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
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ClinicalTrials.gov Identifier: NCT01979939 |
Recruitment Status :
Completed
First Posted : November 8, 2013
Last Update Posted : November 3, 2015
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis C | Drug: DCV/ASV/BMS-791325 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 416 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
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Experimental: A 1: DCV/ASV/BMS-791325 in treatment-naive subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
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Drug: DCV/ASV/BMS-791325 |
Experimental: A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
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Drug: DCV/ASV/BMS-791325 |
- Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 [ Time Frame: Post-Treatment Week 12 ]SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
- Proportion of subjects in the experienced cohort with SVR12 [ Time Frame: Follow up Week 12 ]
- Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) ]
- Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND [ Time Frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 ]
- Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort [ Time Frame: Up to post treatment week 4 (±7 days) ]
- Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort [ Time Frame: Up to post treatment week 4 (±7 days) ]
- Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort [ Time Frame: Up to post treatment week 4 (±7 days) ]
- Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b [ Time Frame: Post treatment week 12 ]
- Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) [ Time Frame: Post treatment week 12 ]
- Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis [ Time Frame: Post treatment week 12 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979939

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01979939 |
Other Study ID Numbers: |
AI443-102 2013-002468-20 ( EudraCT Number ) |
First Posted: | November 8, 2013 Key Record Dates |
Last Update Posted: | November 3, 2015 |
Last Verified: | October 2015 |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepatitis, Chronic |