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A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

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ClinicalTrials.gov Identifier: NCT02032888
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Daclatasvir
Drug: Sofosbuvir
Enrollment 238
Recruitment Details The study was conducted at 37 sites in the United States.
Pre-assignment Details A total of 238 participants were enrolled, and 203 received treatment. Of the 35 participants who were enrolled but did not receive treatment, 2 withdrew consent, 31 no longer met study criteria, 1 was lost to follow-up, and 1 was eliminated for other reasons.
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up. Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up. Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Period Title: Treatment Period
Started 101 50 52
Completed 99 48 52
Not Completed 2 2 0
Reason Not Completed
Poor compliance/noncompliance             1             1             0
Other             1             1             0
Period Title: Follow-up Period
Started 100 [1] 49 [1] 52
Completed 97 47 52
Not Completed 3 2 0
Reason Not Completed
Lost to Follow-up             1             1             0
Death             1             1             0
Other             1             0             0
[1]
All patients who received study drug and not a nonstudy HCV therapy before treatment Week 4
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks Total
Hide Arm/Group Description Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up. Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up. Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up. Total of all reporting groups
Overall Number of Baseline Participants 101 50 52 203
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of active study therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 50 participants 52 participants 203 participants
50.1  (9.77) 50.8  (9.19) 55.7  (6.21) 51.7  (9.12)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 101 participants 50 participants 52 participants 203 participants
<65 years 96 47 49 192
>=65 years 5 3 3 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 50 participants 52 participants 203 participants
Female
9
   8.9%
8
  16.0%
9
  17.3%
26
  12.8%
Male
92
  91.1%
42
  84.0%
43
  82.7%
177
  87.2%
Hepatitis C Virus RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 101 participants 50 participants 52 participants 203 participants
6.50  (0.758) 6.40  (0.71) 6.52  (0.789) 6.48  (0.753)
Hepatitis C Virus RNA distribution  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 101 participants 50 participants 52 participants 203 participants
<800,000 IU/mL 22 6 8 36
≥800,000 IU/mL 79 44 44 167
1.Primary Outcome
Title Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Hide Description SVR12 was defined as HCV RNA <lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame At follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All genotype 1 treatment-naive participants who received at least 1 dose of study therapy. Here, 'number of participants analyzed' (N) signifies the number of participants evaluable for this outcome measure.
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.4
(89.8 to 99.2)
2.Secondary Outcome
Title Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Hide Description SVR12 was defined as HCV RNA<lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame At follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treatment-naive participants coinfected with genotype 1 HCV and HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
75.6
(59.7 to 87.6)
3.Secondary Outcome
Title Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Hide Description SVR12 was defined as HCV RNA <lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame At follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treatment-experienced participants coinfeted with HCV/HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.
Arm/Group Title Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants with prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.7
(88.0 to 99.9)
4.Secondary Outcome
Title Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)
Hide Description SVR12 was defined as HCV RNA levels <lower limit of quantitation, target detected or target not detected. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time Frame At follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus (HCV)treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Participants without prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
Participants with prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 101 50 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.0
(91.6 to 99.4)
76.0
(61.8 to 86.9)
98.1
(89.7 to 100)
5.Secondary Outcome
Title Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24
Hide Description Participants with hepatitis C virus CV) levels to be <lower limit of quantitation, TD or TND at each visit. 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, and follow-up Week 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 101 50 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1
34.7
(25.5 to 44.8)
44.0
(30.0 to 58.7)
34.6
(22.0 to 49.1)
Week 2
77.2
(67.8 to 85.0)
78.0
(64.0 to 88.5)
71.2
(56.9 to 82.9)
Week 4
93.1
(86.2 to 97.2)
98.0
(89.4 to 99.9)
92.3
(81.5 to 97.9)
Week 6
99.0
(94.6 to 100.0)
98.0
(89.4 to 99.9)
98.1
(89.7 to 100.0)
Week 8
98.0
(93.0 to 99.8)
96.0
(86.3 to 99.5)
100.0
(93.2 to 100.0)
Week 12
96.0
(90.2 to 98.9)
NA [1] 
(NA to NA)
98.1
(89.7 to 100.0)
End of treatment
99.0
(94.6 to 100.0)
100.0
(92.9 to 100.0)
100.0
(93.2 to 100.0)
Follow-up Week 4
98.0
(93.0 to 99.8)
82.0
(68.6 to 91.4)
96.2
(86.8 to 99.5)
Follow-up Week 24
92.1
(85.0 to 96.5)
72.0
(57.5 to 83.8)
92.3
(81.5 to 97.9)
[1]
Protocol-defined treatment duration for this arm is 8 weeks.
6.Secondary Outcome
Title Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Hide Description Participants with HCV RNA levels <LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 101 50 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1
9.9
(4.9 to 17.5)
6.0
(1.3 to 16.5)
5.8
(1.2 to 15.9)
Week 2
33.7
(24.6 to 43.8)
34.0
(21.2 to 48.8)
23.1
(12.5 to 36.8)
Week 4
70.3
(60.4 to 79.0)
78.0
(64.0 to 88.5)
63.5
(49.0 to 76.4)
Week 6
89.1
(81.3 to 94.4)
90.0
(78.2 to 96.7)
94.2
(84.1 to 98.8)
Week 8
98.0
(93.0 to 99.8)
96.0
(86.3 to 99.5)
100.0
(93.2 to 100.0)
Week 12
96.0
(90.2 to 99.8)
NA [1] 
(NA to NA)
98.1
(89.7 to 100.0)
End of treatment
99.0
(94.6 to 100.0)
100.0
(92.9 to 100.0)
100.0
(93.2 to 100.0)
[1]
Protocol-defined treatment duration for this arm is 8 weeks
7.Secondary Outcome
Title Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
Hide Description SVR is defined as hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.
Time Frame At Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype.
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvi,r 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 101 50 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
CC Genotype (n=28,13,13)
100.0
(87.7 to 100.0)
69.2
(38.6 to 90.9)
100.0
(75.3 to 100.0)
Non-CC Genotype (n=73,37, 39)
95.9
(88.5 to 99.1)
78.4
(61.8 to 90.2)
97.4
(86.5 to 99.9)
8.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time Frame AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug.
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 101 50 52
Measure Type: Number
Unit of Measure: Participants
AEs 75 29 37
SAEs 1 0 3
AEs requiring dose interruption or discontinuation 0 0 0
Treatment-related AEs 39 13 17
Treatment-related Grade 3 to 4 AEs 0 1 0
Grade 3 to 4 AEs 3 2 4
Death 0 0 0
9.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time Frame AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 101 49 52
Measure Type: Number
Unit of Measure: Participants
AEs 11 5 5
SAEs 3 1 0
AEs Grade 3 to 4 3 1 0
SAEs Grade 3 to 4 2 1 0
Death 1 1 0
10.Secondary Outcome
Title Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Hide Description Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4.
Time Frame From screening up to week 24 of post treatment follow--up
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description:
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
Overall Number of Participants Analyzed 101 50 52
Measure Type: Number
Unit of Measure: Participants
International normalized ratio 1 0 1
Leukocytes 0 0 1
Aspartate aminotransferase 0 1 1
Bilirubin (total) 5 1 2
Lipase (total) 5 1 1
Alanine aminotransferase 0 1 1
Time Frame AEs: From first dose of study drug to 7 days after last dose. SAEs: From baseline to 30 days after last dose of study drug
Adverse Event Reporting Description On-treatment period
 
Arm/Group Title Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Hide Arm/Group Description Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up. Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up. Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
All-Cause Mortality
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/101 (0.99%)   0/50 (0.00%)   3/52 (5.77%) 
General disorders       
Chest pain † 1  0/101 (0.00%)  0/50 (0.00%)  1/52 (1.92%) 
Nervous system disorders       
Syncope † 1  0/101 (0.00%)  0/50 (0.00%)  1/52 (1.92%) 
Presyncope † 1  0/101 (0.00%)  0/50 (0.00%)  1/52 (1.92%) 
Psychiatric disorders       
Drug abuse † 1  0/101 (0.00%)  0/50 (0.00%)  1/52 (1.92%) 
Reproductive system and breast disorders       
Priapism † 1  1/101 (0.99%)  0/50 (0.00%)  0/52 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism † 1  0/101 (0.00%)  0/50 (0.00%)  1/52 (1.92%) 
Vascular disorders       
Hypertensive crisis † 1  0/101 (0.00%)  0/50 (0.00%)  1/52 (1.92%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/101 (50.50%)   14/50 (28.00%)   25/52 (48.08%) 
Gastrointestinal disorders       
Vomiting † 1  6/101 (5.94%)  1/50 (2.00%)  3/52 (5.77%) 
Nausea † 1  14/101 (13.86%)  4/50 (8.00%)  8/52 (15.38%) 
Diarrhoea † 1  11/101 (10.89%)  1/50 (2.00%)  3/52 (5.77%) 
Constipation † 1  3/101 (2.97%)  0/50 (0.00%)  3/52 (5.77%) 
General disorders       
Fatigue † 1  19/101 (18.81%)  5/50 (10.00%)  10/52 (19.23%) 
Nervous system disorders       
Dizziness † 1  1/101 (0.99%)  2/50 (4.00%)  3/52 (5.77%) 
Headache † 1  12/101 (11.88%)  3/50 (6.00%)  8/52 (15.38%) 
Psychiatric disorders       
Insomnia † 1  5/101 (4.95%)  0/50 (0.00%)  3/52 (5.77%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  3/101 (2.97%)  3/50 (6.00%)  1/52 (1.92%) 
Skin and subcutaneous tissue disorders       
Rash † 1  6/101 (5.94%)  0/50 (0.00%)  3/52 (5.77%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032888    
Other Study ID Numbers: AI444-216
First Submitted: January 9, 2014
First Posted: January 10, 2014
Results First Submitted: August 21, 2015
Results First Posted: October 27, 2015
Last Update Posted: October 27, 2015