Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
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.
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.