DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

Stable immunosuppressive therapy : t acrolimus or cyclosporin ; glucocorticoïds at dose = 5 mg/day permitted

Treatment regimens

• Co-formulated ombitasvir / paritaprevir / rironavir / (OBV/PTV/r/): 25/150/100 mg qd = 2 tablets
• Dasabuvir (DSV) : 250 mg bid
• RBV : dose selected by investigator ( most often 600-800 mg/ day )

Objective

• SVR₁₂ , by intention to treat, with 95% CI, descriptive analysis

Baseline characteristics and treatment response

* At relapse : resistance-associated variants R155K in NS3, M28T and Q30R in NS5A, and G554S in NS5B

Adverse events and laboratory abnormalities in the 34 patients, N (%)

Summary

• In this phase II trial of a 24-week, IFN- free, all-oral antiviral regimen for HCV genotype 1 infection, a rate of sustained virologic response of 97% (95% CI , 85 to 100) at post-treatment weeks 12 and 24 was observed among liver-transplant recipients with no fibrosis or mild fibrosis.
• No deaths or episodes of graft rejection
• Very good tolerability and safety
• No patient needed a blood transfusion ; 5 patients (15%) required erythropoietin, all of whom had initially received RBV at a total daily dose of 1000 or 1200 mg
  • Given the high SVR₁₂ , regardless of the initial RBV dose , an initial dose of 600 to 800 mg may provide sufficient therapeutic benefit and minimize the risk of severe anemia
• Limitations
  • Patients with advanced fibrosis excluded
  • Patients with aggressive forms of recurrent HCV infection (e.g., fibrosing cholestatic hepatitis) excluded