HCV-4: SOF/DCV safe, effective in children aged 8 years and older

  • Abdel Ghaffar TY & al.
  • J Viral Hepat
  • 31 Oct 2018

  • curated by Yael Waknine
  • Univadis Clinical Summaries
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Takeaway

  • A 12-week regimen of sofosbuvir/daclatasvir (SOF/DCV) is safe and effective for treating HCV-4 in treatment-naive, noncirrhotic children aged ≥8 years.

Why this matters

  • Direct-acting antivirals (DAAs) were recently approved for pediatric use (SOF with ribavirin or ledipasvir), but limited to children aged ≥12 years.

Study design

  • Prospective Egyptian study of 40 treatment-naive patients aged 8-17.58 years (mean, 12.27 years) with HCV-4 (72.5%) or mixed HCV-4/1 (27.5%) with F0 (35%), F1 (37.5%), or F2-F3 (15%) fibrosis.
  • Children weighing >45 kg received 12 weeks of SOF/DCV 500/60 mg; dose was reduced to 200/30 mg/day for those weighing 17-45 kg.
  • Primary endpoint: sustained virologic response at 12 and 24 weeks posttreatment (SVR12, SVR24).
  • Funding: Egyptian Cure Bank NGO; Society of Friends of Liver Patients in the Arab World.

Key results

  • HCV was most commonly acquired through an infected family member (mother, 25/31 cases) or surgical/invasive medical interventions.
  • 45% of patients were aged
  • End-of-treatment response rate, 97.5%; all patients had normalized liver enzymes by week 12.
  • Intent-to-treat SVR12 and SVR24 rates were 97.5% and 95%, respectively; both rose to 100% in per protocol analysis.
  • Adverse events were mild; none required discontinuation of therapy.

Limitations

  • Open-label, uncontrolled design.

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