ALLY 3: Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02032901
• Collaborator: (none)
• Enrollment: 173
• Locations: 31
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: Daclatasvir; Drug: Sofosbuvir	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 173 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks	Drug: Daclatasvir; Other Names: BMS-790052 ; Drug: Sofosbuvir
Experimental: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks	Drug: Daclatasvir; Other Names: BMS-790052 ; Drug: Sofosbuvir

Outcome Measures

Primary Outcome Measures

1. Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) [Week 12 (Follow-up period)]

   SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.

2. Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) [Week 12 (Follow-up period)]

   SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

Secondary Outcome Measures

1. Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) [Week 4]

   RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

2. Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) [Week 12]

   cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

3. Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) [Up to the end of treatment (up to 24 weeks)]

   EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

4. Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) [Week 1, 2, 6, 8 (treatment period)]

   Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

5. Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND) [Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)]

   Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

6. Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) [Baseline, Week 12 (Follow-up period)]

   SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.

7. Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12) [Week 12 (Follow-up period)]

   Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.

8. Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) [From Day 1 first dose to last dose plus 7 days]

   AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting 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, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Key Inclusion Criteria:

• Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications

• Subjects chronically infected with hepatitis C virus (HCV) genotype 3

• Subjects who are HCV treatment-naive

• Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)

• HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

• HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted

• Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair

• 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 screening

• Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)

• Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic	La Jolla	California	United States	92037
2	Peter J Ruane MD Inc	Los Angeles	California	United States	90036
3	National Research Institute	Los Angeles	California	United States	90057
4	Anthony M. Mills MD Inc	Los Angeles	California	United States	90069
5	Huntington Medical Research Institutes	Pasadena	California	United States	91105
6	Precision Research Institute, LLC	San Diego	California	United States	92114
7	Medical Associates Research Group	San Diego	California	United States	92123
8	Quest Clinical Research	San Francisco	California	United States	94115
9	Midland Florida Clinical Research Center, LLC	Deland	Florida	United States	32720
10	University of Florida Hepatology Research	Gainesville	Florida	United States	32610
11	Atlanta Gastroenterology Associates	Atlanta	Georgia	United States	30308
12	Gastrointestinal Specialists Of Georgia	Marietta	Georgia	United States	30060
13	Dupage Medical Group	Downers Grove	Illinois	United States	60515
14	Mercy Medical Center, Inc.	Baltimore	Maryland	United States	21202
15	Digestive Disease Associates, P.A.	Baltimore	Maryland	United States	21229
16	Kansas City Research Institute	Kansas City	Missouri	United States	64131
17	Southwest Care Center	Santa Fe	New Mexico	United States	87505
18	North Shore University Hospital	Manhasset	New York	United States	11030
19	Premier Medical Group Of The Hudson Valley, Pc	Poughkeepsie	New York	United States	12601
20	Asheville Gastroenterology Associates, PA	Asheville	North Carolina	United States	28801
21	Digestive Health Specialists, PA	Winston-salem	North Carolina	United States	27103
22	Main Line Gastroenterology Associates Pc	Perkasie	Pennsylvania	United States	18944
23	Center For Liver Diseases	Pittsburgh	Pennsylvania	United States	15213
24	Gastro One	Germantown	Tennessee	United States	38138
25	Texas Clinical Research Institute, LLC	Arlington	Texas	United States	76012
26	American Research Corporation	San Antonio	Texas	United States	78215
27	Clinical Research Centers Of America	Murray	Utah	United States	84123
28	Lifetree Clinical Research	Salt Lake City	Utah	United States	84106
29	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
30	Virginia Mason Medical Center	Seattle	Washington	United States	98101
31	Fundacion De Investigacion De Diego	San Juan		Puerto Rico	00927

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02032901
• Other Study ID Numbers: AI444-218
• First Posted: Jan 10, 2014
• Last Update Posted: Oct 1, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hepatitis C; Hepatitis; Sofosbuvir

Study Results

Participant Flow

Recruitment Details	The study was conducted at 31 sites in 2 countries.
Pre-assignment Detail	A total of 173 participants were enrolled in the study. 152 were treated. 21 participants were not treated as they no longer met the study criteria.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Period Title: Treatment Period (12 Weeks)
STARTED	101	51
COMPLETED	100	51
NOT COMPLETED	1	0
Period Title: Treatment Period (12 Weeks)
STARTED	101	51
COMPLETED	101	50
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants	Total
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Total of all reporting groups
Overall Participants	101	51	152
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.3 (10.73)	56.3 (6.64)	52.3 (9.94)
Age, Customized (participants) [Number]
<65 years	95 94.1%	47 92.2%	142 93.4%
>= 65 years	6 5.9%	4 7.8%	10 6.6%
Sex: Female, Male (Count of Participants)
Female	43 42.6%	19 37.3%	62 40.8%
Male	58 57.4%	32 62.7%	90 59.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Description	SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Week 12 (Follow-up period)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101
Number (95% Confidence Interval) [Percentage of participants]	90.1 89.2%

2. Secondary Outcome

Title	Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
Description	RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
Number (95% Confidence Interval) [Percentage of participants]	63.4 62.8%	72.5 142.2%

3. Secondary Outcome

Title	Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
Description	cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
Number (95% Confidence Interval) [Percentage of participants]	98.0 97%	100.0 196.1%

4. Secondary Outcome

Title	Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
Description	EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Up to the end of treatment (up to 24 weeks)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
Number (95% Confidence Interval) [percentage of participants]	99.0 98%	100.0 196.1%

5. Secondary Outcome

Title	Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Description	Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Week 1, 2, 6, 8 (treatment period)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
Week 1	11.9 11.8%	2.0 3.9%
Week 2	34.7 34.4%	29.4 57.6%
Week 6	86.1 85.2%	90.2 176.9%
Week 8	95.0 94.1%	98.0 192.2%

6. Secondary Outcome

Title	Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Description	Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
Week 1	39.6 39.2%	23.5 46.1%
Week 2	77.2 76.4%	68.6 134.5%
Week 4	94.1 93.2%	98.0 192.2%
Week 6	100.0 99%	98.0 192.2%
Week 8	100.0 99%	100.0 196.1%
Week 12	98.0 97%	100.0 196.1%
End of treatment	99.0 98%	100.0 196.1%
Follow-up Week 4	91.1 90.2%	86.3 169.2%
Follow-up Week 24	89.1 88.2%	82.4 161.6%

7. Secondary Outcome

Title	Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
Description	SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
Time Frame	Baseline, Week 12 (Follow-up period)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies the number of evaluable participants with or without cirrhosis in the reporting arm and time point, respectively.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
With cirrhosis (n= 19, 13)	57.9 57.3%	69.2 135.7%
Without cirrhosis (n= 75, 34)	97.3 96.3%	94.1 184.5%

8. Secondary Outcome

Title	Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
Description	Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Week 12 (Follow-up period)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, ''n'' signifies number of participants evaluable for the specified category.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
Genotype: CC (n=40, 20)	90.0 89.1%	95.0 186.3%
Genotype: Non-CC (n=61, 31)	90.2 89.3%	80.6 158%

9. Primary Outcome

Title	Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Description	SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame	Week 12 (Follow-up period)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	51
Number (95% Confidence Interval) [percentage of participants]	86.3 85.4%

10. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
Description	AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting 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, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame	From Day 1 first dose to last dose plus 7 days

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Daclatasvir + Sofosbuvir in Treatment-naive Participants	Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Arm/Group Description	Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.	Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
Measure Participants	101	51
SAEs	1 1%	0 0%
Discontinuations Due to AEs	0 0%	0 0%

Adverse Events

Time Frame	From Day 1 first dose to last dose plus 7 days
Adverse Event Reporting Description	On-treatment period.
Arm/Group Title	Daclatasvir + Sofosbuvir
Arm/Group Description	All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
All Cause Mortality
	Daclatasvir + Sofosbuvir
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Daclatasvir + Sofosbuvir
	Affected / at Risk (%)	# Events
Total	1/152 (0.7%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/152 (0.7%)
Other (Not Including Serious) Adverse Events
	Daclatasvir + Sofosbuvir
	Affected / at Risk (%)	# Events
Total	73/152 (48%)
Gastrointestinal disorders
Abdominal pain	8/152 (5.3%)
Diarrhoea	13/152 (8.6%)
Nausea	18/152 (11.8%)
General disorders
Fatigue	29/152 (19.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/152 (5.3%)
Nervous system disorders
Headache	30/152 (19.7%)
Psychiatric disorders
Insomnia	9/152 (5.9%)

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 submittal 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.