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

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

Abstract

Objectives

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).

Methods

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.

Results

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.

Conclusions

Generic DAAs are effective and safe in TM adolescents with HCV.

Keywords

Hemoglobinopathy Sofosbuvir Ledipasvir Daclatasvir Iron overload 

Abbreviations

ALT

Alanine aminotransferase

CBC

Complete blood count

CHC

Chronic hepatitis C

CI

Confidence interval

DAAs

Direct-acting Antivirals

EASL

European Association for the Study of the Liver

ETR

End of treatment response

FDA

Food and Drug Administration

Hb

Hemoglobin

HBsAg

Hepatitis B surface antigen

HCV

Hepatitis C virus

HIV

Human immunodeficiency virus

kPa

kilopascal

LFT

Liver function test

MRI

Magnetic resonance imaging

PCR

Polymerase chain reaction

PEG-IFN

Pegylated-interferon-alpha

PRBC

Packed red blood cells

RFT

Renal function test

RVR

Rapid virological response

SVR

Sustained virological response

TM

Thalassemia Major

TSH

Thyroid stimulating hormone

VAS

Visual analogue scale

Notes

Acknowledgements

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

None.

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Copyright information

© Dr. K C Chaudhuri Foundation 2018

Authors and Affiliations

  • Aabha Nagral
    • 1
    • 2
    • 3
  • 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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