QUARTZ-II

QUARTZ-II Study: OBV/PTV/r + SOF for HCV genotypes 2 and 3
QUARTZ-II Study: OBV/PTV/r + SOF for HCV genotypes 2 and 3
Shafran S. AASLD 2015, Abs. LB16

Anti-HCV
Paritaprevir/ritonavir
Ombitasvir
Sofosbuvir
Genotype
2
3
Treatment history
Naive
IFN-Experienced
SOF-experienced
Cirrhosis
No

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Design


* Randomisation stratified on prior treatment (naïve or experienced) and IL28B genotype (CCC or non-CC)

Treatment regimens

  • Co-formulated ombitasvir (OBV)/ paritaprevir (PTV)/ rironavir (r): 25/150/100 mg qd = 2 tablets
  • SOF: 400 mg qd
  • RBV: 1000 or 1200 mg/day (bid dosing) according to body weight (< or = 75 kg )

Objective

  • SVR12 (HCV RNA < 25 IU/ml) , by ITT

Baseline characteristics and outcome


* 1 relapse at post- treament W4, had previously failed SOF + RBV
** discontinuation at W1 for adverse event

Adverse events, N %

Laboratory abnormalities, N

Summary

  • In patients without cirrhosis, OBV/PTV/r + SOF achieved a high rate of SVR12
    • with RBV, for 8 weeks, in genotype 2
    • with or without RBV, for 12 weeks , in genotype 3
  • Safety and tolerability was good
  • Larger studies needed, including genotype 3-infected patients with cirrhosis