The Potential Hepatoprotective Effect of Metformin in Hepatitis C Virus-infected Adolescent Patients with Beta Thalassemia Major: Randomized Clinical Trial.

Citation:
Abdel Monem, M. S., S. F. Farid, M. M. Abbassi, I. Youssry, N. G. Andraues, M. Hassany, Y. M. M. Selim, and M. H. El-Sayed, "The Potential Hepatoprotective Effect of Metformin in Hepatitis C Virus-infected Adolescent Patients with Beta Thalassemia Major: Randomized Clinical Trial.", International journal of clinical practice, pp. e14104, 2021.

Abstract:

BACKGROUND: Iron overload-induced oxidative stress and transfusion-acquired hepatitis C viral (HCV) infection are the main reasons of liver damage in beta thalassemia major (β-TM).

OBJECTIVES: Based on metformin's hepatic benefits in non-diabetic populations, the study aims to investigate the safety and the potential hepatoprotective effect of metformin in HCV-infected β-TM adolescent patients.

METHODS: This was a prospective, randomized, parallel, controlled, open label study in which 60 HCV-infected β-TM adolescent patients aged 11 to 18 years and receiving no antiviral therapy; were selected and randomly assigned to treatment or control group in 1:1 allocation. Both groups were receiving β-TM standard of care regimen while metformin (500 mg, twice daily) was added to the treatment group's regimen only. Patients were prospectively followed-up for six months with assessment of liver biochemical profile, oxidative stress markers, liver fibrosis, clinical symptoms improvement and metformin's adverse effects.

RESULTS: Aspartate aminotransferase serum level decreased significantly over time in the treatment group only (P= 0.013). However, improvement was not clinically significant and did not attain normality. Change in total antioxidant capacity and malondialdehyde serum levels indicated significantly improved oxidative stress status in the treatment group versus significant deterioration in the control group (P ˂ 0.001). Fibrosis grade improvement was observed in 14 patients in the treatment group versus one improved case in the control group.

CONCLUSION: Use of metformin in HCV-infected β-TM adolescent patients as an adjuvant antioxidant hepatoprotective agent is promising and can improve liver damage.