Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With 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
- Screening laboratory values within defined thresholds
Key Exclusion Criteria:
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol.
- Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
- Clinical hepatic decompensation (i.e., 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
Experimental
Experimental
Experimental
12 to < 18 Years Old
6 to < 12 Years Old
3 to < 6 Years Old
Participants between 12 to < 18 years of age weighing ≥ 45 kg will receive LDV/SOF FDC (90/400 mg tablet or 4 x 22.5 mg/100 mg tablets or 8 x 11.25/50 mg granules based on swallowability assessment during screening). Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment. United Kingdom: HCV genotypes (GT) 1, 4, 5, or 6 treatment-naive (TN) with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 treatment-experienced (TE) without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks United States/Australia/New Zealand: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
Participants between 6 to < 12 years of age weighing ≥ 17 kg and < 45 kg will receive LDV/SOF FDC (45/200 mg as 2 x 22.5/100 mg tablets or 4 x 11.25/50 mg granules based on swallowability assessment during screening). Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment. United Kingdom: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks United States/Australia/New Zealand: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks
Participants between 3 to < 6 years of age weighing ≥ 17 kg will receive LDV/SOF FDC (45/200 mg granules as 4 x 11.25/50 mg packets) and participants weighing < 17 kg will receive LDV/SOF FDC (33.75/150 mg oral granules as 3 x 11.25/50 mg packets). Treatment duration will be dependent on HCV genotype, prior treatment experience, cirrhosis status, and country of enrollment. United Kingdom: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 3 TE with or without cirrhosis = LDV/SOF+RBV 24 weeks United States/Australia/New Zealand: HCV GT 1, 4, 5, or 6 TN with or without cirrhosis = LDV/SOF 12 weeks HCV GT 1, 4, 5, or 6 TE without cirrhosis = LDV/SOF 12 weeks HCV GT 1 TE with cirrhosis = LDV/SOF 24 weeks HCV GT 4, 5, or 6 TE with cirrhosis = LDV/SOF 12 weeks