Effectiveness and Renal Safety of Tenofovir Alafenamide Fumarate among Chronic Hepatitis B Patients: Real‐World Study

Farag, Mina S.; Fung, Scott; Tam, Edward; Doucette, Karen; Wong, Alexander; Ramji, Alnoor; Conway, Brian; Cooper, Curtis; Tsoi, Kim; Wong, Philip; Sebastiani, Giada; Brahmania, Mayur; Haylock‐Jacobs, Sarah; Coffin, Carla S.; Hansen, Bettina E.; Janssen, Harry L.A.

doi:10.1111/jvh.13500

Cited by 18 publications

(54 citation statements)

References 26 publications

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“…ALT normalisation and improvements in bone and renal safety outcomes upon switching to TAF were also reported. Similar results have been reported in other studies, where virological, biochemical and bone and renal safety outcomes were improved or maintained in patients upon switching from TDF to TAF 40‐44,46‐52 …”

Section: Discussion and Clinical Implicationssupporting

confidence: 89%

“…In Phase 3 studies of CHB patients, TAF demonstrated improved renal and bone safety compared with TDF 19 . Several studies showed that switching from TDF to TAF improved both renal and bone safety 36‐41,43,44,46‐52 . Bone safety was not reported in most studies of TAF switching from ETV or other NAs.…”

Section: Discussion and Clinical Implicationsmentioning

confidence: 99%

“…Given guideline recommendations, it is not surprising that studies evaluating the efficacy and safety of TAF switching in CHB patients have predominantly been performed in those previously treated with TDF. [36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52] Phase 3 study results in patients switched to TAF or continued on TDF showed maintenance of virological suppression at Week 48 in both groups. 36 ALT normalisation and improvements in bone and renal safety outcomes upon switching to TAF were also reported.…”

Section: Discussion and Clinic Al Implic Ationsmentioning

confidence: 99%

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Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

Lim

Seto

Kurosaki

et al. 2022

Aliment Pharmacol Ther

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Summary Background The nucleos(t)ide analogues (NAs) entecavir (ETV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are preferred treatment options for patients with chronic hepatitis B infection (CHB). However, resistance to ETV has been reported, especially with prior exposure to other NAs, and long‐term TDF treatment has been associated with decline in renal function and loss of bone mineral density in some patients. Consequently, TAF may be preferable to ETV, TDF or other NAs in specific circumstances such as in patients with risk of bone or renal complications, elderly patients or those with previous NA experience. Aim To provide a summary of the available efficacy and safety data following switch to TAF from other NAs in patients with CHB in clinical studies and real‐world settings. Methods Literature searches were performed on PubMed and abstracts from three major international liver congresses between 2019 and 2021. Studies that included efficacy and/or safety data for patients with CHB switching from any NA to TAF were selected. Results Thirty‐six papers and abstracts were included in this narrative review. Switching from TDF to TAF maintained or improved virological and biochemical responses with improved bone and renal safety. Switching from ETV or other NAs to TAF maintained or improved virological and biochemical responses and varying results for bone and renal safety. Conclusions Switching to TAF appears to maintain or improve virological, biochemical and bone‐ and renal‐related safety outcomes. These data support the concept of switching to TAF in some patients with CHB based on their individual circumstances.

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Section: Discussion and Clinical Implicationssupporting

confidence: 89%

Section: Discussion and Clinical Implicationsmentioning

confidence: 99%

Section: Discussion and Clinic Al Implic Ationsmentioning

confidence: 99%

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Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

Lim

Seto

Kurosaki

et al. 2022

Aliment Pharmacol Ther

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“…TAF increased the ALT normalization rate according to the American Association for the Study of Liver Diseases (AASLD) criteria in the three randomized trials ( Lampertico et al, 2020 ; Agarwal et al, 2018 ). Recently, three retrospective studies in patients with CHB showed similar findings at 12 to 18 months after switching to TAF, but one study showed that the change was not significant at 6 months after switching to TAF ( Toyoda et al, 2021 ; Bernstein et al, 2021 ; Farag et al, 2021 ; Alghamdi et al, 2020 ). Our study showed that the decrease in ALT level persisted after switching to TAF, but the ALT normalization rate was similar at the time of switching and 48 weeks after switching.…”

Section: Discussionmentioning

confidence: 99%

“…TAF is a prodrug of tenofovir (TFV) that has less renal toxicity than TDF. The renal function of patients stabilized at 48 weeks after switching to TAF in a randomized trial and four retrospective studies ( Lampertico et al, 2020 ; Toyoda et al, 2021 ; Bernstein et al, 2021 ; Farag et al, 2021 ; Alghamdi et al, 2020 ). The renal outcome was similar in our study in that the median eGFR decreased during TDF therapy (100.09 vs 91.97 mL/min/1.73 m²) and stabilized at 48 weeks after switching to TAF (93.47 mL/min/1.73 m²).…”

Section: Discussionmentioning

confidence: 99%

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

Hsu

et al. 2021

PeerJ

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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.

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Tenofovir alafenamide is associated with improved alanine aminotransferase and renal safety compared to tenofovir disoproxil fumarate

Liang

Yip

Lai

et al. 2022

Journal of Medical Virology

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Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir for the treatment of chronic hepatitis B (CHB) infection. We aimed to evaluate the impact of switching to TAF on alanine aminotransferase (ALT) normalization and renal safety. We also described the indications of switching to TAF. Consecutive adult CHB patients switched from tenofovir disoproxil fumarate (TDF) dominant therapy to TAF for more than 12 months were identified retrospectively. A subgroup of patients newly switched to TAF was prospectively invited to perform transient elastography examination and dual-energy X-ray absorptiometry. The time of switching to TAF was defined as baseline. Among 393 patients in the retrospective cohort, the median ALT at month 12 was significantly lower (21.0 [16.0-29.9] U/L vs. 25.0 [19.0-34.0] U/L; p < 0.001) and ALT normalization rate was higher (89.9% vs. 83.7%; p = 0.037) than those at baseline. Estimated glomerular filtration rate decreased from 12 months before baseline and then increased from baseline to month 12 significantly (69.7 ± 22.0 ml/ min/1.73 m 2 vs. 68.5 ± 21.5 ml/min/1.73 m 2 vs. 69.2 ± 21.5 ml/min/1.73 m 2 , p = 0.002 (−12 m vs. baseline), p = 0.004 (baseline vs. 12 m)). In the prospective cohort, 103 patients switched to TAF because of age > 60 years (63.1%), bone diseases (54.4%), and renal alteration (42.7%). TAF is associated with ALT improvement and better renal safety than TDF dominant therapy in CHB patients. Most CHB patients switched to TAF because of advanced age, followed by bone disease and renal alteration.

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Effectiveness and Renal Safety of Tenofovir Alafenamide Fumarate among Chronic Hepatitis B Patients: Real‐World Study

Cited by 18 publications

References 26 publications

Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

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

Tenofovir alafenamide is associated with improved alanine aminotransferase and renal safety compared to tenofovir disoproxil fumarate

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