Trial Outcomes & Findings for Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs (NCT NCT02347345)
NCT ID: NCT02347345
Last Updated: 2019-08-13
Results Overview
Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
Active Injection Drug Use (IDU)
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
|
Former Injection Drug Use (Former IDU)
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
|
Healthy Volunteers
HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs
Baseline characteristics by cohort
| Measure |
Active Injection Drug Use (IDU)
n=10 Participants
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
|
Former Injection Drug Use (Former IDU)
n=12 Participants
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
|
Healthy Volunteers
n=12 Participants
HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
|
Total
n=34 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: 9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study.
Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered.
Outcome measures
| Measure |
Active Injection Drug Use (IDU)
n=10 Participants
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks
Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks
|
Former Injection Drug Use (Former IDU)
n=12 Participants
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks
Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks
|
Healthy Volunteers
n=12 Participants
HIV, HCV and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at the screening visit.
|
|---|---|---|---|
|
sCD14 (ng/mL)
baseline
|
1986 ng/mL
Standard Deviation 217
|
1918 ng/mL
Standard Deviation 208
|
1542 ng/mL
Standard Deviation 249
|
|
sCD14 (ng/mL)
week 4
|
2060 ng/mL
Standard Deviation 443
|
1805 ng/mL
Standard Deviation 183
|
—
|
|
sCD14 (ng/mL)
week 12
|
2036 ng/mL
Standard Deviation 339
|
1782 ng/mL
Standard Deviation 193
|
—
|
|
sCD14 (ng/mL)
week 24
|
1973 ng/mL
Standard Deviation 266
|
1819 ng/mL
Standard Deviation 193
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study. Healthy volunteers are HCV uninfected therefore HCV RNA levels are not measured on this group of participants.
HCV RNA levels in plasma (IU/mL)
Outcome measures
| Measure |
Active Injection Drug Use (IDU)
n=10 Participants
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks
Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks
|
Former Injection Drug Use (Former IDU)
n=12 Participants
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks
Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks
|
Healthy Volunteers
HIV, HCV and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at the screening visit.
|
|---|---|---|---|
|
Virologic Response to Therapy as Measured by HCV RNA
baseline
|
7781148 HCV RNA copies/mL plasma
Standard Deviation 8662099
|
2320026 HCV RNA copies/mL plasma
Standard Deviation 3994266
|
—
|
|
Virologic Response to Therapy as Measured by HCV RNA
week 24
|
0 HCV RNA copies/mL plasma
Standard Deviation 0
|
0 HCV RNA copies/mL plasma
Standard Deviation 0
|
—
|
|
Virologic Response to Therapy as Measured by HCV RNA
week 12
|
0 HCV RNA copies/mL plasma
Standard Deviation 0
|
0 HCV RNA copies/mL plasma
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study. Healthy volunteers were only studied at baseline. No data for weeks 4, 12, 24.
Gene expression profiles in PBMC will be determined using RNA Seq
Outcome measures
| Measure |
Active Injection Drug Use (IDU)
n=9 Participants
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks
Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks
|
Former Injection Drug Use (Former IDU)
n=11 Participants
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks
Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks
|
Healthy Volunteers
n=12 Participants
HIV, HCV and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at the screening visit.
|
|---|---|---|---|
|
Gene Expression Profiles
baseline
|
9 RNA seq different from active IDU
|
11 RNA seq different from active IDU
|
12 RNA seq different from active IDU
|
|
Gene Expression Profiles
4 weeks
|
9 RNA seq different from active IDU
|
11 RNA seq different from active IDU
|
—
|
|
Gene Expression Profiles
12 weeks
|
9 RNA seq different from active IDU
|
11 RNA seq different from active IDU
|
—
|
|
Gene Expression Profiles
24 weeks
|
9 RNA seq different from active IDU
|
11 RNA seq different from active IDU
|
—
|
Adverse Events
Active Injection Drug Use (IDU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Former Injection Drug Use (Former IDU)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Injection Drug Use (IDU)
n=10 participants at risk
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
|
Former Injection Drug Use (Former IDU)
n=12 participants at risk
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
|
Healthy Volunteers
n=12 participants at risk
HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
|
|---|---|---|---|
|
General disorders
Drug overdose
|
0.00%
0/10
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place