Safety of Intravenous Immunoglobulin for Treatment of Auto-Immune Thrombocytopenia

Gutteridge, C. N.; Veys, PA; Newland, A. C.

doi:10.1159/000205727

Cited by 24 publications

(6 citation statements)

References 6 publications

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“…Thus, the trial confirmed that the study IVIG did not transmit hepatitis. The results agree with the outcome of some retrospective or prospective studies [9][10][11]. Our data corroborate the clinical experience with the IVIG prep aration based on this procedure (Central Laboratory of the Swiss Red Cross Blood Transfusion Service, Sandoglobulin) which is now in use for approximately 10 years.…”

Section: Resultssupporting

confidence: 90%

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

Imbach¹,

Perret²,

Babington³

et al. 1991

Vox Sanguinis

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The risk of non-A, non-B hepatitis transmission by an intravenous immunoglobulin (IVIG) preparation was assessed in a prospective multicenter trial in 68 patients with primary immunodeficiency disorders (40 children or adolescents and 28 adults). During the 4-week prestudy evaluation period the clinical examinations and liver function tests including alanine aminotransferase, aspartate aminotransferase, yglutamyl transpeptidase, alkaline phosphatase, and bilirubin were normal in all patients. The treatment consisted of three infusions of 200 mg IVIG (pH 4; pepsin procedure) per kilogram body weight at 2-week intervals. During the observation period of 24 weeks following the first infusion of the study IVIG, the patients were monitored at regular time intervals. No clinical and laboratory signs of hepatitis or liver dysfunction were noticed. All patients completed the study. In 5 patients, one isolated alanine aminotransferase value and in another patient one γ-glutamyl transpeptidase value were moderately elevated, but always below 2.5 times the upper limit of the reference range. Similar isolated and transient elevations were observed for aspartate aminotransferase and alkaline phosphatase. It was concluded that the IVIG preparation did not transmit non-A, non-B hepatitis or other viral liver diseases.

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Section: Resultssupporting

confidence: 90%

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

Imbach¹,

Perret²,

Babington³

et al. 1991

Vox Sanguinis

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“…During the development of immune globulin preparations that would be safe for intravenous use, it was observed that incorporation of a pH4 finishing step, in the presence of low concentrations of porcine pepsin, produced an IVIG preparation with a very low adverse reaction rate that also seemed to be free of hepatitis transmission [17][18][19]. However, in 1989, there was a report of NANBH transmission by an IVIG preparation manufactured by the Scottish National Blood Transfusion Service (SNBTS IV IgG) in which the pH4 finishing step (together with low concentrations of pepsin) was used [9].…”

Section: Nanbh Transmission By Ivig Preparations Involving a Ph4 Finimentioning

confidence: 99%

“…However, as the transfused blood was obtained in a country in which the rate of HCV infection is known to be very low, the source of the HCV infection was probably not the blood transfusion, and could have been the Sandoglobulin preparation. Subsequently, it was reported that there was a failure to detect NANBH in 44 recipients of the same IVIG preparation, although the liver enzyme monitoring was not performed rigorously [19].…”

Section: Nanbh Transmission By Ivig Preparations Involving a Ph4 Finimentioning

confidence: 99%

The viral safety of intravenous immune globulin

Yap

1996

Clinical and Experimental Immunology

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The viral safety of intravenous immune globulin (IVIG) preparations has been investigated since 1983 when it was discovered that non‐A, non‐B hepatitis (NANBH) could be transmitted by an experimental IVIG preparation. Recently, it has been demonstrated that the virus causing NANBH is the hepatitis C virus (HCV). A number of subsequent episodes of HCV transmission by IVIG have been reported, but not all the factors that have led to this transmission arc clearly understood. However, based on two episodes of HCV transmission by anti‐D immune globulin (formulated for intravenous administration), it appears that cold ethanol fractionation is important in ensuring viral safety because both of the implicated anti‐D immune globulin preparations were manufactured without cold ethanol fractionation. Other HCV transmission episodes have been associated with chromatography (particularly DEAE‐Sephadcx chromatography) as a separation step carried out to further purify IgG, after cold ethanol fractionation, and it is possible that such a procedure has only a marginal partitioning capacity for infective HCV virions. The role of anti‐HCV screening in improving the viral safety of IVIG preparations remains unclear, but a recent transmission episode by a previously safe IVIG preparation suggests that the absence of anti‐HCV antibodies during plasma fractionation may affect the partitioning characteristics of HCV and may also cause a loss of neutralizing antibody against HCV. All of the IVIG preparations associated with HCV transmission have been formulated as freeze‐dried preparations and this may have been important in stabilizing HCV during the period prior to administration to patients. No other viruses appear to have been transmitted by IVIG preparations, but prior to seroconversion, HCV‐infected plasma donors may continue to contaminate plasma pools used for the manufacture of blood products, despite anti‐HCV screening, and additional viral inactivation steps such as incubation at pH4 or solvent‐detergent treatment should be incorporated into the production process of all IVIG preparations.

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“…A retrospective analysis of 41 patients treated with IVIG for 6 to 15 months found no evidence of hepatitis (424). Another review of 64 patients treated for ITP showed no evidence of HIV or abnormal liver function (425). However, in late February 1994 there were multiple reports of elevated transaminases related to infusion of several lots of Gammagard@.…”

Section: Transmission Of Viral Infectionsmentioning

confidence: 99%

Intravenous gammaglobulin, 2: pharmacology, clinical uses and mechanisms of action

Schiff¹

1994

Pediatric Allergy Immunology

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Safety of Intravenous Immunoglobulin for Treatment of Auto-Immune Thrombocytopenia

Cited by 24 publications

References 6 publications

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

Safety of Intravenous Immunoglobulin Preparations: A Prospective Multicenter Study to Exclude the Risk of Non-A, Non-B Hepatitis

The viral safety of intravenous immune globulin

Intravenous gammaglobulin, 2: pharmacology, clinical uses and mechanisms of action

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