EMA Weighs Safeguards to Protect Plasma-Derived Drugs Against Hepatitis Contamination

With hepatitis E infections dramatically increasing, the European Medicines Agency (EMA) in a new report is assessing whether existing regulations are adequate to ensure plasma-derived drugs can avoid being tainted with the virus.

The agency notes HEV infections are widespread, and blood/plasma donors are often unknown carriers. The virus has been recognized as a transfusion transmissible agent since 2004, and transfusion-related cases have been documented in several countries including the UK, France, Japan, Saudi Arabia and China.

More recently, an analysis of blood and plasma donations has identified infections in Germany, Sweden and the UK. The EMA says HEV infections in industrialized countries are more prevalent than previously thought.

The review is in its early stages with the EMA seeking feedback from drugmakers on a variety of topics, including:

• Transfusion-associated infections and clinical experience with HEV-infections;
• Latest information on the epidemiology of HEV infection with focus on blood and plasma donors;
• Duration of viraemia and virus loads of blood and plasma donations;
• Potential testing methods for screening of donors and testing of plasma pools;
• HEV-specific antibodies and neutralization;
• Latest information about the development of cell culture systems for HEV and their feasibility for validation of virus inactivation/removal;
• Latest experience from studies on inactivation/removal of HEV;
• Relevance of model viruses for evaluation of virus inactivation/removal of HEV;
• Safety of solvent-detergent treated plasma;
• Risk assessment for plasma-derived medical products and implication for warning statements; and
• Perspective from patients.

Industry may offer comment until July 31 on the proposal. — Nick Otto

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