Real-world experience of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in patients with chronic hepatitis B: a retrospective study

Abstract

Background Tenofovir alafenamide (TAF) has good viral suppression efficacy and less adverse effect than tenofovir disoproxil fumarate (TDF). Real-world studies on the antiviral efficacy and safety of switching from TDF to TAF in patients with chronic hepatitis B (CHB) are limited. Methods This retrospective study included 167 nucleos(t)ide analogue (NA)-naive patients with CHB. All the patients received TDF at least 12 months before switching and TAF at least 12 months after switching at a single medical center. The Friedman test with Dunn–Bonferroni post hoc tests and repeated-measures analysis of variance was used to analyze the effect of complete viral suppression, alanine aminotransferase (ALT) level normalization, renal function changes, body weight, and body mass index in the periods before and after switching. Results The mean age and TDF treatment duration were 52 ± 11 years and 2.8 years (interquartile range, 1.51–5.15 years), respectively. The complete viral suppression rate was similar between the time of switching and 48 weeks after switching to TAF (77.8% vs 76%, P = 1.000). The percentage of alanine aminotransferase (ALT) normalization increased from 26.3% at TDF start to 81.4% (P < 0.001) at time of switching and 89.2% at 48 weeks after switching to TAF (P = 0.428). The median estimated glomerular filtration rate decreased from 100.09 mL/min/1.73 m² at TDF start to 91.97 mL/min/1.73 m² (P < 0.001) at the time of switching and stabilized at 48 weeks after switching to TAF (93.47 mL/min/1.73m², P = 1.000). The body weight decreased from 69.2 ± 12.2 kg at TDF start to 67.4 ± 12.1 kg (P < 0.001) at the time of switching to TAF and returned to 68.7 ± 12.7 kg (P < 0.001) 48 weeks thereafter. The body mass index (BMI) decreased from 25 ± 3.3 kg/m² at TDF start to 24.5 ± 3.3 kg/m² (P = 0.002) at the time of switching to TAF and returned to 25.1 ± 3.6 kg/m² (P < 0.001) 48 weeks thereafter. Conclusions Our study showed that switching to TAF from TDF had good antiviral effectiveness and stabilized renal function. The body weight and BMI decreased during TDF therapy and regained after switching to TAF.

HERACLIS‐TAF: a multi‐centre prospective cohort study on 2‐year safety and efficacy of tenofovir alafenamide in patients with chronic hepatitis B with renal and/or bone disorders or risks

“…As it has been reported in all previous studies, 4,5,10–13 TAF maintained virological suppression defined by undetectable serum HBV DNA in the vast majority (99%) of cases who started TAF without detectable viremia and achieved virological suppression in most (90% or 26/29) switched or naive patients who started TAF with detectable serum HBV DNA. Whether suboptimal initial response and/or compliance issues were responsible for the small proportion of patients with detectable HBV DNA at 12 months of TDF cannot be determined, but viremia levels were always low at 12 months and all (100%) patients remaining under follow‐up achieved HBV DNA undetectability at 24 months of TAF therapy.…”

“…The above findings were also confirmed in subsequent phase III trials in China 9 . In two US and one Taiwanese cohort studies including mostly patients with normal renal function, 10–12 eGFR was reported to stabilise at 48 weeks after switching to TAF while it was declining during previous TDF therapy. It should be noted, however, that eGFR changes should be always considered in relation to the characteristics of the patient population and especially the baseline eGFR levels and whether TAF is used in untreated or NA switched patients.…”

“…This finding is in agreement with previous studies reporting favourable effects of TAF on ALT levels. 4,5,[10][11][12][13] The reduction in ALT levels was observed regardless of the presence of diabetes and/or obesity, two factors that might contribute to ALT elevations associated with liver steatosis. The clinical significance of such a reduction in ALT levels remains unclear, but based on reasonable judgement, it can never be considered as a negative effect and can be easily considered as a potential additional advantage of TAF therapy.…”

“…8 The above findings were also confirmed in subsequent phase III trials in China. 9 In two US and one Taiwanese cohort studies including mostly patients with normal renal function, [10][11][12] eGFR was reported to stabilise at 48 weeks after switching to TAF while it was declining during previous TDF therapy.…”

Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis

“…Chronic hepatitis C virus (HCV) infection is one of the common causes of liver cirrhosis and liver cancer that can now be prevented by effective antiviral therapy [ 1 , 2 , 3 , 4 , 5 , 6 ]. Over the past two decades, interferon-based therapy was the standard of care; however, its use is limited to numerous treatment-related side effects, the risk of liver decompensation among cirrhotic patients, and the need to understand the genotype of HCV to determine the treatment duration.…”