> 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.

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Presentation transcript:

> 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 biopsy or noninvasive tests * No HBV or HIV co-infection GZR/EBR + SOF + RBV W12 Open-label N = 25 SVR 12 GZR/EBR 100/50 mg qd ; SOF 400 mg qd RBV (bid dosing) = 1000 mg/day if 75 kg  Objective –SVR 12 (HCV RNA < 15 IU/mL), with 95% CI, by ITT * Fibroscan ≤ 12.5 kPa or Fibrotest ≤ 0.48 and APRI ≤ 1 Lawitz E. AASLD 2015, LB12 C-SWIFT- Part B C-SWIFT Study - Part B: GZR/EBR + SOF + RBV in genotype 1 patients failing prior treatment with GZR/EBR + SOF  Design

C-SWIFT Study - Part B: GZR/EBR + SOF + RBV in genotype 1 patients failing prior treatment with GZR/EBR + SOF N = 25 Mean age, years54 Female12% Race, white100% IL28B CC20% Genotype 1a 1b 88% 12% Cirrhosis, n (%)20% HCV RNA x 10 6 IU/ml, mean6.19 Baseline RAVs NS3 NS5A NS5B NS3 + NS5A 52% 80% 0 44% Days from virologic failure to enrollment, mean214 (range ) SVR 12, mITT 23/23 (100%) Excludes 2 patients lost to follow-up (D3 and W4) Baseline characteristics and outcome Lawitz E. AASLD 2015, LB12 C-SWIFT- Part B

N = 25 Adverse event52% Serious adverse event1 (4%) Drug-related adverse event9 (36%) Discontinuation due to adverse event0 Death0 Most common adverse events Rash Fatigue Nausea Urinary tract infection 8%8% Hemoglobin < 10 g/dl1 (4%) Total bilirubin > 5 x baseline0 ALT/AST > 5 x ULN0 Safety, N (%) Lawitz E. AASLD 2015, LB12 C-SWIFT- Part B C-SWIFT Study - Part B: GZR/EBR + SOF + RBV in genotype 1 patients failing prior treatment with GZR/EBR + SOF

 Summary –A 12-week regimen of grazoprevir/elbasvir + sofosbuvir + ribavirin was able to successfully treat genotype 1-infected patients who failed short-duration of GZR/EBR + SOF SVR 12 of 100% regardless of subgenotype, cirrhosis or baseline RAVs –GZR/EBR + SOF + RBV was generally safe and well tolerated Dose adjustment of RBV was required in 2 patients Lawitz E. AASLD 2015, LB12 C-SWIFT- Part B