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.
Highlights
Treatment of hepatitis C virus (HCV) infection has significantly improved over the past 2 decades
Sustained virological response (SVR) rates are less than 50% for genotype 1 patients and there is no standard of care (SOC) for non-responders to date [1,2]
For the first primary endpoint the proportion of patients with alanine aminotransferase (ALT) reduction ‡50% was significantly higher with 5·/week GL (28.7%, P < 0.0001) and 3·/week GL + 2·/week placebo (29.0%, P
Summary
Treatment of hepatitis C virus (HCV) infection has significantly improved over the past 2 decades. Contraindications as well as intolerance to IFN based therapies leave a large number of patients ineligible for this medication. These patients are at risk to develop cirrhosis and its complications, including hepatocellular carcinoma (HCC) [3]. Studies with long-term application of low dose peg-IFNa failed to achieve reduced progression of liver disease. These studies showed that inflammation and fibrosis progression could not be suppressed [4,5]. Response rates to triple therapy with HCV protease inhibitors, peg-IFNa and ribavirin in previous nonresponder patients with liver cirrhosis are still below 20% [6]. It is legitimate to search for alternative treatment strategies to suppress inflammatory activity and fibrosis progression in non-responders to IFNbased therapies
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