Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir (TETRA)

Inclusion Criteria:

• Male or female, at least 18 years of age
• Documented CHB defined by HBsAg or HBeAg positive at least 6 month prior
• HBsAg positive at screening visit
• HBeAg positive and Anti-HBe negative at screening visit
• Serum HBV DNA 20,000~200,000,000 IU/mL as determined by Realtime PCR at screening visit
• Serum ALT 80~400 IU/mL at screening visit
• Patient is willing and able to comply with the study drug regimen and all other study requirements
• Patient is willing and able to provide written informed consent to participate in the study

Exclusion Criteria:

• Patient has received interferon, pegylated interferon, nucleoside or nucleotide drugs at any time
• Patient is co-infected with HCV, HDV, or HIV
• Patient with Child Pugh B or C (Child Pugh score ≥ 7)
• Patient has a history of or clinical signs/symptoms of hepatic decompensation such as ascites, esophageal variceal bleeding, hepatic encephalopathy
• Patient has any of the following laboratory values at screening visit:
• Hemoglobin <10 g/dL
• Absolute neutrophil count (ANC) <1,500/mm3
• Platelet count <70,000/mm3
• Patient has a history of clinical and laboratory evidence of chronic renal insufficiency defined as an estimated serum creatinine clearance < 50 mL/min using the MDRD formula at screening visit
• Patient is pregnant or breastfeeding
• Patient with currently abusing illegal drugs or alcohol sufficient
• Patient has organ transplantation
• History of any other acute or chronic medical condition that in the opinion of the investigator would make the patient unsuitable for inclusion into the study
• Patient has one or more additional known primary or secondary causes of liver disease, other than CHB, including steatohepatitis and autoimmune hepatitis
• Patient, if AFP is >50ng/mL at screening visit, has image findings suggestive of HCC at Liver CT or Liver MRI
• Patient with hypersensitivity for study drug