Trial Outcomes & Findings for A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection. (NCT NCT02032888)
NCT ID: NCT02032888
Last Updated: 2015-10-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
238 participants
Primary outcome timeframe
At follow-up Week 12
Results posted on
2015-10-27
Participant Flow
The study was conducted at 37 sites in the United States.
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.
Participant milestones
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
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.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
101
|
50
|
52
|
|
Treatment Period
COMPLETED
|
99
|
48
|
52
|
|
Treatment Period
NOT COMPLETED
|
2
|
2
|
0
|
|
Follow-up Period
STARTED
|
100
|
49
|
52
|
|
Follow-up Period
COMPLETED
|
97
|
47
|
52
|
|
Follow-up Period
NOT COMPLETED
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
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.
|
|---|---|---|---|
|
Treatment Period
Poor compliance/noncompliance
|
1
|
1
|
0
|
|
Treatment Period
Other
|
1
|
1
|
0
|
|
Follow-up Period
Lost to Follow-up
|
1
|
1
|
0
|
|
Follow-up Period
Death
|
1
|
1
|
0
|
|
Follow-up Period
Other
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
Baseline characteristics by cohort
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 9.77 • n=99 Participants
|
50.8 years
STANDARD_DEVIATION 9.19 • n=107 Participants
|
55.7 years
STANDARD_DEVIATION 6.21 • n=206 Participants
|
51.7 years
STANDARD_DEVIATION 9.12 • n=157 Participants
|
|
Age, Customized
<65 years
|
96 participants
n=99 Participants
|
47 participants
n=107 Participants
|
49 participants
n=206 Participants
|
192 participants
n=157 Participants
|
|
Age, Customized
>=65 years
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
11 participants
n=157 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
26 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
177 Participants
n=157 Participants
|
|
Hepatitis C Virus RNA
|
6.50 log10 IU/mL
STANDARD_DEVIATION 0.758 • n=99 Participants
|
6.40 log10 IU/mL
STANDARD_DEVIATION 0.71 • n=107 Participants
|
6.52 log10 IU/mL
STANDARD_DEVIATION 0.789 • n=206 Participants
|
6.48 log10 IU/mL
STANDARD_DEVIATION 0.753 • n=157 Participants
|
|
Hepatitis C Virus RNA distribution
<800,000 IU/mL
|
22 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
36 participants
n=157 Participants
|
|
Hepatitis C Virus RNA distribution
≥800,000 IU/mL
|
79 participants
n=99 Participants
|
44 participants
n=107 Participants
|
44 participants
n=206 Participants
|
167 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: At follow-up Week 12Population: 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.
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=83 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
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.
|
|---|---|---|---|
|
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
|
96.4 Percentage of participants
Interval 89.8 to 99.2
|
—
|
—
|
SECONDARY outcome
Timeframe: At follow-up Week 12Population: 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.
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=41 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
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.
|
|---|---|---|---|
|
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
|
75.6 Percentage of participants
Interval 59.7 to 87.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At follow-up Week 12Population: 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.
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=44 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
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.
|
|---|---|---|---|
|
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
|
97.7 Percentage of participants
Interval 88.0 to 99.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At follow-up Week 12Population: All participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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.
|
|---|---|---|---|
|
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)
|
97.0 Percentage of participants
Interval 91.6 to 99.4
|
76.0 Percentage of participants
Interval 61.8 to 86.9
|
98.1 Percentage of participants
Interval 89.7 to 100.0
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24Population: All participants who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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.
|
|---|---|---|---|
|
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
Week 1
|
34.7 Percentage of participants
Interval 25.5 to 44.8
|
44.0 Percentage of participants
Interval 30.0 to 58.7
|
34.6 Percentage of participants
Interval 22.0 to 49.1
|
|
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
Week 2
|
77.2 Percentage of participants
Interval 67.8 to 85.0
|
78.0 Percentage of participants
Interval 64.0 to 88.5
|
71.2 Percentage of participants
Interval 56.9 to 82.9
|
|
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
Week 4
|
93.1 Percentage of participants
Interval 86.2 to 97.2
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
92.3 Percentage of participants
Interval 81.5 to 97.9
|
|
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
Week 6
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
98.0 Percentage of participants
Interval 89.4 to 99.9
|
98.1 Percentage of participants
Interval 89.7 to 100.0
|
|
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
Week 8
|
98.0 Percentage of participants
Interval 93.0 to 99.8
|
96.0 Percentage of participants
Interval 86.3 to 99.5
|
100.0 Percentage of participants
Interval 93.2 to 100.0
|
|
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
Week 12
|
96.0 Percentage of participants
Interval 90.2 to 98.9
|
NA Percentage of participants
Protocol-defined treatment duration for this arm is 8 weeks.
|
98.1 Percentage of participants
Interval 89.7 to 100.0
|
|
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
Follow-up Week 24
|
92.1 Percentage of participants
Interval 85.0 to 96.5
|
72.0 Percentage of participants
Interval 57.5 to 83.8
|
92.3 Percentage of participants
Interval 81.5 to 97.9
|
|
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
End of treatment
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 93.2 to 100.0
|
|
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
Follow-up Week 4
|
98.0 Percentage of participants
Interval 93.0 to 99.8
|
82.0 Percentage of participants
Interval 68.6 to 91.4
|
96.2 Percentage of participants
Interval 86.8 to 99.5
|
SECONDARY outcome
Timeframe: At Weeks 1, 2, 4, 6, 8, and 12 and at End of TreatmentPopulation: All participants who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Week 12
|
96.0 Percentage of participants
Interval 90.2 to 99.8
|
NA Percentage of participants
Protocol-defined treatment duration for this arm is 8 weeks
|
98.1 Percentage of participants
Interval 89.7 to 100.0
|
|
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Week 1
|
9.9 Percentage of participants
Interval 4.9 to 17.5
|
6.0 Percentage of participants
Interval 1.3 to 16.5
|
5.8 Percentage of participants
Interval 1.2 to 15.9
|
|
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Week 2
|
33.7 Percentage of participants
Interval 24.6 to 43.8
|
34.0 Percentage of participants
Interval 21.2 to 48.8
|
23.1 Percentage of participants
Interval 12.5 to 36.8
|
|
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Week 4
|
70.3 Percentage of participants
Interval 60.4 to 79.0
|
78.0 Percentage of participants
Interval 64.0 to 88.5
|
63.5 Percentage of participants
Interval 49.0 to 76.4
|
|
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Week 6
|
89.1 Percentage of participants
Interval 81.3 to 94.4
|
90.0 Percentage of participants
Interval 78.2 to 96.7
|
94.2 Percentage of participants
Interval 84.1 to 98.8
|
|
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Week 8
|
98.0 Percentage of participants
Interval 93.0 to 99.8
|
96.0 Percentage of participants
Interval 86.3 to 99.5
|
100.0 Percentage of participants
Interval 93.2 to 100.0
|
|
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
End of treatment
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
100.0 Percentage of participants
Interval 92.9 to 100.0
|
100.0 Percentage of participants
Interval 93.2 to 100.0
|
SECONDARY outcome
Timeframe: At Follow-up Week 12Population: All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype.
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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.
|
|---|---|---|---|
|
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)
CC Genotype (n=28,13,13)
|
100.0 Percentage of participants
Interval 87.7 to 100.0
|
69.2 Percentage of participants
Interval 38.6 to 90.9
|
100.0 Percentage of participants
Interval 75.3 to 100.0
|
|
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)
Non-CC Genotype (n=73,37, 39)
|
95.9 Percentage of participants
Interval 88.5 to 99.1
|
78.4 Percentage of participants
Interval 61.8 to 90.2
|
97.4 Percentage of participants
Interval 86.5 to 99.9
|
SECONDARY outcome
Timeframe: 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)Population: All participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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.
|
|---|---|---|---|
|
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
AEs
|
75 Participants
|
29 Participants
|
37 Participants
|
|
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
SAEs
|
1 Participants
|
0 Participants
|
3 Participants
|
|
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
AEs requiring dose interruption or discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Treatment-related AEs
|
39 Participants
|
13 Participants
|
17 Participants
|
|
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
Treatment-related Grade 3 to 4 AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
|
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
Grade 3 to 4 AEs
|
3 Participants
|
2 Participants
|
4 Participants
|
|
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
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.Population: All participants who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=49 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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.
|
|---|---|---|---|
|
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
AEs
|
11 Participants
|
5 Participants
|
5 Participants
|
|
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
SAEs
|
3 Participants
|
1 Participants
|
0 Participants
|
|
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
AEs Grade 3 to 4
|
3 Participants
|
1 Participants
|
0 Participants
|
|
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
SAEs Grade 3 to 4
|
2 Participants
|
1 Participants
|
0 Participants
|
|
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
Death
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening up to week 24 of post treatment follow--upPopulation: All participants who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 Participants
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 Participants
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
International normalized ratio
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Leukocytes
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Aspartate aminotransferase
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Bilirubin (total)
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Lipase (total)
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Alanine aminotransferase
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 participants at risk
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 participants at risk
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 participants at risk
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.
|
|---|---|---|---|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
1.9%
1/52 • 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
On-treatment period
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
1.9%
1/52 • 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
On-treatment period
|
|
General disorders
Chest pain
|
0.00%
0/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
1.9%
1/52 • 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
On-treatment period
|
|
Nervous system disorders
Syncope
|
0.00%
0/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
1.9%
1/52 • 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
On-treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
1.9%
1/52 • 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
On-treatment period
|
|
Nervous system disorders
Presyncope
|
0.00%
0/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
1.9%
1/52 • 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
On-treatment period
|
|
Reproductive system and breast disorders
Priapism
|
0.99%
1/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
0.00%
0/52 • 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
On-treatment period
|
Other adverse events
| Measure |
Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks
n=101 participants at risk
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.
|
Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks
n=50 participants at risk
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.
|
Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks
n=52 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.99%
1/101 • 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
On-treatment period
|
4.0%
2/50 • 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
On-treatment period
|
5.8%
3/52 • 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
On-treatment period
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
6/101 • 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
On-treatment period
|
2.0%
1/50 • 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
On-treatment period
|
5.8%
3/52 • 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
On-treatment period
|
|
Gastrointestinal disorders
Nausea
|
13.9%
14/101 • 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
On-treatment period
|
8.0%
4/50 • 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
On-treatment period
|
15.4%
8/52 • 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
On-treatment period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
3/101 • 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
On-treatment period
|
6.0%
3/50 • 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
On-treatment period
|
1.9%
1/52 • 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
On-treatment period
|
|
Gastrointestinal disorders
Diarrhoea
|
10.9%
11/101 • 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
On-treatment period
|
2.0%
1/50 • 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
On-treatment period
|
5.8%
3/52 • 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
On-treatment period
|
|
Nervous system disorders
Headache
|
11.9%
12/101 • 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
On-treatment period
|
6.0%
3/50 • 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
On-treatment period
|
15.4%
8/52 • 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
On-treatment period
|
|
Psychiatric disorders
Insomnia
|
5.0%
5/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
5.8%
3/52 • 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
On-treatment period
|
|
Gastrointestinal disorders
Constipation
|
3.0%
3/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
5.8%
3/52 • 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
On-treatment period
|
|
General disorders
Fatigue
|
18.8%
19/101 • 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
On-treatment period
|
10.0%
5/50 • 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
On-treatment period
|
19.2%
10/52 • 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
On-treatment period
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
6/101 • 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
On-treatment period
|
0.00%
0/50 • 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
On-treatment period
|
5.8%
3/52 • 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
On-treatment period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER