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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-

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Presentation on theme: "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-"— Presentation transcript:

1 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- experienced with cirrhosis Genotype 3, naïve or experienced, with or without cirrhosis No HBV or HIV co-infection SOF + PEG- IFN + RBV * Randomisation was stratified on genotype (2 or 3), prior therapy (yes or no) and cirrhosis (presence or absence) N = 196 N = 199 N = 197 SVR 12 –SOF 400 mg) : 1 pill QD –RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg) –PEG-IFNa-2a : 180 mg SC once weekly  Objective –SVR 12 (HCV RNA < 15 IU/ml) SVR 12 BOSON Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70  Design W24W16 W12

2 BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3 SOF + RBV 16W N = 196 SOF + RBV 24W N = 199 SOF + PEG-IFN + RBV 12W N = 197 Mean age, years514950 Female32%35%33% Asian14%13% Genotype 392% Cirrhosis37% 38% IL28B CC genotype38%37%40% HCV RNA log 10 IU/ml, mean6.36.26.3 Treatment-experienced54%53%52% BOSON Baseline characteristics Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70

3 BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3 BOSON SVR 12 (HCV RNA < 15 IU/ml), % (95% CI) SOF + RBV 16WSOF + RBV 24WSOF + PEG-IFN + RBV 12W Genotype 2Genotype 3 All patients –In genotype 3, higher SVR 12 with SOF + PEG-IFN + RBV 12W compared to SOF + RBV for 16W or 24W, particularly in patients with cirrhosis and/or prior treatment 15 % 1718116182181 94/11283/100 10/11 7072712122 23 3436355452 54 Treatment NaïveTreatment Experienced TN no cirrhosisTN cirrhosisTE no cirrhosis TE cirrhosis % Genotype 3 by subgroup Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70

4 BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3 BOSON SVR 12 in GT 3 SOF + RBV 16WSOF + RBV 24WSOF + PEG-IFN + RBV 12W 40 60 100 80 n 99 124 20 0 87 95 51 79 88 77 88 95 64 80 91 SVR 12 (%) 109 126 117 123 29 57 44 56 51 58 70 91 83 94 89 94 58 90 70 88 79 87 No CirrhosisCirrhosis Treatment History NaïveExperienced Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70

5 BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3 Reasons for not achieving SVR 12 Resistance analysis BOSON  Deep sequencing successful on 78/88 patients with virologic failure –No S282T variants –SOF treatment-emergent variants L159F and V321A in 9/78 (21%) L159F at baseline and failure, N = 1, only at failure, N = 5 V321A emerged at failure in 2 patients Patients, n (%) SOF + RBV 16W N = 196 SOF + RBV 24W N = 199 SOF + PEG-IFN + RBV 12W N = 197 SVR 12 141 (72)170 (85)183 (93) On-treatment failure03 (2)0 Relapse52/195 (27)24/195 (12)9/195 (5) Other*3 (2)2 (1)5 (3) * Patients who discontinued before achieving HCV RNA < LLOQ or did not return for week 12 post-treatment visit Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70

6 SOF + RBV 16W N = 196 SOF + RBV 24W N = 199 SOF + PEG-IFN + RBV 12W N = 197 Grade 3–4 adverse event11 (6)7 (4)15 (8) Serious adverse event8 (4)10 (5)12 (6) Treatment discontinuation due to AE3 (2)2 (1)1 (< 1) Adverse event ≥ 15% in any arm Fatigue 36%41%46% Headache 31%36% Insomnia 24%28%25% Nausea16%17%25% Rash12%14%20% Flu-like illness4% 19% Decreased appetite7%8%18% Myalgia6%10%17% Dyspnea exertional11% 15% Pyrexia3%4%15% Hemoglobin < 10g/dl / 8.5 g/dL4% / 06% / 012% / 1% BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3 BOSON Adverse events, N (%) Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70

7 BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3  Summary –Genotype 2 : treatment-experienced patients with cirrhosis achieved high SVR 12 rates with all regimens –Genotype 3 : higher SVR 12 rates with SOF + PEG/RBV than with SOF + RBV for 16 or 24 weeks Genotype 3 treatment-experienced patients with cirrhosis achieved an SVR 12 of 86% with SOF + PEG + RBV for 12 weeks –SOF + RBV for 24 weeks achieved SVR 12 rates > 80% in all other subgroups; results consistent with earlier phase III studies –SOF + RBV for 16 or 24 weeks and SOF + PEG + RBV for 12 weeks were well tolerated with a low rate of treatment discontinuations due to adverse events BOSON Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70

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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.
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.

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LDV/SOF 90/400 mg qd Non-randomised Open-label N = 21 W12 SVR 12 NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print ≥ 18 years.

LDV/SOF 90/400 mg qd Non-randomised Open-label N = 21 W12 SVR 12 NIAID SYNERGY GT4 Kohli A. Lancet Infect Dis 2015; Juky 15, ePub ahead of print ≥ 18 years.
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