| Primary | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory. | Posted | | Mean | Standard Deviation | h*ng/mL | | Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. |
| | | Title | Denominators | Categories |
|---|
| GS-331007 (metabolite of SOF) | - ParticipantsOG00010
- ParticipantsOG00110
- ParticipantsOG00213
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| AUCtau of GS-331007 for the 12 to < 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies. | | | | | Percentage Geometric Mean Ratio | 105.20 | | | 2-Sided | 90 | 90.61 | 122.13 | | | | | Equivalence | Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups. | | |
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| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | | Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. | | OG003 |
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| Secondary | For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | | Participants who were enrolled in the PK lead-in phase with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. |
| |
| Secondary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase | | Participants who were enrolled in the PK lead-in phase were analyzed. | Posted | | Number | | percentage of participants | | Up to Day 10 | | | | ID | Title | Description |
|---|
| OG000 | PK Lead-in: 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age weighing ≥ 45 kg received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | PK Lead-in: 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | PK Lead-in: 3 to < 6 Years Old - LDV/SOF 12 Weeks | Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. |
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| Secondary | For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. | Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
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| Secondary | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
|
| Secondary | For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
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| Secondary | For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough | Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
|
| Secondary | For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Up to Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
|
| Secondary | For the Treatment Phase, Change From Baseline in HCV RNA | | Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
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| Secondary | For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | | Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
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| Secondary | For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization | ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. | Participants in the Full Analysis Set with ALT > ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks. | Posted | | Number | | percentage of participants | | Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks |
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| Secondary | For the Treatment Phase, Change From Baseline in Height | | Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks. | Posted | | Mean | Standard Deviation | centimeters | | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
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| Secondary | For the Treatment Phase, Change From Baseline in Weight | | Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks. | Posted | | Mean | Standard Deviation | kilograms | | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 1 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF 12 Weeks | Participants 6 to < 12 years of age with HCV genotypes 1 or 4 TN with or without cirrhosis or HCV genotype 1 TE without cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 12 weeks. | | OG002 | 6 to < 12 Years Old - LDV/SOF 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 1 TE with cirrhosis received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily for 24 weeks. |
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| Secondary | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. | Male participants in the Safety Analysis Set with available data were analyzed. | Posted | | Count of Participants | | Participants | | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Male participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | Male participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks. | | OG002 | 3 to < 6 Years Old - LDV/SOF 12 Weeks |
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| Secondary | For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. | Male participants in the Safety Analysis Set with available data were analyzed. | Posted | | Count of Participants | | Participants | | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Male participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | Male participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks. | | OG002 | 3 to < 6 Years Old - LDV/SOF 12 Weeks |
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| Secondary | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. | Female participants in the Safety Analysis Set with available data were analyzed. | Posted | | Count of Participants | | Participants | | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Female participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | Female participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks. | | OG002 | 3 to < 6 Years Old - LDV/SOF 12 Weeks |
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| Secondary | For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development | Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented. | Female participants in the Safety Analysis Set with available data were analyzed. | Posted | | Count of Participants | | Participants | | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Female participants 12 to < 18 years of age received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | Female participants 6 to < 12 years of age received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks. | | OG002 | 3 to < 6 Years Old - LDV/SOF 12 Weeks |
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| Secondary | Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1 | Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet. | Participants between 6 to <18 years old in the Safety Analysis Set who performed the swallowability assessment were analyzed. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 12 to < 18 Years Old - LDV/SOF 12 Weeks | Participants 12 to < 18 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then received LDV/SOF FDC 90/400 mg (1 x 90/400 mg tablet or 4 x 22.5/100 mg tablets) once daily for 12 weeks. | | OG001 | 6 to < 12 Years Old - LDV/SOF±RBV 12 or 24 Weeks | Participants 6 to < 12 years of age received placebo to match LDV/SOF FDC to assess ability to swallow tablets on Day 1. They then received LDV/SOF FDC 45/200 mg (2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules) once daily ± RBV capsules or oral solution (dose depending on weight) for 12 or 24 weeks. |
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| Secondary | Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1 | Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40. | Participants between 3 to <6 years old in the Safety Analysis Set who performed the palatability test were analyzed. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 3 to < 6 Years Old - LDV/SOF 12 Weeks | Participants 3 to < 6 years of age received LDV/SOF FDC (weight ≥ 17 kg: 45/200 mg granules; weight < 17 kg: 33.75/150 mg granules) once daily for 12 weeks. |
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