Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
Brief Summary: The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.


Options:
A: 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
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: SOF/VEL 12 Weeks; Type: EXPERIMENTAL; Interventions: Drug: SOF/VEL | Arm Label: SOF+RBV 24 Weeks; Type: EXPERIMENTAL; Interventions: Drug: SOF, Drug: RBV | Intervention Type: DRUG; Name: SOF/VEL; Assigned to Arm(s): SOF/VEL 12 Weeks | Intervention Type: DRUG; Name: SOF; Assigned to Arm(s): SOF+RBV 24 Weeks | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): SOF+RBV 24 Weeks
D: Arm Label: BI 207127 low dose + SOC; Type: EXPERIMENTAL; Interventions: Drug: BI 207127 low dose + SOC | Arm Label: BI 207127 middle dose +SOC; Type: EXPERIMENTAL; Interventions: Drug: BI 207127 middle dose +SOC | Arm Label: BI 207127 high dose+SOC; Type: EXPERIMENTAL; Interventions: Drug: BI 207127 high dose+SOC | Arm Label: Placebo + SOC; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo + SOC | Intervention Type: DRUG; Name: BI 207127 middle dose +SOC; Assigned to Arm(s): BI 207127 middle dose +SOC | Intervention Type: DRUG; Name: BI 207127 high dose+SOC; Assigned to Arm(s): BI 207127 high dose+SOC | Intervention Type: DRUG; Name: Placebo + SOC; Assigned to Arm(s): Placebo + SOC | Intervention Type: DRUG; Name: BI 207127 low dose + SOC; Assigned to Arm(s): BI 207127 low dose + SOC

Answer: C