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

Abstract

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.

Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura

“…In this trial, side-effects were frequent (61%), but significant in only one case with the occasionally described complication of cerebrospinal fluid inflammation (19). The risk of transmitting viral disease is negligible using preparations with well-documented virus inactivation during production (20) and with a convincing clinical safety record (21). The preparations are expensive, two 12 g infusions costing approximately US $1000, but dose reduction may be feasible, a single 0.8 g kg-' infusion probably being sufficient in most cases (6, 7.…”

Inactivation of Viruses during Ultraviolet Light Treatment of Human Intravenous Immunoglobulin and Albumin

“…The most frequent virus inactivation methods for IVIG preparations are exampled by low pH storage [8], pH 4/ pepsin treatment [9,10] and ß-propiolactone [11]. Termi nal dry heat treatment [Welch, pers.…”

Immunoglobulin preparations from hepatitis C antibody-positive plasma donors: influence on diagnosis and risk of infection in heart transplant recipients

“…administration are generally considered safe in respect of transmitting non-A, non-B hepatitis [3,17,27]. However, there are reports of non-A, non-B hepatitis transmissions with immunoglobulin preparations [2,10,22,30].…”