Sofosbuvir Plus Daclatasvir Feasible in Patients with Thalassemia and Hepatitis C

Direct-acting antiviral therapy was safe and effective in pediatric patients with thalassemia who contracted hepatitis C virus from blood transfusions, suggested an interventional study, published in the Journal of Clinical and Experimental Hepatology.

Specifically, “sofosbuvir-daclatasvir based treatment in non-cirrhotic, treatment-naive thalassemic children and adolescents infected with HCV is effective and safe,” reported the study’s lead author, Riten K Samadder, MD, of the Institute of Post Graduate Medical Education and Research in Kolkata, India.

The nonrandomized, open-label trial enrolled 70 total patients and divided them by age range into group a (six to 11 years; n=45; 64% male) or b (12 to 18 years; n=25; 40% male). Groups a and b had a mean age and mean hepatitis C virus ribonucleic acid (RNA) level of 8.5 years and 446906.1 IU/ml and 13.9 years and 256187.8 IU/ml, respectively. Group a received sofosbuvir 200 mg plus daclatasvir 30 mg and group b received sofosbuvir 400 mg plus daclatasvir 50 mg. The primary endpoint was sustained virological response at 12 weeks.

The primary endpoint was achieved by 43 of 45 (95.5%) intention-to-treat patients and 43 of 44 (97.7%) per-protocol patients in group a, and all patients in group b. Additionally, there were significant improvements in biochemical parameters in both groups, according to the report.

Of the two patients who did not achieve the primary endpoint in group A, one required treatment discontinuation due to urticaria, according to the authors.

In short, the authors conducted the study to address a lack of data on treating hepatitis C virus in children and adolescents with thalassemia, and they concluded that direct-acting antivirals were safe and effective in this population.

Reference

Samadder RK, Ray G, Dutta S, et al. The efficacy and safety of sofosbuvir and daclatasvir treatment in children and adolescents with thalassemia and hepatitis C virus infection. J Clin Exp Hepatol. 2024;14(3):101310. doi:10.1016/j.jceh.2023.101310