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Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) (FOURward)

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ClinicalTrials.gov Identifier: NCT02175966
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : May 29, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: DCV/ASV/BMS-791325 Drug: Ribavirin Drug: Sofosbuvir Drug: Peginterferon α-2a Phase 2

Detailed Description:

Allocation:

Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance

Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice

Number of Arms:

Initial Therapy: 2 Groups

Rescue Therapy: 2 Groups

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study)
Actual Study Start Date : July 28, 2014
Actual Primary Completion Date : January 28, 2015
Actual Study Completion Date : December 17, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: DCV/ASV/BMS-791325+Sofosbuvir

Initial Therapy:

Daclatasvir/Asunaprevir/BMS-791325 [30 mg (as the free base)/200 mg/75 mg (as the free base)] film coated Fixed Dose Combination tablet twice daily orally for 4 weeks

Sofosbuvir 400 mg tablet once daily orally for 4 weeks

 Drug: DCV/ASV/BMS-791325
Drug: Sofosbuvir
Other Name: Sovaldi®
Experimental: Arm 2: DCV/ASV/BMS-791325 + Sofosbuvir

Initial Therapy

Daclatasvir/Asunaprevir/BMS-791325 [30 mg (as the free base)/200 mg/75 mg (as the free base)] film coated Fixed Dose Combination tablet twice daily orally for 6 weeks

Sofosbuvir 400 mg tablet once daily orally for 6 weeks

 Drug: DCV/ASV/BMS-791325
Drug: Sofosbuvir
Other Name: Sovaldi®
Experimental: Rescue Therapy: Arm 1:DCV/ASV/BMS-791325+RBV±PegIFNα-2a

Daclatasvir/Asunaprevir/BMS-791325 [30 mg (as the free base)/200 mg/75 mg (as the free base)] film coated Fixed Dose Combination tablet twice daily orally for 12 weeks

Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks

With or without Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks

 Drug: DCV/ASV/BMS-791325
Drug: Ribavirin
Drug: Peginterferon α-2a
Rescue Therapy: Arm 2: Sofosbuvir + RBV + PegIFNα-2a

Sofosbuvir 400 mg tablet once daily orally for 12 weeks

Ribavirin 200 mg tablets twice daily (1000 or 1200 mg per day based on weight) orally for 12 weeks

Peginterferon α-2a 180 µg solution for injection subcutaneously once weekly for 12 weeks

 Drug: Ribavirin
Drug: Sofosbuvir
Other Name: Sovaldi®

Drug: Peginterferon α-2a


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 (SVR12) [ Time Frame: 12 Weeks after treatment discontinuation (Follow-up Week 12) ]
    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach.

  2. Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment [ Time Frame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months) ]
    SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.

  3. Number of Participants With Selected Grade 3/4 Laboratory Abnormalities [ Time Frame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months) ]
    Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.


Secondary Outcome Measures :
  1. Percentage of Participants With End of Treatment Response (EOTR) [ Time Frame: End of the treatment ]
    EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.

  2. Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND [ Time Frame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24) ]
    Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24).

  3. Percentage of Participants Who Achieved HCV RNA < LLOQ TND [ Time Frame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24 ]
    Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24).

  4. Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b [ Time Frame: Post-treatment Week 12 ]
    Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b

  5. Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype) [ Time Frame: Post-treatment Week 12 ]
    Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Males and Females ≥18 years of age, inclusive
  • Chronic HCV infection Genotype 1 only
  • Non-cirrhotic
  • Treatment naive subjects with no previous exposure to an Interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease, polymerase inhibitor, etc.)

Exclusion Criteria:

  • HCV Genotype other than Genotype 1
  • Documented or suspected hepatocellular carcinoma
  • Evidence of decompensated liver disease
  • Contraindication(s) to Peg/RBV therapy
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02175966


Locations
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United States, California
Inland Empire Liver Foundation
Rialto, California, United States, 92377
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Health - University Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Med Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, Texas
Texas Liver Institute
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02175966    
Other Study ID Numbers: AI443-131
First Posted: June 26, 2014    Key Record Dates
Results First Posted: May 29, 2019
Last Update Posted: August 11, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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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
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents