- Published on Monday, 10 November 2014 09:51
- Preliminary data presented at the Congress of the American Association for the Study of Liver Disease (AASLD) show prevention of re-infection after liver-transplantation
- More than 50% of study patients have been enrolled in the Civacir Phase III trial
DREIEICH, Germany I November 10, 2014 I Biotest AG announced yesterday in an oral presentation the efficacy and safety interim results from its ongoing US Phase III study (Study 988) with Civacir at the Congress of the American Association of the Study of Liver Disease (AASLD) in Boston, Massachusetts, USA.
Biotest Pharmaceuticals Corporation (BPC) (a subsidiary of Biotest AG) is the only manufacturer of an investigational Hepatitis C immune globulin (Civacir®) worldwide. In the ongoing Phase III trial, Civacir® is being investigated in patients who receive a liver transplant due to chronic hepatitis C infection.
End-stage liver disease due to hepatitis C infection is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by hepatitis C viruses which are still circulating in the patient's body.
Currently, there is no approved treatment available to prevent recurrence of the hepatitis C virus after transplant surgery since current antiviral regimens are generally not used due to toxicities, tolerability issues and drug-drug interactions minimum within the first 6 months after transplantation. Approximately 30% of liver transplant patients require a second liver transplant within 5 years.
This randomized, open-label Phase III trial conducted in 24 clinical centers in the United States is to evaluate the efficacy, safety and pharmacokinetics in the hepatitis C positive transplant population. More than half of the planned patient number has been enrolled in the study.
All patients in the study received antiviral treatment prior to transplantation, including new recently approved virostatics. Patients were randomly assigned to the study drug or the control group. Patients who received the study drug received either 200 mg/kg or 300 mg/kg body weight in the peri- and post transplant periods. The control group received no study drug.
To date, none (0%) of the patients in the higher dosage group have experienced HCV recurrence. Control subjects have a 35% HCV recurrence rate. “The current data are very exciting and we hope that after completion of the study the final evaluation will confirm the presented data”, said Prof Gregor Schulz, CEO of Biotest AG.
The tolerability of tCivacir® was excellent and comparable to the safety profile of other immune globulin products.
Civacir® is an intravenous immune globulin preparation with high titer of hepatitis C (HVC) antibodies. It is currently being investigated for the prevention of HCV recurrence in patients undergoing liver transplantation. Civacir® is administered during the critical time after liver transplantation, when patients are receiving immunosuppressive therapy and treatment with approved antiviral therapies is not indicated.