The randomized, double-blind, active-controlled phase 3 trials were identical in design and differed only by the patient population as previously described.16,17 Briefly, patients were ≥18 years of age, HBsAg positive for ≥6 months with HBV DNA levels ≥20,000 IU/mL, and alanine transaminase (ALT) level of >60 U/L in men or >38 U/L in women. All patients had an estimated creatinine clearance ≥50 mL/min by using the Cockcroft-Gault (eGFRCG) equation. Patients were excluded with clinical or laboratory evidence of decompensated liver disease, aspartate transaminase or ALT >10 times the upper limit of normal (ULN), hepatocellular carcinoma, or co-infection with hepatitis C, hepatitis D, or the human immunodeficiency virus.

Patients were randomly assigned (2:1) to TAF 25 mg or TDF 300 mg given orally once a day for 144 weeks. All patients received placebo tablets that matched the alternative treatment; patients and investigators were blinded to the treatment assignment throughout the double-blind period. A limited number of individuals from the clinical research, biometrics, safety, and regulatory departments of the sponsor were unblinded at the 48-week time point to undertake measures that lead to the submission for TAF registration in China. Randomization was stratified by HBV DNA levels (≥8 log10 IU/mL versus 7 to 8 log10 IU/mL versus <7 log10 IU/mL in Study 108, and ≥8 log10 IU/mL versus <8 log10 IU/mL in Study 110) and by previous oral antiviral (OAV) treatment (treatment-naïve status was defined as <12 weeks of previous OAVs for HBV, and treatment-experienced patients received ≥12 weeks of previous OAV therapy).

Written informed consent was obtained from all patients before enrollment and the study protocols were approved by the institutional review board or independent ethics committees at all participating sites and were conducted according to the principles of the Declaration of Helsinki and Good Clinical Practice. All authors had access to the study data and reviewed and approved the final manuscript.

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