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Trial record 28 of 535 for:    IFNA2 AND RBV AND HCV

Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus

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ClinicalTrials.gov Identifier: NCT01471574
Recruitment Status : Completed
First Posted : November 15, 2011
Results First Posted : December 17, 2015
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Genotype 1
Interventions Drug: Daclatasvir
Drug: Ribavirin
Drug: PEG-Interferon alfa 2a
Enrollment 549
Recruitment Details The study was conducted at 84 sites in 13 countries.
Pre-assignment Details Of 549 participants enrolled, 301 were randomized to receive treatment. Of the 248 participants who were not randomized, 204 no longer met study criteria, and 44 discontinued due to other reasons.
Arm/Group Title Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART: Daclatasvir, 60 mg HAART: Daclatasvir, 30 mg + 60 mg Non-­HAART Therapy
Hide Arm/Group Description Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Period Title: Treatment Period
Started 132 39 106 24
Completed 101 29 82 21
Not Completed 31 10 24 3
Reason Not Completed
Lack of Efficacy             12             4             14             1
Adverse Event             7             3             6             1
Withdrawal by Subject             5             1             1             0
Patient Requested Discontinue Study drug             4             0             1             1
Lost to Follow-up             1             2             2             0
Patient no Longer Meets Study Criteria             1             0             0             0
Not specified             1             0             0             0
Period Title: Follow-up Period
Started 121 34 102 24
Completed 114 32 95 21
Not Completed 7 2 7 3
Reason Not Completed
Withdrawal by Subject             3             0             3             1
Lost to Follow-up             4             1             3             2
Death             0             0             1             0
Follow-up no longer required             0             1             0             0
Arm/Group Title Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART: Daclatasvir, 30 mg + 60 mg Non-HAART Therapy: Daclatasvir, 60 mg Total
Hide Arm/Group Description Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 132 39 106 24 301
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 39 participants 106 participants 24 participants 301 participants
47  (9.72) 47.9  (9.03) 46.5  (9.42) 36  (9.02) 46.1  (9.90)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 132 participants 39 participants 106 participants 24 participants 301 participants
Younger than 65 years 125 39 104 24 292
65 years and older 7 0 2 0 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 39 participants 106 participants 24 participants 301 participants
Female
27
  20.5%
7
  17.9%
27
  25.5%
11
  45.8%
72
  23.9%
Male
105
  79.5%
32
  82.1%
79
  74.5%
13
  54.2%
229
  76.1%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Hide Description SVR12 was defined as hepatitis C virus (HCV) values lower than the 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. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the 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. HAART=highly active antiretroviral therapy.
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all participants who received at least 1 dose of study therapy.
Arm/Group Title Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART: Daclatasvir, 30 mg + 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg Non-HAART Therapy: Daclatasvir, 60 mg
Hide Arm/Group Description:
Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received daclatasvir tablets, 90 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Overall Number of Participants Analyzed 132 39 106 277 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
75
(67.6 to 82.4)
71.8
(57.7 to 85.9)
71.7
(63.1 to 80.3)
73.3
(68.1 to 78.5)
87.5
(74.3 to 100)
2.Secondary Outcome
Title Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)
Hide Description Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.
Time Frame Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.
Arm/Group Title HAART Therapy: Daclatasvir 30 or 60 or 90 mg Non-HAART Therapy: Daclatasvir, 60 mg
Hide Arm/Group Description:
Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Overall Number of Participants Analyzed 277 24
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 39.7 41.7
Week 2 71.5 91.7
Week 4 82.7 95.8
Week 6 84.1 87.5
Week 8 84.1 95.8
Week 12 85.2 91.7
Weeks 4 and 12 78.7 91.7
End of treatment 84.8 95.8
Follow-up Week 12 73.3 87.5
Follow-up Week 24 70.4 83.3
3.Secondary Outcome
Title Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Hide Description Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.
Time Frame Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.
Arm/Group Title HAART Therapy: Daclatasvir 30 or 60 or 90 mg Non-HAART Therapy: Daclatasvir, 60 mg
Hide Arm/Group Description:
Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Overall Number of Participants Analyzed 277 24
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 9 16.7
Week 2 33.9 50
Week 4 64.3 91.7
Week 6 74.4 87.5
Week 8 78 95.8
Week 12 81.2 91.7
Weeks 4 and 12 61.4 87.5
End of treatment 84.8 95.8
Follow-up Week 12 73.3 87.5
Follow-up Week 24 70.4 83.3
4.Secondary Outcome
Title Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL
Hide Description Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.
Time Frame End of treatment (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all participants who received at least 1 dose of study therapy
Arm/Group Title Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir, 30mg + 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg
Hide Arm/Group Description:
Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg),, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Overall Number of Participants Analyzed 132 39 106 277
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HIV RNA <40 copies/mL
88.6
(83.2 to 94.1)
89.7
(80.2 to 99.3)
93.4
(88.7 to 98.1)
90.6
(87.2 to 94.1)
HIV RNA ≥400 copies/mL
0.0
(0.0 to 0.0)
2.6
(0.0 to 7.5)
0.0
(0.0 to 0.0)
0.4
(0.0 to 1.1)
5.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene
Hide Description Percentages calculated as number of responders/number who received treatment.
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all participants who received at least 1 dose of study therapy. Here 'n' signifies number of participants evaluable at the specified time-point.
Arm/Group Title Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir, 30 mg + 60 mg HAART Therapy: Daclatasvir 30, 60 or 90 mg Non-HAART Therapy: Daclatasvir, 60 mg
Hide Arm/Group Description:
Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Overall Number of Participants Analyzed 132 39 106 277 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
CC Genotype (n=36, 14, 39, 89, 6)
94.4
(87.0 to 100.0)
92.9
(79.4 to 100.0)
79.5
(66.8 to 92.2)
87.6
(80.8 to 94.5)
100.0
(100.0 to 100.0)
CT Genotype (n=72, 22, 50,144, 15)
66.7
(55.8 to 77.6)
63.6
(43.5 to 83.7)
70.0
(57.3 to 82.7)
67.4
(59.7 to 75.0)
93.3
(80.7 to 100.0)
TT Genotype (n=22, 3, 12, 37, 2)
68.2
(48.7 to 87.6)
33.3
(0.0 to 86.7)
58.3
(30.4 to 86.2)
62.2
(46.5 to 77.8)
50.0
(0.0 to 100.0)
Not reported (n=2, 0, 5, 7, 1)
100.0
(100.0 to 100.0)
0.0
(0.0 to 0.0)
60.0
(17.1 to 100.0)
71.4
(38.0 to 100.0)
0.0
(0.0 to 0.0)
6.Secondary Outcome
Title Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation
Hide Description Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing 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-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy.
Time Frame From Day 1 to 7 days post last dose of study treatment (up to Week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed in all participants who received at least 1 dose of study drug.
Arm/Group Title Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART Therapy: Daclatasvir, 30 mg + 60 mg HAART Therapy: Daclatasvir 30 or 60 or 90 mg Non-HAART Therapy: Daclatasvir, 60 mg
Hide Arm/Group Description:
Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
Overall Number of Participants Analyzed 132 39 106 277 24
Measure Type: Number
Unit of Measure: Participants
Deaths 0 1 0 2 0
SAEs 12 6 6 24 0
Grade 3 to 4 AEs 46 12 35 93 4
AEs leading to discontinuation 7 4 6 17 1
Time Frame From Day 1 to 7 days post last dose of study treatment (up to Week 48)
Adverse Event Reporting Description On-treatment period
 
Arm/Group Title Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART: Daclatasvir, 30 mg + 60 mg Non-HAART Therapy: Daclatasvir, 60 mg
Hide Arm/Group Description Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks. Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
All-Cause Mortality
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART: Daclatasvir, 30 mg + 60 mg Non-HAART Therapy: Daclatasvir, 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART: Daclatasvir, 30 mg + 60 mg Non-HAART Therapy: Daclatasvir, 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/132 (9.09%)   6/39 (15.38%)   6/106 (5.66%)   0/24 (0.00%) 
Blood and lymphatic system disorders         
Pancytopenia  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Anaemia  1  2/132 (1.52%)  0/39 (0.00%)  1/106 (0.94%)  0/24 (0.00%) 
Cardiac disorders         
Angina pectoris  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Prinzmetal angina  1  0/132 (0.00%)  0/39 (0.00%)  1/106 (0.94%)  0/24 (0.00%) 
Cardiac failure congestive  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Ear and labyrinth disorders         
Sudden hearing loss  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders         
Gastritis  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Pancreatitis acute  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Diarrhoea  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Nausea  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Abdominal pain  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Vomiting  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Infections and infestations         
Cellulitis  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Appendicitis  1  1/132 (0.76%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Bronchitis bacterial  1  0/132 (0.00%)  0/39 (0.00%)  1/106 (0.94%)  0/24 (0.00%) 
Pneumonia  1  0/132 (0.00%)  0/39 (0.00%)  1/106 (0.94%)  0/24 (0.00%) 
Staphylococcal bacteraemia  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Sepsis  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Meningitis  1  0/132 (0.00%)  0/39 (0.00%)  1/106 (0.94%)  0/24 (0.00%) 
Thrombophlebitis septic  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications         
Laceration  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Post-traumatic neck syndrome  1  0/132 (0.00%)  0/39 (0.00%)  1/106 (0.94%)  0/24 (0.00%) 
Metabolism and nutrition disorders         
Hyperkalaemia  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Hypokalaemia  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Hyponatraemia  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Nervous system disorders         
Dizziness  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Psychiatric disorders         
Depression  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Mental status changes  1  1/132 (0.76%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Laryngeal cyst  1  0/132 (0.00%)  1/39 (2.56%)  0/106 (0.00%)  0/24 (0.00%) 
Vascular disorders         
Venous thrombosis  1  0/132 (0.00%)  0/39 (0.00%)  1/106 (0.94%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg HAART Therapy: Daclatasvir, 60 mg HAART: Daclatasvir, 30 mg + 60 mg Non-HAART Therapy: Daclatasvir, 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   122/132 (92.42%)   38/39 (97.44%)   100/106 (94.34%)   23/24 (95.83%) 
Blood and lymphatic system disorders         
Neutropenia  1  42/132 (31.82%)  7/39 (17.95%)  35/106 (33.02%)  4/24 (16.67%) 
Thrombocytopenia  1  9/132 (6.82%)  1/39 (2.56%)  8/106 (7.55%)  0/24 (0.00%) 
Lymphopenia  1  2/132 (1.52%)  2/39 (5.13%)  1/106 (0.94%)  0/24 (0.00%) 
Anaemia  1  32/132 (24.24%)  10/39 (25.64%)  34/106 (32.08%)  4/24 (16.67%) 
Leukopenia  1  8/132 (6.06%)  3/39 (7.69%)  3/106 (2.83%)  0/24 (0.00%) 
Eye disorders         
Dry eye  1  3/132 (2.27%)  2/39 (5.13%)  2/106 (1.89%)  1/24 (4.17%) 
Gastrointestinal disorders         
Constipation  1  6/132 (4.55%)  4/39 (10.26%)  4/106 (3.77%)  0/24 (0.00%) 
Diarrhoea  1  19/132 (14.39%)  6/39 (15.38%)  18/106 (16.98%)  2/24 (8.33%) 
Nausea  1  24/132 (18.18%)  10/39 (25.64%)  21/106 (19.81%)  4/24 (16.67%) 
Cheilitis  1  2/132 (1.52%)  3/39 (7.69%)  2/106 (1.89%)  1/24 (4.17%) 
Dry mouth  1  11/132 (8.33%)  1/39 (2.56%)  9/106 (8.49%)  0/24 (0.00%) 
Abdominal pain upper  1  8/132 (6.06%)  0/39 (0.00%)  4/106 (3.77%)  1/24 (4.17%) 
Abdominal pain  1  2/132 (1.52%)  3/39 (7.69%)  3/106 (2.83%)  0/24 (0.00%) 
Dyspepsia  1  4/132 (3.03%)  2/39 (5.13%)  3/106 (2.83%)  0/24 (0.00%) 
Vomiting  1  12/132 (9.09%)  5/39 (12.82%)  9/106 (8.49%)  0/24 (0.00%) 
General disorders         
Fatigue  1  45/132 (34.09%)  16/39 (41.03%)  47/106 (44.34%)  6/24 (25.00%) 
Chills  1  5/132 (3.79%)  4/39 (10.26%)  6/106 (5.66%)  1/24 (4.17%) 
Asthenia  1  40/132 (30.30%)  7/39 (17.95%)  19/106 (17.92%)  12/24 (50.00%) 
Influenza like illness  1  28/132 (21.21%)  14/39 (35.90%)  15/106 (14.15%)  0/24 (0.00%) 
Pain  1  6/132 (4.55%)  3/39 (7.69%)  4/106 (3.77%)  0/24 (0.00%) 
Pyrexia  1  28/132 (21.21%)  6/39 (15.38%)  19/106 (17.92%)  12/24 (50.00%) 
Chest pain  1  0/132 (0.00%)  2/39 (5.13%)  2/106 (1.89%)  0/24 (0.00%) 
Hyperthermia  1  0/132 (0.00%)  0/39 (0.00%)  1/106 (0.94%)  2/24 (8.33%) 
Hepatobiliary disorders         
Jaundice  1  7/132 (5.30%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Hyperbilirubinaemia  1  8/132 (6.06%)  0/39 (0.00%)  0/106 (0.00%)  0/24 (0.00%) 
Infections and infestations         
Cellulitis  1  0/132 (0.00%)  2/39 (5.13%)  0/106 (0.00%)  0/24 (0.00%) 
Genital herpes  1  1/132 (0.76%)  2/39 (5.13%)  0/106 (0.00%)  0/24 (0.00%) 
Upper respiratory tract infection  1  4/132 (3.03%)  2/39 (5.13%)  2/106 (1.89%)  0/24 (0.00%) 
Bronchitis  1  4/132 (3.03%)  4/39 (10.26%)  1/106 (0.94%)  0/24 (0.00%) 
Oral candidiasis  1  8/132 (6.06%)  0/39 (0.00%)  3/106 (2.83%)  0/24 (0.00%) 
Pharyngitis  1  3/132 (2.27%)  2/39 (5.13%)  1/106 (0.94%)  0/24 (0.00%) 
Respiratory tract infection  1  2/132 (1.52%)  1/39 (2.56%)  0/106 (0.00%)  2/24 (8.33%) 
Investigations         
Weight decreased  1  14/132 (10.61%)  3/39 (7.69%)  8/106 (7.55%)  1/24 (4.17%) 
Metabolism and nutrition disorders         
Decreased appetite  1  32/132 (24.24%)  9/39 (23.08%)  27/106 (25.47%)  5/24 (20.83%) 
Musculoskeletal and connective tissue disorders         
Bone pain  1  0/132 (0.00%)  0/39 (0.00%)  2/106 (1.89%)  2/24 (8.33%) 
Myalgia  1  26/132 (19.70%)  5/39 (12.82%)  14/106 (13.21%)  5/24 (20.83%) 
Arthralgia  1  18/132 (13.64%)  2/39 (5.13%)  6/106 (5.66%)  3/24 (12.50%) 
Back pain  1  6/132 (4.55%)  2/39 (5.13%)  3/106 (2.83%)  0/24 (0.00%) 
Nervous system disorders         
Sciatica  1  0/132 (0.00%)  2/39 (5.13%)  0/106 (0.00%)  0/24 (0.00%) 
Dysgeusia  1  9/132 (6.82%)  4/39 (10.26%)  7/106 (6.60%)  0/24 (0.00%) 
Headache  1  29/132 (21.97%)  13/39 (33.33%)  28/106 (26.42%)  7/24 (29.17%) 
Dizziness  1  11/132 (8.33%)  3/39 (7.69%)  7/106 (6.60%)  2/24 (8.33%) 
Psychiatric disorders         
Abnormal dreams  1  1/132 (0.76%)  2/39 (5.13%)  0/106 (0.00%)  0/24 (0.00%) 
Anxiety  1  5/132 (3.79%)  3/39 (7.69%)  2/106 (1.89%)  0/24 (0.00%) 
Insomnia  1  36/132 (27.27%)  10/39 (25.64%)  17/106 (16.04%)  3/24 (12.50%) 
Irritability  1  16/132 (12.12%)  3/39 (7.69%)  14/106 (13.21%)  1/24 (4.17%) 
Depression  1  20/132 (15.15%)  5/39 (12.82%)  17/106 (16.04%)  0/24 (0.00%) 
Mood swings  1  4/132 (3.03%)  2/39 (5.13%)  5/106 (4.72%)  0/24 (0.00%) 
Sleep disorder  1  4/132 (3.03%)  1/39 (2.56%)  2/106 (1.89%)  3/24 (12.50%) 
Depressed mood  1  3/132 (2.27%)  2/39 (5.13%)  1/106 (0.94%)  2/24 (8.33%) 
Reproductive system and breast disorders         
Dysmenorrhoea  1  0/132 (0.00%)  0/39 (0.00%)  0/106 (0.00%)  3/24 (12.50%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  11/132 (8.33%)  4/39 (10.26%)  8/106 (7.55%)  5/24 (20.83%) 
Dyspnoea exertional  1  7/132 (5.30%)  2/39 (5.13%)  7/106 (6.60%)  1/24 (4.17%) 
Dyspnoea  1  11/132 (8.33%)  2/39 (5.13%)  6/106 (5.66%)  0/24 (0.00%) 
Oropharyngeal pain  1  1/132 (0.76%)  1/39 (2.56%)  2/106 (1.89%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  19/132 (14.39%)  4/39 (10.26%)  8/106 (7.55%)  5/24 (20.83%) 
Dry skin  1  20/132 (15.15%)  3/39 (7.69%)  14/106 (13.21%)  4/24 (16.67%) 
Rash  1  20/132 (15.15%)  4/39 (10.26%)  10/106 (9.43%)  5/24 (20.83%) 
Skin lesion  1  1/132 (0.76%)  2/39 (5.13%)  2/106 (1.89%)  0/24 (0.00%) 
Pruritus  1  18/132 (13.64%)  3/39 (7.69%)  14/106 (13.21%)  6/24 (25.00%) 
Vascular disorders         
Hypertension  1  3/132 (2.27%)  2/39 (5.13%)  4/106 (3.77%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01471574     History of Changes
Other Study ID Numbers: AI444-043
2011-003067-30 ( EudraCT Number )
First Submitted: November 4, 2011
First Posted: November 15, 2011
Results First Submitted: August 18, 2015
Results First Posted: December 17, 2015
Last Update Posted: January 29, 2016