Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Hepatitis C Virus Infection
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection
Eligibility Criteria
Key Inclusion Criteria:
- Consent of parent or legal guardian required
- Chronic HCV infection genotype 2 or 3
- Screening laboratory values within defined thresholds
- PK Lead-in only: all individuals must be treatment naive
Key Exclusion Criteria:
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
- Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
- Pregnant or nursing females
- Known hypersensitivity to study medication
- Use of any prohibited concomitant medications as within 28 days of the Day 1 visit
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2)
12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3)
6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2)
6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3)
3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2)
3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3)
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.
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.
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.
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.
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.
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.