Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study
MassBiologics; Department of Medicine; Department of Biochemistry and Molecular Pharmacology
Medical Subject Headings
Liver Transplantation; Hepacivirus; Hepatitis C Antibodies
Rapid allograft infection complicates liver transplantation (LT) in patients with hepatitis C virus (HCV). Pegylated interferon-alpha and ribavirin therapy after LT has significant toxicity and limited efficacy. The effect of a human monoclonal antibody targeting the HCV E2 glycoprotein (MBL-HCV1) on viral clearance was examined in a randomized, double-blind, placebo-controlled pilot study in patients infected with HCV genotype 1a undergoing LT. Subjects received 11 infusions of 50 mg/kg MBL-HCV1 (n=6) or placebo (n=5) intravenously with three infusions on day of transplant, a single infusion on days 1 through 7 and one infusion on day 14 after LT. MBL-HCV1 was well-tolerated and reduced viral load for a period ranging from 7 to 28 days. Median change in viral load (log10 IU/mL) from baseline was significantly greater (p=0.02) for the antibody-treated group (range -3.07 to -3.34) compared to placebo group (range -0.331 to -1.01) on days 3 through 6 posttransplant. MBL-HCV1 treatment significantly delayed median time to viral rebound compared to placebo treatment (18.7 days vs. 2.4 days, p
Chung, R. T.; Gordon, F. D.; Curry, M. P.; Schiano, T. D.; Emre, S.; Corey, K.; Markmann, J. F.; Hertl, M.; Pomposelli, J. J.; Pomfret, E. A.; Florman, S.; Schilsky, M.; Broering, Teresa J.; Finberg, Robert W.; Szabo, Gyongyi; Zamore, Phillip D.; Khettry, U.; Babcock, Gregory J.; Ambrosino, Donna M.; Leav, Brett A.; Leney, Mark; Smith, H. L.; and Molrine, Deborah C., "Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study" (2013). Biochemistry and Molecular Pharmacology Publications and Presentations. 158.