Efficacy and safety of tenofovir alafenamide fumarate in nucleoside analogue treatment-naïve patients with chronic hepatitis B

Abstract

Tenofovir alafenamide fumarate (TAF) is a first-line drug for the antiviral treatment of patients with chronic hepatitis B (CHB) in China. In the present study, the efficacy and renal safety of TAF were evaluated in treatment-naive patients with CHB. Patients with CHB who had not been previously treated with nucleoside analogues (NAs) were recruited before TAF treatment was initiated. Changes in the levels of hepatitis B virus (HBV) DNA, hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) were analyzed at 24 and 48 weeks using immunoassays. In addition, liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) were analyzed using transient elastography, while alanine aminotransferase (ALT), triglyceride (TG), total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) levels, calcium (Ca) and inorganic phosphorus (IP) levels were measured using biochemistry assay. In addition, the estimated glomerular filtration rate (eGFR) was calculated. After 48 weeks, the ALT normalization rate was 95.24% (40/42), the complete virological response (HBV DNA <20 IU/ml) rate was 69.05% (29/42) and the HBeAg seroconversion rate was 8.57% (3/35). The levels of HBV DNA and HBsAg were significantly decreased from the baseline at 5.49±1.95 to 1.26±0.66 log 10 IU/ml and from 3.59±0.81 to 3.32±0.55 log 10 IU/ml after 48 weeks of treatment, respectively. Compared with that in the baseline measurements, LSM at 48 weeks was significantly decreased from 13.00±8.15 to 8.66±4.45 kPa. No significant differences were observed in the TG, TC, LDL-C, CAP, eGFR, Ca and IP measurements. According to the baseline ALT levels, patients were divided into group A [ALT ≤1 x upper limit of normal (ULN); ULN=50 U/l; n=21], group B (1 x ULN < ALT <2 x ULN; n=22) and group C (ALT ≥2 x ULN; n=18). A significant decrease in HBsAg levels was observed in group B (3.63±0.68 vs. 3.53±0.63 log 10 IU/ml) and group C (4.15±0.57 vs. 3.66±0.48 log 10 IU/ml) at 24 weeks compared with the baseline. In conclusion, TAF was found to be effective and safe in NA treatment-naive patients with CHB. Moreover, the higher the ALT levels, the more prominent the curative effect from TAF treatment. Therefore, NA treatment-naive CHB patients could benefit from TAF treatment in real world.

Real‐world safety and effectiveness of tenofovir alafenamide for 144 weeks in Japanese patients with chronic hepatitis B

“…In this multicentre, real-world observational study that included 580 patients who were prospectively enrolled from 91 sites across Japan between July 2017 and August 2021, the favourable safety and effectiveness profile of TAF that has been demonstrated in clinical trials 10,11 and real-world analyses [36][37][38][43][44][45] Taken together, these findings confirm the excellent safety profile of TAF when administered to community-dwelling adults with CHB regardless of prior treatment status and regimen, comorbidities, and older age.…”

“…48,49 There were no reports of AEs attributed to changes in lipid levels in the current study, which is consistent with findings of other real-world studies. 37,50 However, lipid changes may not have been routinely monitored by hepatologists who participated in this study.…”

“…TAF is a novel phosphonamidate prodrug of tenofovir that offers several advantages over TDF, including greater plasma stability 32–34 and high levels of active drug (TFV diphosphate) delivered to HBV‐infected hepatocytes at a lower dose than TDF 35 . Several real‐world analyses confirm the safety and effectiveness of TAF, including a favourable renal and bone safety profile 36–40 . Long‐term surveillance in real‐world patient populations is important to determine whether the favourable effects seen in controlled trials of TAF are maintained in clinical practice, including demonstrations of no new safety signals.…”

“…35 Several real-world analyses confirm the safety and effectiveness of TAF, including a favourable renal and bone safety profile. [36][37][38][39][40] Long-term surveillance in real-world patient populations is important to determine whether the favourable effects seen in controlled trials of TAF are maintained in clinical practice, including demonstrations of no new safety signals.…”

The diagnostic value of lncRNA HOTAIR for cervical carcinoma in vaginal discharge and serum

“…Serum samples were collected from normal, BCD group and CC group by centrifuged at 2000 × g for 10 minutes. [15] The present study was approved by the Medical Ethics Committee of Tianjin Central Obstetrics and Gynecology Hospital, was performed according to the principles of the Declaration of Helsinki and all patients provided written informed consent prior to participation in the study.…”