Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Study Overview
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Brief Summary
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The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Official Title
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A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: BMS-790052 (NS5A Replication Complex Inhibitor)
* Drug: Placebo matching BMS-790052
* Drug: Pegylated-interferon alfa 2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants chronically infected with HCV Genotype 4 HCV RNA viral load of ≥ 10,000 IU/mL No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted Exclusion Criteria: Evidence of decompensated liver disease Documented or suspected Hepatocellular carcinoma (HCC) Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-790052 + PegIFNα-2a + Ribavirin<br>BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response | Drug: BMS-790052 (NS5A Replication Complex Inhibitor)<br> <br> Drug: Pegylated-interferon alfa 2a<br> <br> * Other names: Pegasys;Drug: Ribavirin<br> <br> * Other names: Copegus;|
| Placebo Comparator: Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin<br>Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks | Drug: Placebo matching BMS-790052<br> <br> Drug: Pegylated-interferon alfa 2a<br> <br> * Other names: Pegasys;Drug: Ribavirin<br> <br> * Other names: Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) | Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12. | Week 12 (Follow-up period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) | Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48 | 
| Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels | Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24. | Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48 | 
| Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene | Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively. | Post Treatment Weeks 12, 24 | 
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation. | From Day 1 (start of study treatment) up to Follow-up Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C virus