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Genotype 1 HCV infection Stable immunosuppressive therapy

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Presentation on theme: "Genotype 1 HCV infection Stable immunosuppressive therapy"— Presentation transcript:

1 Genotype 1 HCV infection Stable immunosuppressive therapy
GALAXY study: SMV + SOF + RBV in recurrent genotype 1 HCV infection post liver transplantation Design Randomisation 1:1:1 Open-label W12 W24 N = 11 SMV + SOF + RBV ≥ 18 years Genotype 1 HCV infection HCV RNA > 10,000 IU/ml No prior DAA therapy Primary orthotopic liver transplant ≥ 6 months to 15 years prior to enrollment Stable immunosuppressive therapy No HIV co-infection SVR12 No cirrhosis N = 11 SMV + SOF N = 11 SMV + SOF SVR12 Cirrhosis or not N = 13 SMV + SOF Open-label No randomisation SMV: 150 mg QD SOF: 400 mg QD RBV: 1000 or 1200 mg/day (BID dosing) according to body weight (< or ≥ 75 kg) Objective SVR12 by ITT GALAXY O’Leary JG. EASL 2016, Abs. FRI-457, J Hepatol 2016;64:S540

2 GALAXY study: SMV + SOF + RBV in recurrent genotype 1 HCV infection post liver transplantation
Baseline characteristics and disposition Randomisation No randomisation SMV + SOF + RBV 12W SMV + SOF 12W 24W Median age, years 60 59 61 Female 27% 36% 15% White / Black / Asian, % 82 / 9 / 9 82 / 18 / 0 64 / 36 / 0 92 / 8 / 0 HCV RNA, log10 IU/mL, median 6.6 6.7 5.8 Fibrosis stage: F0-F1 / F2 / F3 / F4, % 18 / 73 / 9 / 0 9 / 55 / 27 / 0 9 / 55 / 36 / 0 46 / 23 / 8 / 8 Genotype: 1a Q80K / 1a no 80K / 1b, % 27 / 46 / 27 36 / 28 / 36 18 / 54 / 27 23 / 46 / 23 Use of acing reducing agent, % 45 73 64 62 Time since liver transplant, median years 6.0 5.5 4.8 3.5 Discontinued study, N 1 (death: suicide) 2 (physician decision, lost to follow-up) GALAXY O’Leary JG. EASL 2016, Abs. FRI-457, J Hepatol 2016;64:S540

3 GALAXY study: SMV + SOF + RBV in recurrent genotype 1 HCV infection post liver transplantation
SVR12 20 40 60 80 100 SMV + SOF + RBV 12 W * 81.8 11 SMV + SOF 12 W 24W (not randomised) 84.6 13 % N= * 1 relapse (W4 post-treatment) : 53-y, white male, 7.7 years since liver transplant, genotype 1a no 80K, F2, baseline HCV RNA : 4,130,000 IU/ml ; no emerging NS3 or NS5B mutations at failure GALAXY O’Leary JG. EASL 2016, Abs. FRI-457, J Hepatol 2016;64:S540

4 GALAXY study: SMV + SOF + RBV in recurrent genotype 1 HCV infection post liver transplantation
Adverse events, % Randomisation No randomisation SMV + SOF + RBV 12W SMV + SOF 12W SMV + SOF 24W * SMV + SOF 24W Any AE 100 92 Serious AE 18 9 15 Fatal AE 9 (suicide) AE at least possibly related to SMV 64 82 46 Adverse events in > 10% of patients Headache Fatigue Nausea Pruritus Diarrhoea Vomiting Dyspnea Rash Insomnia Decrease appetite Constipation 45 27 36 15 38 * 1 transplant rejection (W12 post-treatment) ; tacrolimus level decreased from 13.8 mg/l (baseline) to 3.2 mg/l (rejection) GALAXY O’Leary JG. EASL 2016, Abs. FRI-457, J Hepatol 2016;64:S540

5 GALAXY study: SMV + SOF + RBV in recurrent genotype 1 HCV infection post liver transplantation
Summary Treatment with SMV + SOF with or without RBV, for 12 weeks, or with SMV + SOF, for 24 weeks, was efficacious in liver transplant recipients with recurrent HCV genotype 1 infection Overall SVR12 of 91.3% 1 relapse occurred after 12 weeks of SMV + SOF + RBV Treatment was generally well tolerated 1 transplant rejection was observed, in the context of decreased tacrolimus plasma levels In conclusion, 12 weeks of SMV + SOF is an effective combination for liver transplant recipients without cirrhosis presenting recurrence of HCV genotype 1 infection GALAXY O’Leary JG. EASL 2016, Abs. FRI-457, J Hepatol 2016;64:S540

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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.
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:
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.
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 =
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 ≥
Reddy KR. Lancet Infect Dis. 2015;15:27-35 ATTAIN SMV + TVR placebo + PEG-IFN + RBV TVR + SMV placebo + PEG-IFN + RBV Randomisation* 1 : 1 Double-blind.

Reddy KR. Lancet Infect Dis. 2015;15:27-35 ATTAIN SMV + TVR placebo + PEG-IFN + RBV TVR + SMV placebo + PEG-IFN + RBV Randomisation* 1 : 1 Double-blind.
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.
W24 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve Early fibrosis to compensated cirrhosis No HBV or HIV co-infection N = 10 SOF + weight-based.

W24 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve Early fibrosis to compensated cirrhosis No HBV or HIV co-infection N = 10 SOF + weight-based.
> 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.
 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.
SOF + RBV Randomisation* 1 : 1 : 1 Open-label BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3 ≥ 18 years Chronic HCV infection Genotype 2, treatment-

SOF + RBV Randomisation* 1 : 1 : 1 Open-label BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3 ≥ 18 years Chronic HCV infection Genotype 2, treatment-
 Design  Objective –Difference in SVR ≥ 40% between the 2 groups, 99% power SOF + RBV Placebo Randomisation 3 : 1* Double blind HCV infection Genotype.

 Design  Objective –Difference in SVR ≥ 40% between the 2 groups, 99% power SOF + RBV Placebo Randomisation 3 : 1* Double blind HCV infection Genotype.
Open-label W24 ≥ 18 years Chronic HCV infection All genotypes HCV RNA ≥ 10,000 IU/ml Liver transplantation 6-150 months earlier Child Pugh ≤ 7 and MELD.

Open-label W24 ≥ 18 years Chronic HCV infection All genotypes HCV RNA ≥ 10,000 IU/ml Liver transplantation months earlier Child Pugh ≤ 7 and MELD.

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