Human Monoclonal Antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study.
Chung R T, Gordon F D, et al.American Journal of Transplantation. 2013; 13(4):1047-54
Aims
To investigate the effect of monoclonal antibody MBL-HCV1 on reducing the viral load of Hepatitis C Virus (HCV), following liver transplantation (LT).
Interventions
Participants were administered either MBL-HCV1 (50mg/kg) or placebo (0.9% sodium chloride). Three infusions were given on the day of LT and daily infusions were administered on days 1-7, followed by a final infusion on day 14±2 post-LT.
Participants
13 patients ≥ 18 years old, HCV genotype 1a-infected and undergoing LT from deceased or living-related donors.
Outcomes
Primary outcomes included HCV RNA serum levels and an assessment of time-to-onset of detectable HCV RNA. Protocol specified biopsies were performed on the allograft on days 0 and 42 ± 7 to identify hepatitis and acute cellular rejection.
Follow-up
56 days.
CET Conclusions
Liver transplant recipients with Hepatitis C Virus were randomized to receive infusions of placebo or the monoclonal antibody MBL-HCV1 (against a highly conserved epitope of Hepatitis C Virus glycoprotein). This pilot study has so far only included results from 11 patients (16 were planned for this stage and a further 16 for the second stage). There was no significant difference in the primary outcome, the proportion of patients with detectable Hepatitis C RNA 42 days after transplantation. The antibody MBL-HCV1 did however significantly reduce viral RNA levels from days 3 to 6 post-operatively compared to the placebo arm. The second stage of the study is ongoing using a higher dose of antibody.
Data analysis
Modified intention-to-treat analysis
Trial registration
Not recorded