Annals of Hepatology (Sep 2021)

P-6 SOFOSBUVIR CONTAINING REGIMENS ARE SAFE AND EFFECTIVE IN ADOLESCENTS WITH CHRONIC HEPATITIS C INFECTION

  • Stefan Wirth,
  • Regino Gonzalez-Peralta,
  • Philip Rosenthal,
  • Winita Hardikar,
  • Jessica Wen,
  • Maureen M. Jonas,
  • Naveen Mittal,
  • Mary Whitworth,
  • Ronen Arnon,
  • Chuan-Hao Lin,
  • Yury Lobzin,
  • Rene Romero,
  • Vladimir Chulanov,
  • Girish Subbarao,
  • Jeffrey Teckman,
  • Vyacheslav Morozov,
  • Eric Bassetti,
  • Kathryn Kersey,
  • Benedetta Massetto,
  • Yanni Zhu,
  • Polina German,
  • Diana M. Brainard,
  • Sanjay Bansal,
  • Karen F. Murray,
  • Kathleen Schwarz,
  • William Balistreri

Journal volume & issue
Vol. 24
p. 100372

Abstract

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Background: HCV-specific DAAs have transformed treatment of chronic HCV, but few studies have evaluated these therapies in children. Methods: Patients aged 12–17 years old with chronic GT1 HCV were enrolled into an open-label study to receive 12 weeks of LDV/SOF 90 mg/400 mg once daily, and those with HCV GT2 or GT3 to receive SOF (400 mg once daily) + RBV (15 mg/kg/day) for 12 (GT2) or 24 weeks (GT3), respectively. Primary efficacy endpoint was SVR12. Safety was assessed by adverse events and clinical/laboratory data. Pharmacokinetic (PK) sampling was conducted to confirm the appropriateness of the doses. Results: 150 adolescents (100 GT1, 13 GT2 and 37 GT3) were enrolled and treated. The majority were female (56%), white (90%), treatment naive (81%), and vertically infected (80%). The mean age was 15 years (range 12–17). LDV, SOF and GS-331007 (primary metabolite) exposures were within the range of adult exposures observed in the SOF and LDV/SOF phase 2/3 studies. The SVR12 rate was 98% in GT1, 100% in GT2 and 97% in GT3; all 3 patients who were considered not to have achieved SVR12 were lost to follow-up. No adverse event (AE) leading to study drug discontinuation or serious AEs have been reported. Conclusion: In adolescents, LDV/SOF for 12 weeks and SOF + RBV for 12 or 24 weeks, resulted in a SVR12 rate of 97–100% with no virologic failures. These regimens were well tolerated, demonstrating their potential as an important treatment option for children with HCV infection.