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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002283-32 | EudraCT Number |
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This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2) | Experimental | Participants between 12 to < 18 years of age with genotype (GT) 2 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks. |
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| 12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3) | Experimental | Participants between 12 to < 18 years of age with genotype 3 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks. |
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| 6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2) | Experimental | Participants between 6 to < 12 years of age with genotype 2 HCV infection weighing ≥ 17 kg and < 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks. |
|
| 6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3) | Experimental | Participants between 6 to < 12 years of age with genotype 3 HCV infection weighing ≥ 17 kg and < 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | SOF administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase | Up to 24 weeks | |
| For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA | Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) | |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents [Poster 1707]. American Association for the Study of Liver Diseases (AASLD); 2015 November 13-17, San Francisco, USA. Hepatology 2015;62 (S1): 1040A-1041A | ||
| Result | Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to <12 Years Old [Poster 878]. American Association for the Study of Liver Diseases (AASLD); 2016 11-15 November; Boston, MA. Hepatology 2016;64 (S1): 436A | ||
| Result | Schwarz KB, Rosenthal P, Gonzales-Peralta RP, Jonas MM, Balistreri WF, Lin CH, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Adolescents with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2016; 63 (Suppl 1): abstract 706. | ||
| 28543053 |
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135 participants were screened.
Participants were enrolled at study sites in Australia, Europe, Russia, New Zealand, and the United States. The first participant was screened on 07 July 2014. The last study visit occurred on 13 September 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 12 to < 18 Years Old - SOF+RBV 12 Weeks | Participants 12 to < 18 years of age with hepatitis C virus (HCV) genotype 2 received sofosbuvir (SOF) 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + ribavirin (RBV) capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the Pharmacokinetic (PK) Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| PK Lead-in Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Dec 20, 2013 | Feb 1, 2019 |
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| 3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2) | Experimental | Participants between 3 to < 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 12 weeks and those weighing < 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 12 weeks. |
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| 3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3) | Experimental | Participants between 3 to < 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 24 weeks and those weighing < 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 24 weeks. |
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| RBV | Drug | RBV oral solution or capsules will be administered orally in a divided daily dose based on weight |
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| Up to Day 7 |
| 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 < LLOQ at 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| 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. | Posttreatment Week 24 |
| 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. | Up to 24 weeks |
| 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. | Up to Posttreatment Week 24 |
| For the Treatment Phase, Change From Baseline in HCV RNA | Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) |
| For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment | Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) |
| 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. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data. | 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 |
| For the Treatment Phase, Change From Baseline in Height | 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 |
| For the Treatment Phase, Change From Baseline in Weight | 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 |
| 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. | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 |
| 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. | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 |
| 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. | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 |
| 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. | Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24 |
| For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules | Participants were asked if they were able to taste the SOF oral granules. | Day 1 |
| San Francisco |
| California |
| United States |
| Washington D.C. | District of Columbia | United States |
| Gainesville | Florida | United States |
| Atlanta | Georgia | United States |
| Indianapolis | Indiana | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| New York | New York | United States |
| Cincinnati | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Seattle | Washington | United States |
| Morgantown | West Virginia | United States |
| Westmead | New South Wales | Australia |
| Melbourne | Victoria | Australia |
| New Lambton Heights | Australia |
| Brussels | Belgium |
| Wuppertal | North Rhine-Westphalia | Germany |
| Berlin | Germany |
| Bologna | Italy |
| Florence | Italy |
| Milan | Italy |
| Padova | Italy |
| San Giovanni Rotondo | Italy |
| Torino | Italy |
| Auckland | New Zealand |
| Saint Petersburg | Russian Federation | Russia |
| Moscow | Russia |
| Novokuznetsk | Russia |
| Saint Petersburg | Russia |
| Tolyatti | Russia |
| Birmingham | United Kingdom |
| Leeds | United Kingdom |
| London | United Kingdom |
| Result |
| Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas MM, Balistreri WF, Lin CH, Hardikar W, Kersey K, Massetto B, Kanwar B, Brainard DM, Shao J, Svarovskaia E, Kirby B, Arnon R, Murray KF, Schwarz KB. Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017 Oct;66(4):1102-1110. doi: 10.1002/hep.29278. Epub 2017 Aug 26. |
| 29193603 | Result | Younossi ZM, Stepanova M, Schwarz KB, Wirth S, Rosenthal P, Gonzalez-Peralta R, Murray K, Henry L, Hunt S. Quality of life in adolescents with hepatitis C treated with sofosbuvir and ribavirin. J Viral Hepat. 2018 Apr;25(4):354-362. doi: 10.1111/jvh.12830. Epub 2017 Dec 26. |
| Result | Rosenthal P, Schwarz KB, Gonzales-Peralta RP, Lin CH, Kelly DA, Nightingale S, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Children 3 to <12 Years Old with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2018; 68 (Suppl 1): abstract 1844. |
| 31222783 | Derived | Rosenthal P, Schwarz KB, Gonzalez-Peralta RP, Lin CH, Kelly DA, Nightingale S, Balistreri WF, Bansal S, Jonas MM, Massetto B, Brainard DM, Hsueh CH, Shao J, Parhy B, Davison S, Feiterna-Sperling C, Gillis LA, Indolfi G, Sokal EM, Murray KF, Wirth S. Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection. Hepatology. 2020 Jan;71(1):31-43. doi: 10.1002/hep.30821. Epub 2019 Aug 13. |
| FG001 | 12 to < 18 Years Old - SOF+RBV 24 Weeks | Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. |
| FG002 | 6 to < 12 Years Old - SOF+RBV 12 Weeks | Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. |
| FG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. |
| FG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. |
| FG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Phase |
|
|
Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 12 to < 18 Years Old - SOF+RBV 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| BG001 | 12 to < 18 Years Old - SOF+RBV 24 Weeks | Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| BG002 | 6 to < 12 Years Old - SOF+RBV 12 Weeks | Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| BG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| BG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| BG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| HCV RNA Category | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of 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 | 6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7 |
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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 took at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 24 weeks |
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| Primary | For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 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 12 |
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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. 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, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only) |
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| 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 7 |
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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 < LLOQ at 4 weeks after stopping study treatment. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 4 |
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| 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 |
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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 |
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| 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 |
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| 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) |
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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) |
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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. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data. | 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. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data. | 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 |
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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 |
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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 |
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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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules | Participants were asked if they were able to taste the SOF oral granules. | Participants in the Safety Analysis Set who performed the palatability assessment were analyzed. | Posted | Number | percentage of participants | Day 1 |
|
Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 12 to < 18 Years Old - SOF+RBV 12 Weeks | Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. | 0 | 13 | 0 | 13 | 12 | 13 |
| EG001 | 12 to < 18 Years Old - SOF+RBV 24 Weeks | Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. | 0 | 39 | 0 | 39 | 27 | 39 |
| EG002 | 6 to < 12 Years Old - SOF+RBV 12 Weeks | Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. | 0 | 13 | 0 | 13 | 9 | 13 |
| EG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. | 0 | 28 | 0 | 28 | 24 | 28 |
| EG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. | 0 | 8 | 1 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oral contusion | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Product use issue | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Product taste abnormal | Product Issues | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Feb 10, 2014 | Feb 1, 2019 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Mar 14, 2014 | Feb 1, 2019 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Oct 10, 2014 | Feb 1, 2019 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 4 | Nov 12, 2014 | Feb 1, 2019 | Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 5 | May 29, 2015 | Feb 1, 2019 | Prot_005.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 6 | Feb 26, 2016 | Feb 1, 2019 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2018 | Feb 1, 2019 | SAP_007.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
Not provided
| Adverse Event |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Other |
|
| Black or African American |
|
| Native Hawaiian or Pacific Islander |
|
| Belgium |
|
| United States |
|
| Italy |
|
| United Kingdom |
|
| Australia |
|
| Germany |
|
| Russia |
|
| ≥ 800,000 IU/mL |
|
AUCtau of GS-331007 for the 6 to < 12 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 |
| 109.80 |
| 2-Sided |
| 90 |
| 93.25 |
| 129.29 |
| Equivalence |
Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups. |
| AUCtau of GS-331007 for the 3 to < 6 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 | 149.67 | 2-Sided | 90 | 127.12 | 176.21 | Equivalence | Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups. |
| OG003 |
| 6 to < 12 Years Old - SOF+RBV 24 Weeks |
Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
Participants 12 to < 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG003 | 12 to < 18 Years Old - SOF+RBV 24 Weeks | Participants 12 to < 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 6 to < 12 Years Old - SOF+RBV 12 Weeks | Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG006 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG007 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
|
| OG003 | PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG002 | 6 to < 12 Years Old - SOF+RBV 12 Weeks | Participants 6 to < 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
|
| OG003 | 6 to < 12 Years Old - SOF+RBV 24 Weeks | Participants 6 to < 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
| OG004 | 3 to < 6 Years Old - SOF+RBV 12 Weeks | Participants 3 to < 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. |
| OG005 | 3 to < 6 Years Old - SOF+RBV 24 Weeks | Participants 3 to < 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. |
|
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| 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks |
Male participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks. |
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| 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks |
Male participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks. |
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| 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks |
Female participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks. |
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| 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks |
Female participants 3 to < 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight < 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks. |
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