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Design

* Randomisation was stratified by prior treatment response (null or partial for genotype 1b; null, partial or relapse for genotype 2)
** Liver biopsy with Metavir = F3 or Ishak = 4, or Fibrotest® = 0.72 + APRI = 2, or Fibroscan < 9.6 kPa

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

Objective

• Primary endpoint : SVR 24 (HCV RNA < 25 IU /ml) , by intent-to-treat-analysis, with expected rate of 80%, two-sided 95% CI

Baseline characteristics

SVR 24 (HCV RNA < 25 IU /ml)

Virologic failure

• Genotype 1b
  • The patient who relapsed had resistance-associated variants in NS3 (D168V) and NS5A (Y93H) at the time of virologic failure
  • The NS5A RAV, Y93H, was present at baseline in 4 patients with genotype 1b ; all achieved SVR 24
• Genotype 2
  • All patients with virologic failure had resistance-associated variants in NS3 and/or NS5A at the time of virologic failure, most commonly D168V or D168Y in NS3 and L28F in NS5A
  • The presence of RAVs in NS3 and NS5A at baseline did not impact response

Adverse events and laboratory abnormalities, N

Summary

• In this randomised phase II study of an IFN- and RBV-free regimen of ombitasvir / paritaprevir / ritonavir in PEG-IFN + RBV treatment–experienced Japanese patients
  • High SVR 24 rates were observed in patients with HCV subtype 1b infection, regardless of paritaprevir dose or treatment duration.
  • Among patients with genotype 2 infection, SVR rates were higher in those receiving paritaprevir 150 mg and those with subtype 2a infection
  • These differences in response rates for genotype 2 may be related to NS3/4A or NS5A polymorphisms between subtypes 2a and 2b
  • Together, these results show promising antiviral activity for this all-oral 2 DAA combination regimen
• Safety and tolerability was good
• Limitations
  • Exclusion of patients with cirrhosis
  • Relatively small number of patients in each treatment arm