Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3
Brief Summary: Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.

Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.


Options:
A: Arm Label: Placebo + Peg-IFN/Ribavirin; Type: PLACEBO_COMPARATOR; Interventions: Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: Ribavirin | Arm Label: Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: Ribavirin | Arm Label: Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: Ribavirin | Arm Label: Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: Ribavirin | Arm Label: Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: Ribavirin, Drug: Comparator: placebo | Intervention Type: DRUG; Name: Comparator: Vaniprevir; Assigned to Arm(s): Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin, Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin | Intervention Type: DRUG; Name: Comparator: Pegylated-Interferon (Peg-IFN); Assigned to Arm(s): Placebo + Peg-IFN/Ribavirin, Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin, Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin | Intervention Type: DRUG; Name: Comparator: Ribavirin; Assigned to Arm(s): Placebo + Peg-IFN/Ribavirin, Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin, Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin | Intervention Type: DRUG; Name: Comparator: placebo; Assigned to Arm(s): Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
B: Arm Label: Sofosbuvir 200 mg (Genotype 1); Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBV | Arm Label: Sofosbuvir 400 mg (Genotype 1); Type: EXPERIMENTAL; Interventions: Drug: PEG, Drug: RBV | Arm Label: Placebo (Genotype 1); Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBV | Arm Label: Sofosbuvir 400 mg (Genotype 2/3); Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: PEG, Drug: RBV | Intervention Type: DRUG; Name: Sofosbuvir; Assigned to Arm(s): Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) | Intervention Type: DRUG; Name: Placebo to match sofosbuvir; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1) | Intervention Type: DRUG; Name: PEG; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3)
C: Arm Label: TMC12/PR24 50 mg; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PegIFNα-2a, Drug: RBV | Arm Label: TMC12/PR24 100 mg; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PegIFNα-2a, Drug: RBV | Arm Label: TMC24/PR24 50 mg; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PegIFNα-2a, Drug: RBV | Arm Label: TMC24/PR24 100 mg; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PegIFNα-2a, Drug: RBV | Arm Label: PR48 Control; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PegIFNα-2a, Drug: RBV | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): PR48 Control, TMC12/PR24 100 mg, TMC12/PR24 50 mg, TMC24/PR24 100 mg, TMC24/PR24 50 mg | Intervention Type: DRUG; Name: PegIFNα-2a; Assigned to Arm(s): PR48 Control, TMC12/PR24 100 mg, TMC12/PR24 50 mg, TMC24/PR24 100 mg, TMC24/PR24 50 mg | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): PR48 Control, TMC12/PR24 100 mg, TMC12/PR24 50 mg, TMC24/PR24 100 mg, TMC24/PR24 50 mg
D: Arm Label: LDV/SOF (treatment naive); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF | Arm Label: LDV/SOF+RBV (treatment naive); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: LDV/SOF (treatment experienced); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF | Arm Label: LDV/SOF+RBV (treatment experienced); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): LDV/SOF (treatment experienced), LDV/SOF (treatment naive), LDV/SOF+RBV (treatment experienced), LDV/SOF+RBV (treatment naive) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): LDV/SOF+RBV (treatment experienced), LDV/SOF+RBV (treatment naive)

Answer: B