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ARV-trial.com C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis Randomisation 1 : 1 Open-label Design W4 W6 W8.

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Presentation on theme: "ARV-trial.com C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis Randomisation 1 : 1 Open-label Design W4 W6 W8."— Presentation transcript:

1 ARV-trial.com C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis Randomisation 1 : 1 Open-label Design W4 W6 W8 W12 N = 31 GZR/EBR + SOF No cirrhosis GZR/EBR + SOF N = 30 Genotype 1 > 18 years Chronic HCV infection Genotype 1 or 3 Treatment-naïve Cirrhosis assessed by liver biopsy or noninvasive tests No HBV or HIV co-infection N = 20 Cirrhosis GZR/EBR + SOF GZR/EBR + SOF N = 21 N = 15 No cirrhosis GZR/EBR + SOF GZR/EBR + SOF Genotype 3 N = 14 Cirrhosis GZR/EBR + SOF N = 12 GZR/EBR 100/50 mg QD ; SOF 400 mg QD SVR12 No randomisation Open-label Objective SVR12 (HCV RNA < 15 IU/ml), with 95% CI, by ITT C-SWIFT Poordad F. EASL 2015, Abs. O006 1

2 Baseline characteristics
ARV-trial.com C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis Baseline characteristics Genotype 1 Genotype 3 No cirrhosis Cirrhosis 4 weeks N = 31 6 weeks N = 30 N = 20 8 weeks N = 21 N = 15 12 weeks N = 14 N = 12 Mean age, years 52 51 56 57 42 55 Female 35% 37% 38% 27% 43% 17% Race, white 97% 93% 100% 95% IL28B CC 36% 30% 24% 40% 21% 50% Genotype 1a 1b 84% 16% 87% 13% 80% 20% 76% - Cirrhosis, N (%) 20 (100) 21 (100) 12 (100) HCV RNA x 106 IU/ml, mean 3.69 3.09 1.66 2.37 3.29 2.57 2.26 C-SWIFT Poordad F. EASL 2015, Abs. O006 2

3 SVR12 (HCV RNA < 15 IU/ml), mITT, Genotype 1
ARV-trial.com C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis SVR12 (HCV RNA < 15 IU/ml), mITT, Genotype 1 33 87 80 94 4 weeks 20 1 6 weeks 4 8 weeks 3 Breakthrough Relapse Non virologic failure 30 40 60 100 % Non-cirrhotic Cirrhotic Poordad F. EASL 2015, Abs. O006 C-SWIFT 3

4 SVR12 (HCV RNA < 15 IU/ml), mITT, Genotype 3
C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis SVR12 (HCV RNA < 15 IU/ml), mITT, Genotype 3 Non-cirrhotic Cirrhotic 93 100 91 20 40 60 80 8 weeks 1 12 weeks Breakthrough Relapse Early discontinuation 15 14 11 % C-SWIFT Poordad F. EASL 2015, Abs. O006

5 SVR12 (HCV RNA < 15 IU/ml), per-protocol, Genotype 3, by subgroups
C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis SVR12 (HCV RNA < 15 IU/ml), per-protocol, Genotype 3, by subgroups 95 100 85 97 91 93 96 20 40 60 80 All patients < 2 M IU/ml > 2 M No cirrhosis Cirrhosis Male Female CC Non-CC 27 13 29 11 28 12 14 26 Baseline HCV RNA Gender IL28B genotype % C-SWIFT Poordad F. EASL 2015, Abs. O006

6 Resistance analysis at failure
ARV-trial.com C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis Resistance analysis at failure NS3 RAV NS5A RAV NS5B RAV Genotype 1 (29 relapses) 56 No resistance-associated variants 28/29 (97%) 18/30 (60%) 30/30 (100%) Pre-existing baseline RAVs only 1 (3%) RAVS detected at failure 9 (30%) 4/9 in 4W arm RAVs at failure in addition of baseline RAVs 2 (7%) Genotype 3 (2 relapses) At baseline Q168Q/R At relapse Q168R Y93H C-SWIFT Poordad F. EASL 2015, Abs. O006 6

7 Non cirrhotic 4 & 6 weeks N = 61
C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis Adverse events, N (%) All patients Genotype 1 Genotype 3 Non cirrhotic 4 & 6 weeks N = 61 Cirrhotic 6 & 8 weeks N = 41 Non cirrhotic 8 & 12 weeks N = 29 Cirrhotic 12 weeks N = 12 Discontinuation due to AE 1 (1) 1 (2) Serious adverse event 2 (2) 2 (5) Death Most common AEs Headache Fatigue Nausea 4 (4) 2 (2) 2 (2) 2 (3) 2 (3) 2 (7) 1 (3) 1 (8) Hemoglobin < 10 g/dl Total bilirubin > 5 x baseline ALT/AST > 5 x ULN C-SWIFT Poordad F. EASL 2015, Abs. O006

8 C-SWIFT Study: grazoprevir/elbasvir + SOF in genotypes 1 or 3, with or without cirrhosis
Summary Grazoprevir/elbasvir + sofosbuvir was able to shorten treatment duration to 8 weeks or less among cirrhotic and non-cirrhotic HCV genotype 1 infected patients Genotype 3 patients achieved high SVR12 rates with 8-12 weeks of therapy, including patients with cirrhosis All virologic failures were due to relapse Patients relapsed most commonly with either wild-type virus or with RAVs already present at baseline GZR/EBR + SOF was generally safe and well tolerated C-SWIFT Poordad F. EASL 2015, Abs. O006

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