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.
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
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.
Labels: AASLD 2014, Cicavir, post-transplant recurrence, prophylaxis