SWIFT-C

SWIFT-C study: SOF + RBV or LDV/SOF for acute hepatitis C in HIV-infected patients

Naggie S. Clin Infect Dis 2017; 64:1035-42

Anti-HCV
Ledipasvir
Sofosbuvir
Ribavirin
Genotype
1
Special population
Acute HCV infection

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Design


* New detectable HCV RNA + ALT = 5 x ULN if normal in prior 12 months, or ALT = 10 x ULN with no baseline ALT, or negative HCV Ab or RNA in prior 6 months

  • RBV dosed twice daily : 1200 mg if = 75 kg, 1000 mg if < 75 kg

Objective

  • SVR12 (HCV RNA < 15 UI/ml) with 2-sided 90% CI, 90% power to show that true SVR12> 60% for SOF + RBV 12 weeks

Baseline characteristics and outcome

Adverse events

Summary

  • SVR12 with 12 weeks of SOF + RBV similar, but not superior to historical PEG-IFN + RBV in acute HCV infection
    • At the end of 12 weeks of SOF + RBV, HCV RNA < limit of quantification
      in 100% of patients
  • High rate of failure (41%), due to relapse or re-infection
  • No significant predictors of failure
  • Very good tolerance