ZIRCON: 3D, 2D yield 100% HCV clearance rate in teenagers

  • Leung DH & al.
  • Hepatol Commun
  • 1 Nov 2018

  • curated by Yael Waknine
  • Univadis Clinical Summaries
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Takeaway

  • Ritonavir-boosted ombitasvir/paritaprevir with/without dasabuvir (3D, 2D) ± ribavirin (RBV) appears well-tolerated and highly effective for clearing HCV-1/4 in adolescents.

Why this matters

  • 2D and 3D (also known as PrOD) are not yet approved for pediatric use.
  • The study has since expanded to include children aged 3-11 years.

Study design

  • Ongoing open-label ZIRCON phase 2/3 study of 3D±RBV and 2D±RBV among 38 adolescents aged 12-17 years (median, 15 years):
    • 12 weeks of 3D±RBV for noncirrhotic HCV-1 (n=12).
    • 12 or 24 weeks of 3D/2D ± RBV for HCV-1/4, based on treatment experience and cirrhosis status (n=26).
  • Primary endpoint: sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: AbbVie Inc.   

Key results

  • Cohort (66% female, 76% white) recruited at 18 sites in Belgium, Germany, Spain, and the United States.
  • 82% had HCV-1 (1a, 42%; 1b, 40%) vs 18% with HCV-4; 34% were treatment-experienced and 1 (3%) was cirrhotic.
  • Overall SVR12 rate was 100% (38/38; 95% CI, 90.8%-100%).
  • No treatment-emergent grade 3/4 adverse events (AEs) or laboratory abnormalities reported.
  • Most common AEs were headache (21%), fatigue (18%), nasopharyngitis (13%), pruritus (13%), and upper respiratory tract infection (11%).
  • Pharmacokinetic data demonstrated drug exposures comparable to that of adults.

Limitations

  • Small sample size, HCV-1 overrepresented.