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BROWSE SLIDES

Design

** Liver biopsy ( Metavir = F3, Ishak score = 4) or F ibroscan < 12.5 kPa or FibroTest = 0.72 + 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

Baseline characteristics

* eGFR 15- 30 ml/min/1.73 m² ; ** eGFR < 15 ml/min/1.73 m²

SRV₁₂, %

* 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

Adverse events and laboratory abnormalities

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