- 50% of liver transplantations are due to hepatitis C infection
- High unmet medical need: Prevention of hepatitis C virus recurrence in liver transplant
- Civacir has received an Orphan Drug designation in both the US and the EU
BOCA RATON, Fla. and DREIEICH, Germany, Aug. 7, 2013 /PRNewswire/ -- Biotest AG has achieved another milestone in the development of intravenous hyperimmune globulins. After treatment with virostatics over several weeks, the first patient underwent liver transplantation and subsequently was treated with the Civacir in the Phase III clinical trial.
Civacir, a 10 % hepatitis C hyperimmune globulin developed and produced at Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, is being used in a clinical trial in North America in patients undergoing liver transplantation as a consequence of Hepatitis C infection.
End-stage liver disease due to hepatitis C virus (HCV) is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by any HCV viruses which are still circulating in the patient's body, resulting in a reinfection rate of around 80 % within 4 weeks after transplantation. Currently, there is no approved treatment available to prevent recurrence of the HCV virus after surgery since current antiviral regimens cannot be safely used after surgery due to toxicities, tolerability issues and drug-drug interactions within the first months after transplantation. Approximately 30% of these patients require a second liver transplant within 5 years.
The aim of this Phase III clinical trial (Study 988) is to evaluate the efficacy and safety as well as the pharmacokinetics of the agent in the HCV transplant population. Study 988 is being conducted at sites in the US and Canada, with a total of up to 90 patients to be enrolled.