Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6
Brief Summary: The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Options:
A: Arm Label: 24-wk Vaniprevir 600 mg + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV) | Arm Label: 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV), Drug: Placebo (PBO) | Arm Label: 48-wk Vaniprevir 300 mg + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV) | Arm Label: 48-wk Vaniprevir 600 mg + Peg-IFN/RBV; Type: EXPERIMENTAL; Interventions: Drug: Vaniprevir, Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV) | Arm Label: 48-wk PBO + Peg-IFN/RBV; Type: PLACEBO_COMPARATOR; Interventions: Drug: Pegylated Interferon (Peg-IFN), Drug: Ribavirin (RBV), Drug: Placebo (PBO) | Intervention Type: DRUG; Name: Vaniprevir; Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Intervention Type: DRUG; Name: Pegylated Interferon (Peg-IFN); Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 24-wk Vaniprevir 600 mg + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV, 48-wk Vaniprevir 300 mg + Peg-IFN/RBV, 48-wk Vaniprevir 600 mg + Peg-IFN/RBV | Intervention Type: DRUG; Name: Placebo (PBO); Assigned to Arm(s): 24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV, 48-wk PBO + Peg-IFN/RBV
B: Arm Label: SOF+PEG+RBV 12 weeks; Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: RBV, Drug: PEG | Arm Label: SOF+PEG+RBV 24 weeks; Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: RBV, Drug: PEG | Arm Label: SOF+PEG+RBV 12 week/Rerandomization Group; Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: RBV, Drug: PEG | Intervention Type: DRUG; Name: Sofosbuvir; Assigned to Arm(s): SOF+PEG+RBV 12 week/Rerandomization Group, SOF+PEG+RBV 12 weeks, SOF+PEG+RBV 24 weeks | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF+PEG+RBV 12 week/Rerandomization Group, SOF+PEG+RBV 12 weeks, SOF+PEG+RBV 24 weeks | Intervention Type: DRUG; Name: PEG; Assigned to Arm(s): SOF+PEG+RBV 12 week/Rerandomization Group, SOF+PEG+RBV 12 weeks, SOF+PEG+RBV 24 weeks
C: Arm Label: TMC435; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Drug: Ribavirin (RBV) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b), Drug: Ribavirin (RBV) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): TMC435 | Intervention Type: DRUG; Name: Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b); Assigned to Arm(s): Placebo, TMC435 | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): Placebo, TMC435
D: Arm Label: TMC435 25 mg (Cohort 1/Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 75mg (Cohort 1/Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 1/Panel A and B); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 2, Panel A and B); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 2/Panel A and B); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 75 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 150 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 4/Panel C); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: Placebo (Cohort 4/Panel C); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Arm Label: TMC435 200 mg (Cohort 5/Panel D); Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peginterferon (PegIFNα-2a), Drug: Ribavirin | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C) | Intervention Type: DRUG; Name: Peginterferon (PegIFNα-2a); Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C), TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B) | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Placebo (Cohort 1/Panel A and B), Placebo (Cohort 2/Panel A and B), Placebo (Cohort 4/Panel C), TMC435 150 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 2, Panel A and B), TMC435 200 mg (Cohort 4/Panel C), TMC435 200 mg (Cohort 5/Panel D), TMC435 25 mg (Cohort 1/Panel A and B), TMC435 75 mg (Cohort 4/Panel C), TMC435 75mg (Cohort 1/Panel A and B)

Answer: B