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Title: A pilot study of therapeutic vaccination with envelope protein E1 in 35 patients with chronic hepatitis C
Authors: Nevens, Frederik ×
Roskams, Tania
Van Vlierberghe, Hans
Horsmans, Yves
Sprengers, Dirk
Elewaut, Ann
Desmet, Valeer
Leroux-Roels, Geert
Quinaux, Emmanuel
Depla, Erik
Dincq, Stephanie
Vander Stichele, Christine
Maertens, Geert
Hulstaert, Frank #
Issue Date: Nov-2003
Series Title: Hepatology (Baltimore, Md.) vol:38 issue:5 pages:1289-96
Abstract: New treatments are needed for chronic hepatitis C patients in whom viral clearance cannot be achieved. Thirty-five chronic hepatitis C patients (genotype 1) were randomized to receive 20 mug of recombinant HCV E1 (E1) (n = 26) or placebo (n = 9) intramuscularly at weeks 0, 4, 8, 12, and 24. Thirty-four then received open-label E1 vaccine at weeks 50, 53, 56, 59, 62, and 65. Twenty-four patients (12 men, 12 women; mean age, 52 y; 18 interferon-based treatment failures; mean baseline alanine aminotransferase [ALT] level, 118 IU/L) underwent a biopsy before and after 2 courses of E1, 17 months later. Liver histology was scored by 2 blinded pathologists according to the Ishak and Metavir systems. Postinjection reactions were similar to placebo (alum only). Nine of 24 patients (38%) had improvement of 2 points or more, 10 (41%) remained stable, and 5 (21%) showed worsening in total Ishak score. Nine patients (38%) improved both on Ishak and Metavir fibrosis scores. Plasma HCV-RNA levels remained unchanged, whereas ALT levels showed a trend toward a decrease during treatment. All but 3 patients developed a significant de novo E1-specific T-cell response. The increase in anti-E1 antibody levels correlated with the decrease in total Ishak score and with the relative decreases in both Ishak fibrosis score and ALT level (all P < or =.01). In conclusion, E1 therapeutic vaccination is well tolerated and the observed effects warrant further study.
URI: 
ISSN: 0270-9139
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Translational Cell & Tissue Research
Hepatology
× corresponding author
# (joint) last author

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