Phase 3
N=301
Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus
Hepatitis C, Genotype 1
Bottom Line
View on ClinicalTrials.gov: NCT01471574 ↗Enrolled (actual)
301
Serious AEs
8.0%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) — 75; 71.8; 71.7; 73.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Daclatasvir (Drug); Ribavirin (Drug); PEG-Interferon alfa 2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) |
75; 71.8; 71.7; 73.3; 87.5 | — |
| SECONDARY Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND) |
39.7; 41.7; 71.5; 91.7; 82.7; 95.8 | — |
| SECONDARY Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) |
9; 16.7; 33.9; 50; 64.3; 91.7 | — |
| SECONDARY Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL |
88.6; 89.7; 93.4; 90.6; 0.0; 2.6 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene |
94.4; 92.9; 79.5; 87.6; 100.0; 66.7 | — |
| SECONDARY Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation |
0; 1; 0; 2; 0; 12 | — |
Summary
The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria
- Males and females, 18 to 70 years of age
- Hepatitis C virus (HCV) genotype 1a or 1b
- HCV-treatment naive
- HCV RNA >10,000 IU/mL at screening
- HIV-1 infection (approximately 250 patients receiving highly active antiretroviral therapy [HAART], up to 50 patients not receiving HAART)
- For patients receiving HAART, HIV RNA must be below <40 copies/mL at screening and must be <400 copies/ml for at least 6 months prior to screening
Key Exclusion Criteria
- Patients receiving HAART who first initiated antiretroviral therapy within the last 6 months of Day 1
- Patients receiving HAART who have changed their antiretroviral regimen due to safety or efficacy associated to HIV treatment within the last 3 months prior to Day 1. However, if changes are required to a patient's HAART regimen to meet the requirements of the protocol, these changes are allowed at the screening visit. The patient should wait a minimum of 1 month prior to Day 1 after a repeat of HIV viral load has been confirmed, <40 copies/ mL
- Use of prohibited HAART regimens within 1 month of Day 1 and throughout the treatment period of the trial (patients receiving HAART who have changed their antiretroviral regimen to initiate any HCV treatment within 6 weeks prior to Day 1)
- Laboratory values:
- Neutrophil count <1500 cells/μL (<1200 cells/ μL for Blacks)
- Platelet count <90,000 cells/μL
- Hemoglobin ≤12 g/dL for females, hemoglobin ≤13 g/dL for males
- Total bilirubin ≥34 μmol/L (or ≥2 mg/dL) unless a patient has a documented history of Gilbert's disease or antiretroviral regimen contains atazanavir
- Alanine aminotransferase ≥5*upper limit of normal
Data sourced from ClinicalTrials.gov (NCT01471574). 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.