Safety and Efficacy of Sofosbuvir and Daclatasvir for Hepatitis C Virus Infection in Patients with β-Thalassemia Major.

Background and Aims: β-thalassemia major patients are susceptible to Hepatitis C Virus (HCV) infection owing to life-long dependency for blood-transfusion. Moreover, this patient population is at risk of progression of liver fibrosis or development of cirrhosis as a consequence of both iron overload and HCV infection. Hence, this study was carried out to evaluate efficacy and safety of the combination regimen of sofosbuvir and daclatasvir for HCV infection in β-thalassemia major patients.

Methods: The present study was a prospective observational study which enrolled multi-transfused β-thalassemia major patients treated with a combination regimen of sofosbuvir (400 mg) and daclatasvir (60 mg) daily for 12 weeks for HCV infection during May 2016 and November 2016 depending upon inclusion and exclusion criteria of the study. Sustained virological response at post-treatment week-12 (SVR-12) was defined as negative HCV-RNA at week-12 after completion of antiviral treatment.

Results: A total of 10 multi-transfused patients with β-thalassemia major were included in the study. Average age of the patient was 13.60 ± 4.38 years. All the included patients were treatment-naïve, non-cirrhotic and infected with HCV genotype-3. All the patients achieved SVR-12. There was significant reduction in aspartate aminotransferase ( p  = 0.005) and alanine aminotransferase level ( p  = 0.005) and serum ferritin level ( p  = 0.028) after completion of the antiviral treatment. The reported adverse events include nausea, vomiting and anorexia which were managed conservatively. None of the patient required dose reduction or termination of antiviral treatment.

Conclusion: The study reports safety and efficacy of sofosbuvir-based treatment in non-cirrhotic, treatment-naive β-thalassemia major patients infected with HCV genotype-3. However, further studies with larger patient populations are needed to build up stronger evidence of safety and efficacy of this treatment approach for HCV infection in thalassemic patients.