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ARV-trial.com RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Design Open label W12.

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Presentation on theme: "ARV-trial.com RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Design Open label W12."— Presentation transcript:

1 ARV-trial.com RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Design Open label W12 ≥ 18 years Chronic HCV infection Genotype 1a or 4 Treatment-naïve Stage 4 or 5 chronic kidney disease with eGFR (MDRD) < 30 ml/min/1.73m2 (dialysis permitted) No cirrhosis No HBV or HIV co-infection Genotype 1a OBV/PTV/r + DSV N = 13 SVR12 Genotype 4 OBV/PTV/r N = 5 Treatment regimens Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r): 25/150/100 mg QD = 2 tablets Dasabuvir (DSV): 250 mg BID Objective SVR12 (HCV RNA < 25 IU/mL), by ITT and mITT (exclusion of non-virologic failures) RUBY-II Gane E. AASLD 2016, Abs. 935 1

2 Baseline characteristics and outcome
ARV-trial.com RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Baseline characteristics and outcome Genotype 1a (N = 13) OBV/PTV/r + DSV Genotype 4 (N = 5) OBV/PTV/r Median age, years 57 58 Female, % 31 40 Race : white, % 62 60 Fibrosis stage F0-F1 / F2 / F3, % 62 / 8 / 31 60 / 20 / 20 IL28B CC genotype, % 46 HCV RNA log10 IU/mL, median 5.8 5.7 Chronic kidney disease, % Stage 4 Stage 5 100 (hemodialysis : 62, peritoneal dialysis : 38) 20 80 (all on hemodialysis) Mean eGFR, ml/min/1.73 m2 SVR12, % ITT mITT 100 80 * * The patient underwent elective renal transplantation and withdrew consent at treatment W2 and did not achieve SVR12 RUBY-II Gane E. AASLD 2016, Abs. 935 2

3 Adverse events and laboratory abnormalities, N (%)
RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Adverse events and laboratory abnormalities, N (%) OBV/PTV/r + DSV + RBV N = 13 (Genotype 1a) OBV/PTV/r + DSV N = 5 (Genotype 4) Serious adverse event (not related to study drugs) 3 (23%) 1 (20%) Adverse event leading to discontinuation 1 (8%) * 1 (20%) ** Adverse event in > 15% in any group, % Abdominal pain Fatigue Diarrhea Headache Hypertension Nausea Pruritus 23 31 15 20 Hemoglobin 8-10 g/dL / g/dL, N 4 / 0 2 / 0 Total bilirubin grade ≥ 2 (> 1.5 x ULN), N ALT or AST grade 3, N 1 * Discontinued study drug (on treatment D77) due to grade 3 ALT, but achieved SVR12 ** Discontinued study drug due to renal failure and transplantation at treatment W2, and did not achieve SVR12 RUBY-II Gane E. AASLD 2016, Abs. 935

4 RUBY-II Study: ombitasvir/paritaprevir/ritonavir + dasabuvir for HCV genotype 1a or 4 with severe renal impairment Summary In this study of non-cirrhotic, treatment-naïve patients with stage 4 or 5 chronic kidney disease, including those receiving dialysis, the RBV- free regimen of OBV/PTV/r ± DSV resulted in ITT SVR12 rate of 100% for genotype 1a and 80% for genotype 4 (only 5 patients enrolled), and a mITT SVR12 rate of 100% for genotypes 1a and 4, with no on- treatment virologic failure or relapse The RBV-free 2-DAA and 3-DAA regimens were generally well tolerated in this patient population Most adverse events were mild to moderate in severity, and there were no serious adverse event deemed related to study drugs These data suggest that RBV may not be necessary in some genotype 1a- or genotype 4-infected patients with severe renal impairment treated with OBV/PTV/r ± DSV larger trials are needed to confirm the results of this exploratory study RUBY-II Gane E. AASLD 2016, Abs. 935

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