This paper is only available as a PDF. To read, Please Download here.
In Sweden, 44 patients were reported to have contracted hepatitis C virus (HCV) infections from treatment with intravenous immunoglobulin. Gammagard® was the product implicated in HCV transmission in 12 patients; 8 of these 12 patients were HCV ribonucleic acid (RNA)—negative during the 2 years before Gammagard was administered and 10 showed clustering by sequencing of the HCV core gene. Further studies are being conducted to correlate the sequenced HCV RNA with specific batches of Gammagard. Nine patients who received Gammonativ® in 1983 and 1984 had a strong time-related possibility of HCV infection. Sequencing analyses are being performed in these patients as is being done for the patients who received Gammagard. Another 21 patients who received Gammonativ from 1982 to 1985 are probably infected with HCV, but confirmation of implicated batches is lacking. The association between Sandoglobulin® and HCV is questionable in two patients, although plausible because of a time relationships. In Norway, relationships between Gammonativ and the incidence of HCV infection are similar to those in the 21 sporadic cases in Sweden. Also in Denmark and Finland, HCV infection appears to be related to the lack of additional viral inactivation steps used in the preparation of intravenous immunoglobulin. Clearly, there is a need for increased antiviral inactivation and antiviral screening in the production of intravenous immunoglobulin products.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to Clinical Therapeutics
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- Non-A, non-B hepatitis from intravenous immunoglobulin.Lancet. 1983; 2 (Letter): 974-975
- Immunoglobulin replacement therapy by slow subcutaneous infusion.Ann Intern Med. 1980; 93: 55-56
- Subcutaneous infusion of gammaglobulins in management of agammaglobulinemia.Lancet. 1982; 1 (Letter): 226
- Home treatment in patients with antibody deficiency by slow subcutaneous infusion of gammaglobulin.Lancet. 1982; 1: 689-690
- Immunodeficiency: Suggested Investigations of Infectious Prone Patients Because of Suspected Immunodeficiency. Kabi Pharmacia AB, Stockholm, Sweden1991: 1-39 (In Swedish)
- Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: Safety and costs.Lancet. 1995; 345: 365-369
- Hepatitis C virus transmission by intravenous immunoglobulin.J Hepatol. 1994; 21: 455-460
- Intravenous immunoglobulin prophylaxis causing liver damage in 16 of 77 patients with hypogammaglobulinemia or IgG subclass deficiency.Am J Med. 1988; 84: 107-111
- IgM production in hypogammaglobulinaemic patients during non-A, non-B hepatitis.Lancet. 1986; 1 (Letter): 743
- Non-A, non-B hepatitis after intravenous gammaglobulin.Lancet. 1986; 1: 976-977
- Acute unidentified hepatitis in a hypogammaglobulinaemic patient on intravenous gammaglobulin successfuly treated with interferon.Acta Med Scand. 1987; 221: 413-415
- Hepatitis C infection in patients with primary hypogammaglobulinemia after treatment with contaminated immune globulin.NEJM. 1994; 331: 1607-1611
- Inactivation of viruses in blood and plasma products.Transfus Med Rev. 1993; 7: 42-57
- and The European Study Group. Transmission of non-A, non-B hepatitis by heat-treated factor VIII concentrate.Lancet. 1985; 2: 1-4
© 1996 Published by Elsevier Inc.