Efficacy of the new Direct Acting Antiviral drugs in the treatment of Thalassemic HCV patients

Abstract

Background and Objectives: B-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. However, patients with haemoglobinopathies and CHC have been excluded from the major clinical trials that led to the approval of DAAs, Hence, at present, limited experience is available regarding the safety and efficacy of DAAs in this population which is traditionally considered difficult to treat. Hence, this study was carried out to evaluate efficacy and safety of the combination regimen of sofosbuvir and daclatasvir for HCV infection in B-thalassemia major patients. Methods: This study was conducted on 200 subjects divided into two groups, first group contains150 HCV-Thalassemic patients while the second group contains 50 HCV only patients. Each group was classified into easy to treat or difficult to treat and received sofosbuvir 400mg + daclatasvir 60mg once/day for the duration of 12 or 24 weeks according to the NCCVH Hepatitis C treatment protocol 2015. Sustained virological response at post-treatment week-12 (SVR-12) was defined as negative HCV-RNA at week-12 post treatment. Results: In group (I), successful SVR was achieved in all patients (100%) in subgroup (Ia) while in subgroup (Ib) 12 patients didn’t achieve SVR (15.38%), 4 patients stopped due to side effects(5.13%) and 62 patient achieved SVR (79.49) with overall successful SVR of 134 out of 150 HCV-Thalassemic patients in group (I) (89.33%). in group (II), 2 patients didn’t achieve SVR (5.71%)and 33 patients achieved SVR (94.29%) in subgroup (IIa) while in subgroup (IIb) 2 patients didn’t achieve SVR (13.33%) and 13 patients achieved SVR (86.67%) with overall successful SVR of 46out of 50 HCV only patients in group (II) (92%). few patients suffered from minor side effects that didn’t require cessation of treatment but 4 patients developed major side effects in group (Ib) that required cessation of treatment. There were marked improvement in liver enzymes, Fib4 score, hemoglobin level and transfusion requirements in HCV-Thalassemic group after treatment. Conclusion: A combination of sofosbuvir and daclatasvir is an efficacious and tolerable treatment regimen with negligible side effects for patients with thalassemia major and HCV infection.