Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Efficacy, Tolerability, Safety and Pharmacokinetics of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin In Treatment-Naive Genotype 1 Hepatitis C-Infected Subjects
Brief Summary: The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA \[less than 25 IU per mL undetectable\] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.


Options:
A: Arm Label: SOF+RBV+placebo; Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV, Drug: Placebo to match SOF, Drug: Placebo to match RBV | Arm Label: SOF+RBV; Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Intervention Type: DRUG; Name: SOF; Assigned to Arm(s): SOF+RBV, SOF+RBV+placebo | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF+RBV, SOF+RBV+placebo | Intervention Type: DRUG; Name: Placebo to match SOF; Assigned to Arm(s): SOF+RBV+placebo | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): SOF+RBV+placebo
B: Arm Label: TMC435 75 mg 12 Wks + PR 24/48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Ribavirin (R), Drug: PegIFNα-2a (P), Drug: Placebo | Arm Label: TMC435 75 mg 24 Wks + PR 24/48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Ribavirin (R), Drug: PegIFNα-2a (P), Drug: Placebo | Arm Label: TMC435 150 mg 12 Wks + PR 24/48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Ribavirin (R), Drug: PegIFNα-2a (P), Drug: Placebo | Arm Label: TMC435 150 mg 24 Wks + PR 24/48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Ribavirin (R), Drug: PegIFNα-2a (P), Drug: Placebo | Arm Label: Placebo 24 Wks + PR48; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ribavirin (R), Drug: PegIFNα-2a (P), Drug: Placebo | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): TMC435 150 mg 12 Wks + PR 24/48, TMC435 150 mg 24 Wks + PR 24/48, TMC435 75 mg 12 Wks + PR 24/48, TMC435 75 mg 24 Wks + PR 24/48 | Intervention Type: DRUG; Name: Ribavirin (R); Assigned to Arm(s): Placebo 24 Wks + PR48, TMC435 150 mg 12 Wks + PR 24/48, TMC435 150 mg 24 Wks + PR 24/48, TMC435 75 mg 12 Wks + PR 24/48, TMC435 75 mg 24 Wks + PR 24/48 | Intervention Type: DRUG; Name: PegIFNα-2a (P); Assigned to Arm(s): Placebo 24 Wks + PR48, TMC435 150 mg 12 Wks + PR 24/48, TMC435 150 mg 24 Wks + PR 24/48, TMC435 75 mg 12 Wks + PR 24/48, TMC435 75 mg 24 Wks + PR 24/48 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo 24 Wks + PR48, TMC435 150 mg 12 Wks + PR 24/48, TMC435 150 mg 24 Wks + PR 24/48, TMC435 75 mg 12 Wks + PR 24/48, TMC435 75 mg 24 Wks + PR 24/48
C: Arm Label: Arm A; Type: EXPERIMENTAL; Interventions: Drug: ombitasvir/paritaprevir/ritonavir, Drug: ribavirin | Arm Label: Arm B; Type: EXPERIMENTAL; Interventions: Drug: ombitasvir/paritaprevir/ritonavir, Drug: ribavirin | Arm Label: Arm C; Type: EXPERIMENTAL; Interventions: Drug: ombitasvir/paritaprevir/ritonavir, Drug: ribavirin | Arm Label: Arm D; Type: EXPERIMENTAL; Interventions: Drug: ombitasvir/paritaprevir/ritonavir, Drug: ribavirin | Intervention Type: DRUG; Name: ombitasvir/paritaprevir/ritonavir; Assigned to Arm(s): Arm A, Arm B, Arm C, Arm D | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Arm A, Arm B, Arm C, Arm D
D: Arm Label: Part 1: Single Dose Escalation in Healthy Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2336805 10mg, Drug: GSK2336805 30mg, Drug: GSK2236805 100mg, Drug: GSK2236805 200mg | Arm Label: Part 2: Repeat Dose Escalation in Healthy Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2236805 10mg, Drug: GSK2236805 dose to be determined up to 100mg | Arm Label: Part 3: Single Dose Escalation in HCV Infected Subjects; Type: EXPERIMENTAL; Interventions: Drug: GSK2236805 5mg, Drug: GSK2236805 30mg, Drug: GSK2236805 100mg | Intervention Type: DRUG; Name: GSK2336805 10mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2336805 30mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 100mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 200mg; Assigned to Arm(s): Part 1: Single Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 10mg; Assigned to Arm(s): Part 2: Repeat Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 dose to be determined up to 100mg; Assigned to Arm(s): Part 2: Repeat Dose Escalation in Healthy Subjects | Intervention Type: DRUG; Name: GSK2236805 5mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects | Intervention Type: DRUG; Name: GSK2236805 30mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects | Intervention Type: DRUG; Name: GSK2236805 100mg; Assigned to Arm(s): Part 3: Single Dose Escalation in HCV Infected Subjects

Answer: B