Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV (NCT NCT02124044)
NCT ID: NCT02124044
Last Updated: 2017-05-16
Results Overview
The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
12 weeks after stop of treatment
Results posted on
2017-05-16
Participant Flow
Participant milestones
| Measure |
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325
Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
|
HIV/HCV GT-1b, 24 Wks ASV/DCV
Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
|
Overall Study
COMPLETED
|
20
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV
Baseline characteristics by cohort
| Measure |
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325
n=20 Participants
Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
|
HIV/HCV GT-1b, 24 Wks ASV/DCV
n=10 Participants
Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after stop of treatmentPopulation: Subjects who received treatment drugs per arm as listed in the Outcome Measure Description
The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Outcome measures
| Measure |
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325
n=20 Participants
Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
|
HIV/HCV GT-1b, 24 Wks ASV/DCV
n=10 Participants
Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
|
|---|---|---|
|
The Percentage of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
|
90 Percentage of subjects
|
80 Percentage of subjects
|
Adverse Events
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
HIV/HCV GT-1b, 24 Wks ASV/DCV
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325
n=20 participants at risk
Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
|
HIV/HCV GT-1b, 24 Wks ASV/DCV
n=10 participants at risk
Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
5.0%
1/20
|
0.00%
0/10
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.0%
1/20
|
0.00%
0/10
|
|
Infections and infestations
Influenza
|
0.00%
0/20
|
10.0%
1/10
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20
|
10.0%
1/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/20
|
10.0%
1/10
|
|
Nervous system disorders
Cerebrovascular accident
|
5.0%
1/20
|
10.0%
1/10
|
|
Psychiatric disorders
Paranoia
|
5.0%
1/20
|
0.00%
0/10
|
|
Psychiatric disorders
Depression
|
0.00%
0/20
|
10.0%
1/10
|
Other adverse events
| Measure |
HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325
n=20 participants at risk
Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
|
HIV/HCV GT-1b, 24 Wks ASV/DCV
n=10 participants at risk
Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
|
|---|---|---|
|
General disorders
Fatigue
|
5.0%
1/20
|
0.00%
0/10
|
|
General disorders
Pain
|
5.0%
1/20
|
0.00%
0/10
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20
|
10.0%
1/10
|
|
Investigations
Lipase increased
|
0.00%
0/20
|
10.0%
1/10
|
|
Investigations
Platelet count decreased
|
0.00%
0/20
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.0%
3/20
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20
|
0.00%
0/10
|
|
Psychiatric disorders
Panic disorder
|
5.0%
1/20
|
0.00%
0/10
|
|
Psychiatric disorders
Psychotic disorder
|
5.0%
1/20
|
0.00%
0/10
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.0%
1/20
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place