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One-year efficacy of tenofovir alafenamide in patients with chronic hepatitis B: An observational study
Authors:Yi-Cheng Chen  Chao-Wei Hsu  Rong-Nan Chien  Dar-In Tai
Affiliation:aDepartment of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, No 5, Fu Hsing Street, Guishan Dist., Taoyuan City, Taiwan, R.O.C.;bCollege of Medicine, Chang Gung University, No.259, Wen Hua 1st Rd., Guishan Dist., Taoyuan City, Taiwan, R.O.C.
Abstract:
Non-inferior antiviral efficacy and better renal safety have been reported in chronic hepatitis B patients with tenofovir alafenamide (TAF) treatment. The experience in real-world clinical practice is limited.We aimed to explore the efficacy after 1-year TAF treatment.A total of 148 patients (42 HBeAg-positive and 106 HBeAg-negative) with TAF treatment ≥1 year were included. Virological suppression (<20 IU/mL or undetectable), HBsAg level, alanine aminotransferase (ALT) normalization (≤36 U/L), and estimated glomerular filtration rate (eGFR) were analyzed at 1 year. Multivariate logistic regression analysis was performed to determine the associated factors for virological suppression and ALT normalization.Virological suppression was achieved in 83% and the 1-year median decline of hepatitis B virus DNA was 5.18 log IU/mL. ALT normalization occurred in 75.7%. HBsAg level decreased at a median of 0.27 log IU/mL with significant difference from baseline (P < .001). Baseline ALT (odds ratio [OR] 1.005, 95% confidence interval [CI] 1.000–1.010, P = .036) and hepatitis B virus DNA (OR 0.222, 95% CI 0.079–0.621, P = .004) were significant factors for 1-year virological suppression. Age (OR 1.064, 95% CI 1.003–1.130, P = .041) was associated with ALT normalization. Significant changes were observed in creatinine (mean increase 0.03 mg/dL, P = .011) and eGFR (mean decrease 2.6 mL/min/1.73 m2, P = .004) after 1-year TAF treatment.One-year TAF treatment came to good virological response, modest ALT normalization rate and significant HBsAg decline. The observation of significant changes in eGFR warranted further studies.
Keywords:alanine aminotransferase normalization   chronic hepatitis B   estimated glomerular filtration rate   tenofovir alafenamide   virological suppression
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