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 ; Naggie S. AASLD 2017, Abs. 196

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, N


LDV/SOF group: 2 patients on TDF- boosted regimens met renal toxicity threshold

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
  • SVR12 of 100% with 8 weeks of LDV/SOF (superior to historical control rate of 60%)
    • Well tolerated
    • No treatment-related serious adverse events
    • No discontinuation for adverse event
    • 2 renal toxicity in TDF-boosted regimens