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AL study: AL ODV + SMV in naïve patients, phase II

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Presentation on theme: "AL study: AL ODV + SMV in naïve patients, phase II"— Presentation transcript:

1 AL-335-604 study: AL-335 + ODV + SMV in naïve patients, phase II
ARV-trial.com AL study: AL ODV + SMV in naïve patients, phase II Open-label Design W6 W8 3D-1 AL mg QD + ODV 50 mg QD + SMV 100 mg QD 18-65 years Chronic HCV infection, Genotype 1 or 3 Treatment-naïve Fibrosis stage F0-F3 Creatinine clearance < 60 mL/min No HBV or HIV co-infection Genotype 1 2D AL mg QD + ODV 50 mg QOD 3D-2 AL mg QD + ODV 50 mg QOD + SMV 75 mg QD Genotype 1 AL mg QD + ODV 50 mg QOD + SMV 75 mg QD 3D-2 Genotype 3 AL mg QD + ODV 50 mg QOD + SMV 75 mg QD 3D-2 AL-335: 400 or 800 mg QD ODV: 25 mg QD, 50 mg QD or every other day (QOD) SMV: 75 or 100 mg QD Objective Primary endpoint: SVR12 (HCV RNA < LLOQ) AL Gane E. AASLD 2016, Abs. PS-153 1

2 AL-335-604 study: AL-335 + ODV + SMV in naïve patients, phase II
ARV-trial.com AL study: AL ODV + SMV in naïve patients, phase II Baseline characteristics and outcome 3D-1 Genotype 1 8 weeks N = 20 2D N = 33 3D-2 6 weeks Genotype 3 N = 19 Median age, years 53 52 54 46 Female, % 35 39 30 40 5 Caucasian, % 100 70 90 74 HCV genotype 1a / 1b, N 18 / 2 26 / 7 15 / 5 - Fibroscan, median kPa 6.3 5.8 5.7 5.4 6.1 HCV RNA log10 IU/mL, median 6.4 5.9 SVR12 100% * 21/25 = 84% 7/8 = 88% if 12 weeks 100% 0/5 10/13 = 77% if 12 weeks * 2 premature discontinuations: 1 due to an AE, 1 due to entry criterion violation AL Gane E. AASLD 2016, Abs. PS-153 2

3 AL-335-604 study: AL-335 + ODV + SMV in naïve patients, phase II
ARV-trial.com AL study: AL ODV + SMV in naïve patients, phase II Adverse events, N 3D-1 Genotype 1 8 weeks N = 20 2D N = 33 3D-2 6 weeks Genotype 3 N = 19 Grade 3-4 adverse events Serious adverse events 1 (Wenckebach) (bladder cancer) Adverse events in > 6 patients Headache Fatigue Upper resp. infection Back pain Contusion Cough Discontinuation of study drugs 2 Grade 3-4 laboratory abnormalities Hematology Biochemistry 0 1 0 5 0 3 0 0 AL Gane E. AASLD 2016, Abs. PS-153 3

4 AL-335-604 study: AL-335 + ODV + SMV in naïve patients, phase II
ARV-trial.com AL study: AL ODV + SMV in naïve patients, phase II Summary HCV genotype 1, treatment naïve patients without cirrhosis achieved SVR12 of 100% with AL ODV + SMV for 6 or 8 weeks Tolerability was good Further development in phase 3 Inadequate efficacy In genotype 1 of AL ODV, without SMV In genotype 3 of AL ODV + SMV Development halted Phase IIb and III studies with AL mg + ODV 25 mg + SMV 75 mg QD AL Gane E. AASLD 2016, Abs. PS-153 4

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 Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg QD = 2 tablets –Dasabuvir (DSV) : 250 mg bid  Objective.

 Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg QD = 2 tablets –Dasabuvir (DSV) : 250 mg bid  Objective.
No randomization N = 59 W12W24 Arm B : compensated cirrhosis N = 31 N = 29 Arm C : compensated cirrhosis Arm A : No cirrhosis AGATE-II Study: OBV/PTV/r.

No randomization N = 59 W12W24 Arm B : compensated cirrhosis N = 31 N = 29 Arm C : compensated cirrhosis Arm A : No cirrhosis AGATE-II Study: OBV/PTV/r.
SMV + DCV + SOF Open label Chronic HCV infection Genotype 1 or 4 Treatment-naïve or pre-treated with PEG-IFN ± RBV Portal hypertension or liver decompensation.

SMV + DCV + SOF Open label Chronic HCV infection Genotype 1 or 4 Treatment-naïve or pre-treated with PEG-IFN ± RBV Portal hypertension or liver decompensation.
ALLY-3  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI DCV 60 mg qd + SOF 400 mg qd Not randomised Open-label ALLY-3 Study: DCV + SOF for.

ALLY-3  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI DCV 60 mg qd + SOF 400 mg qd Not randomised Open-label ALLY-3 Study: DCV + SOF for.
Asselah T. AASLD 2015, Abs. 714 Randomisation 1:1 Open-label 18-65 years HCV genotype 4 HCV RNA ≥ 1,000 IU/ml Naïve or pre-treated with PEG-IFN + RBV (Part.

Asselah T. AASLD 2015, Abs. 714 Randomisation 1:1 Open-label years HCV genotype 4 HCV RNA ≥ 1,000 IU/ml Naïve or pre-treated with PEG-IFN + RBV (Part.
OBV/PTV/r + DSV Open label Chronic HCV infection Genotype 1 Treatment-naïve HCV RNA > 1,000 IU/ml Chronic kidney disease with eGFR < 30 ml/min/1.73m 2.

OBV/PTV/r + DSV Open label Chronic HCV infection Genotype 1 Treatment-naïve HCV RNA > 1,000 IU/ml Chronic kidney disease with eGFR < 30 ml/min/1.73m 2.
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.

No randomisation Open-label 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.
Asselah T. AASLD 2015, Abs. 1179 OSIRIS  Design SMV + PEG-IFN + RBV Open label Chronic HCV infection Genotype 4 Treatment-naïve Mild to moderate fibrosis.

Asselah T. AASLD 2015, Abs OSIRIS  Design SMV + PEG-IFN + RBV Open label Chronic HCV infection Genotype 4 Treatment-naïve Mild to moderate fibrosis.
 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.

 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.
LDV/SOF Failure Open-label W24 Chronic HCV infection Genotype 1 Failure to achieve SVR on LDV/SOF-containing regimen Compensated cirrhosis (liver biopsy.

LDV/SOF Failure Open-label W24 Chronic HCV infection Genotype 1 Failure to achieve SVR on LDV/SOF-containing regimen Compensated cirrhosis (liver biopsy.
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*
 Objective –SVR 12 (HCV RNA < 25 IU/ml), by ITT OBV/PTV/r + SOF + RBV OBV/PTV/r + SOF Not randomised Open-label QUARTZ-II Study: OBV/PTV/r + SOF for HCV.

 Objective –SVR 12 (HCV RNA < 25 IU/ml), by ITT OBV/PTV/r + SOF + RBV OBV/PTV/r + SOF Not randomised Open-label QUARTZ-II Study: OBV/PTV/r + SOF for HCV.
No cirrhosis or compensated cirrhosis * No HBV or HIV coinfection

No cirrhosis or compensated cirrhosis * No HBV or HIV coinfection
Genotype 1 HCV infection Stable immunosuppressive therapy

Genotype 1 HCV infection Stable immunosuppressive therapy
ARV-trial.com RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Design Open label W12.

ARV-trial.com RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Design Open label W12.
eGFR (MDRD) > 50 mL/min

eGFR (MDRD) > 50 mL/min
Glecaprevir-Pibrentasvir in GT 1-6 with Renal Disease EXPEDITION-4

Glecaprevir-Pibrentasvir in GT 1-6 with Renal Disease EXPEDITION-4
Design Randomisation * 1 : 1 Open-label W16 W24 > 18 years

Design Randomisation * 1 : 1 Open-label W16 W24 > 18 years
Design Randomisation 1 : 1 Double-blind W8 W12

Design Randomisation 1 : 1 Double-blind W8 W12
Design Single arm Open label W12 ≥ 18 years, HCV genotype 1 to 6

Design Single arm Open label W12 ≥ 18 years, HCV genotype 1 to 6

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