Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Ribavirin; Drug: Peginterferon α-2a; Drug: DCV/ASV/BMS-791325; Drug: Sofosbuvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02175966

AI443-131

Details and patient eligibility

About

The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

Full description

Allocation:

Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance

Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice

Number of Arms:

Initial Therapy: 2 Groups

Rescue Therapy: 2 Groups

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Males and Females ≥18 years of age, inclusive
• Chronic HCV infection Genotype 1 only
• Non-cirrhotic
• Treatment naive subjects with no previous exposure to an Interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease, polymerase inhibitor, etc.)

Exclusion Criteria:

• HCV Genotype other than Genotype 1
• Documented or suspected hepatocellular carcinoma
• Evidence of decompensated liver disease
• Contraindication(s) to Peg/RBV therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 4 patient groups

Arm 1: DCV/ASV/BMS-791325+Sofosbuvir

Experimental group

Description:

Initial Therapy: Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 4 weeks Sofosbuvir 400 mg tablet once daily orally for 4 weeks

Treatment:

Drug: Sofosbuvir

Drug: DCV/ASV/BMS-791325

Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir

Experimental group

Description:

Initial Therapy Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 6 weeks Sofosbuvir 400 mg tablet once daily orally for 6 weeks

Treatment:

Drug: Sofosbuvir

Drug: DCV/ASV/BMS-791325

Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a

Experimental group

Description:

Daclatasvir/Asunaprevir/BMS-791325 \[30 mg (as the free base)/200 mg/75 mg (as the free base)\] film coated Fixed Dose Combination tablet twice daily orally for 12 weeks Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks With or without Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks

Treatment:

Drug: Ribavirin

Drug: Peginterferon α-2a

Drug: DCV/ASV/BMS-791325

Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a

Other group

Description:

Sofosbuvir 400 mg tablet once daily orally for 12 weeks Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Drug: Peginterferon α-2a