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SOF + PEG-IFN  -2a + RBV Open-label Single arm ≥ 18 years Chronic HCV infection Genotype 1, 4, 5 or 6 Treatment-naïve HCV RNA ≥ 10,000 IU/ml Compensated.

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Presentation on theme: "SOF + PEG-IFN  -2a + RBV Open-label Single arm ≥ 18 years Chronic HCV infection Genotype 1, 4, 5 or 6 Treatment-naïve HCV RNA ≥ 10,000 IU/ml Compensated."— Presentation transcript:

1 SOF + PEG-IFN  -2a + RBV Open-label Single arm ≥ 18 years Chronic HCV infection Genotype 1, 4, 5 or 6 Treatment-naïve HCV RNA ≥ 10,000 IU/ml Compensated cirrhosis allowed W12 SVR 12 W24 N = 327 NEUTRINO Lawitz E. NEJM 2013;368:1878-87 NEUTRINO Study: SOF + PEG-IFN  -2a + RBV  Design –SOF : 400 mg qd –PEG-IFN  -2a : 180  g SC once weekly –RBV (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg  Objective –SVR 12 > 60%, 90% power

2 NEUTRINO Study: SOF + PEG-IFN  -2a + RBV SOF + PEF-IFN  -2a + RBV Mean age, years52 Female36% Race : white/black79% / 17% HCV genotype 1a 1b 4 5 6 225 (69%) 66 (20%) 28 (9%) 1 (< 1%) 6 (2%) IL28B CC genotype29% HCV RNA log 10 IU/ml, mean (SD) 6.4 ± 0.7 Cirrhosis17% Discontinued treatment, N7 (5 due to AE) Returned for post-treatment W4 visit324 Returned for post-treatment W12 visit301 NEUTRINO Lawitz E. NEJM 2013;368:1878-87 Baseline characteristics and patient disposition

3 HCV RNA < 25 IU/ml 25 50 100 75 99 % 99.7 During treatment W4 92 90 N =325327 W12 Post-treatment (SVR) W4W12 GenotypeCirrhosis SVR 12 by genotype, cirrhosis and IL28B IL28B SVR 12 = 90% (95% CI : 87 -93) : superiority to adjusted historal SVR 12 of 60% (two-sided exact test, p < 0.001) NEUTRINO Lawitz E. NEJM 2013;368:1878-87 NEUTRINO Study: SOF + PEG-IFN  -2a + RBV 92 1a 225 82 1b 66 96 4 28 98 CC 95 No 92 273 Non-CC 87 232 Yes 80 54 100 5-6 7 0

4 OR (95% CI)p Cirrhosis (no vs yes)3.92 (1.66 – 9.27)0.0018 IL28B (CC vs non-CC)7.99 (1.82 – 35.17)0.006 RBV exposure, mg/kg/day1.38 (1.15 – 1.66)0.0005 NEUTRINO Lawitz E. NEJM 2013;368:1878-87 NEUTRINO Study: SOF + PEG-IFN  -2a + RBV  Virologic breakthrough during treatment : none  Relapse in patients with HCV RNA < 25 IU/ml at end of completed treatment : 28 –25/320 (8%) in patients who completed treatment –3/6 (50%) in patients who did not complete treatment  Multivariate analysis of factors associated with SVR 12  Resistance testing (sequencing) –28 relapse No SOF-associated mutation (S282T) 2 NS5B substitutions in > 2 subjects (no change in susceptibility to SOF)

5 NEUTRINO Study: SOF + PEG-IFN  -2a + RBV SOF + PEF-IFN  -2a + RBV, N = 327 AE leading to treatment discontinuation5 (2%) Serious adverse event4 (1%) Most frequent adverse event Fatigue59% Headache36% Nausea34% Insomnia25% Decreased appetite18% Influenza-like illness16% Chills17% Pyrexia18% Rash18% Diarrhea12% Pruritus17% Myalgia14% Irritability13% NEUTRINO Lawitz E. NEJM 2013;368:1878-87 Adverse events, n (%)

6 NEUTRINO Study: SOF + PEG-IFN  -2a + RBV  Summary –In this open-label, single-group study of SOF + PEG-IFN and RBV in previously untreated patients with HCV genotype 1 or 4 infection, a SVR of 90% at 12 weeks was obtained In patients with genotype 1 infection who had cirrhosis SVR 12 was lower than for patients without cirrhosis (81% vs 92%) –Patients with genotype 1, 4, 5, or 6 infection who received 12 weeks of SOF + PEG-IFN + RBV had a very low rate of treatment discontinuation (2%) –No virologic resistance was detected in patients who did not have a sustained virologic response NEUTRINO Lawitz E. NEJM 2013;368:1878-87

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VALENCE SOF + RBV Not randomised Open label* ≥ 18 years Chronic HCV infection Genotype 2 or 3 HCV RNA ≥ 10,000 IU/ml Treatment naïve or prior IFN-based.

VALENCE SOF + RBV Not randomised Open label* ≥ 18 years Chronic HCV infection Genotype 2 or 3 HCV RNA ≥ 10,000 IU/ml Treatment naïve or prior IFN-based.
ATOMIC  Design  Objective –SVR 24 by ITT-analysis, detection of a 30% or 25% difference between two treatment groups, 2-sided significance level of 5%,

ATOMIC  Design  Objective –SVR 24 by ITT-analysis, detection of a 30% or 25% difference between two treatment groups, 2-sided significance level of 5%,
ALLY-1  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml) in genotype 1 DCV 60 mg qd + SOF 400 mg qd + RBV DCV 60 mg qd + SOF 400 mg qd + RBV Not randomised.

ALLY-1  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml) in genotype 1 DCV 60 mg qd + SOF 400 mg qd + RBV DCV 60 mg qd + SOF 400 mg qd + RBV Not randomised.
ELECTRON  Design SOF + RBV Randomisation* 1 : 1 : 1 : 1 Open-label ELECTRON Study: SOF-based therapy for genotypes 1, 2 and 3 W8W4W12 ≥ 19 years Chronic.

ELECTRON  Design SOF + RBV Randomisation* 1 : 1 : 1 : 1 Open-label ELECTRON Study: SOF-based therapy for genotypes 1, 2 and 3 W8W4W12 ≥ 19 years Chronic.
OBV/PTV/r + DSV + RBV Placebo Randomisation** 3 : 1 Double blind 18-70 years Chronic HCV genotype 1 HCV RNA ≥ 10,000 IU/ml Failure to pre-treatment with.

OBV/PTV/r + DSV + RBV Placebo Randomisation** 3 : 1 Double blind years Chronic HCV genotype 1 HCV RNA ≥ 10,000 IU/ml Failure to pre-treatment with.
OBV/PTV/r + DSV + RBV OBV/PTV/r + DSV Randomisation* 1 : 1 Open label 18-70 years Chronic HCV infection Genotype 1b Prior failure to PEG-IFN + RBV HCV.

OBV/PTV/r + DSV + RBV OBV/PTV/r + DSV Randomisation* 1 : 1 Open label years Chronic HCV infection Genotype 1b Prior failure to PEG-IFN + RBV HCV.
No prior therapy with PI

No prior therapy with PI
CURRY  Design Open-label CURRY Study: SOF + RBV for HCV with liver cancer before transplantation ≥ 18 years Chronic HCV infection Any genotype HCV RNA.

CURRY  Design Open-label CURRY Study: SOF + RBV for HCV with liver cancer before transplantation ≥ 18 years Chronic HCV infection Any genotype HCV RNA.
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:

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:
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*
COSMOS SOF + SMV + RBV SOF + SMV Randomisation 2 : 1 : 2 : 1* Open-label * Randomisation was stratified on genotype (1a or 1b) in both cohorts, IL28B in.

COSMOS SOF + SMV + RBV SOF + SMV Randomisation 2 : 1 : 2 : 1* Open-label * Randomisation was stratified on genotype (1a or 1b) in both cohorts, IL28B in.
SMV + PEG-IFN + RBV Open-label W12 W24* or W48* N = 107 18-70 years Chronic HCV infection Genotype 4 Treatment-naïve or experienced with relapse or partial.

SMV + PEG-IFN + RBV Open-label W12 W24* or W48* N = years Chronic HCV infection Genotype 4 Treatment-naïve or experienced with relapse or partial.
Randomisation* 2 : 1 Double blind *Randomisation was stratified on genotype (1a or 1b or other) and IL28B genotype (CC, CT or TT) N = 133 N = 260 W24W48.

Randomisation* 2 : 1 Double blind *Randomisation was stratified on genotype (1a or 1b or other) and IL28B genotype (CC, CT or TT) N = 133 N = 260 W24W48.
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.
ALLY-2  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI, in treatment-naïve genotype 1 treated for 12 weeks DCV + SOF 400 mg QD DCV + SOF.

ALLY-2  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI, in treatment-naïve genotype 1 treated for 12 weeks DCV + SOF 400 mg QD DCV + SOF.
FISSION  Design  Objective –Non inferiority of SOF + RBV : SVR 12 (2-sided significance level of 5%, lower margin of the 95% CI for the difference =

FISSION  Design  Objective –Non inferiority of SOF + RBV : SVR 12 (2-sided significance level of 5%, lower margin of the 95% CI for the difference =
AI444040 Study  Design SOF 1W then DCV + SOF 23W DVC + SOF Randomisation* 1 : 1 : 1 Open-label AI444040 Study: DCV + SOF + RBV for genotypes 1, 2 and.

AI Study  Design SOF 1W then DCV + SOF 23W DVC + SOF Randomisation* 1 : 1 : 1 Open-label AI Study: DCV + SOF + RBV for genotypes 1, 2 and.
No HBV or HIV co-infection

No HBV or HIV co-infection
SMV 150 + SOF 400 Open-label OPTIMIST-2 Study: SMV + SOF for genotype 1 and cirrhosis W12  Objective –Superiority of SVR 12 (HCV RNA historical control.

SMV SOF 400 Open-label OPTIMIST-2 Study: SMV + SOF for genotype 1 and cirrhosis W12  Objective –Superiority of SVR 12 (HCV RNA historical control.
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 ≥

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