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ARV-trial.com RUBY-I Study, cohort 2: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment Design Open label W12.

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Presentation on theme: "ARV-trial.com RUBY-I Study, cohort 2: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment Design Open label W12."— Presentation transcript:

1 ARV-trial.com RUBY-I Study, cohort 2: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment Design Open label W12 W24 ≥ 18 years Chronic HCV infection Genotype 1 Treatment-naïve or PEG-IFN + RBV-experienced HCV RNA > 1,000 IU/ml Chronic kidney disease with eGFR (MDRD) < 30 ml/min/1.73m2 (dialysis permitted) Compensated cirrhosis allowed ** No HBV or HIV co-infection Genotype 1a F0-F3 N = 28 OBV/PTV/r DSV + RBV Genotype 1a F4 N = 9 OBV/PTV/r DSV + RBV Genotype 1b F0-F4 N = 11 OBV/PTV/r + DSV ** Liver biopsy (Metavir ≤ F3, Ishak score ≤ 4) or Fibroscan < 12.5 kPa or FibroTest ≤ APRI ≤ 2 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) Objective SVR12 (HCV RNA < 25 IU/ml) by intent-to-treat with 2-sided 95% CI RUBY-I, cohort 2 Vierling JM. AASLD 2016, Abs. 886 1

2 Baseline characteristics
ARV-trial.com RUBY-I Study, cohort 2: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment Baseline characteristics Genotype 1a F0-F3 N = 28 F4 N = 9 Genotype 1b F0-F4 n = 11 Median age, years 59 56 58 Female, % 18 27 Race : white / black, % 43 / 57 33 / 44 36 / 55 Body mass index, mean 27.9 27.3 25.0 Fibrosis stage F0-F1 / F2 / F3, F4, % 50 / 32 / 18 / 0 0 / 0 / 0 / 100 27 / 9 / 9 / 55 IL28B CC genotype, % 14 44 HCV RNA log10 IU/ml, median (range) 6.2 ( ) 6.0 ( ) 5.8 ( ) IFN-RBV experienced, % Null-response, % Relapse, % Other, % 33 CKD stage 4 *, N KD stage 5 ** or dialysis, N 4 24 2 7 9 * eGFR ml/min/1.73 m2 ; ** eGFR < 15 ml/min/1.73 m2 RUBY-I, cohort 2 Vierling JM. AASLD 2016, Abs. 886 2

3 RUBY-I Study, cohort 2: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment SRV12, % % 100 96 * 100 89 ** 80 60 40 20 n 28 9 11 Genotype 1a F0-F3 12 weeks Genotype 1a F4 24 weeks Genotype 1b F0_F4 12 weeks * on-treatment breakthrough (non compliance, stopped taking all study drugs on D73 of treatment) ** discontinuation of study drug at D6 due to an adverse event (volvulus) not related to study drug RUBY-I, cohort 2 Vierling JM. AASLD 2016, Abs. 886 3

4 Adverse events and laboratory abnormalities
ARV-trial.com RUBY-I Study, cohort 2: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment Adverse events and laboratory abnormalities Genotype 1a F0-F3 N = 28 F4 N = 9 Genotype 1b F0-F4 N = 11 Any adverse event, % 96 89 55 Discontinuation for adverse event, n (%) 1 (4) 1 (11) Serious adverse event, % 29 44 9 Adverse event in > 10% of patients, % Anemia Fatigue Diarrhea Hemoglobin decreased Nausea Vomiting Pruritus Headache 18 Hemoglogin grade ≥ 2 / grade ≥ 3, % 71 / 4 75 / 25 27 / 0 ALT grade ≥ 2 / grade ≥ 3 4 / 4 0 / 0 AST grade ≥ 2 / grade ≥ 3 Total bilirubin grade ≥ 2 / grade ≥ 3 4 / 0 38 / 13 * eGFR ml/min/1.73 m2 ; ** eGFR < 15 ml/min/1.73 m2 or hemodialysis RUBY-I, cohort 2 Vierling JM. AASLD 2016, Abs. 886 4

5 RUBY-I Study, cohort 2: ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV for HCV genotype 1 with renal impairment Summary OBV/PTV/r + DSV ± RBV resulted in an SVR12 rate of 96% in patients with CKD stages 4 or 5 in cohort 2 of the RUBY-I study The regimen was generally well tolerated for this group of patients with severe underlying comorbidities, with 1 possibly DAA-related serious adverse event of diarrhea and 1 discontinuation due to an adverse event unrelated to treatment A large proportion of patients on RBV required RBV dose modification for anemia Most adverse events were mild or moderate in severity These results of efficacy and safety support the use of this regimen in patients with advanced renal disease, for whom treatment options are limited RUBY-I, cohort 2 Vierling JM. AASLD 2016, Abs. 886

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