Phase III data demonstrate prophylactic efficacy of Civacir® in patients who undergo antiviral therapy prior to transplantation
New data from an ongoing Phase III trial revealed at The International Liver CongressTM 2015 show that the use of hepatitis C immune globulin (HCIG, Civacir®) can effectively prevent hepatitis C virus (HCV) recurrence in patients following a liver transplant (LT). The data demonstrate that intravenous Civacir given both peri- and post-LT prevents HCV-reinfection in patients who also received antiviral therapy (AVT) before their transplant operation.
Civacir is a hepatitis C immune globulin (HCIG) produced from pooled plasma from hundreds of screened donors who have high antibody titers against HCV. In this trial, patients received AVT before their LT and those in the active treatment groups received 16 infusions of Civacir in the peri- and immediate post-LT period for 10 weeks. The control group received current standard of care (no treatment) post-LT.
The preliminary results suggest that Civacir provides an effective alternative approach as compared to current standard of care to prevent HCV recurrence in post-LT patients. Civacir was well tolerated with no drug-related serious adverse events observed during the study.
Hepatitis C virus (HCV) remains the leading cause for liver transplantation (LT) and recurrent HCV disease is the most frequent cause of graft loss. Prevention of recurrence independent of genotype and severity of cirrhosis is highly desirable because it simplifies post-LT management.