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: Arm 1; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PSI-7977 (GS7977), Drug: Ribavirin | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PSI-7977 (GS7977) | Arm Label: Arm 3; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PSI-7977 (GS7977), Drug: Ribavirin | Arm Label: Arm 4; Type: EXPERIMENTAL; Interventions: Drug: TMC435, Drug: PSI-7977 (GS7977) | Intervention Type: DRUG; Name: TMC435; Assigned to Arm(s): Arm 1, Arm 2, Arm 3, Arm 4 | Intervention Type: DRUG; Name: PSI-7977 (GS7977); Assigned to Arm(s): Arm 1, Arm 2, Arm 3, Arm 4 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Arm 1, Arm 3
B: Arm Label: SOF+RBV; Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to match SOF, Drug: Placebo to match RBV | Intervention Type: DRUG; Name: SOF; Assigned to Arm(s): SOF+RBV | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF+RBV | Intervention Type: DRUG; Name: Placebo to match SOF; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Placebo to match RBV; Assigned to Arm(s): Placebo
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: Group A: T12/PR48; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Peg-IFN-alfa-2a, Drug: Ribavirin, Drug: Placebo | Arm Label: Group B: T12(DS)/PR48; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Peg-IFN-alfa-2a, Drug: Ribavirin, Drug: Placebo | Arm Label: Group C: Pbo/PR48; Type: EXPERIMENTAL; Interventions: Drug: Peg-IFN-alfa-2a, Drug: Ribavirin, Drug: Placebo | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): Group A: T12/PR48, Group B: T12(DS)/PR48 | Intervention Type: DRUG; Name: Peg-IFN-alfa-2a; Assigned to Arm(s): Group A: T12/PR48, Group B: T12(DS)/PR48, Group C: Pbo/PR48 | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Group A: T12/PR48, Group B: T12(DS)/PR48, Group C: Pbo/PR48 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Group A: T12/PR48, Group B: T12(DS)/PR48, Group C: Pbo/PR48

Answer: C