Francisco. Since then, HemaCare has been negotiating with California health authorities to allow a larger phase III trial including up to 900 persons. The interchange proved fruitless and HemaCare is now seeking approval from the U.S. Food and Drug Administration. One of HemaCare's problems may be the equivocal conclusion of the previous study. Half of the 220 trial participants had baseline CD4 counts of under 50, and for them, there was no evidence of benefit. The same was true for the trial as a whole. HemaCare then analyzed the 72-person subgroup with CD4 counts of 50 to 200. The company found slight advantages in terms of CD4 count and survival after twelve months of "full- dose" PIT (a monthly 500 ml plasma infusion) compared to half-dose PIT or placebo. No reduction in opportunistic infections was observed in any group.

A number of concerns have been raised about the way HemaCare handled this study -- including breaking off relations with its original statistician. His analysis of the study data was less positive than the published one described here. (For further details on the initial problems, see this author's article in AIDS Treatment News, number 165, December 18, 1992, pages 1-3.)

A small French PIT study presented at the London conference, and also a year ago in Washington, D.C.,3 did find a two- thirds drop in the incidence of AIDS-related opportunistic infections. The 82 participants had less than 200 CD4 cells per milliliter of blood and symptoms of advanced immune deficiency. The 40 people in the placebo arm received plasma from HIV-negative donors. A published report on this study has not yet appeared, so interpreting its findings is difficult.

Future Studies of PIT

The London conference could be dismissed as a public relations move designed to garner support for further research. The studies may be weak, but the data they contain plus various anecdotal reports do provide argument for further research on PIT, especially in people with fewer symptoms.

PIT has no well-funded backer, nor is it cheap. One U.S. practice that performs this technique is the Southern New England Community Consortium (SNECC) in Greenwich, Connecticut. SNECC charges recipients $900 a month. The organization's director, Gary Blick, M.D., claims that even at this price, PIT has been a financial disaster. Finding enough eligible plasma donors also has been difficult. Dr. Blick and HemaCare both have suggested that there may be some benefit for those who are donating plasma with HIV antibodies. (The benefits are certainly not financial -- SNECC does not pay donors for their plasma). There is little data, however, to indicate that donating plasma either helps or hurts donors.

1 Karpas A et al. Proceedings of the national academy of sciences of the United States of America. Dec 1988; 85(23):9234-7.

2 Levy J et al. Blood. Oct 1 1994; 84(7):2130-5.

3 Vittecoq D et al. First National conference on human retrovirus infections. Dec 1993; (abstract L12):153.

Copyright (c) 1994 - Gay Men's Health Crisis. Noncommercial reproduction encouraged. DISTRIBUTED BY GENA/aegis * 714.248.2836 * 8N1/Full Duplex * v.34.
9411
GM081003

Copyright © 1994 - Treatment Issues. Reproduced with permission. Treatment Issues is published twelve times yearly by GMHC, Inc. All rights reserved. Noncommercial reproduction is encouraged. Subscription lists are kept confidential. GMHC Treatment Issues, The Tisch Building, 119 West 24th Street, New York, NY 10011  fredg@gmhc.org  http://www.gmhc.org

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .