Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (PEG) Versus TDF or PEG Monotherapy in Chronic Hepatitis B

Inclusion Criteria:

- Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen
(HBsAg) or HBV DNA for at least 6 months) prior to baseline

- Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside
therapy with the last dose ≥ 24 weeks prior to screening are also eligible.

- Positive or negative for hepatitis B e antigen (HBeAg)

- HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml
(HBeAg-negative participants)

- Alanine aminotransferase (ALT) > 54 U/L and ≤ 400 U/L for men and > 36 U/L and ≤ 300
U/L for women

- Creatinine clearance ≥ 70 mL/min

- Negative serum pregnancy test for females of childbearing potential

- Sexually active females of childbearing potential must agree to use a
protocol-recommended method of contraception throughout the study and for 30 days
following the last dose of study medication

- Lactating females must agree to discontinue nursing before initiation of study
investigational medicinal product

Exclusion Criteria:

- Known bridging fibrosis or cirrhosis and/or decompensated liver disease

- Evidence of hepatocellular carcinoma

- Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease
(eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis,
multiple bone fractures)

- Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL
(female) or < 11 g/dL (male)

- History of severe depression or severe psychiatric disease

- Thyroid dysfunction

- Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)

- Pregnant