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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.

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Presentation on theme: "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."— Presentation transcript:

1 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 HCV infection HCV RNA ≥ 50,000 IU/ml No cirrhosis No HBV or HIV co-infection SOF + RBV SOF + RBV + PEG-IFN SOF, N = 10 SOF + RBV + PEG-IFN, N = 10 SOF + RBV, N = 10 SOF + RBV, N = 25 + PEG-IFN 4W + PEG-IFN 8W Genotype 2, 3 Treatment-naïve * Randomisation stratified on genotype (2 or 3) and IL28 (CC or non-CC) Genotype 2, 3 Treatment-naïve No randomisation Genotype 1, No response to prior treatment Genotype 1, Treatment naïve  Objective : SVR 24 with two-sided 95% CI, descriptive analysis N = 10 N = 9 N = 10 N = 11 Gane EJ. NEJM 2013;368:34-44

2 Drug regimenN Genotype N Female % Age, years mean BMI, kg/m 2 mean HCV RNA, log 10 IU/ml, median IL28B CC SOF + RBV 12W10 2, N = 4 3, N = 6 20%47286.750% SOF + RBV 12W + PEG-IFNa-2a 4W 9 2, N = 3 3, N = 6 44%48266.644% SOF + RBV 12W + PEG-IFNa-2a 8W 10 2, N = 4 3, N = 6 50%49256.540% SOF + RBV + PEG-IFNa- 2a 12W 11 2, N = 4 3, N = 7 18%46246.536% SOF 12W10 2, N = 3 3, N = 7 60%43265.920% SOF + RBV + PEG-IFNa- 2a 8W 103, N = 1050%39256.030% SOF + RBV 12W, no response to prior therapy 10 1a, N = 9 1b, N = 1 30%48287.020% SOF + RBV 12W, naïve25 1a, N = 22 1b, N = 3 40%49266.244% Baseline characteristics and dosing of medication SOF : 400 mg qd ; RBV weight based (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg ; PEG-IFN  -2a : 180  g SC once weekly ELECTRON ELECTRON Study: SOF-based therapy for genotypes 1, 2 and 3 Gane EJ. NEJM 2013;368:34-44

3 Drug regimenGenotypeN HCV RNA < 15 IU/mL End of treatment % (95% CI) SVR 24 % (95% CI) SOF + RBV 12W2 + 310100% (69-100) SOF + RBV 12W + PEG-IFNa-2a 4W2 + 39100% (66-100) SOF + RBV 12W + PEG-IFNa-2a 8W2 + 310100% (69-100) SOF + RBV + PEG-IFNa-2a 12W2 + 311100% (72-100) SOF 12W2 + 310100% (69-100)60% (26-88) SOF + RBV + PEG-IFNa-2a 8W310100% (69-100)100% (66-100) SOF + RBV 12W, no response to prior therapy1a + 1b10100% (69-100)10% (0-45) SOF + RBV 12W, naïve1a + 1b25100% (86-100)84% (64-96) HCV RNA < 15 IU/ml All patients had HCV RNA < 15 IU/ml at W4 on treatment ELECTRON ELECTRON Study: SOF-based therapy for genotypes 1, 2 and 3 Gane EJ. NEJM 2013;368:34-44

4  Resistance testing (sequencing)  4 relapse (2 genotype 2 and 2 genotype 3) in the SOF 12W group  1 patient with S282T mutation (genotype 2b)  No NS5B substitutions in the other 3 patients  15 relapse in genotype 1 patients  No NS5B substitutions  Adverse events  Most common : headache, fatigue, insomnia, nausea, rash, anemia  IFN-free groups : less severe reductions in hemoglobin, no neutropenia, no thrombopenia  SOF monotherapy : mean decrease of 0.54g/dl of hemoglobin ELECTRON ELECTRON Study: SOF-based therapy for genotypes 1, 2 and 3 Gane EJ. NEJM 2013;368:34-44

5  Summary –By W4 of treatment, all 95 patients in the study had an undetectable level of HCV RNA –All 50 previously untreated patients with HCV genotype 2 or 3 infection who received 8 or 12 weeks of treatment with SOF + RBV, with or without PEG-IFN-alfa 2a, had a sustained virologic response at 24 weeks after treatment –SOF alone 12W was associated with 40% of relapse, suggesting a role for RBV in genotype 2 or 3 to maintain antiviral response –In genotype 1, SVR was much higher in patients naïve to treatment –There was no discontinuation of SOF or RBV in any group –Sofosbuvir plus ribavirin for 12 weeks may be effective in previously untreated patients with HCV genotype 1, 2, or 3 infection ELECTRON ELECTRON Study: SOF-based therapy for genotypes 1, 2 and 3 Gane EJ. NEJM 2013;368:34-44

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