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DOI: 10.1055/s-0038-1648438
Immune Status of Asymptomatic HIV-Infected Hemophiliacs: Randomized, Prospective, Two-Year Comparison of Treatment with a High-Purity or an Intermediate-Purity Factor VIII Concentrate
Publication History
Received 13 June 1991
Accepted after revision 17 September 1991
Publication Date:
03 July 2018 (online)
Summary
It has been postulated that high-purity factor VIII (FVIII) concentrates, since they contain less alloantigenic proteins than intermediate-purity concentrates, might cause lesser deterioration of the immune systems of hemophilic patients infected with the human immunodeficiency virus (HIV). To evaluate this hypothesis, we have prospectively compared T-lymphocytes subsets and delayed hypersensitivity reactions to skin tests in 17 asymptomatic HIV-positive hemophiliacs randomly assigned to continue treatment with an intermediate-purity concentrate with those of 16 hemophiliacs changed to a high-purity concentrate. For both groups, during the 24-month follow-up period CD4 cell counts showed similar rates of fall from baseline values. There was also no difference in the number of patients anergic to skin tests. Three patients treated with the intermediate purity concentrate and one treated with the high-purity concentrate developed symptoms of HIV infection. On the whole, no striking benefit is conferred to the immune status of asymptomatic HIV-positive hemophiliacs by using this high-purity concentrate for 2 years.
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References
- 1 Morfini M, Rafanelli D, Filimberti E, Cinotti S, Piazza E, Longo G, Rossi Ferrini P. Protein content and factor VIII complex in untreated, treated and monoclonal factor VIII concentrates. Thromb Res 1989; 56: 169-178
- 2 Griffith M, Liu S, Neslund G, Tsang I, Lettelier D, Berkebile R. Preparation of high specific activity plasma AHF by anti-FVIII:C immunoaffinity chromatography. Thromb Haemostas 1987; 58: 307 (abstract)
- 3 Schreiber AB. The pre-clinical characterization of monoclate factor VIII :C antihemophilic factor (human). Semin Hematol 1988; 25: 27-32
- 4 Mannucci PM, Gringeri A, Cattaneo M. High-purity factor VIII concentrates produced without using monoclonal antibodies. Res Clin Lab 1990; 20: 227-238
- 5 Brettler DB, Levine PH. Factor concentrates for treatment of hemophilia: which one to choose?. Blood 1989; 73: 2067-2073
- 6 Gallo RC, Salahuddin SZ, Popovic M, Shearer GM, Kaplan M, Haynes BF, Palker TJ, Redfield R, Oleske J, Safai B, White G, Foster P, Markham PD. Frequent detection and isolation of cytopathic retrovirus (HTLV-III) from patients with AIDS and at risk for AIDS. Science 1984; 224: 500-503
- 7 Margolick JB, Volkman DJ, Folks TM. HTLV-III/LAV detection by antigen induced activation of T-cells and amplification of direct suppression by virus of lymphocyte blastogenic responses. J Immunol 1987; 138: 1719-1728
- 8 Lederman MM, Saunders C, Toossi Z, Lemon N, Everson B, Ratnoff OD. Antihemophilic factor (factor VIII) preparations inhibit lymphocytes proliferation and production of interleukin-2. J Lab Clin Med 1986; 107: 471-478
- 9 Thorpe R, Dilger P, Dawson NJ, Barrowcliffe TW. Inhibition of interleukin-2 secretion by factor VIII concentrates: a possible cause of immuno suppression in hemophiliacs. Br J Haematol 1989; 71: 387-391
- 10 Eibl MM, Ahmad R, Wolf VM, Linnau Y, Gotz E, Mannhalter JW. A component of factor VIII preparations which can be separated from factor VIII activity down modulates human monocyte function. Blood 1987; 69: 1153-1160
- 11 Brettler DB. Proposed protocol for the evaluation of the effect of high-purity factor concentrates on the immune system of hemophilia patients. Thromb Haemostas 1989; 62: 811-812
- 12 Wober G, Domer F, Eibl H. Steam treatment of freeze-dried plasma fractions. Haemostasis 1985; 15: 13 (abstract)
- 13 Longo G, Matucci M, Messori A, Morfini M, Rossi Ferrini P. Pharmacokinetic of a new heat-treated concentrate of factor VIII estimated by model-independent methods. Thromb Res 1986; 42: 471-480
- 14 Blomback M, Cinotti S, Longo G, Messori A, Morfini M, Schimpf K. Pharmacokinetics of two pasteurized factor VIII concentrates: a multicenter study on the reproducibility of parameters using different assay methods. 19th International Congress of the World Federation of Hemophilia. Washington DC: August 14-19 1990. (Abstract No. 103)
- 15 Mannucci PM, Schimpf K, Brettler DB, Ciavarella N, Colombo M, Haschke F, Lechner K, Lusher JM, Weissbach G. and the International Study Group Low risk of hepatitis C after a high-purity, pasteurized factor VIII concentrate. Ann Intern Med 1990; 113: 27-32
- 16 Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trials. Biometrics 1975; 31: 103-115
- 17 Goedert JJ, Kessler CM, Aledort LM, Biggar RJ, Abe Andes W, White CG, Drummond JE, Vaidja K, Mann DL, Eyster ML, Ragni MV, Lederman MM, Cohen AR, Brag GL, Rosenberg PS, Friedman RM, Hilgartner MW, Blattner WA, Kroner B, Gail M. A prospective study of human immunodeficiency virus type 1 infection and the development of AIDS in subjects with hemophilia. N Engl J Med 1989; 321: 1141-1148
- 18 Gjerset GF. Impact of allotypic proteins in the treatment of HIV-1 infected hemophiliacs. Blood 1989; 74 Suppl (01) 101a (abstract)
- 19 Brettler DB, Forsberg AD, Levine PH, Petillo J, Lamon K, Sullivan JL. Factor VIII: C concentrate purified from plasma using monoclonal antibodies: human studies. Blood 1989; 73: 1859-1863
- 20 Gomperts E, Addiego J, Gill J. What is the impact of monoclonal Ab purified, plasma derived FVIII on immune function in hemophilia A patients?. Blood 1989; 75 Suppl (01) 39a (abstract)
- 21 Friedland GH. Early treatment for HIV. The time has come. N Engl J Med 1990; 322: 1000-1002
- 22 de Biasi R, Rocino A, Miraglia E, Mastrullo L, Quirino A. The impact of a very high purity factor VIII concentrate on the immune system of human immunodeficiency virus-infected hemophiliacs: a randomized, prospective, two-year comparison with an intermediate purity concentrate. Blood 1991; 78: 1919-1922