Trial Outcomes & Findings for 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 (NCT NCT03067129)

Last Updated: 2023-05-09

Results Overview

The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of GLE was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

129 participants

Primary outcome timeframe

Week 2 from predose to 24 hours post-dose

Results posted on

2023-05-09

Participant Flow

Participants were enrolled at 38 sites in North America, Europe, and Japan. Cohort 1 enrolled adolescent participants aged 12 to \< 18 years old. Subsequently, children aged 9 to \< 12 (Cohort 2), 6 to \< 9 (Cohort 3), and 3 to \< 6 (Cohort 4) years old were enrolled in parallel.

In each cohort participants were first enrolled into an intense pharmacokinetic (IPK) portion to characterize the PK and safety, followed by a non-IPK safety/efficacy part. PK samples from the first 6 participants in the IPK part were analyzed to determine the final dose used for the remaining IPK participants and in the non-IPK group. A total of 129 participants were enrolled and 127 participants received at least 1 dose of study drug and were included in the intention-to-treat population.

Participant milestones

Participant milestones
Measure	Cohort 1: 12 to < 18 Years Adolescents aged 12 to \< 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience.	Cohort 2: 9 to < 12 Years Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: 6 to < 9 Years Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening.	Cohort 4: 3 to < 6 Years Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening.
Overall Study STARTED	47	29	27	24
Overall Study Intense Pharmacokinetic Portion	14	19	18	18
Overall Study COMPLETED	42	24	22	18
Overall Study NOT COMPLETED	5	5	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: 12 to < 18 Years Adolescents aged 12 to \< 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience.	Cohort 2: 9 to < 12 Years Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: 6 to < 9 Years Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening.	Cohort 4: 3 to < 6 Years Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening.
Overall Study Partially Dosed; Refused to Swallow Entire Dose	0	0	0	1
Overall Study Withdrawal by Subject	0	0	1	2
Overall Study Lost to Follow-up	5	5	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=24 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg; one participant received GLE 200 mg + PIB 80 mg based on weight at screening.	Total n=127 Participants Total of all reporting groups	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=47 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on hepatitis C virus (HCV) genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=29 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=27 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg; one participant received GLE 250 mg + PIB 100 mg based on weight at screening.
Baseline Fibrosis Stage F2	0 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	3.79 years STANDARD_DEVIATION 0.78 • n=4 Participants	9.79 years STANDARD_DEVIATION 4.14 • n=21 Participants	14.26 years STANDARD_DEVIATION 1.51 • n=5 Participants	10.00 years STANDARD_DEVIATION 0.85 • n=7 Participants	7.11 years STANDARD_DEVIATION 0.89 • n=5 Participants
Sex: Female, Male Female	12 Participants n=4 Participants	70 Participants n=21 Participants	26 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=4 Participants	57 Participants n=21 Participants	21 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=4 Participants	18 Participants n=21 Participants	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=4 Participants	109 Participants n=21 Participants	42 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=4 Participants	90 Participants n=21 Participants	35 Participants n=5 Participants	21 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=4 Participants	7 Participants n=21 Participants	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=4 Participants	20 Participants n=21 Participants	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=4 Participants	7 Participants n=21 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Baseline Fibrosis Stage F0-F1	24 Participants n=4 Participants	123 Participants n=21 Participants	45 Participants n=5 Participants	28 Participants n=7 Participants	26 Participants n=5 Participants
Baseline Fibrosis Stage F3	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Fibrosis Stage F4	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 1	17 Participants n=4 Participants	95 Participants n=21 Participants	37 Participants n=5 Participants	19 Participants n=7 Participants	22 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 2	0 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 3	7 Participants n=4 Participants	22 Participants n=21 Participants	4 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 4	0 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 5	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Hepatitis C Virus Genotype Genotype 6	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prior HCV Treatment History Naive	24 Participants n=4 Participants	114 Participants n=21 Participants	36 Participants n=5 Participants	27 Participants n=7 Participants	27 Participants n=5 Participants
Prior HCV Treatment History Experienced	0 Participants n=4 Participants	13 Participants n=21 Participants	11 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants
Co-infection with Human Immunodeficiency Virus (HIV) Yes	0 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Co-infection with Human Immunodeficiency Virus (HIV) No	24 Participants n=4 Participants	124 Participants n=21 Participants	45 Participants n=5 Participants	29 Participants n=7 Participants	26 Participants n=5 Participants
HCV Ribonucleic Acid (RNA) Level	5.83 Log₁₀ IU/mL n=4 Participants	6.07 Log₁₀ IU/mL n=21 Participants	6.20 Log₁₀ IU/mL n=5 Participants	6.20 Log₁₀ IU/mL n=7 Participants	5.89 Log₁₀ IU/mL n=5 Participants

PRIMARY outcome

Timeframe: Week 2 from predose to 24 hours post-dose

Population: Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (\> 20 kg) is summarized in Cohort 3 for PK analyses based on the actual dose received.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=14 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=13 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=13 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=12 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir	4790 ng*h/mL Interval 3520.0 to 6500.0	7870 ng*h/mL Interval 4140.0 to 14900.0	6860 ng*h/mL Interval 4080.0 to 11500.0	7520 ng*h/mL Interval 3870.0 to 14600.0	—	—

PRIMARY outcome

Timeframe: Week 2 from predose to 24 hours post-dose

Population: Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (\> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received.

The area under the plasma concentration-time curve (AUC) is a method of measurement of the total exposure of a drug in blood plasma. The steady-state exposure of PIB was measured up to 24 hours after dosing at Week 2 and estimated using non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=14 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=13 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=13 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=12 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Steady-state AUC0-24 of Pibrentasvir	1380 ng*h/mL Interval 1150.0 to 1660.0	2200 ng*h/mL Interval 1460.0 to 3310.0	1640 ng*h/mL Interval 1230.0 to 2190.0	1790 ng*h/mL Interval 1350.0 to 2370.0	—	—

PRIMARY outcome

Timeframe: 12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration)

Population: Intention-to-treat population: all participants who received at least 1 dose of study drug; Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backwards imputation were counted as nonresponders.

SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last actual dose of study drug. Plasma HCV RNA levels were collected using the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test v2.0. SVR12 was considered a primary efficacy endpoint by the United States (US) regulatory agency and was considered secondary outside of the US.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=47 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=29 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=27 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=24 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years n=80 Participants Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total n=127 Participants Participants in Cohorts 1 to 4.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)	100 percentage of participants Interval 92.4 to 100.0	93.1 percentage of participants Interval 78.0 to 98.1	100 percentage of participants Interval 87.5 to 100.0	95.8 percentage of participants Interval 79.8 to 99.3	96.3 percentage of participants Interval 89.5 to 98.7	97.6 percentage of participants Interval 93.3 to 99.2

SECONDARY outcome

Timeframe: Week 2 from predose to 24 hours post-dose

Population: Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (\> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=14 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=13 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=13 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=12 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Maximum Plasma Concentration (Cmax) of Glecaprevir	1040 ng/mL Interval 733.0 to 1480.0	1370 ng/mL Interval 773.0 to 2440.0	1600 ng/mL Interval 926.0 to 2770.0	1530 ng/mL Interval 711.0 to 3290.0	—	—

SECONDARY outcome

Timeframe: Week 2 from predose to 24 hours post-dose

Population: Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (\> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received.

CL/F 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=14 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=13 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=13 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=12 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Apparent Clearance (CL/F) of Glecaprevir From Plasma	62.6 L/h Interval 46.1 to 85.1	31.8 L/h Interval 16.7 to 60.3	29.1 L/h Interval 17.3 to 49.0	19.9 L/h Interval 10.2 to 38.7	—	—

SECONDARY outcome

Timeframe: Week 2 from predose to 24 hours post-dose

Population: Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (\> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received.

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.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=14 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=13 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=13 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=12 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Maximum Plasma Concentration of Pibrentasvir	174 ng/mL Interval 148.0 to 205.0	225 ng/mL Interval 164.0 to 310.0	197 ng/mL Interval 154.0 to 251.0	233 ng/mL Interval 184.0 to 296.0	—	—

SECONDARY outcome

Timeframe: Week 2 from predose to 24 hours post-dose

Population: Participants with intense pharmacokinetic samples who received the final dose regimen of GLE + PIB. One participant in Cohort 4 who received GLE 200 mg + PIB 80 mg based on weight (\> 20 kg) was summarized in Cohort 3 for PK analyses based on the actual dose received.

CL/F 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.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=14 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=13 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=13 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=12 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Apparent Clearance of Pibrentasvir From Plasma	86.9 L/h Interval 72.4 to 104.0	45.4 L/h Interval 30.1 to 68.5	48.7 L/h Interval 36.6 to 64.8	33.6 L/h Interval 25.4 to 44.5	—	—

SECONDARY outcome

Timeframe: Up to Week 8, 12, or 16 (depending on treatment duration)

Population: Intention-to-treat population

On-treatment virologic failure is defined as meeting one of the following: * A confirmed (defined as two consecutive HCV RNA measurements) increase of \> 1 log₁₀ IU/mL above nadir during treatment; * Confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during treatment; * HCV RNA ≥ 15 IU/mL at the end of treatment with at least 6 weeks of treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=47 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=29 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=27 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=24 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years n=80 Participants Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total n=127 Participants Participants in Cohorts 1 to 4.
Percentage of Participants Who Experienced On-treatment Virologic Failure	0 percentage of participants Interval 0.0 to 7.6	0 percentage of participants Interval 0.0 to 11.7	0 percentage of participants Interval 0.0 to 12.5	0 percentage of participants Interval 0.0 to 13.8	0 percentage of participants Interval 0.0 to 4.6	0 percentage of participants Interval 0.0 to 2.9

SECONDARY outcome

Timeframe: Up to 12 weeks after the last dose of study drug (Week 20, 24, or 28 depending on treatment duration)

Population: Participants in the ITT population who completed treatment (based on study drug duration) with HCV RNA \< 15 IU/mL at the final treatment visit and with at least one post-treatment HCV RNA value.

Post-treatment relapse is 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; excluding participants who had been shown to be re-infected.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=47 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=28 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=27 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=23 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years n=78 Participants Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total n=125 Participants Participants in Cohorts 1 to 4.
Percentage of Participants With Post-treatment Relapse up to 12 Weeks Post Treatment	0 percentage of participants Interval 0.0 to 7.6	3.6 percentage of participants Interval 0.6 to 17.7	0 percentage of participants Interval 0.0 to 12.5	0 percentage of participants Interval 0.0 to 14.3	1.3 percentage of participants Interval 0.2 to 6.9	0.8 percentage of participants Interval 0.1 to 4.4

SECONDARY outcome

Timeframe: From the end of treatment up to post-treatment Week 144

Population: Intention-to-treat population

Reinfection is defined as confirmed HCV RNA ≥ 15 IU/mL in the post-treatment period in a participant who had HCV RNA \< 15 IU/mL at the Final Treatment Visit, along with post-treatment detection of a different HCV genotype, subtype, or clade compared with Baseline, as determined by phylogenetic analysis of the nonstructural viral protein 3 (NS3) or NS5A, and/or NS5B gene sequences.

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=47 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=29 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=27 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=24 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years n=80 Participants Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total n=127 Participants Participants in Cohorts 1 to 4.
Percentage of Participants With New Hepatitis C Virus Infection (Reinfection)	0 percentage of participants Interval 0.0 to 7.6	0 percentage of participants Interval 0.0 to 11.7	0 percentage of participants Interval 0.0 to 12.5	0 percentage of participants Interval 0.0 to 13.8	0 percentage of participants Interval 0.0 to 4.6	0 percentage of participants Interval 0.0 to 2.9

SECONDARY outcome

Timeframe: Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration)

Population: Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit

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. Question 1 "How Convenient or Inconvenient Was it to Prepare the Dose?" was answered as "very convenient", "convenient", "borderline", "inconvenient", or "very inconvenient".

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=28 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=27 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=23 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=78 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? Very convenient	7 Participants	9 Participants	9 Participants	25 Participants	—	—
Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? Convenient	13 Participants	10 Participants	8 Participants	31 Participants	—	—
Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? Borderline	2 Participants	7 Participants	4 Participants	13 Participants	—	—
Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? Inconvenient	6 Participants	1 Participants	1 Participants	8 Participants	—	—
Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? Very inconvenient	0 Participants	0 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Final treatment visit (up to Week 8, 12, or 16, depending on duration of treatment)

Population: Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit

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. Question 2 "How Long Did it Typically Take for the Child to Take the Dose?" was answered as "5 minutes or less", "5 to 15 minutes", "15 to 30 minutes", or "more than 30 minutes".

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=28 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=27 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=23 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=78 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? 5 minutes or less	22 Participants	23 Participants	21 Participants	66 Participants	—	—
Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? 5 to 15 minutes	5 Participants	4 Participants	2 Participants	11 Participants	—	—
Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? 15 to 30 minutes	1 Participants	0 Participants	0 Participants	1 Participants	—	—
Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? More than 30 minutes	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration)

Population: Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit

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. 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?" was answered as "Yes" or "No".

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=28 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=27 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=23 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=78 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
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? Yes	20 Participants	19 Participants	19 Participants	58 Participants	—	—
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? No	8 Participants	8 Participants	3 Participants	19 Participants	—	—
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? Missing	0 Participants	0 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Final treatment visit (up to Week 8, 12, or 16 depending on treatment duration)

Population: Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=28 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=27 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=23 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=78 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? Yes	6 Participants	4 Participants	7 Participants	17 Participants	—	—
Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? No	22 Participants	23 Participants	15 Participants	60 Participants	—	—
Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? Missing	0 Participants	0 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to final treatment visit (up to Week 8, 12, or 16 depending on treatment duration)

Population: Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit

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. Question 4a "Type of feeding resistance?" tracks feeding resistance experienced at any time during treatment, and was answered as "Did not like taste of medicine", "Did not like texture of medicine", "Did not like the soft food used", "Did not like to swallow the amount of medicine", or "Unrelated to the medicine".

Outcome measures

Outcome measures
Measure	Cohort 1: Adult Formulation GLE/PIB; 12 to < 18 Years n=28 Participants Adolescents aged 12 to \< 18 years old received the adult formulation of GLE/PIB 100 mg/40 mg co-formulated film-coated tablets for a once daily total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Cohort 2: Pediatric Formulation GLE + PIB; 9 to < 12 Years n=27 Participants Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 30 to \< 45 kg was GLE 250 mg + PIB 100 mg.	Cohort 3: Pediatric Formulation GLE + PIB; 6 to < 9 Years n=23 Participants Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 20 to \< 30 kg was GLE 200 mg + PIB 80 mg.	Cohort 4: Pediatric Formulation GLE + PIB; 3 to < 6 Years n=78 Participants Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The final dose for children weighing 12 to \< 20 kg was GLE 150 mg + PIB 60 mg.	Cohorts 2-4: Pediatric Formulation GLE + PIB; 3 to < 12 Years Children aged 3 to \< 12 years old received a pediatric formulation of GLE + PIB at a final dose of GLE 250 mg + PIB 100 mg (children 9 to \< 12 years of age), GLE 200 mg + PIB 80 mg (children 6 to \< 9 years of age), or GLE 150 mg + PIB 60 mg (children 3 to \< 6 years of age) as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.	Total Participants in Cohorts 1 to 4.
Palatability Questionnaire Question 4a: Type of Feeding Resistance Did not like taste of medicine	3 Participants	5 Participants	6 Participants	14 Participants	—	—
Palatability Questionnaire Question 4a: Type of Feeding Resistance Did not like texture of medicine	2 Participants	2 Participants	5 Participants	9 Participants	—	—
Palatability Questionnaire Question 4a: Type of Feeding Resistance Did not like the soft food used	3 Participants	2 Participants	0 Participants	5 Participants	—	—
Palatability Questionnaire Question 4a: Type of Feeding Resistance Did not like to swallow the amount of medicine	3 Participants	2 Participants	3 Participants	8 Participants	—	—
Palatability Questionnaire Question 4a: Type of Feeding Resistance Unrelated to the medicine	0 Participants	0 Participants	1 Participants	1 Participants	—	—
Palatability Questionnaire Question 4a: Type of Feeding Resistance Missing	0 Participants	0 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Final treatment visit (up to Week 8, 12, or 16, depending on treatment duration)

Population: Participants in the intention-to-treat population who completed the Palatability Questionnaire at the final treatment visit

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. Question 5 "How Easy or Difficult Was it for the Child to Swallow the Medicine?" was answered as "very easy", "easy", "borderline", "difficult", or "very difficult."