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 Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin
Brief Summary: This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA \[HCV-RNA\] viral load \>=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with peginterferon plus RBV alone.


Options:
A: 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
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: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV; Type: EXPERIMENTAL; Interventions: Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin, Drug: Placebo for ABT-450/r/ABT-267, Drug: Placebo for 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 RBV, Placebo Followed by 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, Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ABT-450/r/ABT-267; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ABT-333; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Intervention Type: DRUG; Name: Placebo for ribavirin; Assigned to Arm(s): Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
C: Arm Label: Placebo+PEG2b+RBV, x 44 weeks; Type: PLACEBO_COMPARATOR; Interventions: Biological: Pegylated interferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908), Drug: Boceprevir placebo | Arm Label: Boceprevir+PEG2b+RBV, Response Guided Therapy; Type: EXPERIMENTAL; Interventions: Drug: Boceprevir (SCH 503034), Biological: Pegylated interferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908), Drug: Boceprevir placebo | Arm Label: Boceprevir+PEG2b+RBV, x 44 weeks; Type: EXPERIMENTAL; Interventions: Drug: Boceprevir (SCH 503034), Biological: Pegylated interferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908) | Intervention Type: DRUG; Name: Boceprevir (SCH 503034); Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Boceprevir+PEG2b+RBV, x 44 weeks | Intervention Type: BIOLOGICAL; Name: Pegylated interferon alfa-2b (SCH 54031); Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Boceprevir+PEG2b+RBV, x 44 weeks, Placebo+PEG2b+RBV, x 44 weeks | Intervention Type: DRUG; Name: Ribavirin (SCH 18908); Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Boceprevir+PEG2b+RBV, x 44 weeks, Placebo+PEG2b+RBV, x 44 weeks | Intervention Type: DRUG; Name: Boceprevir placebo; Assigned to Arm(s): Boceprevir+PEG2b+RBV, Response Guided Therapy, Placebo+PEG2b+RBV, x 44 weeks
D: Arm Label: Part 1: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Copegus, Drug: Pegasys, Drug: Placebo | Arm Label: Part 1: RO5190591 300mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Arm Label: Part 1: RO5190591 600mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Arm Label: Part 1: RO5190591 900mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Arm Label: Part 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Copegus, Drug: Pegasys, Drug: Placebo | Arm Label: Part 2: RO5190591 300mg po; Type: EXPERIMENTAL; Interventions: Drug: Copegus, Drug: Pegasys, Drug: RO5190591 (Danoprevir) | Intervention Type: DRUG; Name: Copegus; Assigned to Arm(s): Part 1: Placebo, Part 1: RO5190591 300mg po, Part 1: RO5190591 600mg po, Part 1: RO5190591 900mg po, Part 2: Placebo, Part 2: RO5190591 300mg po | Intervention Type: DRUG; Name: Pegasys; Assigned to Arm(s): Part 1: Placebo, Part 1: RO5190591 300mg po, Part 1: RO5190591 600mg po, Part 1: RO5190591 900mg po, Part 2: Placebo, Part 2: RO5190591 300mg po | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 1: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 2: Placebo | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 1: RO5190591 300mg po | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 1: RO5190591 600mg po | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 1: RO5190591 900mg po | Intervention Type: DRUG; Name: RO5190591 (Danoprevir); Assigned to Arm(s): Part 2: RO5190591 300mg po

Answer: C