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 Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI, next observation carried backward DCV + SOF + RBV Randomised* 1:1 Open-label ALLY-3+ study: DCV.

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Presentation on theme: " Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI, next observation carried backward DCV + SOF + RBV Randomised* 1:1 Open-label ALLY-3+ study: DCV."— Presentation transcript:

1  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI, next observation carried backward DCV + SOF + RBV Randomised* 1:1 Open-label ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis W16 ≥ 18 years Chronic HCV infection Genotype 3 Treatment-naïve or experienced NS5A inhibitor-naïve HCV RNA ≥ 50,000 IU/ml Advanced fibrosis (F3) or compensated cirrhosis (F4)** No HBV or HIV co-infection Leroy V. Hepatology 2016, Jan 28 (Epub ahead of print) ** Liver biopsy or Fibroscan (≥ 9.6 to 14.6 = F3 ; > 14.6 kPa = F4), or Fibrotest ® ≥ 0.75 + APRI > 2 * Randomisation was stratified by fibrosis stage (F3 or F4) W12 SVR 12 –DCV : 60 mg qd –SOF : 400 mg qd –RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg) N = 24 N = 26  Design ALLY-3+

2 DCV + SOF + RBV 12W N = 24 DCV + SOF + RBV 16W N = 26 Median age, years5356 Female25%15% White / Asian96% / 4%100% / 0 HCV RNA, log 10 IU/ml, median6.706.91 IL28B CC genotype46%42% Fibrosis stage : F3 / F425% / 75%31% / 69% Albumin, g/l, median43.042.5 Platelets, 10 9 cells/l161155 Prior HCV treatment experience Naïve Failure to IFN-based regimen Relapse after SOF-based regimen* 6 (25%) 15 (63%) 3 (13%) 7 (27%) 16 (62%) 3 (12%) Baseline characteristics * 5 patients with relapse to SOF + RBV, and 1 to SOF + PEG-IFN + RBV ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis ALLY-3+ Leroy V. Hepatology 2016, Jan 28 (Epub ahead of print)

3 ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis ALLY-3+ Leroy V. Hepatology 2016, Jan 28 (Epub ahead of print) SVR 12 : all treated patientsSVR 12 : patients with advanced fibrosis (F3) SVR 12 : patients with cirrhosis (F4) * Dilated cardiomyopathy on D72, not related to treatment; 0 20 40 60 80 100 12W 88 24 16W 92 26 0 20 40 60 80 100 12W 100 6 16W 100 8 0 20 40 60 80 100 12W 18 16W 89 18 00 22 Virologic breakthrough Relapse 10Death* 83 % %

4 ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis ALLY-3+ Leroy V. Hepatology 2016, Jan 28 (Epub ahead of print) Baseline characteristics of patients experiencing relapse –All patients had cirrhosis Age / Sex Treatment group Prior treatment IL28 genotype HCV RNA (log 10 UI/ml) Fibroscan (kPa) Albumin (g/l) Platelets (x 10 9 /l) 51 / Male12WNoneCC6.766.53383 53 / Male12W IFN-based (breakthrough) CT7.019.043157 61 / Male16W SOF + RBV (relapse) CT5.3 NA (biopsy) 41188 57 / Male16W SOF + RBV (relapse) CT6.816.446201

5 DCV + SOF + RBV 12W N = 24 DCV + SOF + RBV 16W N = 26 Serious adverse event (all unrelated)2 (8%)3 (12%) Death1 (unrelated)0 Discontinuation for adverse event00 Grade 3-4 adverse events2 (8%) Adverse event ≥ 10% of patients Insomnia Fatigue Headache Irritability Asthenia Diarrhea Dyspnea 8 (33%) 6 (25%) 7 (29%) 5 (21%) 2 (8%) 1 (4%) 2 (8%) 7 (27%) 5 (19%) 2 (8%) 5 (19%) 4 (15%) 3 (12%) RBV dose reduction2 (8%)4 (15%) Grade 3 laboratory abnormalities Hemogloblin 4.5 g/dl Total bilirubin > 2.5 x ULN Platelet count < 50 x 10 9 /l AST or ALT > 5 x ULN / Creatinine > 1.9 x ULN 0 1 (4%) 0 0 / 0 1 (4%) 0 0 / 0 Adverse events ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis ALLY-3+ Leroy V. Hepatology 2016, Jan 28 (Epub ahead of print)

6 ALLY-3+ study: DCV + SOF + RBV for HCV genotype 3 with advanced fibrosis or cirrhosis  Summary –Overall, 90% SVR 12 was achieved in HCV genotype 3-infected patients with advanced fibrosis or compensated cirrhosis treated with DCV + SOF + RBV SVR 12 was comparable for the 12-week (88%) and 16-week (92%) groups No on-treatment virologic failures; two relapses in each treatment arm –100% SVR 12 among patients with advanced fibrosis –86% SVR 12 among patients with cirrhosis (mostly treatment experienced) –Treatment was safe and well tolerated; no patient discontinued for adverse event –DCV + SOF + RBV for 12 or 16 weeks is a highly efficacious therapy for genotype 3-infected patients with advanced fibrosis or compensated cirrhosis ALLY-3+ Leroy V. Hepatology 2016, Jan 28 (Epub ahead of print)

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