A study evaluating the risk of a commercial factor VIII (FVIII) concentrate's transmitting the human immunodeficiency virus (HIV) was carried out on hemophiliacs, by using multiple serological markers and the polymerase chain reaction (PCR). Twenty‐nine hemophiliacs, negative for HIV antibodies, were treated for 18 months with a concentrate that had been inactivated by solvent‐detergent. HIV‐1 antibodies and antigen were assayed during the follow‐up period. At the end of the study, all patients were also tested by the HIV 1+2 combined antibody assay; Western blot (WB) antibody analysis; and in eight cases, by an HIV‐1 PCR technique. Patients received a yearly median FVIII dose of 35,330 IU (range 3,300‐306,000); the median number of lots given to each patient was 6 (1‐45). During the follow‐up period and at the end of the study, HIV‐1 antibodies and antigen were not detected in any of the subjects. The HIV 1+2 combined assay and WB analysis carried out only at the end of the study were negative. HIV‐1 PCR was negative in all the tested patients. This study has shown that this solvent‐detergent‐treated FVIII concentrate did not transmit HIV.
Journal of Medical Virology – Wiley
Published: Feb 1, 1992
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