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PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection

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Presentation on theme: "PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection"— Presentation transcript:

1 PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection
ARV-trial.com PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection Design Not randomised Open -label W12 W24 ≥ 18 years Chronic HCV infection Genotype 1, 2 , 3 or 4 HCV RNA ≥ 10,000 IU/ml Treatment-naïve (GT 1, 2, 3, 4) or experienced (GT 2 and 3) Chronic HIV infection On ARV with HIV RNA < 50 c/ml, or not on ARV with CD4 > 500/mm3 Compensated cirrhosis allowed Genotype 1, 3, 4 Naïve SOF + RBV, N = 200 Genotype 2 Naïve SOF + RBV, N = 19 Genotype 2, 3 Experienced SOF + RBV, N = 55 SOF : 400 mg qd RBV (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Objective SVR12 with 2-sided 95% CI, descriptive analysis Multivariate analyses of predictors of SVR12 PHOTON-2 Molina JM. Lancet 2015;385: 1

2 PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection
ARV-trial.com PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection Baseline characteristics GT1 naïve N = 112 GT2 N = 19 GT 2 experienced N = 6 GT 3 N = 57 N = 49 GT 4 N = 31 Mean age, years 45 55 47 49 Female 11% 21% 33% 22% 23% HCV RNA log10 IU/ml, mean 6.3 6.7 6.4 5.9 Cirrhosis 15% 5% 47% 26% No response/relapse to previous HCV treatment - 50% / 50% 27% / 51% CD4/mm3, mean 627 499 633 572 575 545 On ARV 97% 89% 100% 94% ARV = TDF/FTC + EFV RAL DRV/r ATV/r RPV Other 31% 17% 14% 5% 8% 35% 6% 29% 29% 33% 17% 16% 32% 12% 30% 13% 4% 20% 27% 7% 10% PHOTON-2 Molina JM. Lancet 2015;385: 2

3 PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection
ARV-trial.com PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection SVR12 (HCV RNA < 25 IU/ml), % (95% CI) SOF + RBV 24W SOF + RBV 12 W SOF + RBV 24 W % 88 (69-98) 89 (81-94) 85 (77-91) 91 91 84 (66-95) 100 89 83 83 86 75 50 25 N 112 100 11 25 19 6 106 57 49 31 All 1a 1b All Naïve Experienced All Naïve Experienced Genotype 4 Naïve Genotype 1 Naïve Genotype 2 Genotype 3 SVR12 not affected by the presence of cirrhosis, except in patients with genotype 1 PHOTON-2 Molina JM. Lancet 2015;385: 3

4 PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection
Multivariate analysis of factors associated with SVR12 in genotype 1 OR (95% CI) p No cirrhosis 4.9 (1.42 to 16.86) 0.012 HCV RNA < 6 log10 IU/ml 34.35 (0.88 to 21.39) 0.07 PHOTON-2 Molina JM. Lancet 2015;385:

5 PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection
Virologic failure GT1 naïve N = 112 GT2 N = 19 GT 2 experienced N = 6 GT 3 N = 57 N = 49 GT 4 N = 31 Virologic breakthrough 1 Relapse In treatment completers 12 (11%) 1 (5%) 1 (20%) 2 (4%) 5 (11%) 5 (16%) In treatment non completers 2 (33%) 2 (67%) 1 (100%) Deep sequencing of NS5B in 31 failures No emergence of S282T variant Low-levels of emergent variants, N = 2 1 virologic breakthrough, genotype 3a, L159F variant 1 with slow response, genotype 3a, L159N + S282N + V321A variants 2 patients (genotype 1, genotype 3a) with L159F at relapse PHOTON-2 Molina JM. Lancet 2015;385:

6 PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection
Adverse events and laboratory abnormalities, N (%) GT 1, 3, 4 Naïve 24W N = 200 GT2 Naïve 12W N = 19 GT 2, 3 Experienced 24W N = 55 Discontinuation because of an AE 5 (3%) 1 (2%) Serious adverse event 10 (5%) 5 (9%) Adverse event ≥ 10% overall Fatigue 20% 60% Insomnia 18% 16% 9% Asthenia 5% Headache 13% Nausea 7% Diarrhea 12% Hemoglobin < 10 g/dl Grade 3-4 total bilirubin increased* 21% 19% * 83% on ATV/r PHOTON-2 Molina JM. Lancet 2015;385:

7 PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection
ARV-trial.com PHOTON-2 Study: SOF + RBV in HCV-HIV co-infection Summary Patients co-infected with HIV and HCV genotypes 1-4 achieved high SVR12 with an interferon-free regimen of SOF plus RBV For treatment-naïve genotypes 1, 3, 4, SVR12 was 84-91% with 24 weeks of SOF + RBV Higher SVR12 in genotype 1b (91%) than in genotype 1a (84%) Presence of cirrhosis was a negative predictor of SVR12 only in genotype 1 patients For treatment-naïve genotype 2, SVR12 was 89% with 12 weeks of SOF + RBV For treatment-experienced genotypes 2 and 3, SVR12 was 83-86% with 24 weeks of SOF + RBV Compared to studies in HCV mono-infection, HIV co-infection does not have a negative effect on response to SOF-based therapy Unclear clinical relevance of NS5B variants emerging at failure PHOTON-2 Molina JM. Lancet 2015;385: 7

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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%,
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.
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.
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.
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.
C-EDGE co-infection study: grazoprevir/ elbasvir in HIV coinfection GZR/EBR 100/50 mg qd N = 218  Design W12 W24 C-EDGE co-infection Rockstroh JK. Lancet.

C-EDGE co-infection study: grazoprevir/ elbasvir in HIV coinfection GZR/EBR 100/50 mg qd N = 218  Design W12 W24 C-EDGE co-infection Rockstroh JK. Lancet.
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.

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.
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 ≥
UNITY-1 DCV/ASV/BCB No randomisation Open-label UNITY-1 Study: daclatasvir/asunaprevir/beclabuvir in genotype 1 without cirrhosis  Design W12 ≥ 18 years.

UNITY-1 DCV/ASV/BCB No randomisation Open-label UNITY-1 Study: daclatasvir/asunaprevir/beclabuvir in genotype 1 without cirrhosis  Design W12 ≥ 18 years.
NIAID ERADICATE Open-label W12 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve HIV infection on stable ART ≥ 8 weeks and HIV RNA < 50 c/ml.

NIAID ERADICATE Open-label W12 ≥ 18 years Chronic HCV infection Genotype 1 Treatment naïve HIV infection on stable ART ≥ 8 weeks and HIV RNA < 50 c/ml.
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.
ION-4  Design LDV/SOF Open-label ION-4 Study: LDV/SOF in HIV co-infection W12 ≥ 18 years Chronic HCV infection Genotype 1 or 4 HCV RNA ≥ 10,000 IU/ml.

ION-4  Design LDV/SOF Open-label ION-4 Study: LDV/SOF in HIV co-infection W12 ≥ 18 years Chronic HCV infection Genotype 1 or 4 HCV RNA ≥ 10,000 IU/ml.
TURQUOISE-I OBV/PTV/r + DSV + RBV Randomisation* 1 : 1 Open-label 18-70 years HCV genotype 1 HCV RNA ≥ 10,000 IU/ml Naïve or pre-treated with PEG-IFN +

TURQUOISE-I OBV/PTV/r + DSV + RBV Randomisation* 1 : 1 Open-label years HCV genotype 1 HCV RNA ≥ 10,000 IU/ml Naïve or pre-treated with PEG-IFN +
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.
Sulkowski M. Lancet 2015;385:1087-97 C-WORTHY  Design Randomisation* Open-label > 18 years HCV genotype 1, treatment naïve HCV RNA ≥ 10,000 IU/ml No cirrhosis.

Sulkowski M. Lancet 2015;385: C-WORTHY  Design Randomisation* Open-label > 18 years HCV genotype 1, treatment naïve HCV RNA ≥ 10,000 IU/ml No cirrhosis.
 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.

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