Trial Outcomes & Findings for Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients (NCT NCT03117569)
NCT ID: NCT03117569
Last Updated: 2019-12-11
Results Overview
Number of participants with undetectable HCV RNA based on ITT population.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
380 participants
Primary outcome timeframe
12 weeks post end of treatment (SVR12)
Results posted on
2019-12-11
Participant Flow
From 21 August 2017 to 16 July 2018, participants were screened and enrolled at 33 sites in Australia (n=6), Canada (n=7), France (n=3), Germany (n=4), New Zealand (n=4), Switzerland (n=2), United Kingdom (n=3), and United States (n=4). Study recruitment was in tertiary specialist viral hepatitis clinics (n=30) and primary care clinics (n=3).
Participant milestones
| Measure |
Standard Monitoring Schedule
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
253
|
|
Overall Study
COMPLETED
|
123
|
241
|
|
Overall Study
NOT COMPLETED
|
4
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients
Baseline characteristics by cohort
| Measure |
Standard Monitoring Schedule
n=127 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 Years
n=5 Participants
|
52 Years
n=7 Participants
|
51 Years
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
72 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
53 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Transgender
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
97 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
12 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
11 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
29 participants
n=5 Participants
|
57 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
28 participants
n=5 Participants
|
58 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
22 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
15 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=5 Participants
|
30 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
France
|
14 participants
n=5 Participants
|
28 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
8 participants
n=5 Participants
|
15 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
28 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
HCV RNA
|
6.29 Log10 IU/mL
n=5 Participants
|
6.27 Log10 IU/mL
n=7 Participants
|
6.28 Log10 IU/mL
n=5 Participants
|
|
Genotype
Genotype 1
|
61 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Genotype
Genotype 2
|
17 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Genotype
Genotype 3
|
41 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Genotype
Genotype 4
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Genotype
Genotype 5
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Genotype
Genotype 6
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Genotype
Indeterminate
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fibrosis Stage
No or mild fibrosis (F0/F1)
|
93 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
|
Fibrosis Stage
Mild fibrosis (F2)
|
29 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Fibrosis Stage
Severe fibrosis (F3)
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
HIV Infection
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Opioid Substitution Therapy (OST)
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post end of treatment (SVR12)Population: ITT
Number of participants with undetectable HCV RNA based on ITT population.
Outcome measures
| Measure |
Standard Monitoring Schedule
n=127 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Undetectable HCV RNA (ITT Population)
|
121 Participants
|
233 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post end of treatment (SVR12)Population: The mITT population wexcludes patients who have completed treatment (\>95% adherence) (according to phone contact at week 8), but have not returned for their SVR12 assessment.
Number of participants with undetectable HCV RNA based on mITT population.
Outcome measures
| Measure |
Standard Monitoring Schedule
n=123 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=241 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Undetectable HCV RNA (mITT Population)
|
121 Participants
|
233 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post end of treatment (SVR12)Population: ITT
Number adherent to treatment and study visits (on-treatment adherence and early treatment discontinuation).
Outcome measures
| Measure |
Standard Monitoring Schedule
n=127 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Treatment and Study Visits Adherence
>=95% Adherence
|
125 Participants
|
241 Participants
|
|
Treatment and Study Visits Adherence
<95% Adherence
|
2 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Screening and 12 weeks post end of treatment (SVR12)Change in health-related quality of life score pre and post-treatment (measured by EQ-5D-3L). The EQ visual analogue scale records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (value of 100) and 'Worst imaginable health state' (value of 0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. Higher scores indicate better outcomes.
Outcome measures
| Measure |
Standard Monitoring Schedule
n=127 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Health-related Quality of Life
Screening
|
80 score on a scale
Interval 20.0 to 100.0
|
80 score on a scale
Interval 40.0 to 100.0
|
|
Health-related Quality of Life
Post-treatment week 12
|
85 score on a scale
Interval 20.0 to 100.0
|
89 score on a scale
Interval 40.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks post-treatmentPopulation: Number of participants in the ITT population with virological failure (detectable HCV RNA)
Distribution of baseline resistance associated substitutions (RAS) in participants with virological failures. Baseline polymorphisms were detected by Sanger sequencing at the following amino acid positions: NS3: 36, 56, 80, 155, 156, 166, 168 NS5A: 24, 28, 30, 31, 58, 93
Outcome measures
| Measure |
Standard Monitoring Schedule
n=2 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=6 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12
NS3 Variants at Baseline
|
0 Participants
|
1 Participants
|
|
Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12
NS3 Variants at Failure
|
1 Participants
|
3 Participants
|
|
Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12
NS5A Variants at Baseline
|
0 Participants
|
3 Participants
|
|
Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12
NS5A Variants at Failure
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post end of treatment (SVR12)Population: ITT population
Patient was satisfied with their treatment follow-up plan.
Outcome measures
| Measure |
Standard Monitoring Schedule
n=127 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Patient Treatment Satisfaction
Strongly Disagree
|
1 Participants
|
4 Participants
|
|
Patient Treatment Satisfaction
Disagree
|
0 Participants
|
2 Participants
|
|
Patient Treatment Satisfaction
No Opinion
|
3 Participants
|
9 Participants
|
|
Patient Treatment Satisfaction
Agree
|
29 Participants
|
61 Participants
|
|
Patient Treatment Satisfaction
Strongly Agree
|
83 Participants
|
149 Participants
|
|
Patient Treatment Satisfaction
Missing
|
11 Participants
|
28 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks post end of treatment (SVR12)Population: ITT
Proportion of patients with common adverse events (reported in greater than 5%).
Outcome measures
| Measure |
Standard Monitoring Schedule
n=127 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Common Adverse Events (Safety Outcome)
Fatigue
|
30 participants
|
52 participants
|
|
Common Adverse Events (Safety Outcome)
Headache
|
26 participants
|
43 participants
|
|
Common Adverse Events (Safety Outcome)
Nausea
|
25 participants
|
17 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks post end of treatment (SVR12)Population: ITT
Proportion of patients with at least one severe or potentially life threatening (grade 3 or 4) adverse event.
Outcome measures
| Measure |
Standard Monitoring Schedule
n=127 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Severe/Life Threatening Adverse Events (Safety Outcome)
|
1 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks post end of treatment (SVR12)Provider acceptability of simplified monitoring strategy measured by study specific questionnaire completed by each site Principal Investigator and the primary Research Nurse.
Outcome measures
| Measure |
Standard Monitoring Schedule
n=66 Participants
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=62 Participants
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Provider Acceptability of Simplified Monitoring Strategy (Exploratory Outcome)
Prefers Standard Monitoring
|
14 Participants
|
7 Participants
|
|
Provider Acceptability of Simplified Monitoring Strategy (Exploratory Outcome)
Prefers Simplified Monitoring
|
52 Participants
|
54 Participants
|
|
Provider Acceptability of Simplified Monitoring Strategy (Exploratory Outcome)
Other
|
0 Participants
|
1 Participants
|
Adverse Events
Standard Monitoring Schedule
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Simplified Monitoring Schedule
Serious events: 3 serious events
Other events: 112 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Monitoring Schedule
n=127 participants at risk
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 participants at risk
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/127 • Any treatment emergent adverse events up to 30 days after last dose
|
0.40%
1/253 • Number of events 1 • Any treatment emergent adverse events up to 30 days after last dose
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/127 • Any treatment emergent adverse events up to 30 days after last dose
|
0.40%
1/253 • Number of events 1 • Any treatment emergent adverse events up to 30 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Lung adenocarcinoma
|
0.00%
0/127 • Any treatment emergent adverse events up to 30 days after last dose
|
0.40%
1/253 • Number of events 1 • Any treatment emergent adverse events up to 30 days after last dose
|
Other adverse events
| Measure |
Standard Monitoring Schedule
n=127 participants at risk
Participants will have on-treatment clinic visits at weeks 4 and 8. Participants have also phone contact-based visits at weeks 4 and 8 (1-2 days prior to scheduled clinic visits).
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
Simplified Monitoring Schedule
n=253 participants at risk
Participants will have no on-treatment clinic visits at weeks 4 and 8. Participants have phone contact-based visits at weeks 4 and 8.
Participants receive glecaprevir (300mg)/pibrentasvir (120mg): glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
|
|---|---|---|
|
General disorders
Fatigue
|
23.6%
30/127 • Any treatment emergent adverse events up to 30 days after last dose
|
20.6%
52/253 • Any treatment emergent adverse events up to 30 days after last dose
|
|
Nervous system disorders
Headache
|
20.5%
26/127 • Any treatment emergent adverse events up to 30 days after last dose
|
17.0%
43/253 • Any treatment emergent adverse events up to 30 days after last dose
|
|
Gastrointestinal disorders
Nausea
|
19.7%
25/127 • Any treatment emergent adverse events up to 30 days after last dose
|
6.7%
17/253 • Any treatment emergent adverse events up to 30 days after last dose
|
Additional Information
Clinical Trials Manager
Viral Hepatitis Clinical Research Program Kirby Institute
Phone: +61 9385 0900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place