Journal
AMERICAN JOURNAL OF TRANSPLANTATION
Volume 13, Issue 4, Pages 1047-1054Publisher
WILEY-BLACKWELL
DOI: 10.1111/ajt.12083
Keywords
HCV RNA titer; hepatitis C virus; liver transplantation; monoclonal antibody
Categories
Funding
- MassBiologics, University of Massachusetts, Boston, MA
- CTSA grant [UL1TR000067]
- NIH [DK078772]
- MassBiologics
- Merck
- Gilead
- Pfizer
- Romark
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Rapid allograft infection complicates liver transplantation (LT) in patients with hepatitis C virus (HCV). Pegylated interferon- 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 < 0.001). As with other HCV monotherapies, antibody-treated subjects had resistance-associated variants at the time of viral rebound. A combination study of MBL-HCV1 with a direct-acting antiviral is underway.
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