Ground Truth
Key Inclusion Criteria:Aged 12 to <18 yearsParent or legal guardian must provide written informed consentTreatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimenReceiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancyChronic HCV infection (≥ 6 months) documented by medical history or liver biopsyScreening laboratory values within defined thresholdsNo History of solid organ or bone marrow transplantationNo history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Prediction
**Amended Eligibility Criteria (version 2):**
Inclusion Criteria:
- Aged 12 to <18 years
- Parent or legal guardian must provide written informed consent
- Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen
- Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy
- Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
- Screening laboratory values within defined thresholds, including:
- Hemoglobin ≥ 8 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,000/mm³
- Platelets ≥ 50,000/mm³
- ALT ≤ 5 x upper limit of normal (ULN)
- Direct bilirubin ≤ 1.5 x baseline
- No history of solid organ or bone marrow transplantation
- No history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage)
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use effective contraception during the study and for 30 days after the last dose of study drug.