Trial Outcomes & Findings for Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C] (NCT NCT03480932)
NCT ID: NCT03480932
Last Updated: 2021-05-18
Results Overview
Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
150 participants
Primary outcome timeframe
12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DAC
Results posted on
2021-05-18
Participant Flow
Participant milestones
| Measure |
SOF+DAC, DOT
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, Standard
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC+PEG
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
45
|
45
|
47
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
3
|
Reasons for withdrawal
| Measure |
SOF+DAC, DOT
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, Standard
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC+PEG
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
0
|
|
Overall Study
Incarcerated
|
2
|
2
|
2
|
Baseline Characteristics
Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C]
Baseline characteristics by cohort
| Measure |
SOF+DAC+PEG
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, DOT
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, Standard
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25 years
n=99 Participants
|
26 years
n=107 Participants
|
25 years
n=206 Participants
|
25 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
150 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Indian
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
150 Participants
n=7 Participants
|
|
Region of Enrollment
India
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
50 participants
n=206 Participants
|
150 participants
n=7 Participants
|
|
Educational attainment
None
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Educational attainment
Primary school
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Educational attainment
Secondary school
|
9 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Educational attainment
At least high school
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Employment
Monthly wages
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Employment
Weekly wages
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Employment
Daily wages
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
|
Employment
Unemployment
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Employment
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Marital status
Never married
|
31 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
93 Participants
n=7 Participants
|
|
Marital status
Currently married
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Marital status
Separated
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Marital status
Living with partner
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Injection drug use frequency in prior month
None
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Injection drug use frequency in prior month
Once a week to less than twice a week
|
24 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Injection drug use frequency in prior month
Twice a week to six times a week
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Injection drug use frequency in prior month
Daily
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Non-injection drug use in prior month
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
121 Participants
n=7 Participants
|
|
Alcohol use
No/mild use
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Alcohol use
Harmful/hazardous use
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Alcohol use
Alcohol dependence
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Depressive symptoms
None
|
37 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Depressive symptoms
Mild
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Depressive symptoms
Moderate
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Depressive symptoms
Moderately severe to severe
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Quality of life
|
90 Self-rated health scale (0-100))
n=99 Participants
|
78 Self-rated health scale (0-100))
n=107 Participants
|
80 Self-rated health scale (0-100))
n=206 Participants
|
80 Self-rated health scale (0-100))
n=7 Participants
|
|
HIV-infected
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Median HCV RNA
|
5.4 log 10 copies/ml
n=99 Participants
|
5.6 log 10 copies/ml
n=107 Participants
|
5.7 log 10 copies/ml
n=206 Participants
|
5.6 log 10 copies/ml
n=7 Participants
|
|
Median calculated fibrosis score (FIB-4)
|
0.69 units on a scale
n=99 Participants
|
0.68 units on a scale
n=107 Participants
|
0.73 units on a scale
n=206 Participants
|
0.68 units on a scale
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after treatment completion, 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DACPopulation: Intention to treat
Percentage of participants achieving sustained virologic response 12 weeks quantification) after treatment is completed (SVR12) as assessed by HCV RNA less than the lower limit of quantification measured 12 weeks after treatment completion
Outcome measures
| Measure |
SOF+DAC+PEG
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, DOT
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, Standard
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
|---|---|---|---|
|
SVR12
|
26 Participants
|
30 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 16 weeks for SOF+DAC+PEG and 24 weeks for SOF+DACPopulation: Intention to treat
Number of participants with treatment-related serious adverse events by laboratory tests and physician examination
Outcome measures
| Measure |
SOF+DAC+PEG
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, DOT
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, Standard
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
|---|---|---|---|
|
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks for SOF+DAC+PEG and 12 weeks for SOF+DACPopulation: Intention to treat
Adherence to medication regimen defined using a combination of the biometric data for Arms 1 and 2 and self-report and pill counts for Arm 3. Percentage reporting at least 90% adherence
Outcome measures
| Measure |
SOF+DAC+PEG
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) for 4 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, DOT
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with a field-based DOT approach
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
SOF+DAC, Standard
n=50 Participants
Sofosbuvir (400mg/daily) + Daclatasvir (60mg/daily) for 12 weeks with standard of care dispensation (4 monthly doses)
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Daclatasvir: Direct acting antiviral agent used for the treatment of hepatitis C
|
|---|---|---|---|
|
Medication Adherence
|
35 Participants
|
31 Participants
|
10 Participants
|
Adverse Events
SOF+DAC+PEG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOF+DAC, DOT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOF+DAC, Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shruti Mehta
Johns Hopkins Bloomberg School of Public Health
Phone: 4432873837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place