Phase 3
Completed N=246
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
Source: ClinicalTrials.gov NCT01389323 ↗Enrolled (actual)
246
Serious AEs
8.5%
Results posted
Sep 2015
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) — 50.8; 57.0; 66.7 percentage of participants
Summary
The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) |
50.8; 57.0; 66.7 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene |
80.0; 70.8; 80.0; 53.4; 50.7; 58.8 | — |
| SECONDARY Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points |
32.8; 44.9; 33.3; 64.1; 72.0; 60.0 | — |
| SECONDARY Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points |
6.3; 12.1; 6.7; 28.1; 27.1; 30.0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died |
12; 9; 5; 16; 21; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Participants chronically infected with Hepatitis C virus (HCV) genotype 1
- HCV RNA viral load of ≥10, 000 IU/mL at screening
- No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
- Self-described as Black-African American, Latino or White-Caucasian
- Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.
Compensated cirrhotics were capped at approximately 25%
Exclusion Criteria
- Evidence of decompensated liver disease
- Documented or suspected Hepatocellular carcinoma (HCC)
- Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
Data sourced from ClinicalTrials.gov (NCT01389323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.