Biochemical and histological effects of 26 weeks of glycyrrhizin treatment in chronic hepatitis C: a randomized phase II trial.

Abstract

BACKGROUND/AIMS:

Phase I/II studies of 4 weeks duration have confirmed the ALT lowering effect of glycyrrhizin in Western chronic hepatitis C patients. Our aim was to determine the dose frequency of glycyrrhizin required to maintain the ALT response beyond 4 weeks and evaluate its effect on liver histology and quality of life.

METHODS:

HCV-RNA-positive patients with elevated ALT and marked fibrosis or necro-inflammation who were not eligible for interferon therapy were treated for 4 weeks with six infusions weekly of glycyrrhizin. Patients with an ALT response at week 4 were randomized to continue treatment for 22 weeks in three dose frequency groups: 6x, 3x or once weekly.

RESULTS:

72/121 (60%) patients were randomized. At the end of treatment the ALT response was maintained in 60%, 24% and 9% of patients in the 6x, 3x, and once weekly groups, respectively (p<0.001). In ALT responders the necro-inflammation score improved non-significantly compared to ALT non-responders. Quality of life assessed by SF-36 increased in patients treated with the study drug, albeit unrelated to the occurrence of ALT response.

CONCLUSIONS:

ALT responses induced by 4 weeks glycyrrhizin therapy can be maintained in a subset of chronic hepatitis C patients receiving at least three injections weekly. The observed ALT response did not translate in a significant histological improvement after 6 months treatment.

• Authors: Hans Orlent, Bettina E Hansen, Marc Willems, Johannes T Brouwer, Roman Huber, Gerd A Kullak-Ublick, Guido Gerken, Stefan Zeuzem, Frederik Nevens, Wanda C M Tielemans, Pieter E Zondervan, Martin Lagging, Johan Westin, Solko W Schalm
• Journal: Journal of hepatology (J Hepatol) Vol. 45 Issue 4 Pg. 539-46 (Oct 2006) ISSN: 0168-8278 [Print] Netherlands
• PMID: 16905220 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• RNA, Viral
• Glycyrrhizic Acid
• Alanine Transaminase

Topics

• Adolescent
• Adult
• Aged
• Alanine Transaminase (blood)
• Antiviral Agents (administration & dosage, adverse effects)
• Drug Monitoring (methods)
• Female
• Glycyrrhizic Acid (administration & dosage, adverse effects)
• Hepacivirus (drug effects, genetics)
• Hepatitis C, Chronic (drug therapy, pathology)
• Humans
• Male
• Middle Aged
• Quality of Life
• RNA, Viral (blood)
• Treatment Outcome