Trial Outcomes & Findings for A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection (NCT NCT02966795)
NCT ID: NCT02966795
Last Updated: 2021-07-30
Results Overview
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
Results posted on
2021-07-30
Participant Flow
This study was conducted in 24 hospitals or clinics in Europe (Belgium, France), Oceania (Australia, New Zealand), North America (Canada, USA), South Africa, and southeast Asia (Singapore, Vietnam). Participants were screened between January 17, 2017, and December 26, 2017.
Enrolled participants with genotype 5 or 6 hepatitis C (HCV) were assigned to treatment with glecaprevir/pibrentasir for either 8 weeks or 12 weeks based on cirrhotic status.
Participant milestones
| Measure |
Genotype 5-infected
Participants with HCV genotype 5 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
Genotype 6-infected
Participants with HCV genotype 6 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
61
|
|
Overall Study
COMPLETED
|
23
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Genotype 5-infected
Participants with HCV genotype 5 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
Genotype 6-infected
Participants with HCV genotype 6 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
|---|---|---|
|
Overall Study
Patient Left the Country
|
0
|
1
|
Baseline Characteristics
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Baseline characteristics by cohort
| Measure |
Genotype 5-infected
n=23 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
Genotype 6-infected
n=61 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.0 years
n=5 Participants
|
54.0 years
n=7 Participants
|
59.0 years
n=5 Participants
|
|
Age, Customized
< 65 years
|
8 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Vietnam
|
0 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
0 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Cirrhosis Status
Cirrhotic
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Cirrhosis Status
Non-cirrhotic
|
20 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Prior HCV Treatment History
Naive
|
19 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Prior HCV Treatment History
Experienced
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
HCV Ribonucleic Acid (RNA) Concentration
|
6.52 log10 IU/mL
STANDARD_DEVIATION 0.53 • n=5 Participants
|
6.64 log10 IU/mL
STANDARD_DEVIATION 0.74 • n=7 Participants
|
6.61 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)Population: All enrolled participants who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
Outcome measures
| Measure |
Genotype 5-infected
n=23 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
Genotype 6-infected
n=61 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
|
95.7 percentage of participants
Interval 79.0 to 99.2
|
98.4 percentage of participants
Interval 91.3 to 99.7
|
SECONDARY outcome
Timeframe: 8 or 12 weeks (depending on the treatment regimen)Population: All enrolled participants who received at least one dose of study drug.
HCV virologic failure was defined as one of the following conditions: * confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.
Outcome measures
| Measure |
Genotype 5-infected
n=23 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
Genotype 6-infected
n=61 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
|---|---|---|
|
Percentage of Participants With On-treatment HCV Virologic Failure
|
0.0 percentage of participants
Interval 0.0 to 14.3
|
1.6 percentage of participants
Interval 0.3 to 8.7
|
SECONDARY outcome
Timeframe: End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.Population: All enrolled participants who received at least one dose of study drug, with HCV RNA \< 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.
Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA \< 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
Outcome measures
| Measure |
Genotype 5-infected
n=23 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
Genotype 6-infected
n=60 Participants
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
|
|---|---|---|
|
Percentage of Participants With Relapse
|
4.3 percentage of participants
Interval 0.8 to 21.0
|
0.0 percentage of participants
Interval 0.0 to 6.0
|
Adverse Events
Glecaprevir/Pibrentasvir
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glecaprevir/Pibrentasvir
n=84 participants at risk
Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily for 8 or 12 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.2%
1/84 • Number of events 1 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Infections and infestations
ESCHERICHIA PYELONEPHRITIS
|
1.2%
1/84 • Number of events 1 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Infections and infestations
GASTRIC ULCER HELICOBACTER
|
1.2%
1/84 • Number of events 1 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Infections and infestations
GIARDIASIS
|
1.2%
1/84 • Number of events 1 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
1.2%
1/84 • Number of events 1 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Infections and infestations
VIRAL INFECTION
|
1.2%
1/84 • Number of events 1 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
1.2%
1/84 • Number of events 1 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
Other adverse events
| Measure |
Glecaprevir/Pibrentasvir
n=84 participants at risk
Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily for 8 or 12 weeks.
|
|---|---|
|
Gastrointestinal disorders
NAUSEA
|
6.0%
5/84 • Number of events 5 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
General disorders
FATIGUE
|
13.1%
11/84 • Number of events 11 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Nervous system disorders
DIZZINESS
|
7.1%
6/84 • Number of events 6 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Nervous system disorders
HEADACHE
|
13.1%
11/84 • Number of events 11 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Psychiatric disorders
INSOMNIA
|
6.0%
5/84 • Number of events 5 • From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER