Treatment of Chronic Hepatitis C Infection with Direct Acting Antivirals in Adolescents with Thalassemia Major
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To assess the efficacy and safety of sofosbuvir based generic Direct Acting Antivirals (DAAs) in treatment of Hepatitis C virus (HCV) in adolescents with thalassemia major (TM).
In this prospective single-arm study, 18 TM adolescents with Chronic Hepatitis C received sofosbuvir based generic DAAs. Patients with genotype 1 and genotype 3 received ledipasvir and daclatasvir respectively. Two cirrhotic patients with genotype 3 also received ribavirin.
The mean age of patients was 15.1 y, of which 12 had genotype 1, 5 had genotype 3 and 1 had an undetermined genotype. Six patients had cirrhosis and 1 was treatment experienced. Sixteen of 18 patients (89%; 95% confidence interval 74 to 100%) achieved sustained virological response at 3 mo post completion of treatment with DAAs. There was a significant reduction in alanine aminotransferase levels (p < 0.001), HCV RNA load (p < 0.001) and ferritin levels (p < 0.026) at 3 mo post completion of treatment. There were no major adverse events associated with the use of DAAs.
Generic DAAs are effective and safe in TM adolescents with HCV.
KeywordsHemoglobinopathy Sofosbuvir Ledipasvir Daclatasvir Iron overload
Complete blood count
Chronic hepatitis C
European Association for the Study of the Liver
End of treatment response
Food and Drug Administration
Hepatitis B surface antigen
Hepatitis C virus
Human immunodeficiency virus
Liver function test
Magnetic resonance imaging
Polymerase chain reaction
Packed red blood cells
Renal function test
Rapid virological response
Sustained virological response
Thyroid stimulating hormone
Visual analogue scale
The authors extend their thanks to all the patients and their families as well as all the participating investigators. They thank the ethics committee of Bhatia Hospital, Mumbai, India. They also thank the Children's Liver foundation for funding the study and Mr. Vinay Shetty of the Think Foundation for facilitating this project.
AN and RM conceptualized and supervised the study; AJ and NSP reviewed the literature and prepared the manuscript; SS and NN collected and entered the data for the manuscript; MG performed the statistical analysis. All authors reviewed and approved the final version of the manuscript. AN will act as guarantor for this paper.
Compliance with Ethical Standards
The study followed the principles of the Helsinki Declaration of 1975, as revised in 2000 and 2009, concerning Human and Animal Rights. The protocol was approved by the Institutional Ethics Committee.
Conflict of Interest
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