30 June 2010

Biotest AG launch ZUTECTRA,a new subcutaneous prophylaxis against hepatitis B reinfection

Hepatitis B reinfection prophylaxis after liver transplantation is crucial for long-term graft and patient survival. Over the past decades, hepatitis B immunoglobulin (HBIG) in combination with nucleoside/ nucleotide analogues have been widely adopted as the most effective treatment strategy against recurrent hepatitis B virus (HBV) disease after liver transplantation. While intravenous application of HBIG is the standard of care for inpatient and outpatient HBV reinfection prophylaxis since 1993 (EUROHEP), Biotest's newly-introduced HBIG preparation, Zutectra®, offers an additional convenient and feasible treatment option for long-term use: Zutectrais the first HBIG for subcutaneous application which allows for self administration. Key data of the approval study and prevention strategies against HBV reinfection in liver transplant patients have been presented during a satellite symposium sponsored by Biotest AG at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna.
“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.

The percentage even rose to 83% in patients with pre-transplant high viral load.“Based on current understanding of the immunopathogenesis, HBV may persist for decades even after liver transplantation. Therefore, HBV-reinfection prophylaxis should aim at maximal suppression of residual viral load using the most appropriate virostatic agent in combination with HBIG”, Professor Shouval explained. After systematic review and meta-analysis of 20 clinical studies with different mono-and combination treatment protocols, results are clearly supporting long-term combination therapy with HBIG and virostatic agents such as lamivudine, adefovir, entecavir or tenofovir. A clinical study comparing HBIG plus lamivudine versus lamivudine monotherapy in patients with HBV DNA >10vEq/ml at the time of transplantation showed a recurrence of 88% under monotherapy versus 28% in the combined group. Today, the combined HBV-reinfection treatment suppresses viral replication through two different mechanisms and as a result limits post transplantation HBV-reinfection rates and breakthrough infection to 5-10%.
“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.

Zutectra was evaluated in an open, prospective, single-arm phase III trial, in which 23 liver transplanted patients (intention-to-treat set) were switched from i.v. to weekly s.c. hepatitis B immunoglobulin administration. Patients with a body weight <>100 IU/l and not a single case of HBV reinfection was found during the study. No relevant changes in safety parameters in terms of laboratory values, vital signs or physical conditions have been observed. “Results of the study underline the feasibility, efficacy and safety of homecare treatment with ZutectraÒ”, PD Dr. Beckebaum concluded from the key study results. The number of patients who administered the subcutaneous HBIG themselves steadily increased over the study period: on study day 120, 96 percent of the patients were able to self-administer.

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