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: Treatment Arm A; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: VX-222 | Arm Label: Treatment Arm B; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: VX-222 | Arm Label: Treatment Arm C; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: VX-222, Drug: ribavirin, Biological: peginterferon-alfa-2a | Arm Label: Treatment Arm D; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: ribavirin, Biological: peginterferon-alfa-2a, Drug: VX-222 | Arm Label: Treatment Arm E; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: ribavirin, Drug: VX-222 | Arm Label: Treatment Arm F; Type: EXPERIMENTAL; Interventions: Drug: telaprevir, Drug: ribavirin, Drug: VX-222 | Intervention Type: DRUG; Name: telaprevir; Assigned to Arm(s): Treatment Arm A, Treatment Arm B, Treatment Arm C, Treatment Arm D, Treatment Arm E, Treatment Arm F | Intervention Type: DRUG; Name: VX-222; Assigned to Arm(s): Treatment Arm A, Treatment Arm C | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Treatment Arm C, Treatment Arm D, Treatment Arm E, Treatment Arm F | Intervention Type: BIOLOGICAL; Name: peginterferon-alfa-2a; Assigned to Arm(s): Treatment Arm C, Treatment Arm D | Intervention Type: DRUG; Name: VX-222; Assigned to Arm(s): Treatment Arm B, Treatment Arm D, Treatment Arm E, Treatment Arm F
B: Arm Label: Arm 1. PEG +RBV for 48 Wks (Part I); Type: ACTIVE_COMPARATOR; Interventions: Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 2. PEG + RBV + BOC for 28 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 4. PEG +RBV + BOC for 48 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 6. PEG + RBV + BOC for 48 Wks (Part II); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Arm Label: Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin (low-dose) | Arm Label: Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I); Type: EXPERIMENTAL; Interventions: Drug: boceprevir (SCH 503034), Drug: peginterferon-alfa 2b (PegIntron), Drug: ribavirin | Intervention Type: DRUG; Name: boceprevir (SCH 503034); Assigned to Arm(s): Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: peginterferon-alfa 2b (PegIntron); Assigned to Arm(s): Arm 1. PEG +RBV for 48 Wks (Part I), Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Arm 1. PEG +RBV for 48 Wks (Part I), Arm 2. PEG + RBV + BOC for 28 Wks (Part I), Arm 3. PEG + RBV + BOC (from Wk 4) for 24 Wks (Part I), Arm 4. PEG +RBV + BOC for 48 Wks (Part I), Arm 5. PEG + RBV + BOC (from Wk 4) for 44 Wks (Part I), Arm 6. PEG + RBV + BOC for 48 Wks (Part II), Arm 8. PEG + RBV + BOC (from Wk 24) for 48 Wks (Part I) | Intervention Type: DRUG; Name: ribavirin (low-dose); Assigned to Arm(s): Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)
C: 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
D: Arm Label: Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: peg-interferon alfa-2a, Drug: ribavirin | Arm Label: Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg); Type: EXPERIMENTAL; Interventions: Drug: Daclatasvir, Drug: peg-interferon alfa-2a, Drug: ribavirin | Arm Label: Placebo plus peg-interferon alfa-2a and ribavirin; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: peg-interferon alfa-2a, Drug: ribavirin | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg) | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo plus peg-interferon alfa-2a and ribavirin | Intervention Type: DRUG; Name: peg-interferon alfa-2a; Assigned to Arm(s): Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg), Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg), Placebo plus peg-interferon alfa-2a and ribavirin | Intervention Type: DRUG; Name: ribavirin; Assigned to Arm(s): Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg), Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg), Placebo plus peg-interferon alfa-2a and ribavirin

Answer: C