Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective

Authors

Radha K. Dhiman, Department of Hepatology, Postgraduate Institute of Medical Education and Research
Gagandeep S. Grover, Department of Hepatology, Postgraduate Institute of Medical Education and Research; Technical Consultant, Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF), Punjab Government, Punjab, India
Madhumita Premkumar, Department of Hepatology, Postgraduate Institute of Medical Education and Research; Directorate of Health and Family Welfare, Chandigarh, Punjab, India
Sunil Taneja, Department of Hepatology, Postgraduate Institute of Medical Education and Research
Ajay Duseja, Department of Hepatology, Postgraduate Institute of Medical Education and Research
Sahaj Rathi, Department of Hepatology, Postgraduate Institute of Medical Education and Research
Sandeep Satsangi, Department of Hepatology, Postgraduate Institute of Medical Education and Research

Document Type

Article

Publication Date

1-1-2019

Abstract

OBJECTIVES: We assessed the efficacy of decentralized public health services and safety of direct-acting antiviral agents (DAAs) in the treatment of pediatric chronic hepatitis C (CHC) in the Mukh-Mantri Punjab Hepatitis C Relief Fund, a public-health initiative for prevention and control of CHC in Punjab, India.

METHODS: Consecutive children with CHC [age ≥12 to <18 >years; both treatment-naïve (TN) and treatment-experienced (TE)] were enrolled. Genotyping was not recommended for non-cirrhotic patients and were treated with sofosbuvir (SOF)+ daclatasvir (DCV) for 12 weeks, while genotyping was recommended for patients with cirrhosis. Patients with cirrhosis and genotype (G2) were treated with SOF+DCV+ribavirin (RBV) for 12 weeks, G3 with SOF+DCV+RBV for 24 weeks and G1, 4, 5, and 6 patients were treated with SOF+ledipasvir (LDV)+RBV for 12 weeks. Treatment duration was increased to 24 weeks if RBV was not tolerated.

RESULTS: In the first 16 months (June 18, 2016-October 31, 2017), 88 children (mean age 15.8 years; 69.3.3% boys, 72.3% rural) were enrolled. The mean baseline hepatitis C virus RNA log10 IU/mL was 6.0 (range 4.2-7.5 log10 IU/mL), 65.5% with G3, and 2 (2.5%) with cirrhosis. Of 57 with completed treatment, sustained virological response (SVR) 12 was achieved in 56 (98.2%). Unsafe medical practices (55.5%), IV drug abuse (11.1%), and prior surgery (2.7%) were risk-factors for transmission (n = 36). Comparable results were noted in G3 (SVR at 12 weeks [SVR12], 94.3%) versus non-G3 (SVR12, 100%; P = 0.073). No serious adverse effects like anemia and decompensation were reported.

CONCLUSIONS: The study demonstrates that the decentralized algorithm-based public-health program can ensure high efficacy (SVR12, 98.2%) and low-cost DAA-based treatment of pediatric patients with CHC.

Recommended Citation

Dhiman RK, Grover GS, Premkumar M, Taneja S, Duseja A, Rathi S, Satsangi S. Direct-acting antiviral Therapy Is Safe and Effective in Pediatric Chronic Hepatitis C: The Public Health Perspective. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):74-80. doi: 10.1097/MPG.0000000000002139. PMID: 30211847.