Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
Brief Summary: This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.

The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).


Options:
A: Arm Label: TMC435 100 mg 12 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 100 mg 24 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 100 mg 48 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 12 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 24 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Placebo, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: TMC435 150 mg 48 Wks + PR48; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Arm Label: Placebo 48 Wks + PR48; Type: PLACEBO_COMPARATOR; Interventions: Drug: TMC435, Drug: Peg-IFN-alfa-2a (P), Drug: Ribavirin (R) | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48 | Intervention Type: DRUG; Name: Peg-IFN-alfa-2a (P); Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48 | Intervention Type: DRUG; Name: Ribavirin (R); Assigned to Arm(s): Placebo 48 Wks + PR48, TMC435 100 mg 12 Wks + PR48, TMC435 100 mg 24 Wks + PR48, TMC435 100 mg 48 Wks + PR48, TMC435 150 mg 12 Wks + PR48, TMC435 150 mg 24 Wks + PR48, TMC435 150 mg 48 Wks + PR48
B: Arm Label: ABT-450/r/ABT-267 and ABT-333, Plus RBV; Type: EXPERIMENTAL; Interventions: Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin | Arm Label: ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV; Type: EXPERIMENTAL; Interventions: Drug: ABT-450/r/ABT-267, ABT-333, Drug: Placebo for ribavirin | Intervention Type: DRUG; Name: ABT-450/r/ABT-267, ABT-333; Assigned to Arm(s): ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV, ABT-450/r/ABT-267 and ABT-333, Plus RBV | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): ABT-450/r/ABT-267 and ABT-333, Plus RBV | Intervention Type: DRUG; Name: Placebo for ribavirin; Assigned to Arm(s): ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
C: Arm Label: A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: Asunaprevir, Drug: BMS-791325, Drug: Placebo matching Ribavirin | Arm Label: A2: DCV/ASV/BMS-791325 + RBV (naive); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: Asunaprevir, Drug: BMS-791325, Drug: Ribavirin | Arm Label: A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: Asunaprevir, Drug: BMS-791325, Drug: Placebo matching Ribavirin | Arm Label: A4: DCV/ASV/BMS-791325 + RBV (experienced); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: Asunaprevir, Drug: BMS-791325, Drug: Ribavirin | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive), A2: DCV/ASV/BMS-791325 + RBV (naive), A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced), A4: DCV/ASV/BMS-791325 + RBV (experienced) | Intervention Type: DRUG; Name: Asunaprevir; Assigned to Arm(s): A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive), A2: DCV/ASV/BMS-791325 + RBV (naive), A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced), A4: DCV/ASV/BMS-791325 + RBV (experienced) | Intervention Type: DRUG; Name: BMS-791325; Assigned to Arm(s): A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive), A2: DCV/ASV/BMS-791325 + RBV (naive), A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced), A4: DCV/ASV/BMS-791325 + RBV (experienced) | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): A2: DCV/ASV/BMS-791325 + RBV (naive), A4: DCV/ASV/BMS-791325 + RBV (experienced) | Intervention Type: DRUG; Name: Placebo matching Ribavirin; Assigned to Arm(s): A1: DCV/ASV/BMS-791325+Placebo matching RBV (naive), A3: DCV/ASV/BMS-791325+Placebo matching RBV (experienced)
D: Arm Label: 1. Placebo + PEG + RBV; Type: PLACEBO_COMPARATOR; Interventions: Biological: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV), Drug: Placebo | Arm Label: 2. Boceprevir + PEG + RBV - 24 Weeks (RGT); Type: EXPERIMENTAL; Interventions: Biological: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV), Drug: Boceprevir | Arm Label: 3. Boceprevir + PEG + RBV - 44 Weeks; Type: EXPERIMENTAL; Interventions: Biological: Peginterferon alfa-2b (PEG), Drug: Ribavirin (RBV), Drug: Boceprevir | Intervention Type: BIOLOGICAL; Name: Peginterferon alfa-2b (PEG); Assigned to Arm(s): 1. Placebo + PEG + RBV, 2. Boceprevir + PEG + RBV - 24 Weeks (RGT), 3. Boceprevir + PEG + RBV - 44 Weeks | Intervention Type: DRUG; Name: Ribavirin (RBV); Assigned to Arm(s): 1. Placebo + PEG + RBV, 2. Boceprevir + PEG + RBV - 24 Weeks (RGT), 3. Boceprevir + PEG + RBV - 44 Weeks | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 1. Placebo + PEG + RBV | Intervention Type: DRUG; Name: Boceprevir; Assigned to Arm(s): 2. Boceprevir + PEG + RBV - 24 Weeks (RGT), 3. Boceprevir + PEG + RBV - 44 Weeks

Answer: D