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A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6- to 12- year old children

M H F El-Shabrawi1, N M Kamal1, H R El-Khayat2

  • 1Pediatric Hepatology, Faculty of Medicine, Cairo University, Cairo, Egypt.

Alimentary Pharmacology & Therapeutics
|April 27, 2018
PubMed

Insights

This study shows that a fixed dose of sofosbuvir/ledipasvir is safe and effective for treating chronic hepatitis C genotype 4 in children aged 6-12 years. All participants achieved sustained virological response without side effects.

Area of Science:

  • Pediatric Gastroenterology
  • Hepatology
  • Infectious Diseases

Background:

  • Limited data exists on sofosbuvir/ledipasvir for treating hepatitis C virus (HCV) in children aged 6-12.
  • Chronic HCV infection in pediatric populations requires safe and effective treatment options.

Purpose of the Study:

  • To evaluate the safety and efficacy of sofosbuvir/ledipasvir in children aged 6-12 with chronic HCV genotype 4.
  • To establish optimal dosing for pediatric HCV treatment.

Main Methods:

  • Pilot prospective, single-arm, observational, open-label, multicenter study.
  • 20 children (6-12 years) with chronic HCV genotype 4 received a fixed sofosbuvir/ledipasvir dose (200/45 mg) daily for 12 weeks.
  • Virological markers and safety assessments were conducted throughout treatment and for 12 weeks post-treatment for sustained virological response (SVR12).

Main Results:

  • The intention-to-treat SVR12 rate was 95% (19/20 children).
  • 100% of patients who completed the study (19/19) achieved SVR12.
  • No side effects or fatalities were reported; liver, hematological, and renal function tests remained normal.

Conclusions:

  • The fixed dose of sofosbuvir/ledipasvir is a safe and effective treatment for chronic hepatitis C genotype 4 in children aged 6-12 years.
  • These findings support larger multicenter studies to confirm efficacy in this pediatric age group.
Abstract

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