Trial Outcomes & Findings for Directly Observed Therapy for HCV in Chennai, India (NCT NCT02541409)
NCT ID: NCT02541409
Last Updated: 2021-04-15
Results Overview
The percentage of subjects that complete their course of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
12 weeks from baseline for SOF+PEG+RBV and 24 weeks from baselne for SOF+RBV
Results posted on
2021-04-15
Participant Flow
Participant milestones
| Measure |
SOF+PEG+RBV
Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
SOF+RBV
Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SOF+PEG+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
SOF+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
46 years
n=25 Participants
|
46 years
n=25 Participants
|
46 years
n=50 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
|
HCV Genotype 3a
|
22 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
42 Participants
n=50 Participants
|
|
HCV Genotype 1a
|
2 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
7 Participants
n=50 Participants
|
|
HCV Genotype 6n
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Lifetime Injection Drug Use: Heroin
|
24 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
49 Participants
n=50 Participants
|
|
Lifetime Injection Drug Use: Sedatives
|
19 Participants
n=25 Participants
|
16 Participants
n=25 Participants
|
35 Participants
n=50 Participants
|
|
Lifetime Injection Drug Use: Other Opioids
|
24 Participants
n=25 Participants
|
23 Participants
n=25 Participants
|
47 Participants
n=50 Participants
|
|
Injection Drug use in Prior 6 Months
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
NonInjection Drug Use in Prior 6 Months
|
7 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
9 Participants
n=50 Participants
|
|
Marijuana Use in Prior 6 Months
|
4 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
5 Participants
n=50 Participants
|
|
No Alcohol Use in Prior 6 Months
|
14 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
27 Participants
n=50 Participants
|
|
Alcohol Use in Prior 6 Months: 1-4 Drinks Daily
|
9 Participants
n=25 Participants
|
9 Participants
n=25 Participants
|
18 Participants
n=50 Participants
|
|
Alcohol Use in Prior 6 Months: >5 Drinks Daily
|
2 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
5 Participants
n=50 Participants
|
|
Alcohol Use: No/Mild Alcohol Use
|
14 Participants
n=25 Participants
|
14 Participants
n=25 Participants
|
28 Participants
n=50 Participants
|
|
Alcohol Use: Harmful/Hazardous Alcohol Use
|
1 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
|
Alcohol Use: Alcohol Dependence
|
10 Participants
n=25 Participants
|
9 Participants
n=25 Participants
|
19 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 12 weeks from baseline for SOF+PEG+RBV and 24 weeks from baselne for SOF+RBVThe percentage of subjects that complete their course of treatment
Outcome measures
| Measure |
SOF+PEG+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
SOF+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
|---|---|---|
|
HCV Treatment Completion
|
22 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 24 weeks from baseline for SOF+PEG+RBV and 36 weeks from baseline for SOF+RBVThe percentage of participants who achieve SVR as assessed by undetectable HCV RNA measured 12 weeks after treatment completion
Outcome measures
| Measure |
SOF+PEG+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
SOF+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
|---|---|---|
|
Sustained Virologic Response (SVR)
|
22 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 24 weeks from baseline SOF+PEG+RBV and 36 weeks from baseline for SOF+RBVNumber of participants with treatment-related serious adverse events by laboratory tests and physician examination
Outcome measures
| Measure |
SOF+PEG+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
SOF+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
|---|---|---|
|
Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Difference from entry to 24 weeks for SOF+PEG+RBV and difference from entry to 36 weeks for SOF+RBVChange in insulin resistance while on treatment by the homeostasis model assessment - insulin resistance (HOMA-IR). HOMA-IR is calculated according to the formula (fasting insulin (microU/L)+fasting glucose (nmol/L)/22.5. Fasting insulin and glucose measurements are obtained using whole blood.
Outcome measures
| Measure |
SOF+PEG+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Pegylated Interferon alfa-2a: Antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
SOF+RBV
n=25 Participants
Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Sofosbuvir: Direct acting antiviral agent used for the treatment of hepatitis C
Ribavirin: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
|
|---|---|---|
|
Change in Insulin Resistance
|
1.2 HOMA-IR
Interval -0.1 to 9.1
|
0.2 HOMA-IR
Interval -1.3 to 6.0
|
Adverse Events
SOF+PEG+RBV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOF+RBV
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 University Bloomberg School of Public Health
Phone: 443-287-3837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place