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BROWSE SLIDES

Design

* Metavir F4 or Ishak > 4 or F ibroscan > 14 .6 kPa or FibroTest, Child score = 6

Treatment regimen

• Co-formulated ombitasvir (OBV)/ paritaprevir (PTV)/ rironavir (r) : 25/150/100 mg QD = 2 tablets

Objective

• SVR₁₂ (HCV RNA < 25 IU/ml) with 95% CI : hypothesis of a 25% difference between treatment-naïve (95%) and prior null-responders without cirrhosis (70%), 80% power with two-sided significance level of 0.05, analysis by intention-to-treat

Baseline characteristics and patient disposition

SVR₁₂ (HCV RNA < 25 IU/mL), % (95% CI)

• No differences between groups

Virologic failure, N = 5

• Prior null-responders without cirrhosis, N = 4 (1 virologic breakthrough, 3 relapses)
• Prior null-responder with cirrhosis, N = 1 (relapse)
• IL28B CT : 5/5

Resistance-associated variants at baseline

Resistance-associated variants at virologic failure

Adverse events, N or %

Summary

• An interferon - and ribavirin-free regimen of ombitasvir , paritaprevir , and ritonavir , achieved rates of SVR₁₂ > 90% in patients with HCV genotype 1b infection with and without cirrhosis, with a 24-weeks or 12-weeks duration of treatment, respectively
  • SVR₁₂ was 95-98% in naïve patients
  • SVR₁₂ was 90-96% in treatment-experienced patients
• There were few virologic failures, all occurring in prior null responders (failure rate 5/65 = 7.6%), who also harbored CT IL28B genotype
  • All 5 patients had NS3 and NS5A RAVs at failure
• The regimen was well tolerated and was associated with low rate (1.7%) of treatment discontinuation
  • The majority of adverse events were mild in severity