The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.
Study Type
OBSERVATIONAL
Enrollment
12,522
Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision
Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision
Number of Participants With Adjudicated Overall Malignant Neoplasms
The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)
Time frame: 10 years
Number of Deaths
The number of deaths, as adjudicated by Events Adjudication Committee (EAC)
Time frame: 10 years
Number of Participants With Liver-related HBV Disease Progression
The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)
Time frame: 10 years
Number of Participants With Non-HCC Malignant Neoplasm
The number of participants with non-HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)
Time frame: 10 years
Number of Participants With HCC Malignant Neoplasm
The number of participants with HCC malignant neoplasm, as adjudicated by Events Adjudication Committee (EAC)
Time frame: 10 years
Number of Participants With Liver-related Death
The number of participants with Liver-related death, as adjudicated by Events Adjudication Committee (EAC)
Time frame: 10 years
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