Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients With Chronic Hepatitis C Infection

J Pediatr Gastroenterol Nutr. 2018 Jul;67(1):86-89. doi: 10.1097/MPG.0000000000001968.

Abstract

Objectives: Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by the European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus (HCV) infection in adults for all genotypes; however, it is still not considered for patients younger than 18 years old. We aimed to test safety and efficacy of SOF/DCV in adolescent patients 12 to 17 years old with chronic HCV, genotype 4 infection.

Methods: We conducted a prospective, uncontrolled, open-label multicenter study. A total of 30 chronic HCV-infected adolescents, aged from 12 to 17 years old were included and treated with dual SOF/DCV for 12 weeks. Patients were monitored throughout the treatment and follow-up period for safety and efficacy outcome measures including the sustained virologic response 12 (SVR12) rate.

Results: The intention-to-treat (ITT) SVR12 rate was 29 of 30 (96.7%; 95% confidence interval [CI] 83.3%-99.4%). The only patient who did not achieve SVR12 was lost to follow-up after showing viral negativity at the end of treatment (EOT) visit. Whereas all the remaining 29 patients (100%, 95% CI 88.3%-100%) who completed the follow-up visits achieved SVR12. All patients showed normalized liver enzymes with normal hematological, liver and renal function tests at the end of the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study.

Conclusions: SOF/DCV combined therapy could be a safe and effective treatment in adolescent patients 12 to 17 years old with chronic HCV genotype 4 infection. (See Video, Supplemental Digital Content, http://links.lww.com/MPG/B348).

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Child
  • Drug Therapy, Combination
  • Female
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Imidazoles / adverse effects
  • Imidazoles / therapeutic use*
  • Male
  • Prospective Studies
  • Sofosbuvir / adverse effects
  • Sofosbuvir / therapeutic use*
  • Sustained Virologic Response
  • Viral Load

Substances

  • Antiviral Agents
  • Imidazoles
  • daclatasvir
  • Sofosbuvir