“Transplantation due to HBV-associated liver cirrhosis with active HBV replication is the major risk factor for reinfection of the transplanted liver”, Professor Daniel Shouval, Liver Unit of Hadassah University Hospital, Jerusalem, Israel, stated in his opening remarks. A retrospective European study showed that 67% of transplanted patients with cirrhosis who did not receive immunoprophylaxis or only short-term prophylaxis developed a HBV reinfection of the graft.
“It has been suggested to discontinue HBIG treatment after stabilization of the patient for compliance reasons as well as high costs. However, cases of late recurrence after discontinuation, residual HBV DNA in >50% of patients after ten years as well as the difficulty to identify patients who have cleared HBV led to a consensus to maintain long-term prophylaxis”, Professor Shouval reported. This requirement made it even more important to search for alternatives that would lower patients' discomfort with intramuscular or intravenous injection as well as cost. The research resulted in the development of Zutectraas the first HBIG product for subcutaneous selfadministration which was recently launched in Germany, Austria and the UK and soon will be launched in Italy, Ireland as well as other countries with active liver transplantation programs.
“We have seen that weekly administration of Zutectra® is safe and well tolerated and can maintain stable anti-HBs-concentrations irrespective of the plasma antibody titres aimed for. It is expected that the introduction of a s.c. HBIG preparation will lead to lower frequency of physician consultations and healthcare costs. Moreover, the option for self-administration of Zutectraat home enhances the patients' convenience during maintenance treatment as well as their professional and social life”, PD Dr. Susanne Beckebaum summarized the major outcomes of the approval study. The clinical study was conducted by Dr. Ruth Neuhaus, Virchow-Clinic of the Charité University, Berlin, and PD Dr. Susanne Beckebaum at the Liver Transplant Unit, University Hospital Essen.