This study will compare monotherapy with tenofovir to sequential therapy with pegylated
interferon alpha-2b (pegIFN-2b) followed by tenofovir, and to combination therapy with
pegIFN-2b + tenofovir, in participants with hepatitis B e antigen (HBeAg)-positive chronic
hepatitis B and elevated alanine aminotransferase (ALT). All enrolled participants will be
be administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3
treatment arms.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Chronic hepatitis B (hepatitis B surface antigen [HBsAg]-positive for >6 months or
evidence of chronic hepatitis B in liver biopsy)
- Elevated serum ALT level
- Liver biopsy or a non-invasive investigation within 12 months prior to randomization
with Chronic Hepatitis B
- Treatment naïve or history of interferon for not more than 1 month, taken at least 6
months before enrollment
- Compensated liver disease
Exclusion Criteria:
- Known hypersensitivity to tenofovir, interferon alpha-2b, and/or any other component
of the study products
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV) or human
immunodeficiency virus (HIV)
- Need for prolonged or frequent use of systemic acyclovir or famciclovir
- Previously received lamivudine or an investigational anti-hepatitis B virus (HBV)
nucleoside or nucleotide analog and were resistant to these drugs
- History of variceal bleeding or other GI bleeding due to portal hypertension, hepatic
encephalopathy, spontaneous bacterial peritonitis, Grade III and IV esophageal
varices unless banded or other clinical signs of hepatic decompensation
- History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
- Need for potentially hepatotoxic drugs (e. g. dapsone, erythromycin, fluconazole,
ketoconazole, rifampin, and anti-tuberculosis regimens) or nephrotoxic drugs (e. g.
frequent nonsteroidal anti-inflammatories, aminoglycosides, amphotericin B, and
foscarnet)
- One or more additional known primary or secondary causes of liver disease, other than
hepatitis B
- History of clinical pancreatitis
- Pregnant or breastfeeding
- Female participants of childbearing potential and male participants must be willing
to use acceptable method of birth control.
- Medical condition that requires frequent or prolonged use of systemic corticosteroids
- Use of warfarin or other anticoagulants during 30 days prior to screening or if
expected to be needed during the study period