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Design

Treatment regimens

• Co-formulated ombitasvir (OBV)/ paritaprevir (PTV)/ rironavir (r): 25/150/100 mg qd = 2 tablets
• Dasabuvir (DSV): 250 mg bid
• RBV: 1 000 or 1 200 mg/day in 2 doses according to body weight (< or > 75 kg)

Objective

• SVR₁₂ (HCV RNA <15 IU/ml), with 95% CI, by ITT, descriptive analysis

Baseline characteristics

SVR₁₂, % (ITT)

SVR₁₂, % (mITT*)

* Sensitivity analysis excluding excluding patients lost to follow-up and patients that prematurely discontinued study drug with no on-treatment virologic failure

Patients not achieving SVR₁₂ (ITT population)

*2 patients discontinued due to an adverse event ; 1 patient withdrew consent

Treatment emerging adverse events and laboratory abnormalities, N (%)

* Nausea (N = 2), fatigue (N = 1), lethargy/vomiting (N = 1), hypercortisolism (N = 1), peritonitis (N = 1)
** Death due to metastatic pancreatic adenocarcinoma (Stage IV). Unrelated to HCV therapy

Summary

• In the TOPAZ-II study, treatment-naïve or -experienced patients with HCV genotype 1 infection with or without cirrhosis achieved high SVR₁₂ rates (95.3% in the ITT population and 97.3% in the mITT population) with 12- or 24-weeks of treatment with OBV/PTV/r + DSV ± RBV
• Treatment was well tolerated with low rates of serious adverse events and study drug discontinuations due to adverse events