 Objective –SVR 12 (HCV RNA < 25 IU/ml), by ITT OBV/PTV/r + SOF + RBV OBV/PTV/r + SOF Not randomised Open-label QUARTZ-II Study: OBV/PTV/r + SOF for HCV.

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Presentation transcript:

 Objective –SVR 12 (HCV RNA < 25 IU/ml), by ITT OBV/PTV/r + SOF + RBV OBV/PTV/r + SOF Not randomised Open-label QUARTZ-II Study: OBV/PTV/r + SOF for HCV genotypes 2 and 3 W12 ≥ 18 years Chronic HCV Genotype 2 or 3 HCV RNA > 10,000 IU/ml Naïve or treatment- experienced with PEG-IFN + RBV or SOF No cirrhosis Shafran S. AASLD 2015, Abs. LB16 W8 SVR 12 N = 10 N = 9 OBV/PTV/r + SOF + RBV  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) SVR 12 N = 11 GT2 SVR 12 GT3 Randomisation* 1:1 Open-label * Randomisation stratified on prior treatment (naïve or experienced) and IL28B genotype (CCC or non-CC) QUARTZ-II  Design

QUARTZ-II Study: OBV/PTV/r + SOF for HCV genotypes 2 and 3 Genotype 2 OBV/PTV/r + SOF + RBV N = 10 Genotype 3 OBV/PTV/r + SOF N = 9 Genotype 3 OBV/PTV/r + SOF + RBV N = 11 Median age, years5754 Female50%56%36% White100% HCV RNA, log 10 IU/ml, median IL28B genotype CC30%56%36% Fibrosis stage : F0-F1 / F2 / F3, n10 / 0 / 07 / 1 / 19 / 0 / 2 Treatment-experienced20%33%45% SVR 4 9/10 (90%) *100%10/11 (91%) ** SVR 12 NA100%10/11 (91%) Baseline characteristics and outcome * 1 relapse at post-treament W4, had previously failed SOF + RBV ** discontinuation at W1 for adverse event Shafran S. AASLD 2015, Abs. LB16 QUARTZ-II

QUARTZ-II Study: OBV/PTV/r + SOF for HCV genotypes 2 and 3 Genotype 2 OBV/PTV/r + SOF + RBV N = 10 Genotype 3 OBV/PTV/r + SOF N = 9 Genotype 3 OBV/PTV/r + SOF + RBV N = 11 Any adverse event100%89%91% Serious adverse event1 (not related)00 Adverse event leading to discontinuation001 Adverse event leading to RBV dose reduction2NA2 Adverse event in ≥ 10% of patients Fatigue333 Headache612 Diarrhea301 Nausea301 Upper respiratory tract infection400 Dyspnea003 Insomnia210 Pruritus012 Vomiting012 Adverse events, N % Shafran S. AASLD 2015, Abs. LB16 QUARTZ-II

QUARTZ-II Study: OBV/PTV/r + SOF for HCV genotypes 2 and 3 Laboratory abnormalities, N Shafran S. AASLD 2015, Abs. LB16 QUARTZ-II Genotype 2 OBV/PTV/r + SOF + RBV N = 10 Genotype 3 OBV/PTV/r + SOF N = 9 Genotype 3 OBV/PTV/r + SOF + RBV N = 11 Hemoglobin 8-10 g/dl d/dl Total bilirubin > 1.5 x ULN 4 01 ALT > 5 x ULN 1 00 AST > 5 x ULN 0 00

Shafran S. AASLD 2015, Abs. LB16 QUARTZ-II QUARTZ-II Study: OBV/PTV/r + SOF for HCV genotypes 2 and 3  Summary –In patients without cirrhosis, OBV/PTV/r + SOF achieved a high rate of SVR 12 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