QUARTZ II-III

QUARTZ II-III : OBV/PTV/r + SOF RBV in genotype 2 or 3

Shafran S. AASLD 2015, Abs. LB16 ; Shafran SD. AASLD 2016, Abs. 885

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

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Design


* Randomisation stratified on prior treatment (naïve or experienced) and IL28B genotype (CCC or non-CC)
** Liver biopsy or Fibroscan® > 12.5 kPa or Fibrotest® > 0.72 + APRI > 2

Treatment regimens

  • Co-formulated OBV/PTV/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

  • Primary endpoint: SVR12 (HCV RNA < 25 IU/mL), by ITT [ *** The 2 OBV/PTV/r + SOF groups were pooled for analysis]

Baseline characteristics and outcome


* 1 relapse (no treatment-emergent substitutions), this patient had previously failed SOF + RBV
** 1 discontinuation of treatment on D8 due to an adverse event of influenza-like illness deemed unrelated to study drugs ; this patient did not achieve SVR12

Adverse events and laboratory abnormalities


* Pneumonia on D26 unrelated to DAA ;
** 1 respir . tract infection on D33 ; 1 anemia on D28 , both unrelated to DAA;
***on D8 due to influenza - like symptoms unrelated to DAA ;
****on D78 due vertigo possibly related to DAA

Summary

  • In patients with genotype 3 and no cirrhosis, high SVR rates were seen with 2D + SOF with or without RBV for 12 weeks
    • 100% without RBV and 91% with RBV (1 discontinuation for AE)
  • In patients with genotype 3 and compensated cirrhosis, SVR12 was 100% after 12 weeks of 2D + SOF + RBV
  • In patients with genotype 2 and no cirrhosis, an 8-week regimen of 2D + SOF + RBV achieved an SVR12 rate of 90 %
    • Shortening treatment duration to 6 weeks resulted in a high rate of relapse
  • 2D + SOF ± RBV had a favorable safety profile consistent with previous studies
  • Conclusion : 2D + SOF ± RBV may be a useful treatment option for patients with genotype 3 infection with or without cirrhosis
    • Limitation : small sample size