UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: DCV/ASV/BMS-791325

Study type: Interventional

Funder types: Industry

Identifiers

NCT01979939

2013-002468-20 (EudraCT Number)

AI443-102

Details and patient eligibility

About

To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

Enrollment: 416 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• Subjects chronically infected with HCV genotype 1
• HCV RNA ≥ 10,000 IU/mL at screening
• Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
• Treatment-experienced subjects are eligible

Exclusion Criteria:

• Evidence of cirrhosis
• Liver or any other organ transplant
• Current or known history of cancer within 5 years prior to enrollment
• Documented or suspected HCC
• Evidence of decompensated liver

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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416 participants in 2 patient groups

A 1: DCV/ASV/BMS-791325 in treatment-naive subjects

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Treatment:

Drug: DCV/ASV/BMS-791325

A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects

Experimental group

Description:

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Treatment:

Drug: DCV/ASV/BMS-791325