Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Daclatasvir; Drug: Ribavirin; Drug: PSI-7977

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359644

AI444-040

Details and patient eligibility

About

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Enrollment: 350 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, ages 18 to 70 years.
• Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
• Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion criteria

• Evidence of a medical condition associate with chronic liver disease other than HCV.
• History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
• History of hemophilia.
• History of torsade de pointes.
• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
• History of gastrointestinal disease or surgical procedure (except cholecystectomy).
• History of clinically significant cardiac disease.
• Blood transfusion within 4 weeks prior to study drug administration.
• Poor venous access.
• Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 10 patient groups

Treatment A: PSI-7977 + Daclatasvir

Experimental group

Description:

Genotype 1a or 1b

Treatment:

Drug: PSI-7977

Drug: Daclatasvir

Treatment B: PSI-7977 + Daclatasvir

Experimental group

Description:

Genotype 2 or 3

Treatment:

Drug: PSI-7977

Drug: Daclatasvir

Treatment C: PSI-7977 + Daclatasvir

Experimental group

Description:

Genotype 1a or 1b

Treatment:

Drug: PSI-7977

Drug: Daclatasvir

Treatment D: PSI-7977 + Daclatasvir

Experimental group

Description:

Genotype 2 or 3

Treatment:

Drug: PSI-7977

Drug: Daclatasvir

Treatment E: PSI-7977 + Daclatasvir + Ribavirin

Experimental group

Description:

Genotype 1a or 1b

Treatment:

Drug: Ribavirin

Drug: PSI-7977

Drug: Daclatasvir

Treatment F: PSI-7977 + Daclatasvir+ Ribavirin

Experimental group

Description:

Genotype 2 or 3

Treatment:

Drug: Ribavirin

Drug: PSI-7977

Drug: Daclatasvir

Treatment G: PSI-7977 + Daclatasvir

Experimental group

Description:

Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b

Treatment:

Drug: PSI-7977

Drug: Daclatasvir

Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Experimental group

Description:

Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b

Treatment:

Drug: Ribavirin

Drug: PSI-7977

Drug: Daclatasvir

Treatment I: PSI-7977 + Daclatasvir

Experimental group

Description:

Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b

Treatment:

Drug: PSI-7977

Drug: Daclatasvir

Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Experimental group

Description:

Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b

Treatment:

Drug: Ribavirin

Drug: PSI-7977

Drug: Daclatasvir