Trial Outcomes & Findings for Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs (NCT NCT02940691)
NCT ID: NCT02940691
Last Updated: 2020-03-09
Results Overview
Number with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following 12 weeks of daily grazoprevir/elbasvir (100mg/50mg)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
12 weeks post treatment
Results posted on
2020-03-09
Participant Flow
Participant milestones
| Measure |
Grazoprevir/Elbasvir
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Grazoprevir/Elbasvir
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Incarceration
|
1
|
Baseline Characteristics
Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs
Baseline characteristics by cohort
| Measure |
Grazoprevir/Elbasvir
n=32 Participants
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
Age, Customized
≤46 years
|
16 Participants
n=99 Participants
|
|
Age, Customized
>46 years
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Caucasian
|
22 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-caucasian
|
10 Participants
n=99 Participants
|
|
Income
Full time employment
|
0 Participants
n=99 Participants
|
|
Income
Part time employment
|
1 Participants
n=99 Participants
|
|
Income
Disability/social services
|
30 Participants
n=99 Participants
|
|
Income
Other
|
1 Participants
n=99 Participants
|
|
Any non-injecting drug use in the previous month
|
11 Participants
n=99 Participants
|
|
Any injecting drug use in the previous month
|
29 Participants
n=99 Participants
|
|
Any alcohol use in the previous month
|
24 Participants
n=99 Participants
|
|
Hazardous alcohol use in the previous month
|
23 Participants
n=99 Participants
|
|
History of opioid substitution therapy (OST)
|
23 Participants
n=99 Participants
|
|
Current opioid substitution therapy (OST)
|
18 Participants
n=99 Participants
|
|
Hepatitis C virus (HCV) genotype
1a
|
29 Participants
n=99 Participants
|
|
Hepatitis C virus (HCV) genotype
1b
|
3 Participants
n=99 Participants
|
|
Stage of liver disease
No or mild fibrosis (F0-F1)
|
23 Participants
n=99 Participants
|
|
Stage of liver disease
Moderate or advanced fibrosis (F2-F3)
|
7 Participants
n=99 Participants
|
|
Stage of liver disease
Cirrhosis (F4)
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: All enrolled
Number with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following 12 weeks of daily grazoprevir/elbasvir (100mg/50mg)
Outcome measures
| Measure |
Grazoprevir/Elbasvir
n=32 Participants
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)
SVR12
|
24 Participants
|
|
Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)
No test performed
|
2 Participants
|
|
Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)
Lost to follow-up
|
5 Participants
|
|
Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)
Incarcerated
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeks from treatment administrationPopulation: All enrolled
Number who completed HCV treatment as prescribed (12 weeks of grazoprevir/elbasvir (100mg/50mg) daily)
Outcome measures
| Measure |
Grazoprevir/Elbasvir
n=32 Participants
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
Number of Participants With Treatment Completion
Treatment completion
|
26 Participants
|
|
Number of Participants With Treatment Completion
Lost to follow-up
|
5 Participants
|
|
Number of Participants With Treatment Completion
Incarcerated
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeks from treatment administrationPopulation: Those who completed treatment
Number with undetectable HCV RNA at end of treatment following 12 weeks of daily Grazoprevir/Elbasvir (100mg/50mg)
Outcome measures
| Measure |
Grazoprevir/Elbasvir
n=26 Participants
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
End of Treatment Response (Negative HCV RNA at the End of Treatment)
ETR
|
24 Participants
|
|
End of Treatment Response (Negative HCV RNA at the End of Treatment)
Not tested
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 week post treatmentPopulation: Only 22 had both Xpert and plasma samples collected. Some participants had \>1 paired sample. HCV RNA from plasma was compared to the Xpert result. Sensitivity is number of positive Xpert results divided by the number of positive plasma results. The specificity is number of negative Xpert results divided by the number of negative plasma results.
To determine the sensitivity and specificity of the Xpert® HCV Viral Load assay for HCV RNA detection in samples collected by finger-stick capillary whole-blood.
Outcome measures
| Measure |
Grazoprevir/Elbasvir
n=36 Samples
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
Sensitivity and Specificity of the Finger-stick Xpert® HCV Viral Load Assay for HCV RNA Detection
Sensitivity
|
100 Percentage
Interval 75.3 to 100.0
|
|
Sensitivity and Specificity of the Finger-stick Xpert® HCV Viral Load Assay for HCV RNA Detection
Specificity
|
95.7 Percentage
Interval 78.1 to 99.9
|
Adverse Events
Grazoprevir/Elbasvir
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Grazoprevir/Elbasvir
n=32 participants at risk
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
|
|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
3.1%
1/32 • Number of events 1 • Adverse events were not collected in the study. Only serious adverse events were collected from Screening through to 4 weeks post end of treatment
The studied medication was registered in the country of use and the study used the medication according to the indication. As the toxicity profile of this regimen is well known including within the patient population in this study, adverse events were not collected. Drug was accessed via the government subsidized medications program. Any adverse drug reactions were reported to the government health authority as per standard practice for medications supplied through the government program.
|
|
Injury, poisoning and procedural complications
Laceration of arm
|
3.1%
1/32 • Number of events 1 • Adverse events were not collected in the study. Only serious adverse events were collected from Screening through to 4 weeks post end of treatment
The studied medication was registered in the country of use and the study used the medication according to the indication. As the toxicity profile of this regimen is well known including within the patient population in this study, adverse events were not collected. Drug was accessed via the government subsidized medications program. Any adverse drug reactions were reported to the government health authority as per standard practice for medications supplied through the government program.
|
|
Psychiatric disorders
Schizoaffective Disorder
|
3.1%
1/32 • Number of events 1 • Adverse events were not collected in the study. Only serious adverse events were collected from Screening through to 4 weeks post end of treatment
The studied medication was registered in the country of use and the study used the medication according to the indication. As the toxicity profile of this regimen is well known including within the patient population in this study, adverse events were not collected. Drug was accessed via the government subsidized medications program. Any adverse drug reactions were reported to the government health authority as per standard practice for medications supplied through the government program.
|
|
Psychiatric disorders
Drug-Induced Psychosis
|
3.1%
1/32 • Number of events 1 • Adverse events were not collected in the study. Only serious adverse events were collected from Screening through to 4 weeks post end of treatment
The studied medication was registered in the country of use and the study used the medication according to the indication. As the toxicity profile of this regimen is well known including within the patient population in this study, adverse events were not collected. Drug was accessed via the government subsidized medications program. Any adverse drug reactions were reported to the government health authority as per standard practice for medications supplied through the government program.
|
|
Psychiatric disorders
Psychosis
|
3.1%
1/32 • Number of events 1 • Adverse events were not collected in the study. Only serious adverse events were collected from Screening through to 4 weeks post end of treatment
The studied medication was registered in the country of use and the study used the medication according to the indication. As the toxicity profile of this regimen is well known including within the patient population in this study, adverse events were not collected. Drug was accessed via the government subsidized medications program. Any adverse drug reactions were reported to the government health authority as per standard practice for medications supplied through the government program.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place