The Indian Journal of Pediatrics

, Volume 86, Issue 2, pp 148–153 | Cite as

Treatment of Chronic Hepatitis C Infection with Direct Acting Antivirals in Adolescents with Thalassemia Major

  • Aabha NagralEmail author
  • Ajay Jhaveri
  • Smita Sawant
  • Nirzar Samir Parikh
  • Nishtha Nagral
  • Rashid Merchant
  • Mihir Gandhi
Original Article



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.


Hemoglobinopathy Sofosbuvir Ledipasvir Daclatasvir Iron overload 



Alanine aminotransferase


Complete blood count


Chronic hepatitis C


Confidence interval


Direct-acting Antivirals


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


Thalassemia Major


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.

Author’s Contributions

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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Copyright information

© Dr. K C Chaudhuri Foundation 2018

Authors and Affiliations

  • Aabha Nagral
    • 1
    • 2
    • 3
    Email author
  • Ajay Jhaveri
    • 1
  • Smita Sawant
    • 4
  • Nirzar Samir Parikh
    • 1
  • Nishtha Nagral
    • 5
  • Rashid Merchant
    • 6
  • Mihir Gandhi
    • 7
    • 8
    • 9
  1. 1.Department of GastroenterologyJaslok Hospital & Research CentreMumbaiIndia
  2. 2.Department of GastroenterologyApollo HospitalMumbaiIndia
  3. 3.Department of GastroenterologyBhatia HospitalMumbaiIndia
  4. 4.Medical OfficerNagral ClinicMumbaiIndia
  5. 5.Topiwala National Medical College & BYL Nair Charitable HospitalMumbaiIndia
  6. 6.Department of PediatricsDr. Balabhai Nanavati HospitalMumbaiIndia
  7. 7.Department of BiostatisticsSingapore Clinical Research InstituteSingaporeSingapore
  8. 8.Quantitative Services & Collaborations, Centre for Quantitative MedicineDuke-NUS Medical SchoolSingaporeSingapore
  9. 9.Global Health Group, Faculty of Medicine and Life SciencesUniversity of TampereTampereFinland

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