AEGiS-11IAC: Passive immunotherapy in advanced HIV infection and therapeutic plasmapheresis in asymptomatic HIV-positive individuals.

11th International AIDS Conference

Vancouver, British Columbia — July 7-12, 1996

Passive immunotherapy in advanced HIV infection and therapeutic plasmapheresis in asymptomatic HIV-positive individuals.

Int Conf AIDS 1996 Jul 7-12; 11:221 (abstract no. Th.B.175)
Blick G, Scott WF, Crook SW, Buchanan SL, Garton T, Hopkins U, Vadeboncoeur AM, Bulcraig IA, Karpas A; Southern New England Community Consortium, Greenwich, CT, USA. Fax: 203 622 1499. E-mail: BLICKMD@AOL.COM.

OBJECTIVE: To demonstrate the safety and possible efficacy of Passive Immunotherapy administered to individuals with AIDS and of Therapeutic Plasmapheresis of asymptomatic HIV-positive individuals.

METHODS: Fifty-nine patients with a mean CD4 count of 55 and a mean HIV p24 antigen of 328pg/ml were transfused monthly with 500cc of hyperimmune plasma pooled from at least 5 healthy asymptomatic donors. Fifty-one asymptomatic HIV-positive individuals with a CD4% greater than or equal to 20 and/or CD4# greater than or equal to 350(mean 478), p24 antigen less than 100, p24 antibodies greater than 100 Fl.u., and no chronic Hepatitis B or C, donated 500-750cc of plasma once or twice monthly. Collected plasma was frozen at -20 degrees C. for 7 days before 6 units were pooled, treated with beta-propiolactone for 2 hours, separated into 500cc units, refrozen at -20 degrees C. for an additional 7 days, and thawed and transfused. Patients were followed for up to 49 months.

RESULTS: Asymptomatic Group(n=8); in these individuals with a mean CD4 count of 92 and who received an average 24 infusions over 28 months, no deaths or disease progression to ARC or AIDS occurred; ARC Group(n=15): in these individuals with a mean CD4 count of 90, a mean p24 antigen of 670pg/ml, and who received an average of 23 infusions over 26 months, no deaths occurred and no progression to AIDS occurred with the first 17 months; AIDS Group(n=36): in these individuals with 51 AIDS diagnoses at enrollment, a mean CD4 count of 33 and a p24 antigen of 247, and who received an average 18 infusions over 20 months, 7 deaths occurred with a median survival time of 29.5 months. The estimated meantime to new AIDS-related events was 14 months. Passive Immunotherapy was safely administered to all groups; one ARC patient was withdrawn following an urticarial reaction. A rapid decline (greater then 90%) in p24 antigen levels occurred within 3 months in all groups. CD4 improvements were demonstrated in the Asymptomatic and ARC groups. P24 antibody levels rose rapidly and were sustained for the duration of the study; DONORS(n=51): these individuals donated an average 27 times over 30 months and experienced no disease progression or deaths or adverse effects. 86% had CD4 counts stable or improved when compared to baseline, and 3 of 4 donors had stable or improved p24 antibody levels.

CONCLUSIONS: Passive Immunotherapy appears to be a safe, non-toxic and possible efficacious therapy for at least 4 years, especially in asymptomatic individuals with CD4 counts below 200. Once or twice monthly plasma donations by healthy asymptomatic HIV-positive individuals may delay disease progression and stabilize CD4 cell counts and p24 antibody levels for up to 49 months.

Keywords: AEGIS, HIV Infections, HIV Seropositivity, CD4 Lymphocyte Count, HIV Core Protein p24, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Plasmapheresis, Immunization, Passive, Plasma Exchange, Disease Progression, Antigens, CD4, Plasma, Human, ICA11

960707
ThB175