• Int. J. Clin. Pract. · Jun 2021

    Randomized Controlled Trial

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

    • Mona S Abdel Monem, Samar F Farid, Maggie M Abbassi, Ilham Youssry, Nevine G Andraues, Mohamed Hassany, Yasmeen M M Selim, and Manal H El-Sayed.
    • Department of Clinical Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
    • Int. J. Clin. Pract. 2021 Jun 1; 75 (6): e14104.

    BackgroundIron overload-induced oxidative stress and transfusion-acquired hepatitis C virus (HCV) infection are the main reasons of liver damage in beta thalassemia major (β-TM).ObjectivesBased on metformin's hepatic benefits in nondiabetic populations, the study aims to investigate the safety and the potential hepatoprotective effect of metformin in HCV-infected β-TM adolescent patients.MethodsThis was a prospective, randomised, 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, whereas metformin (500 mg, twice daily) was added to the treatment group's regimen only. Patients were prospectively followed up for 6 months with assessment of liver biochemical profile, oxidative stress markers, liver fibrosis, clinical symptom improvement and metformin's adverse effects.ResultsAspartate aminotransferase serum level decreased significantly over time in the treatment group only (P = .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 < .001). Fibrosis grade improvement was observed in 14 patients in the treatment group versus one improved case in the control group.ConclusionThe use of metformin in HCV-infected β-TM adolescent patients as an adjuvant antioxidant hepatoprotective agent is promising and can improve liver damage.© 2021 John Wiley & Sons Ltd.

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