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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02175966
• Collaborator: (none)
• Enrollment: 35
• Locations: 7
• Arms: 4
• Actual Duration (Months): 16.7
• Patients Per Site: 5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jul 28, 2014
• Actual Primary Completion Date: Jan 28, 2015
• Actual Study Completion Date: Dec 17, 2015

Arms and Interventions

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 Names: 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 Names: 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
Other: 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 Names: Sovaldi® ; Drug: Peginterferon α-2a

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 12 (SVR12) [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 [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 [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) [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 [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 [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 [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) [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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Inland Empire Liver Foundation	Rialto	California	United States	92377
2	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
3	Northwestern University Feinberg School Of Medicine	Chicago	Illinois	United States	60611
4	Indiana University Health - University Hospital	Indianapolis	Indiana	United States	46202
5	Indiana University Med Center	Indianapolis	Indiana	United States	46202
6	Johns Hopkins University	Lutherville	Maryland	United States	21093
7	Texas Liver Institute	San Antonio	Texas	United States	78215

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS clinical trial educational resource
• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02175966
• Other Study ID Numbers: AI443-131
• First Posted: Jun 26, 2014
• Last Update Posted: Aug 11, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ribavirin; Sofosbuvir

Study Results

Participant Flow

Pre-assignment Detail	35 participants enrolled in the study, 28 were randomized. Of the 7 not randomized, 1 participant withdrew consent and 6 no longer met study criteria

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Period Title: Treatment Period
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0
Period Title: Treatment Period
STARTED	14	14
COMPLETED	4	8
NOT COMPLETED	10	6

Baseline Characteristics

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF	Total
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Total of all reporting groups
Overall Participants	14	14	28
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	58.0	59.0	58.5
Sex: Female, Male (Count of Participants)
Female	9 64.3%	8 57.1%	17 60.7%
Male	5 35.7%	6 42.9%	11 39.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 7.1%	0 0%	1 3.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.1%	1 7.1%	2 7.1%
White	12 85.7%	13 92.9%	25 89.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 (SVR12)
Description	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.
Time Frame	12 Weeks after treatment discontinuation (Follow-up Week 12)

Outcome Measure Data

Analysis Population Description

It included treated participants (randomized participants) who received at least 1 dose of study therapy (DCV 3DAA or SOF).

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
Number (80% Confidence Interval) [Percentage of participants]	28.6 204.3%	57.1 407.9%

2. Secondary Outcome

Title	Percentage of Participants With End of Treatment Response (EOTR)
Description	EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.
Time Frame	End of the treatment

Outcome Measure Data

Analysis Population Description

All treated participants.

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
Number (95% Confidence Interval) [Percentage of participants]	92.9 663.6%	100.0 714.3%

3. Primary Outcome

Title	Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
Description	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.
Time Frame	From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study therapy (DCV 3DAA or SOF).

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
Death	0 0%	0 0%
Serious Adverse Events	1 7.1%	0 0%
AEs Leading to Discontinuation	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Description	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.
Time Frame	From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

Outcome Measure Data

Analysis Population Description

Safety analysis population included participants who received at least 1 dose of study therapy.

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND
Description	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).
Time Frame	Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)

Outcome Measure Data

Analysis Population Description

It included modified Intent-to-treat treated population.

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
Week 1	35.7 255%	71.4 510%
Week 2	78.6 561.4%	100.0 714.3%
Week 4	100.0 714.3%	100.0 714.3%
Week 6	NA NaN	100.0 714.3%
Follow-Up Week 2	78.6 561.4%	100.0 714.3%
Follow-Up Week 4	42.9 306.4%	78.6 561.4%
Follow-Up Week 12	28.6 204.3%	57.1 407.9%
Follow-Up Week 24	28.6 204.3%	57.1 407.9%

6. Secondary Outcome

Title	Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Description	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).
Time Frame	Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24

Outcome Measure Data

Analysis Population Description

It included modified ITT treated population.

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
Week 1	21.4 152.9%	7.1 50.7%
Week 2	42.9 306.4%	64.3 459.3%
Week 4	92.9 663.6%	100.0 714.3%
Week 6	NA NaN	100.0 714.3%
Follow-Up Week 2	71.4 510%	92.9 663.6%
Follow-Up Week 4	42.9 306.4%	71.4 510%
Follow-Up Week 12	28.6 204.3%	57.1 407.9%
Follow-Up Week 24	28.6 204.3%	57.1 407.9%

7. Secondary Outcome

Title	Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b
Description	Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b
Time Frame	Post-treatment Week 12

Outcome Measure Data

Analysis Population Description

All included treated participants. Here n' signifies number of participants analysed for specific category.

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
Genotype 1a	27.3 195%	54.5 389.3%
Genotype 1b	33.3 237.9%	66.7 476.4%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All included treated participants. Here, n' signifies number of participants analysed for specific category.

Arm/Group Title	4 Weeks DCV 3DAA + SOF	6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
Measure Participants	14	14
CC genotype	40.0 285.7%	66.7 476.4%
Non-CC Genotype	22.2 158.6%	50.0 357.1%

Adverse Events

Time Frame	All AEs were collected from signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Arm/Group Title	4 Weeks DCV 3DAA + SOF		6 Weeks DCV 3DAA + SOF
Arm/Group Description	Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir (referred to as DCV 3DAA), plus sofosbuvir 400 mg 1 tablet daily for 4 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.		Oral dose of a fixed dose combination regimen administered as 1 tablet BID comprising of 30 mg daclatasvir, 200 mg asunaprevir, and 75 mg beclabuvir, plus sofosbuvir 400 mg 1 tablet daily for 6 weeks (treatment period). Thereafter, participants entered a follow-up period of 24 weeks after completion of study treatment or upon early discontinuation of treatment.
All Cause Mortality
	4 Weeks DCV 3DAA + SOF		6 Weeks DCV 3DAA + SOF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Serious Adverse Events
	4 Weeks DCV 3DAA + SOF		6 Weeks DCV 3DAA + SOF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		0/14 (0%)
Injury, poisoning and procedural complications
Overdose	1/14 (7.1%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	4 Weeks DCV 3DAA + SOF		6 Weeks DCV 3DAA + SOF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/14 (35.7%)		11/14 (78.6%)
Ear and labyrinth disorders
VERTIGO	1/14 (7.1%)		1/14 (7.1%)
Gastrointestinal disorders
NAUSEA	2/14 (14.3%)		1/14 (7.1%)
DIARRHOEA	1/14 (7.1%)		1/14 (7.1%)
CONSTIPATION	0/14 (0%)		1/14 (7.1%)
DRY MOUTH	1/14 (7.1%)		0/14 (0%)
DYSPEPSIA	0/14 (0%)		1/14 (7.1%)
FLATULENCE	1/14 (7.1%)		0/14 (0%)
TOOTHACHE	0/14 (0%)		1/14 (7.1%)
General disorders
FATIGUE	3/14 (21.4%)		4/14 (28.6%)
CHEST DISCOMFORT	0/14 (0%)		1/14 (7.1%)
CHILLS	1/14 (7.1%)		0/14 (0%)
OEDEMA PERIPHERAL	1/14 (7.1%)		0/14 (0%)
PYREXIA	1/14 (7.1%)		0/14 (0%)
Infections and infestations
URINARY TRACT INFECTION	1/14 (7.1%)		1/14 (7.1%)
ORAL HERPES	0/14 (0%)		1/14 (7.1%)
SINUSITIS	1/14 (7.1%)		0/14 (0%)
Injury, poisoning and procedural complications
TOOTH FRACTURE	0/14 (0%)		1/14 (7.1%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/14 (0%)		1/14 (7.1%)
INTERVERTEBRAL DISC PROTRUSION	0/14 (0%)		1/14 (7.1%)
MUSCULOSKELETAL PAIN	0/14 (0%)		1/14 (7.1%)
PAIN IN EXTREMITY	0/14 (0%)		1/14 (7.1%)
Nervous system disorders
HEADACHE	2/14 (14.3%)		3/14 (21.4%)
DIZZINESS	1/14 (7.1%)		1/14 (7.1%)
Psychiatric disorders
INSOMNIA	0/14 (0%)		2/14 (14.3%)
AFFECT LABILITY	0/14 (0%)		1/14 (7.1%)
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN	1/14 (7.1%)		0/14 (0%)
Skin and subcutaneous tissue disorders
RASH	1/14 (7.1%)		0/14 (0%)
RASH PRURITIC	0/14 (0%)		1/14 (7.1%)
Vascular disorders
FLUSHING	0/14 (0%)		1/14 (7.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period <=60 days from submitting for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.