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PHOTON-1  Design  Objective –SVR 12 with 2-sided 95% CI, descriptive analysis –Multivariate analyses of predictors of SVR 12 SOF + RBV, N= 114 SOF +

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Presentation on theme: "PHOTON-1  Design  Objective –SVR 12 with 2-sided 95% CI, descriptive analysis –Multivariate analyses of predictors of SVR 12 SOF + RBV, N= 114 SOF +"— Presentation transcript:

1 PHOTON-1  Design  Objective –SVR 12 with 2-sided 95% CI, descriptive analysis –Multivariate analyses of predictors of SVR 12 SOF + RBV, N= 114 SOF + RBV, N = 68 Not randomised Open -label ≥ 18 years Chronic HCV infection Genotype 1, 2 or 3 HCV RNA ≥ 10,000 IU/ml Treatment-naïve (Genotype 1, 2, 3) or experienced (Genotype 2 and 3) Chronic HIV infection On ARV with HIV RNA < 50 c/ml, or not on ARV with CD4 > 500/mm 3 Compensated cirrhosis allowed PHOTON-1 Study: SOF + RBV in HCV-HIV co-infection W12 W24 –SOF : 400 mg qd –RBV (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Genotype 1 Naïve Genotype 2, 3 Naïve Genotype 2, 3 Experienced Sulkowski M. JAMA 2014;312:353-61 SOF + RBV, N = 41

2 PHOTON-1 Study: SOF + RBV in HCV-HIV co-infection Genotype 1 naïve N = 115 Genotype 2, 3 naïve N = 68 Genotype 2, 3 experienced N = 41 Mean age, years484954 Female18%19%10% Race : white/black61% / 33%79% / 12%78% / 17% Body mass index, mean27.327.427.3 HCV genotype1a: 79% / 1b: 21%2: 38% / 3: 62%2: 59% / 3 : 41% IL28B CC genotype26.5%36.8%48.8% HCV RNA log 10 IU/ml, mean (SD) 6.6 ± 0.836.3 ± 0.606.5 ± 0.69 Cirrhosis4.4%10.3%24.4% CD4/mm 3, median581562579 On ARV98.2%89.7%95.1% ARV (%) : EFV ; ATV/r ; DRV/r ; RAL ; RPV38 ; 21 ; 13 ; 19 ; 633 ; 12 ; 28 ; 13 ; 841 ; 21 ; 5 ; 18 ; 5 Discontinued treatment, N11 (3 AE, 1 Failure)6 (3 AE)1 (1 AE) Returned for post-treatment W12 visit1136440 Baseline characteristics and patient disposition PHOTON-1 Sulkowski M. JAMA 2014;312:353-61

3 SVR 12 (HCV RNA < 25 IU/ml), % (95% CI) % Genotype 1 NaïveGenotype 2 and 3 NaïveGenotype 2 and 3 Experienced PHOTON-1 Study: SOF + RBV in HCV-HIV co-infection PHOTON-1 25 50 100 75 76.3 (67.4-83.8) 82 Sub-genotype All 54 75 (63-84.7) 92.7 (80.1-98.5) 88 92 N 1a1b 94 GT2GT3 67 All GT2GT3 All 0 1149024684241241726 Sulkowski M. JAMA 2014;312:353-61

4 Multivariate analysis of factors associated with SVR 12 in genotype 1 OR (95% CI)p Non black race2.87 (1.01 - 8.20)0.049 Genotype 1a3.42 (1.15 - 10.16)0.03 Completion of the 24 weeks of therapy17.54 (3.77 - 83.33)< 0.001 Genotype 1 naïve N = 115 Genotype 2, 3 naïve N = 68 Genotype 2, 3 experienced N = 41 Virologic breakthrough 1 Non adherence 1 (genotype 2) Non adherence 0 Relapse In treatment completers In non-completers 19/103 (18%) 6/10 (60%) All genotype 3 11/61 (18%) 1/6 (17%) 1/40 (2.5%) 1/1 (100%) Mutations at relapse (deep sequencing) S282T or V321A L159F None 2 None 2 (genotype 3a) Virologic failures PHOTON-1 Study: SOF + RBV in HCV-HIV co-infection PHOTON-1 Sulkowski M. JAMA 2014;312:353-61

5 PHOTON-1 Study: SOF + RBV in HCV-HIV co-infection Genotype 1 naïve N = 115 Genotype 2, 3 naïve N = 68 Genotype 2, 3 experienced N = 41 AE leading to treatment discontinuation331 Serious adverse event8 (7%)5 (7%)1 (2%) AE occurring in ≥ 10% in either group Fatigue36%35%46% Insomnia13%21%20% Nausea16%18%15% Headache14%13%12% Irritability12%10%5% Cough12%6%10% Upper respiratory tract infection11%12% Diarrhea11%9%12% Dizziness6%1.5%12% Anemia11%9%7% Decreased hemoglobin < 10g/dl ; < 8.5 g/dl19% / 2%10% / 1.5%12% / 0 Adverse events, n (%) PHOTON-1 Sulkowski M. JAMA 2014;312:353-61

6 PHOTON-1 Study: SOF + RBV in HCV-HIV co-infection  Summary In this open-label, non-randomised, uncontrolled study, patients with HCV who were co-infected with HIV had high rates of SVR 12 with the oral, IFN-free, combination of SOF + RBV –After 24 weeks of therapy for genotype 1 treatment-naïve and genotype 2 and 3 treatment-experienced –After 12 weeks of therapy for genotype 2 treatment-naïve Low rate of discontinuation for adverse events, however somewhat higher than in HCV monoinfected patients Confirmation of the high barrier to resistance of SOF (no resistance mutations at failure) Limitations –Underrepresentation of women and patients with cirrhosis –Absence of a control group Sulkowski M. JAMA 2014;312:353-61 PHOTON-1

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