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A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection (DORA)

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ClinicalTrials.gov Identifier: NCT03067129
Recruitment Status : Completed
First Posted : March 1, 2017
Results First Posted : July 13, 2021
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus (HCV)
Interventions Drug: Glecaprevir/pibrentasvir adult formulation
Drug: Glecaprevir/pibrentasvir pediatric formulation
Enrollment 127
Recruitment Details  
Pre-assignment Details Safety population: all participants who received at least 1 dose of study drug
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs
Hide Arm/Group Description Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Period Title: Overall Study
Started 47 29 27 24
Completed 2 1 0 0
Not Completed 45 28 27 24
Reason Not Completed
Ongoing             45             28             27             23
Partially dosed; refused to swallow entire dose             0             0             0             1
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Total
Hide Arm/Group Description Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age Total of all reporting groups
Overall Number of Baseline Participants 47 29 27 24 127
Hide Baseline Analysis Population Description
Intention-to-treat (ITT population): all participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 29 participants 27 participants 24 participants 127 participants
14.26  (1.51) 10.00  (0.85) 7.11  (0.89) 3.79  (0.78) 9.79  (4.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 29 participants 27 participants 24 participants 127 participants
Female 26 15 17 12 70
Male 21 14 10 12 57
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 47 participants 29 participants 27 participants 24 participants 127 participants
White 35 21 18 16 90
Black or African American 4 1 1 1 7
Asian 6 5 5 4 20
American Indian or Alaska Native 0 1 0 1 2
Native Hawaiian or other Pacific Islander 0 0 0 1 1
Multiple 2 1 3 1 7
Baseline Fibrosis Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 47 participants 29 participants 27 participants 24 participants 127 participants
F0-F1 45 28 26 24 123
F2 1 1 1 0 3
F3 1 0 0 0 1
F4 0 0 0 0 0
[1]
Measure Description: Fibrosis stage was determined by biopsy score, FibroScan score (if biopsy not available), or FibroTest score (if biopsy and FibroScan not available) and is equivalent to the liver biopsy Metavir score: F0-F1 (0 or 1), F2 (2), F3 (3), F4 (4). F0 indicates no signs of fibrosis and F4 indicates presence of cirrhosis.
Co-infection with Human Immunodeficiency Virus (HIV)  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 47 participants 29 participants 27 participants 24 participants 127 participants
Yes 2 0 1 0 3
No 45 29 26 24 124
1.Primary Outcome
Title Steady-state Area Under the Plasma Concentration-time Curve (AUC) of Glecaprevir (GLE) at Week 2
Hide Description AUC is a measure of how long and how much drug is present in the body after dosing. The amount of glecaprevir present was measured up to 24 hours after dosing and estimated using non-compartmental analysis.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received)
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Overall Number of Participants Analyzed 14 13 13 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng•h/mL
4790
(3520 to 6500)
7870
(4140 to 14900)
6860
(4080 to 11500)
7520
(3870 to 14600)
2.Primary Outcome
Title Steady-state Area Under the Plasma Concentration-time Curve (AUC) of Pibrentasvir (PIB) at Week 2
Hide Description AUC is a measure of how long and how much drug is present in the body after dosing. The amount of pibrentasvir present was measured up to 24 hours after dosing and estimated using non-compartmental analysis.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received)
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Overall Number of Participants Analyzed 14 13 13 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng•h/mL
1380
(1150 to 1660)
2200
(1460 to 3310)
1640
(1230 to 2190)
1790
(1350 to 2370)
3.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Hide Description SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Time Frame 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT population): all participants who received at least 1 dose of study drug; those with missing data after backwards imputation were counted as nonresponders
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Participants who received at least 1 dose of study drug
Overall Number of Participants Analyzed 47 29 27 24 80 127
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(92.4 to 100.0)
93.1
(78.0 to 98.1)
100
(87.5 to 100.0)
95.8
(79.8 to 99.3)
96.3
(89.5 to 98.7)
97.6
(93.3 to 99.2)
4.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Glecaprevir (GLE) at Week 2
Hide Description Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. It was estimated by non-compartmental pharmacokinetic analysis.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received)
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Overall Number of Participants Analyzed 14 13 13 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
1040
(733 to 1480)
1370
(773 to 2440)
1600
(926 to 2770)
1530
(711 to 3290)
5.Secondary Outcome
Title Clearance (CL) of Glecaprevir (GLE) From Plasma at Week 2
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received)
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Overall Number of Participants Analyzed 14 13 13 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: L/h
62.6
(46.1 to 85.1)
31.8
(16.7 to 60.3)
29.1
(17.3 to 49.0)
19.9
(10.2 to 38.7)
6.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Pibrentasvir (PIB) at Week 2
Hide Description Cmax is the peak concentration that a drug or drug metabolite achieves in a specified compartment after the drug has been administered and before administration of a second dose. It was estimated by non-compartmental pharmacokinetic analysis.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received)
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Overall Number of Participants Analyzed 14 13 13 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
174
(148 to 205)
225
(164 to 310)
197
(154 to 251)
233
(184 to 296)
7.Secondary Outcome
Title Clearance (CL) of Pibrentasvir (PIB) From Plasma at Week 2
Hide Description CL is a quantitative measure of the rate at which a drug substance is removed from the body. It was estimated by non-compartmental pharmacokinetic analysis.
Time Frame At Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Part 1 participants with intensive pharmacokinetic (IPK) sampling in Part 1 (3 participants were excluded due to abnormally low values at the Week 2 visit) and Part 2 participants with IPK sampling in Part 2 following the final proposed dosing regimen (1 participant in Cohort 4 received 200/80 mg dose [weight > 20kg] and was summarized in Cohort 3 based on actual dose received)
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Overall Number of Participants Analyzed 14 13 13 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: L/h
86.9
(72.4 to 104)
45.4
(30.1 to 68.5)
48.7
(36.6 to 64.8)
33.6
(25.4 to 44.5)
8.Secondary Outcome
Title Percentage of Participants Who Experienced On-treatment Virologic Failure
Hide Description On-treatment virologic failure is defined as hepatitis C virus ribonucleic acid (HCV RNA) confirmed increase of > 1 (subscript)10(subscript) IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < lower limit of quantification (LLOQ) during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment.
Time Frame Up to Week 8, 12, or 16 (depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT population): all participants who received at least 1 dose of study drug
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Participants who received at least 1 dose of study drug
Overall Number of Participants Analyzed 47 29 27 24 80 127
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 7.6)
0
(0.0 to 11.7)
0
(0.0 to 12.5)
0
(0.0 to 13.8)
0
(0.0 to 4.6)
0
(0.0 to 2.9)
9.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description Post-treatment relapse is defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) 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 < LLOQ at the end of treatment; excluding participants who had been shown to be re-infected.
Time Frame Up to 12 weeks after the last dose of study drug (Week 20, 24, or 28 depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in ITT population with HCV RNA < LLOQ at the final treatment visit who completed treatment (based on study drug duration) and had post-treatment HCV RNA data, excluding participants with HCV re-infection
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Participants who received at least 1 dose of study drug
Overall Number of Participants Analyzed 47 28 27 23 78 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 7.6)
3.6
(0.6 to 17.7)
0
(0.0 to 12.5)
0
(0.0 to 14.3)
1.3
(0.2 to 6.9)
0.8
(0.1 to 4.4)
10.Secondary Outcome
Title Percentage of Participants With New Hepatitis C Virus (HCV) Infection (i.e., Reinfection)
Hide Description Reinfection is defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) in the post-treatment period along with post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline.
Time Frame Up to 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT population): all participants who received at least 1 dose of study drug
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Hide Arm/Group Description:
Adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Participants who received at least 1 dose of study drug
Overall Number of Participants Analyzed 47 29 27 24 80 127
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 7.6)
0
(0.0 to 11.7)
0
(0.0 to 12.5)
0
(0.0 to 13.8)
0
(0.0 to 4.6)
0
(0.0 to 2.9)
11.Secondary Outcome
Title Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose?
Hide Description For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
Time Frame At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data
Arm/Group Title Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs
Hide Arm/Group Description:
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Overall Number of Participants Analyzed 28 27 23 78
Measure Type: Number
Unit of Measure: number of participants
Very convenient 7 9 9 25
Convenient 13 10 8 31
Borderline 2 7 4 13
Inconvenient 6 1 1 8
Very inconvenient 0 0 1 1
12.Secondary Outcome
Title Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose?
Hide Description For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
Time Frame At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data
Arm/Group Title Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs
Hide Arm/Group Description:
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Overall Number of Participants Analyzed 28 27 23 78
Measure Type: Number
Unit of Measure: number of participants
5 minutes or less 22 23 21 66
5 to 15 minutes 5 4 2 11
15 to 30 minutes 1 0 0 1
More than 30 minutes 0 0 0 0
13.Secondary Outcome
Title Palatability Questionnaire Question 3: Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food?
Hide Description For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
Time Frame At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data
Arm/Group Title Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs
Hide Arm/Group Description:
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Overall Number of Participants Analyzed 28 27 23 78
Measure Type: Number
Unit of Measure: number of participants
Yes 20 19 19 58
No 8 8 3 19
Missing data 0 0 1 1
14.Secondary Outcome
Title Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine?
Hide Description For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
Time Frame At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data
Arm/Group Title Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs
Hide Arm/Group Description:
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Overall Number of Participants Analyzed 28 27 23 78
Measure Type: Number
Unit of Measure: number of participants
Yes 6 4 7 17
No 22 23 15 60
Missing data 0 0 1 1
15.Secondary Outcome
Title Palatability Questionnaire Question 4a: Type of Feeding Resistance
Hide Description For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
Time Frame At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data who answered "Yes" to question 4 of the Palatability Questionnaire
Arm/Group Title Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs
Hide Arm/Group Description:
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Overall Number of Participants Analyzed 6 4 7 17
Measure Type: Number
Unit of Measure: number of participants
Did not like taste of medicine 3 5 6 14
Did not like texture of medicine 2 2 5 9
Did not like the soft food used 3 2 0 5
Did not like to swallow the amount of medicine 3 2 3 8
Unrelated to the medicine 0 0 1 1
16.Secondary Outcome
Title Palatability Questionnaire Question 5: How Easy or Difficult Was it for the Child to Swallow the Medicine?
Hide Description For each participant who received the pediatric formulation (Cohorts 2 - 4), the parent(s)/guardian(s) completed a Palatability Questionnaire to provide feedback on the perception of the dosage form. The Palatability Questionnaire included 6 questions related to the administration and ingestion of the pediatric GLE/PIB formulation.
Time Frame At the End of Treatment visit or at the premature discontinuation visit (up to 8, 12, or 16 weeks, depending on treatment duration)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population: participants who received at least one dose of the pediatric GLE/PIB formulation with available data
Arm/Group Title Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs
Hide Arm/Group Description:
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB)15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age
Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age
Overall Number of Participants Analyzed 28 27 23 78
Measure Type: Number
Unit of Measure: number of participants
Very easy 10 8 11 29
Easy 13 16 10 39
Borderline 4 3 1 8
Difficult 1 0 0 1
Very difficult 0 0 0 0
Missing data 0 0 1 1
Time Frame Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after last study drug administration, up to 20 weeks. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent.
Adverse Event Reporting Description TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of study drug is administered until 30 days have elapsed following discontinuation of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Hide Arm/Group Description Adult formulation glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg co-formulated film-coated tablets once daily (QD) by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience in participants 12 to < 18 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 9 to < 12 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 6 to < 9 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 6 years of age Pediatric formulation of separate glecaprevir (GLE)/pibrentasvir (PIB) 15.67% and 8.25% film-coated pellets/granules dosed based on body weight/age once daily (QD) by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience in participants 3 to < 12 years of age Participants who received at least 1 dose of study drug
All-Cause Mortality
Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)      0/29 (0.00%)      0/27 (0.00%)      0/24 (0.00%)      0/80 (0.00%)      0/127 (0.00%)    
Hide Serious Adverse Events
Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/47 (0.00%)      0/29 (0.00%)      0/27 (0.00%)      0/24 (0.00%)      0/80 (0.00%)      0/127 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Adult Formulation GLE/PIB, Participants 12 to < 18 Yrs Cohort 2: Pediatric Formulation GLE/PIB, Participants 9 to < 12 Yrs Cohort 3: Pediatric Formulation GLE/PIB, Participants 6 to < 9 Yrs Cohort 4: Pediatric Formulation GLE/PIB, Participants 3 to < 6 Yrs Cohorts 2- 4: Pediatric Formulation GLE/PIB, Participants 3 to < 12 Yrs Participants in Cohorts 1, 2, 3, and 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/47 (65.96%)      15/29 (51.72%)      16/27 (59.26%)      17/24 (70.83%)      48/80 (60.00%)      79/127 (62.20%)    
Cardiac disorders             
PALPITATIONS † 1  0/47 (0.00%)  0 0/29 (0.00%)  0 2/27 (7.41%)  2 0/24 (0.00%)  0 2/80 (2.50%)  2 2/127 (1.57%)  2
Ear and labyrinth disorders             
MOTION SICKNESS † 1  0/47 (0.00%)  0 2/29 (6.90%)  2 0/27 (0.00%)  0 0/24 (0.00%)  0 2/80 (2.50%)  2 2/127 (1.57%)  2
Gastrointestinal disorders             
ABDOMINAL PAIN † 1  2/47 (4.26%)  2 2/29 (6.90%)  2 1/27 (3.70%)  1 0/24 (0.00%)  0 3/80 (3.75%)  3 5/127 (3.94%)  5
ABDOMINAL PAIN UPPER † 1  1/47 (2.13%)  1 2/29 (6.90%)  2 1/27 (3.70%)  1 2/24 (8.33%)  3 5/80 (6.25%)  6 6/127 (4.72%)  7
DIARRHOEA † 1  3/47 (6.38%)  3 2/29 (6.90%)  2 4/27 (14.81%)  4 2/24 (8.33%)  2 8/80 (10.00%)  8 11/127 (8.66%)  11
NAUSEA † 1  4/47 (8.51%)  4 2/29 (6.90%)  2 2/27 (7.41%)  2 1/24 (4.17%)  1 5/80 (6.25%)  5 9/127 (7.09%)  9
VOMITING † 1  5/47 (10.64%)  5 1/29 (3.45%)  1 6/27 (22.22%)  6 4/24 (16.67%)  4 11/80 (13.75%)  11 16/127 (12.60%)  16
General disorders             
FATIGUE † 1  5/47 (10.64%)  5 1/29 (3.45%)  1 3/27 (11.11%)  3 3/24 (12.50%)  3 7/80 (8.75%)  7 12/127 (9.45%)  12
PYREXIA † 1  5/47 (10.64%)  6 2/29 (6.90%)  2 2/27 (7.41%)  3 2/24 (8.33%)  2 6/80 (7.50%)  7 11/127 (8.66%)  13
Infections and infestations             
LICE INFESTATION † 1  0/47 (0.00%)  0 0/29 (0.00%)  0 0/27 (0.00%)  0 2/24 (8.33%)  2 2/80 (2.50%)  2 2/127 (1.57%)  2
NASOPHARYNGITIS † 1  11/47 (23.40%)  12 4/29 (13.79%)  4 1/27 (3.70%)  1 1/24 (4.17%)  1 6/80 (7.50%)  6 17/127 (13.39%)  18
UPPER RESPIRATORY TRACT INFECTION † 1  9/47 (19.15%)  11 1/29 (3.45%)  1 3/27 (11.11%)  5 2/24 (8.33%)  2 6/80 (7.50%)  8 15/127 (11.81%)  19
VIRAL INFECTION † 1  0/47 (0.00%)  0 0/29 (0.00%)  0 2/27 (7.41%)  2 2/24 (8.33%)  2 4/80 (5.00%)  4 4/127 (3.15%)  4
Metabolism and nutrition disorders             
INCREASED APPETITE † 1  0/47 (0.00%)  0 0/29 (0.00%)  0 0/27 (0.00%)  0 2/24 (8.33%)  2 2/80 (2.50%)  2 2/127 (1.57%)  2
Nervous system disorders             
HEADACHE † 1  8/47 (17.02%)  12 2/29 (6.90%)  2 6/27 (22.22%)  6 3/24 (12.50%)  3 11/80 (13.75%)  11 19/127 (14.96%)  23
Respiratory, thoracic and mediastinal disorders             
COUGH † 1  2/47 (4.26%)  2 1/29 (3.45%)  1 1/27 (3.70%)  1 5/24 (20.83%)  6 7/80 (8.75%)  8 9/127 (7.09%)  10
DYSPNOEA † 1  0/47 (0.00%)  0 0/29 (0.00%)  0 0/27 (0.00%)  0 3/24 (12.50%)  3 3/80 (3.75%)  3 3/127 (2.36%)  3
NASAL CONGESTION † 1  4/47 (8.51%)  4 0/29 (0.00%)  0 0/27 (0.00%)  0 0/24 (0.00%)  0 0/80 (0.00%)  0 4/127 (3.15%)  4
OROPHARYNGEAL PAIN † 1  5/47 (10.64%)  5 2/29 (6.90%)  2 1/27 (3.70%)  1 0/24 (0.00%)  0 3/80 (3.75%)  3 8/127 (6.30%)  8
RHINORRHOEA † 1  0/47 (0.00%)  0 0/29 (0.00%)  0 0/27 (0.00%)  0 2/24 (8.33%)  2 2/80 (2.50%)  2 2/127 (1.57%)  2
Skin and subcutaneous tissue disorders             
PRURITUS † 1  0/47 (0.00%)  0 2/29 (6.90%)  2 1/27 (3.70%)  1 0/24 (0.00%)  0 3/80 (3.75%)  3 3/127 (2.36%)  3
RASH † 1  1/47 (2.13%)  1 2/29 (6.90%)  3 1/27 (3.70%)  1 0/24 (0.00%)  0 3/80 (3.75%)  4 4/127 (3.15%)  5
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03067129    
Other Study ID Numbers: M16-123
2016-004102-34 ( EudraCT Number )
First Submitted: February 24, 2017
First Posted: March 1, 2017
Results First Submitted: May 14, 2021
Results First Posted: July 13, 2021
Last Update Posted: September 30, 2022