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
• RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or = 75 kg )

Objective

• Primary endpoint : SVR₁₂ (HCV RNA < 25 IU/ml), with 95% CI
• Intensive 24 hours steady-state PK analysis

Baseline characteristics and outcome

Adverse events, N (%)

Steady- stade pharmacokinetic parameters (N = 22)

* Median (arithmetic mean ± SD) ; ** AUC 24 for drugs qd , AUC 12 for drugs BID

• The steady-state exposures for OBV, PTV, and RTV were comparable to exposures in phase I studies of adults receiving similar formulations of OBV/PTV/r + DSV without methadone or buprenorphine, while exposures of DSV and DSV M1 were slightly lower

Summary

• The 3D + RBV regimen achieved an SVR₁₂ rate of 97.4% among these 38 genotype 1- infected patients receiving opioid replacement therapy
• No viral breakthroughs or relapses were observed
• The regimen was well tolerated, with low rate of discontinuation
• Adverse events were generally mild
• Drug-drug interactions did not impact HCV treatment or opioid maintenance
  • No patient required a change in the dosage of methadone or buprenorphine during study treatment
• 12 weeks all -oral regimen of OBV/PTV/r + DSV + RBV is well-tolerated and may be an attractive treatment option for genotype 1 infected patients receiving opioid replacement therapy