LP17 : Novel approach for the prevention of recurrent hepatitis C in liver transplant recipients: Preliminary results from ongoing phase III trial with civacir®

Current Management of Hepatitis C Virus

“…In a phase 3, open-label randomized study, 84 HCV-infected wait-listed patients receiving DAAs leading up to transplant were randomized 1:1:1 to hepatitis C immunoglobulin (HCIG) 200 mg/kg, 300 mg/kg, or observation. 47 In preliminary data, 63 patients were treated pre-LT with DAA-based therapy for a median of 63 days with post-transplant reinfection occurring in 1/21 (5%) in the 300 mg/kg, 7/22 (32%) in 200 mg/kg group and 6/20 (30%) controls. 47 These preliminary results suggest use of higher dose HCIG may be beneficial as an adjuvant therapy for patients on HCV therapy undergoing LT.…”

Broad neutralization of hepatitis C virus‐resistant variants by Civacir hepatitis C immunoglobulin

“…Indeed, preliminary results of the ongoing clinical trial evaluating Civacir revealed a high frequency of hepatitis C recurrence (30%) in the low‐dose arm (200 mg/kg), which was similar to the control group (32%). In contrast, recurrence of infection was observed in only 5% patients in the high‐dose group (300 mg/kg) . Notably, the Civacir concentrations required for inhibition of HCV infection in cell‐based models (IC50 240 μg/mL observed for escape variant P1VL in HCVcc) are in the range of concentrations used in clinical trials (200‐300 mg/kg).…”

“…From the 1 safety and efficacy at preventing the recurrence of HCV after LT in the United States. (13) Civacir has not been approved for safety and effectiveness by competent regulatory authorities. It is prepared from pooled plasma of hundreds of donors obtained from chronically HCVinfected patients and purified employing several steps of fractionation, virus elimination, and inactivation.…”

“…The HCIG Civacir is an investigational drug that is currently being developed in an ongoing phase 3 clinical trial (clinical trial identifier NCT01804829) assessing its safety and efficacy at preventing the recurrence of HCV after LT in the United States . Civacir has not been approved for safety and effectiveness by competent regulatory authorities.…”

“…In the ongoing phase 3 randomized controlled clinical trial with Civacir, patients receive any antiviral treatment prior to LT that reduces HCV RNA levels to below 100 IU/mL at the time of transplantation and are randomized to either a control (no Civacir or other antiviral treatment post‐LT) or an active treatment arm to receive Civacir at 200 mg/kg or 300 mg/kg doses for 10 weeks in the pre‐LT and post‐LT periods to prevent recurrence post‐LT. Preliminary data showed a reinfection rate of 32% for the control versus a 5% reinfection rate for the 300 mg/kg dose arm . Aiming to understand the potential role of Civacir for difficult‐to‐treat patients, we investigated the activity of Civacir against viruses resistant to host neutralizing responses and antiviral therapies.…”