BUTI

SOF/VEL ± RBV in genotype 3 with compensated cirrhosis

Buti M. EASL 2018, Abs. PS-035

Anti-HCV
Velpatasvir (GS-5816)
Sofosbuvir
Ribavirin
Genotype
3
Treatment history
Naive
IFN-Experienced
PI (NS3)-experienced
NS5A experienced
SOF-experienced
Cirrhosis
Yes
Special population
HIV co-infection

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Design


* Stratification by treatment experience

  • SOF/VEL: 400/100 mg 1 tablet QD
  • Patients enrolled in 29 sites in Spain

Primary endpoint

  • SVR12 (HCV < 15 IU/mL)

Baseline characteristics

Primary Endpoint (SVR12)


NS5A RAS: 19% in SOF/VEL (SVR12 : 84%), 22% in SOF/VEL + RBV (SVR12 : 96%)
Patients with Y93H: N = 4 in SOF/VEL (SVR12 : 50%), N = 9 in SOF/VEL + RBV (SVR12 : 88.9%)

Primary Endpoint (SVR12) by prior treatment

Adverse events (AE) and laboratory abnormalities, N (%)

Conclusion

  • High rates of SVR12 were observed with 12 weeks of SOF/VEL ± RBV in patients with GT3 and compensated cirrhosis
  • Adding RBV reduced the relapse rate from 5% to 2%
  • Treatment was well-tolerated