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Most immune globulin products ineffective for hepatitis A prophylaxis
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A recent letter published in JAMA Internal Medicine reports two of nine human immune globulin products tested for hepatitis A prophylaxis efficacy just meet the minimal potency level required by the European Pharmacopeia.
“Because anti-HAV antibody levels are declining in plasma donors from developing countries, we evaluated antibody levels in currently marketed [immune globulin (IG)] products,” Alexandra Tejada-Strop, MS, from the division of viral hepatitis at CDC, and colleagues wrote. “Several products had lower-than-expected anti-HAV potencies, potentially conferring protection of reduced magnitude of duration against hepatitis A.”
The researchers evaluated nine intramuscular IG preparations: 4 single lots of GammaQuin (Sanquin; the Netherlands), Beriglobin (CSL Behring; Germany), Subgam (Blood Products Laboratory; United Kingdom) and Gamma-globulin (Green Cross; Korea); and 5 lots of GamaSTAN S/D (Grifols; United States).
Tejada-Strop and colleagues found that GammaQuin had a far higher anti-HAV neutralizing potency and IgG potency compared with the other eight preparations. Beriglobin had the second highest anti-HAV IgG potency, but Gamma-globulin, Subgam and all five lots of GamaSTAN S/D were not significantly different from each other. The investigators observed that only the IG preparations GammaQuin and Beriglobin were considered protective against infection, meaning they reached anti-HAV neutralizing antibody levels greater than 10 mIU/mL. Although the products should provide 90-days of protection, no hepatitis A prophylaxis reached this.
In an accompanying commentary, Mitchell H. Katz, MD, from the Los Angeles County Department of Health Services, stated that he never considered the possibility that certain preparations for hepatitis A prophylaxis would be ineffective. The decline in donors exposed to hepatitis A, he wrote, is likely the reason for the lack of potency in these products. Katz recommended that until regulations are changed, doctors should use the two preparations with the highest tested potency and duration of protective levels — GammaQuin and Beriglobin. He advised that instead of IG, to use hepatitis A vaccine for pre-exposure prophylaxis or post-exposure prophylaxis whenever possible.
“Approaches to improve anti-HAV protection by IG potentially include increasing the dosage or producing lots from plasma of hyperimmunized donors,” Tejada-Strop and colleagues wrote. “Adopting a functional HAV neutralization assay such as ARTA would be appropriate for future evaluation of postimmunization protection and product efficacy.” – by Savannah Demko
Disclosure: The researchers report no relevant financial disclosures.
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