Glycyrrhizin in patients who failed previous interferon alpha-based therapies: biochemical and histological effects after 52 weeks.

Manns, M P;Wedemeyer, H;Singer, A;Khomutjanskaja, N;Horsmans, Yves;et.al.
(2012) Journal of Viral Hepatitis — Vol. 19, n° 8, p. 537-546 (2012)

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Authors
  • Manns, M P
    Author
  • Wedemeyer, H
    Author
  • Singer, A
    Author
  • Khomutjanskaja, N
    Author
  • Horsmans, YvesUCLouvain
    Author
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Abstract
Chronic hepatitis C patients often fail to respond to interferon-based therapies. This phase III study aimed at confirming the efficacy and safety of glycyrrhizin in interferon + ribavirin-based therapy non-responders. A randomised, double-blind, placebo-controlled, comparison of glycyrrhizin, administered intravenously 5×/or 3×/week, and 5×/week placebo for 12 weeks to 379 patients, was followed by a randomised, open comparison of glycyrrhizin i.v. 5×/versus 3×/week for 40 weeks. Primary endpoints were: (1) the proportion of patients with ≥50% ALT (alanine aminotransferase) reduction after 12 weeks double-blind phase, and (2) the proportion of patients with improvement of necro-inflammation after 52 weeks as compared with baseline. The proportion of patients with ALT reduction ≥50% after 12 weeks was significantly higher with 5×/week glycyrrhizin (28.7%, P < 0.0001) and 3×/week glycyrrhizin (29.0%, P < 0.0001) compared with placebo (7.0%). The proportion of patients with improvement in necro-inflammation after 52 weeks was 44.9% with 5×/week and 46.0% with 3×/week, respectively. Glycyrrhizin exhibited a significantly higher ALT reduction compared to placebo after 12 weeks of therapy and an improvement of necro-inflammation and fibrosis after 52-weeks treatment. Generally, glycyrrhizin treatment was well tolerated.
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Manns, M. P., Wedemeyer, H., Singer, A., Khomutjanskaja, N., Dienes, H. P., Roskams, T., Goldin, R., Hehnke, U., Inoue, H., & Horsmans, Y. (2012). Glycyrrhizin in patients who failed previous interferon alpha-based therapies: biochemical and histological effects after 52 weeks. Journal of Viral Hepatitis, 19(8), 537-546. https://doi.org/10.1111/j.1365-2893.2011.01579.x (Original work published 2012)