Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection (NCT NCT03219216)
NCT ID: NCT03219216
Last Updated: 2020-03-17
Results Overview
SVR12 was defined as plasma 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 dose of study drug.
COMPLETED
PHASE3
100 participants
12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen)
2020-03-17
Participant Flow
A total of 100 participants were enrolled and received ≥ 1 dose of study drug.
Participant milestones
| Measure |
Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
|
Arm B: GLE/PIB for 12 Weeks
Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
25
|
|
Overall Study
COMPLETED
|
75
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
|
Arm B: GLE/PIB for 12 Weeks
Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
Baseline characteristics by cohort
| Measure |
Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
n=75 Participants
Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
|
Arm B: GLE/PIB for 12 Weeks
n=25 Participants
Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg once daily (QD) for 12 weeks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.87 years
STANDARD_DEVIATION 11.28 • n=99 Participants
|
56.44 years
STANDARD_DEVIATION 9.62 • n=107 Participants
|
54.51 years
STANDARD_DEVIATION 10.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
46 participants
n=99 Participants
|
17 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
22 participants
n=99 Participants
|
4 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multi-race
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last dose of study drug (week 20 or 24 depending on 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. Data are reported for the overall study population according to the prespecified analysis plan for this study.
SVR12 was defined as plasma 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 dose of study drug.
Outcome measures
| Measure |
All Participants
n=100 Participants
Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 or 12 weeks
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
|
98.0 percentage of participants
Interval 93.0 to 99.4
|
SECONDARY outcome
Timeframe: 8 or 12 weeks (depending on treatment regimen)Population: All enrolled participants who received at least 1 dose of study drug. Data are reported for the overall study population according to the prespecified analysis plan for this study.
On-treatment HCV virologic failure was defined as one of the following: * Confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ 100 IU/mL after HCV RNA \< 15 IU/mL at any time point during treatment; or * Confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) during study drug treatment; or * HCV RNA ≥ 15 IU/mL at the end of treatment with at least 6 weeks of treatment.
Outcome measures
| Measure |
All Participants
n=100 Participants
Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 or 12 weeks
|
|---|---|
|
Percentage of Participants With On-treatment HCV Virologic Failure
|
0 percentage of participants
Interval 0.0 to 3.7
|
SECONDARY outcome
Timeframe: From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drugPopulation: All enrolled participants who received at least 1 dose of study drug and who completed treatment, had HCV RNA \< 15 IU/mL at final treatment visit, and had at least one post-treatment HCV RNA value. Data are reported for the overall study population according to the prespecified analysis plan for this study.
Post-treatment HCV virologic 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 levels \< 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 |
All Participants
n=100 Participants
Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 or 12 weeks
|
|---|---|
|
Percentage of Participants With Post-treatment HCV Virologic Relapse
|
1.0 percentage of participants
Interval 0.2 to 5.4
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=100 participants at risk
All enrolled participants who received at least one dose of study drug.
|
|---|---|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.0%
1/100 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
Other adverse events
| Measure |
All Participants
n=100 participants at risk
All enrolled participants who received at least one dose of study drug.
|
|---|---|
|
Gastrointestinal disorders
NAUSEA
|
6.0%
6/100 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
General disorders
FATIGUE
|
5.0%
5/100 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Nervous system disorders
HEADACHE
|
18.0%
18/100 • Number of events 18 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.0%
7/100 • Number of events 7 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug.
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