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Retreatment study: SOF/VEL + RBV in prior NS5A failure - Phase II

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Presentation on theme: "Retreatment study: SOF/VEL + RBV in prior NS5A failure - Phase II"— Presentation transcript:

1 Retreatment study: SOF/VEL + RBV in prior NS5A failure - Phase II
Design Open-label W24 > 18 years Failure to SOF/VEL or SOF/VEL + VOX (LEPTON study) Any genotype Compensated cirrhosis allowed No HBV or HIV co-infection N = 69 SOF/VEL + RBV SVR12 SOF/VEL: 400/100 mg FDC QD ; RBV: weight based in twice daily dose (1000 mg/day if < 75 kg, 1200 mg/day if ≥ 75 kg) Objective SVR12 (HCV RNA < 15 IU/mL), by ITT RETREATMENT STUDY Gane EJ, Hepatology 2017 (Epub ahead of print)

2 Retreatment study: SOF/VEL + RBV in prior NS5A failure - Phase II
Baseline characteristics, disposition and outcome SOF/VEL + RBV N = 69 Age, years, mean 57 Female, % 23 White, % 88 HCV RNA, log10 IU/mL, mean 6.4 IL28B CC, % 33 Cirrhosis, % 26 Genotype 1a / 1b / 2 / 3, % 46 / 7 / 20 / 26 Prior SOF/VEL + VOX, % 41 Prior VEL dose : 25 mg / 50 mg, % 41 / 59 Prior treatment duration, 4-6W / 8W /12W, % 36 / 39 / 25 Relapse of prior treatment, % 99 Mean time to retreatment, days 356 Discontinuation, N 3 (adverse event, incarceration, withdrew consent) SVR12 * 63/69 (91% [95% CI : 82-97]) * 4 patients excluded from analysis (still in follow-up) RETREATMENT STUDY Gane EJ, Hepatology 2017 (Epub ahead of print)

3 Retreatment study: SOF/VEL + RBV in prior NS5A failure - Phase II
SVR12 by genotype, and by baseline RASs Genotype 3 20 40 60 80 100 97 37 93 78 14 18 % N= Genotype 2 Genotype 1 SVR12 in cirrhosis : 78% vs 96% if no cirrhosis Failures Genotype 1: 1 on-treatment virological failure after discontinuation for AE Genotype 2: 1 post-treatment relapse after discontinuation at W8 (pre-treatment with SOF/VEL) Genotype 3: 1 non-response ((pre-treatment with SOF/VEL), 2 relapses (pre-treatment with SOF/VEL in 1, SOF/VEL + RBV in 1) , 1 withdrew consent N SVR12 No RASs 32 97% 5 100% 4 RASs 5 (14%) 9 (64%) 89% 13 (76%) 77% RETREATMENT STUDY Gane EJ, Hepatology 2017 (Epub ahead of print)

4 Retreatment study: SOF/VEL + RBV in prior NS5A failure - Phase II
Adverse events and laboratory abnormalities, % SOF/VEL + RBV Any adverse event 88 Grade 3 adverse event 4 Serious adverse event 1 Discontinuation for adverse event 1 (N = 1, irritability) Death Adverse events in ≥ 10% of patients Fatigue 32 Nausea 22 Headache 17 Insomnia 16 Rash Pruritus 14 Irritability 13 Upper respiratory tract infection Grade 3 laboratory abnormalities Grade 4 laboratory abnormalities Hemoglobin < 10 g/dL 6 RETREATMENT STUDY Gane EJ, Hepatology 2017 (Epub ahead of print)

5 Retreatment study: SOF/VEL + RBV in prior NS5A failure - Phase II
Summary SOF/VEL + RBV for 24 weeks resulted in high SVR12 rates in patients with genotype 1 or 2 who had failed prior SOF/VEL-containing regimens Genotype 1: no impact of RASs on SVR12 Genotype 3: SVR12 of 100% in patients without NS5A RASs, but low SVR12 among those with NS5A RASs Good tolerability RETREATMENT STUDY Gane EJ, Hepatology 2017 (Epub ahead of print)

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LDV/SOF 90/400 mg qd Non-randomised Open-label N = 21 W12 SVR 12 NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print ≥ 18 years.

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Egyptian Ancestry  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI SOF 400 mg qd + RBV Randomised 1 : 1 Open-label Egyptian Ancestry Study:

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OBV/PTV/r Open label 18-70 years Chronic HCV infection Genotype 1b Treatment-naïve or failure to PEG-IFN + RBV HCV RNA > 10,000 IU/ml Without or with cirrhosis*

OBV/PTV/r Open label years Chronic HCV infection Genotype 1b Treatment-naïve or failure to PEG-IFN + RBV HCV RNA > 10,000 IU/ml Without or with cirrhosis*
FUSION  Design  Objectives –SVR ≥ 20% compared with historical control of 25%, 97% power –Difference of SVR > 20% between the 2 groups, 82% power SOF.

FUSION  Design  Objectives –SVR ≥ 20% compared with historical control of 25%, 97% power –Difference of SVR > 20% between the 2 groups, 82% power SOF.
No HBV or HIV co-infection

No HBV or HIV co-infection
SMV 150 mg QD + SOF 400 mg QD Randomisation 1 : 1 18-70 years HCV genotype 1 Naïve or pre-treated with IFN-based regimen No cirrhosis HCV RNA ≥ 10.000.

SMV 150 mg QD + SOF 400 mg QD Randomisation 1 : years HCV genotype 1 Naïve or pre-treated with IFN-based regimen No cirrhosis HCV RNA ≥
Placebo + PR W48 Placebo + PR Yes Hezode C. Gut 2015;64:948-56 COMMAND-1 COMMAND-1 Study: daclatasvir + PEG-IFN + RBV for genotype 1 or 4 DCV60 + PEG-IFN.

Placebo + PR W48 Placebo + PR Yes Hezode C. Gut 2015;64: COMMAND-1 COMMAND-1 Study: daclatasvir + PEG-IFN + RBV for genotype 1 or 4 DCV60 + PEG-IFN.
OBV/PTV/r Placebo Randomisation** 2 : 1 18-75 years Chronic HCV Genotype 1b HCV RNA ≥ 10,000 IU/ml Naïve or pre-treated, no prior failure with DAA Without.

OBV/PTV/r Placebo Randomisation** 2 : years Chronic HCV Genotype 1b HCV RNA ≥ 10,000 IU/ml Naïve or pre-treated, no prior failure with DAA Without.
> 18 years Chronic HCV infection Genotype 1 Failure (relapse) to 4, 6 or 8 weeks of GZR/EBR + SOF in C-SWIFT Part A Compensated cirrhosis assessed by liver.

> 18 years Chronic HCV infection Genotype 1 Failure (relapse) to 4, 6 or 8 weeks of GZR/EBR + SOF in C-SWIFT Part A Compensated cirrhosis assessed by liver.
SOF/VEL 400/100 mg qd N = 500 N = 100 W12 Placebo > 18 years Chronic HCV infection Genotype 1, 2, 4, 5 or 6 Naïve or pre-treatment with IFN-based regimen.

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SOF/VEL 400/100 mg qd N = 250 W24 SOF + RBV W12 * Randomisation was stratified on prior treatment (naïve or experienced) and cirrhosis (yes or no) ** Metavir.

SOF/VEL 400/100 mg qd N = 250 W24 SOF + RBV W12 * Randomisation was stratified on prior treatment (naïve or experienced) and cirrhosis (yes or no) ** Metavir.
No randomisation Open-label 18-70 years HCV genotype 1 Naïve or null-response to PEG-IFN + RBV HCV RNA > 10,000 IU/ml No cirrhosis No HBV or HIV co-infection.

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SOF/VEL 400/100 mg qd N = 120 W12 SOF + RBV > 18 years Chronic HCV infection Genotype 2 Naïve or pre-treatment with IFN-based regimen Compensated cirrhosis.
SOF/VEL 400/100 mg qd N = 106 W12 > 18 years Chronic HCV infection Genotype 1-6 Naïve or pre-treatment with IFN-based regimen Compensated cirrhosis allowed*

SOF/VEL 400/100 mg qd N = 106 W12 > 18 years Chronic HCV infection Genotype 1-6 Naïve or pre-treatment with IFN-based regimen Compensated cirrhosis allowed*
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