Skip to main content

Advertisement

SpringerLink
Log in

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

  • Original Article
  • Published:
The Indian Journal of Pediatrics Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

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

References

  1. Vidja PJ, Vachhani JH, Sheikh SS, Santwani PM. Blood transfusion transmitted infections in multiple blood transfused patients of beta thalassaemia. Indian J Hematol Blood Transfus. 2011;27:65–9.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Sidhu M, Meenia R, Yasmeen I, Sawhney V, Dutt N. Prevalence of transfusion-transmitted infections in multiple blood transfused thalassemia patients: a report from a tertiary care center in North India. Ann Trop Med Public Health. 2015;8:202–5.

    Article  Google Scholar 

  3. El-Shabrawi MH, Kamal NM. Burden of pediatric hepatitis C. World J Gastroenterol. 2013;19:7880–8.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Irshad M, Peter S. Spectrum of viral hepatitis in thalassemic children receiving multiple blood transfusions. Indian J Gastroenterol. 2002;21:183–4.

    PubMed  Google Scholar 

  5. Yang CHT, Yoo ER, Ahmed A. The role of direct-acting antivirals in the treatment of children with chronic hepatitis C. J Clin Transl Hepatol. 2017;5:59–66.

    PubMed  PubMed Central  Google Scholar 

  6. Murray KF. Treatment of chronic hepatitis C in children. In: Jonas MM, editor. Viral hepatitis in children: unique features and opportunities. New York: Humana Press; 2010. p. 67–88.

    Chapter  Google Scholar 

  7. Hu J, Doucette K, Hartling L, Tjosvold L, Robinson J. Treatment of hepatitis C in children: a systematic review. PLoS One. 2010;5:e11542.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. Nagral A, Sawant S, Nagral N, Parikh P, Malde P, Merchant R. Generic direct acting antivirals in treatment of chronic hepatitis C infection in patients of thalassemia major. J Clin Exp Hepatol. 2017;7:172–8.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Wirth S. Current treatment options and response rates in children with chronic hepatitis C. World J Gastroenterol. 2012;18:99–104.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Di Marco V, Lo Iacono O, Capra M, et al. Alpha-interferon treatment of chronic hepatitis C in young patients with homozygous beta-thalassemia. Haematologica. 1992;77:502–6.

    PubMed  Google Scholar 

  11. Balistreri W, Murray K, Rosenthal P, et al. The safety and effectiveness of ledipasvir−sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017;66:371–8.

    Article  CAS  PubMed  Google Scholar 

  12. Wirth S, Rosenthal P, Gonzalez-Peralta RP, et al. Sofosbuvir and ribavirin in adolescents 12–17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017;66:1102–10.

    Article  CAS  PubMed  Google Scholar 

  13. Murray KF, Balistreri W, Bansal S, et al. Ledipasvir/sofosbuvir ± ribavirin for 12 or 24 weeks is safe and effective in children 6–11 years old with chronic hepatitis C infection. J Hepatol. 2017;66:S57–8.

    Article  Google Scholar 

  14. Sokal EM. Direct acting anti virals for paediatric HCV: we got there. Nat Rev Gastroenterol Hepatol. 2017;14:452–3.

    Article  PubMed  Google Scholar 

  15. EASL recommendations on treatment of hepatitis C 2016. J Hepatol. 2017;66:153–94.

  16. Giannini EG, Afdhal NH, Sigal SH, et al. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015;30:1301–8.

    Article  CAS  PubMed  Google Scholar 

  17. Goodman ZD, Makhlouf HR, Liu L, et al. Pathology of chronic hepatitis C in children: liver biopsy findings in the Peds-C trial. Hepatology. 2008;47:836–43.

    Article  PubMed  PubMed Central  Google Scholar 

  18. González-Peralta RP, Langham MR Jr, Andres JM, et al. Hepatocellular carcinoma in 2 young adolescents with chronic hepatitis C. J Pediatr Gastroenterol Nutr. 2009;48:630–5.

    Article  PubMed  Google Scholar 

  19. Barshes NR, Udell IW, Lee TC, et al. The natural history of hepatitis C virus in pediatric liver transplant recipients. Liver Transpl. 2006;12:1119–23.

    Article  PubMed  Google Scholar 

  20. Sood A, Sobti P, Midha V, et al. Efficacy and safety of pegylated IFN alfa 2b alone or in combination with ribavirin in thalassemia major with chronic hepatitis C. Indian J Gastroenterol. 2010;29:62–5.

    Article  PubMed  Google Scholar 

Download references

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 information

Authors and Affiliations

  1. Department of Gastroenterology, Jaslok Hospital & Research Centre, Mumbai, India

    Aabha Nagral, Ajay Jhaveri & Nirzar Samir Parikh

  2. Department of Gastroenterology, Apollo Hospital, Mumbai, India

    Aabha Nagral

  3. Department of Gastroenterology, Bhatia Hospital, Mumbai, India

    Aabha Nagral

  4. Medical Officer, Nagral Clinic, Mumbai, India

    Smita Sawant

  5. Topiwala National Medical College & BYL Nair Charitable Hospital, Mumbai, India

    Nishtha Nagral

  6. Department of Pediatrics, Dr. Balabhai Nanavati Hospital, Mumbai, India

    Rashid Merchant

  7. Department of Biostatistics, Singapore Clinical Research Institute, Singapore, Singapore

    Mihir Gandhi

  8. Quantitative Services & Collaborations, Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore, Singapore

    Mihir Gandhi

  9. Global Health Group, Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland

    Mihir Gandhi

Authors
  1. Aabha Nagral
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ajay Jhaveri
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Smita Sawant
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Nirzar Samir Parikh
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Nishtha Nagral
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Rashid Merchant
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Mihir Gandhi
    View author publications

    You can also search for this author in PubMed Google Scholar

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.

Corresponding author

Correspondence to Aabha Nagral.

Ethics declarations

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.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Nagral, A., Jhaveri, A., Sawant, S. et al. Treatment of Chronic Hepatitis C Infection with Direct Acting Antivirals in Adolescents with Thalassemia Major. Indian J Pediatr 86, 148–153 (2019). https://doi.org/10.1007/s12098-018-2752-7

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12098-018-2752-7

Keywords

Search

Navigation