Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3
Brief Summary: Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.

Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.


Options:
A: 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)
B: Arm Label: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Other: Placebo | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Arm Label: Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Arm Label: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week; Type: EXPERIMENTAL; Interventions: Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a | Intervention Type: DRUG; Name: Telaprevir; Assigned to Arm(s): Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: DRUG; Name: Pegylated Interferon Alfa 2a; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
C: Arm Label: Treatment A: PSI-7977 + Daclatasvir; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir | Arm Label: Treatment B: PSI-7977 + Daclatasvir; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir | Arm Label: Treatment C: PSI-7977 + Daclatasvir; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir | Arm Label: Treatment D: PSI-7977 + Daclatasvir; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir | Arm Label: Treatment E: PSI-7977 + Daclatasvir + Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir, Drug: Ribavirin | Arm Label: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir, Drug: Ribavirin | Arm Label: Treatment G: PSI-7977 + Daclatasvir; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir | Arm Label: Treatment H: PSI-7977 + BMS-790052 + Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir, Drug: Ribavirin | Arm Label: Treatment I: PSI-7977 + Daclatasvir; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir | Arm Label: Treatment J: PSI-7977 + Daclatasvir + Ribavirin; Type: EXPERIMENTAL; Interventions: Drug: PSI-7977, Drug: Daclatasvir, Drug: Ribavirin | Intervention Type: DRUG; Name: PSI-7977; Assigned to Arm(s): Treatment A: PSI-7977 + Daclatasvir, Treatment B: PSI-7977 + Daclatasvir, Treatment C: PSI-7977 + Daclatasvir, Treatment D: PSI-7977 + Daclatasvir, Treatment E: PSI-7977 + Daclatasvir + Ribavirin, Treatment F: PSI-7977 + Daclatasvir+ Ribavirin, Treatment G: PSI-7977 + Daclatasvir, Treatment H: PSI-7977 + BMS-790052 + Ribavirin, Treatment I: PSI-7977 + Daclatasvir, Treatment J: PSI-7977 + Daclatasvir + Ribavirin | Intervention Type: DRUG; Name: Daclatasvir; Assigned to Arm(s): Treatment A: PSI-7977 + Daclatasvir, Treatment B: PSI-7977 + Daclatasvir, Treatment C: PSI-7977 + Daclatasvir, Treatment D: PSI-7977 + Daclatasvir, Treatment E: PSI-7977 + Daclatasvir + Ribavirin, Treatment F: PSI-7977 + Daclatasvir+ Ribavirin, Treatment G: PSI-7977 + Daclatasvir, Treatment H: PSI-7977 + BMS-790052 + Ribavirin, Treatment I: PSI-7977 + Daclatasvir, Treatment J: PSI-7977 + Daclatasvir + Ribavirin | Intervention Type: DRUG; Name: Ribavirin; Assigned to Arm(s): Treatment E: PSI-7977 + Daclatasvir + Ribavirin, Treatment F: PSI-7977 + Daclatasvir+ Ribavirin, Treatment H: PSI-7977 + BMS-790052 + Ribavirin, Treatment J: PSI-7977 + Daclatasvir + Ribavirin
D: Arm Label: Sofosbuvir 200 mg (Genotype 1); Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBV | Arm Label: Sofosbuvir 400 mg (Genotype 1); Type: EXPERIMENTAL; Interventions: Drug: PEG, Drug: RBV | Arm Label: Placebo (Genotype 1); Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBV | Arm Label: Sofosbuvir 400 mg (Genotype 2/3); Type: EXPERIMENTAL; Interventions: Drug: Sofosbuvir, Drug: PEG, Drug: RBV | Intervention Type: DRUG; Name: Sofosbuvir; Assigned to Arm(s): Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) | Intervention Type: DRUG; Name: Placebo to match sofosbuvir; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1) | Intervention Type: DRUG; Name: PEG; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3)

Answer: D