Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C
Brief Summary: The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.

Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.

If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.


Options:
A: Arm Label: Velpatasvir 5 mg (GT 1a); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 25 mg (GT 1a); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 50 mg (GT 1a); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 100 mg (GT 1a); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 150 mg (GT 1a); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 150 mg (GT 1b); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 150 mg (GT 2); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 25 mg (GT 3); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 50 mg (GT 3); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 150 mg (GT 3); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir 150 mg (GT 4); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Arm Label: Velpatasvir up to 400 mg (GT 2); Type: EXPERIMENTAL; Interventions: Drug: Velpatasvir, Drug: Placebo | Intervention Type: DRUG; Name: Velpatasvir; Assigned to Arm(s): Velpatasvir 100 mg (GT 1a), Velpatasvir 150 mg (GT 1a), Velpatasvir 150 mg (GT 1b), Velpatasvir 150 mg (GT 2), Velpatasvir 150 mg (GT 3), Velpatasvir 150 mg (GT 4), Velpatasvir 25 mg (GT 1a), Velpatasvir 25 mg (GT 3), Velpatasvir 5 mg (GT 1a), Velpatasvir 50 mg (GT 1a), Velpatasvir 50 mg (GT 3), Velpatasvir up to 400 mg (GT 2) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Velpatasvir 100 mg (GT 1a), Velpatasvir 150 mg (GT 1a), Velpatasvir 150 mg (GT 1b), Velpatasvir 150 mg (GT 2), Velpatasvir 150 mg (GT 3), Velpatasvir 150 mg (GT 4), Velpatasvir 25 mg (GT 1a), Velpatasvir 25 mg (GT 3), Velpatasvir 5 mg (GT 1a), Velpatasvir 50 mg (GT 1a), Velpatasvir 50 mg (GT 3), Velpatasvir up to 400 mg (GT 2)
B: 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
C: Arm Label: LDV/SOF (treatment naive); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF | Arm Label: LDV/SOF+RBV (treatment naive); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Arm Label: LDV/SOF (treatment experienced); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF | Arm Label: LDV/SOF+RBV (treatment experienced); Type: EXPERIMENTAL; Interventions: Drug: LDV/SOF, Drug: RBV | Intervention Type: DRUG; Name: LDV/SOF; Assigned to Arm(s): LDV/SOF (treatment experienced), LDV/SOF (treatment naive), LDV/SOF+RBV (treatment experienced), LDV/SOF+RBV (treatment naive) | Intervention Type: DRUG; Name: RBV; Assigned to Arm(s): LDV/SOF+RBV (treatment experienced), LDV/SOF+RBV (treatment naive)
D: 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)

Answer: B