Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants. Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.
Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
143
Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.
Simeprevir will be supplied as 75 and 150 mg oral capsules.
Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.
TMC647055 will be supplied as 150 mg oral capsules.
Ritonavir will be supplied as 80 mg/mL oral solution.
Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.
Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.
Percentage of participants who experienced an adverse event (AE)
Time frame: Up to approximately 95 weeks
Percentage of participants who experienced a serious adverse event (SAE)
Time frame: Up to approximately 95 weeks
Percentage of participants who experienced a Grade 1-4 laboratory abnormality
Time frame: Up to 66 weeks
Percentage of participants who experienced sustained virologic response 4 weeks after the end of treatment (SVR4)
Time frame: Up to 16 weeks
Percentage of participants who experienced rapid virologic response (RVR)
Time frame: Week 4
Percentage of participants who experienced early virologic response (EVR)
Time frame: Week 12
Percentage of participants who experienced sustained virologic response 8 weeks after the end of treatment (SVR8)
Time frame: Up to 20 weeks
Percentage of participants who experienced sustained virologic response 12 weeks after the end of treatment (SVR12)
Time frame: Up to 24 weeks
Percentage of participants who experienced sustained virologic response 24 weeks after the end of treatment (SVR24)
Time frame: Up to 36 weeks
Pharmacokinetic Parameter:Area under the concentration-time curve from time zero to t
Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
Pharmacokinetic Parameter: Maximum observed drug concentration (Cmax)
Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
Pharmacokinetic Parameter: Trough drug concentration (Ctrough)
Time frame: Days 1, 4, 7, 10, 14, 21, 28, 42, 56 and 84
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