Effectiveness and safety of orally administered silymarin (milk thistle) for pegylated interferon unresponsive chronic delta hepatitis patients

Abstract

Objective: Silymarin is a natural extract from milk thistle (Silybum marianum), a natural herb that contains flavonoids. Silymarin also has anti-inflammatory properties and lipid peroxidation effects on human hepatocytes. It has also been used for the treatment of acute alpha-amanitin poisoning and chronic hepatitis C infection. Chronic Hepatitis D virus (HDV) infection is a severe health problem leading to fibrosis and hepatocellular carcinoma. Patients with chronic HDV infection can be treated with Peg-IFN with lower treatment success. Most patients with chronic HDV are unable or unwilling to use interferon (IFN)-based treatment due to liver cirrhosis. Our objective was to establish the long-term clinical outcomes with silymarin for interferon-experienced chronic HDV patients.
 Materials and Methods: We studied ten patients from one centre with interferon who experienced chronic HDV, of which 8 had cirrhosis, and 2 had chronic hepatitis who received HDV treatment with silymarin 600 mg/day after a median period of 12 months. Information collected included demographic, clinical, virologic, and outcomes data. MELD and Child-Pugh (CP) scores were also obtained. Friedman test was used to evaluate the laboratory parameters during the study period.
 Results: 10 chronic HDV patients (median age 54 yrs, six female, all of them previous null responders to Peg-IFN with mildly decompensated cirrhosis [CP 7 (range 6-11), MELD 11 (range 6-20] were followed for 12 months from the start of silymarin 600 mg/day. There was no decompensation of both MELD and CP scores among patients at the end of therapy. In addition, no patients stopped silymarin treatment early due to side effects. At the end of treatment, there was no significant change in prothrombin time (p= 0.949), AST (p=0.662) and AFP (p=0.983) levels and platelets counts (p=0.988) compared to the pre-treatment period (all p>0.005). Finally, HDV-RNA suppression was seen in all patients at the end of treatment (p=0.009).
 Conclusions: In the light of the presented data, silymarin seems to be effective in treating chronic HDV infection. Further research is needed for validation. The study is ongoing with a collection of data on sustained viral response.