DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

Treatment regimens

• Co-formulated ombitasvir (OBV)/ paritaprevir (PTV)/ rironavir (r): 25/150/100 mg QD = 2 tablets
• Dasabuvir (DSV) : 250 mg bid

Objective

• SVR₁₂ (HCV RNA < 15 IU/ml )
• Virologic failures and relapses
• SVR₁₂ in patients with baseline HCV RNA < 6 000 000 IU/mL

Baseline characteristics and outcome

* Exclusion of 3 patients with non-1b genotype : 1 genotype 1a, 1 genotype 1d, 1 genotype 6
** Exclusion of non- virologic failures (1 early discontinuation for non-compliance)

SRV₁₂ rates by subgroups, mITT-GT, %

Virologic failures, n = 2 (exclusion of a 3rd failure in a patient with genotype 6)

Treatment-emergent adverse events

* One 24-year-old female patient with F0–F1 fibrosis discontinued study drug on D45 due to grade 3 hyperbilirubinemia (direct and indirect) that was considered possibly related to study drugs. A grade 3 ALT elevation occurred following hyperbilirubinemia ; both returned to normal. The patient achieved SVR₁₂
** syncope on D17, gastroenteritis on post-treatment D8 ; both were deemed unrelated to study drugs

Summary

• The 3D regimen administered for 8 weeks achieved a 98% SVR₁₂ in treatment-naïve genotype 1b patients without cirrhosis
• Both patients who experienced virologic failure had F3 fibrosis at baseline
• Fibrosis (F3 vs F0–F2) was the only significant predictor of SVR₁₂
• Baseline HCV RNA, sex, BMI, age, and former IV drug use were not predictive of treatment failure
• Presence of resistance-associated polymorphisms at baseline did not impact SVR
• The 8-week, RBV-free 3D regimen was well tolerated
  • Most adverse events were mild or moderate in severity
  • Serious adverse events and clinically significant laboratory abnormalities were rare (<1% )
• The 98% SVR₁₂ rate demonstrates that treatment- naïve genotype 1b patients without cirrhosis can be eff ecti vely treated with 3D for 8 weeks