Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection

Key Inclusion Criteria:

- Male or Female, 2 to < 12 years of age

- Weight ≥ 10 kg

- Chronic HBV infection ≥ 6 months

- HBeAg-positive or HBeAg-negative

- HBV Viral Load ≥ 100,000 copies/mL

- Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at
screening

- Creatinine Clearance ≥ 80 mL/min/1.73m^2

- Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10 g/dL

- Negative pregnancy test at screening

- No prior tenofovir DF therapy (subjects may have received prior interferon‑alfa and/or
other oral anti‑HBV nucleoside/nucleotide therapy; subjects must have discontinued
interferon-alfa therapy ≥ 6 months prior to screening; subjects experienced on other
anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior
to screening to avoid flare if randomized to the placebo arm)

Key Exclusion Criteria:

- Pregnant or lactating

- Decompensated liver disease

- Received interferon therapy within 6 months of Screening

- Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of Screening

- Alpha-fetoprotein levels > 50 ng/mL

- Evidence of hepatocellular carcinoma (HCC)

- Co-infection with HIV, acute hepatitis A virus (HAV), hepatitis C virus (HCV), or
hepatitis D virus (HDV)

- Chronic liver disease not due to HBV

- History of significant renal, cardiovascular, pulmonary, neurological or bone disease

- Long term non-steroidal, anti-inflammatory drug therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply