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 Objective –SVR 12 (HCV RNA < 25 IU/ml), by ITT OBV/PTV/r + DSV + SOF +RBV Open-label W24 ≥ 18 years Chronic HCV Genotype 1 Prior failure on DAA-regimen.

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Presentation on theme: " Objective –SVR 12 (HCV RNA < 25 IU/ml), by ITT OBV/PTV/r + DSV + SOF +RBV Open-label W24 ≥ 18 years Chronic HCV Genotype 1 Prior failure on DAA-regimen."— Presentation transcript:

1  Objective –SVR 12 (HCV RNA < 25 IU/ml), by ITT OBV/PTV/r + DSV + SOF +RBV Open-label W24 ≥ 18 years Chronic HCV Genotype 1 Prior failure on DAA-regimen HCV RNA > 10,000 IU/ml Creatinine clearance ≥ 30 ml/min, serum albumin ≥ 2.8 g/dl, platelet count ≥ 25 x 10 9 /l, total bilirubin ≤ 3.0 g/dl Poordad F. AASLD 2015, Abs. LB20 W12 SVR 12 OBV/PTV/r + DSV + SOF  Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r): 25/150/100 mg qd = 2 tablets –Dasabuvir (DSV): 250 mg bid –RBV: 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg) SVR 12 N = 2 GT1a no cirrhosis GT1a cirrhosis GT1b N = 6 N = 14 QUARTZ-I QUARTZ-I Study: OBV/PTV/r + DSV + SOF + RBV for HCV genotype 1 after failure of DAA regimens  Design

2 OBV/PTV/r + DSV + SOF + RBV 12W (N = 14) GT1a no cirrhosis OBV/PTV/r + DSV + SOF + RBV 24W (N = 6) GT1a cirrhosis OBV/PTV/r + DSV + SOF 12W (N = 2) GT1b Median age, years596061 Female43%050% HCV RNA, log 10 IU/mL, median6.606.556.29 Fibrosis stage : F0-F2 / F3 / F4, N9 / 2 / 20 / 1 / 51 / 1 / 0 Prior DAA relapse / breakthrough11 / 36 / 01 / 1 Prior DAA regimen, N OBV/PTV/r OBV/PTV/r + DSV SMV + SOF SMV + samatasvir + RBV SOF + RBV SOF + PEG-IFN + RBV TVR + PEG-IFN + RBV 28001122800112 06000000600000 00110000011000 Baseline characteristics QUARTZ-I Study: OBV/PTV/r + DSV + SOF + RBV for HCV genotype 1 after failure of DAA regimens At baseline, NS3-Q80K, N = 14, other NS3 RAV, N = 3, RAVs in 2 targets, N = 7, RAVs in 3 targets, N = 2 Poordad F. AASLD 2015, Abs. LB20 QUARTZ-I

3 OBV/PTV/r + DSV + SOF + RBV 12W (N = 14) GT1a no cirrhosis OBV/PTV/r + DSV + SOF + RBV 24W (N = 6) GT1a cirrhosis OBV/PTV/r + DSV + SOF 12W (N = 2) GT1b NS3 Q80K * D168E/V 9292 5151 0000 NS5A M28T/V Q30E/H/R L31M H58D Y93C/F/H 8700287002 0201002010 0010100101 NS5B M414I/T Y448H S556G 214214 002002 001001 Resistance-associated variants at baseline QUARTZ-I Study: OBV/PTV/r + DSV + SOF + RBV for HCV genotype 1 after failure of DAA regimens Poordad F. AASLD 2015, Abs. LB20 QUARTZ-I * Does not confer clinically significant resistance to PTV

4 100 75 50 25 0 92 100 Genotype 1a no cirrhosis*, ** Genotype 1a cirrhosis Genotype 1b 1362 % Virologic response, % * 1 patient had treatment extended to 24W, as HCV RNA was >25 IU/ml at treatment W4 ** 1 patient relapsed, prior treatment with TVR + PEG-IFN + RBV, no RAVs at baseline or failure Poordad F. AASLD 2015, Abs. LB20 QUARTZ-I QUARTZ-I Study: OBV/PTV/r + DSV + SOF + RBV for HCV genotype 1 after failure of DAA regimens SVR 12 SVR 4 SVR 12

5 OBV/PTV/r + DSV + SOF + RBV 12W (N = 14) GT1a no cirrhosis OBV/PTV/r + DSV + SOF + RBV 24W (N = 6) GT1a cirrhosis OBV/PTV/r + DSV + SOF 12W (N = 2) GT1b Serious adverse event * 0 1 1 AE leading to study drug discontinuation 0 0 1 AEt leading to RBV dose modification 2 0 - Adverse event in ≥ 10% of patients Headache 6 2 0 Fatigue 5 2 0 Diarrhea 2 2 0 Insomnia 1 1 1 Nausea 2 1 0 Hemoglobin < 10 g/dl 0 0 0 Total bilirubin > 1.5 x ULN 2 1 0 ALT > 5 x ULN / AST > 5 x ULN 1** / 0 0 / 0 Adverse events QUARTZ-I Study: OBV/PTV/r + DSV + SOF + RBV for HCV genotype 1 after failure of DAA regimens Poordad F. AASLD 2015, Abs. LB20 QUARTZ-I * 1 case of pneumonia, 1 case of cellulitis (both unrelated) ; ** at D15 and D22, resolved by end of treatment

6 QUARTZ-I Study: OBV/PTV/r + DSV + SOF + RBV for HCV genotype 1 after failure of DAA regimens  Summary –A virologic response of 95.2% was achieved with the multi- targeted regimen of OBV/PTV/r + DSV + SOF ± RBV in patients with DAA treatment experience, including those with RAVs at baseline SVR 12 rate of 93% (14/15) in patients having terminated follow-up –Treatment was well tolerated with no discontinuations Poordad F. AASLD 2015, Abs. LB20 QUARTZ-I

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