Low risk of transmission of the human immunodeficiency virus by a solvent-detergent-treated commercial factor VIII concentrate.
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.
Di Paolantonio
T
T
Department of Human Biopathology, University of Rome La Sapienza, Italy.
Mariani
G
G
Ghirardini
A
A
Gringeri
A
A
Mannucci
P M
PM
Mastrullo
L
L
De Biasi
R
R
Giustarini
G
G
Morfini
M
M
Schiavoni
M
M
D003902:Detergents; D004340:Drug Contamination / Q000517:prevention & control; D005069:Evaluation Studies as Topic; D005169:Factor VIII / Q000009:adverse effects* / Q000302:isolation & purification*; D015483:HIV Antibodies / Q000097:blood; D015488:HIV Antigens / Q000097:blood; D015658:HIV Infections / Q000150:complications / Q000517:prevention & control / Q000635:transmission*; D006467:Hemophilia A / Q000150:complications / Q000382:microbiology / Q000628:therapy; D006801:Humans; D012307:Risk Factors; D012449:Safety; D012997:Solvents
D003902:Detergents; D015483:HIV Antibodies; D015488:HIV Antigens; D012997:Solvents; D005169:Factor VIII