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OBV/PTV/r + DSV Open label Chronic HCV infection Genotype 1 Treatment-naïve HCV RNA > 1,000 IU/ml Chronic kidney disease with eGFR < 30 ml/min/1.73m 2.

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Presentation on theme: "OBV/PTV/r + DSV Open label Chronic HCV infection Genotype 1 Treatment-naïve HCV RNA > 1,000 IU/ml Chronic kidney disease with eGFR < 30 ml/min/1.73m 2."— Presentation transcript:

1 OBV/PTV/r + DSV Open label Chronic HCV infection Genotype 1 Treatment-naïve HCV RNA > 1,000 IU/ml Chronic kidney disease with eGFR < 30 ml/min/1.73m 2 (dialysis permitted) No cirrhosis** No HBV or HIV co-infection RUBY-I Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment SVR 12 ** Liver biopsy or fibroscan < 14.6 kPa or FibroTest ≤ 0.72 + APRI ≤ 2 OBV/PTV/r DSV + RBV N = 7 Genotype 1a Genotype 1b N = 13 Pockros PJ. AASLD 2015, Abs. 1039 RUBY-I  Design  Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r): 25/150/100 mg qd = 2 tablets –Dasabuvir (DSV): 250 mg bid –RBV 200 mg qd (genotype 1a), dosed 4h prior to start of hemodialysis (if applicable)  Objective –SVR 12 (HCV RNA < 25 IU/ml ) W12

2 Baseline characteristics and outcome * 2 failures –1 death at D14 after the end of treatment (unrelated cardiac cause) ; HCV RNA undetectable –1 relapse : black male, 49, GT1a, F3, IL28B CT, RBV discontinued at D58 due to anemia, compliance not optimal, RAVs emergence at failure : NS3 (D168V) and NS5A (Q30R) Pockros PJ. AASLD 2015, Abs. 1039 RUBY-I N = 20 Median age, years60 Female15% Race : white / black30% / 70% Body mass index, mean30.5 Genotype 1a / 1b, N13 / 7 Fibrosis stage F0-F1 / F2 / F3, N10 / 6 / 4 IL28B CC genotype30% HCV RNA log 10 IU/ml, median6.57 History of diabetes11 (55%) eGFR 15-30 ml/min/1.73 m 2 (CKD stage 4), N eGFR < 15 ml/min/1.73 m 2 or dialysis (CKD stage 5), N 6 14 SVR 12 (HCV RNA < 25 IU/ml)18/20 (90%) * RUBY-I Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment

3 Adverse events and laboratory abnormalities, N (%) Pockros PJ. AASLD 2015, Abs. 1039 RUBY-I RUBY-I Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment OBV/PTV/r + DSV + RBV N = 13 (Genotype 1a) OBV/PTV/r + DSV N = 7 (Genotype 1b) Serious adverse event3 (23)1 (14) Adverse event related to study drug82 Adverse event leading to discontinuation00 Adverse event leading to RBV dose reduction9 (69)NA Adverse event in > 15% in any group Anemia9 (69)0 Fatigue5 (38)2 (29) Diarrhea4 (31)1 (14) Nausea5 (38)0 Headache3 (23)0 Peripheral edema1 (8)2 (29) Hemoglobin < 10-8 g/dl / < 8-6.5 g/dl, N7 / 12 / 0 Total bilirubin > 1.5 to 4 x ULN, N20 ALT or AST grade 300

4 Pockros PJ. AASLD 2015, Abs. 1039 RUBY-I RUBY-I Study: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment  Summary –In HCV genotype 1-infected patients with stage 4 or 5 chronic kidney disease, including patients on dialysis, 12 weeks of therapy achieved a SVR 12 of 90% overall –Among patients with post-treatment data available, the SVR 12 rate was For genotype 1a : 92.3% (12/13) with OBV/PTV/r + DSV + RBV ; 1 relapse, possibly related to poor treatment compliance For genotype 1b : 100% (7/7) with OBV/PTV/r + DSV –OBV/PTV/r + DSV ± RBV was well tolerated with no treatment discontinuations –The majority of patients receiving RBV 200 mg/day required RBV interruption –Laboratory abnormalities and safety findings were otherwise consistent with the safety profile in patients with normal renal function –These data support the use of the 3D regimen with no dose adjustment in patients with severe or end-stage renal disease


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