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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 12000 mg/day divided twice daily

Objective

• SVR₁₂ (HCV RNA < 25 IU/mL), with 95% CI, by ITT, descriptive analysis

Baseline characteristics

SVR₁₂ by subgroup, ITT population

* 1 virologic failure ; ** 3 premature discontinuations

Adverse events, %

* Nausea and vomiting leading to withdrawal of consent (N = 1), atypical pneumonia with acute renal injury followed by acute respiratory failure (N = 1), and tacrolimus overdose (N = 1)
** 1 patient (tacrolimus overdose)

Laboratory abnormalities, %

Summary

• In liver transplant recipients with or without cirrhosis and infected with HCV genotype 1 or 4, treatment with OBV/PTV/r ± DSV ± RBV was associated
  • with high SVR₁₂ rates
  • and good tolerability
• In renal transplant recipients, SVR₁₂ was achieved in 9/12 patients, with 3 premature discontinuations due to adverse events, including 1 fatality
• Need for tacrolimus dose reduction and therapeutic drug monitoring of tacrolimus levels to manage the interaction with ritonavir
• Patients with genotype 1b achieved SVR₁₂ of 100% with RBV-free regimens