Safety and efficacy of switching to tenofovir alafenamide (TAF) in virally suppressed chronic hepatitis B (CHB) patients with renal impairment: week 48 results from a phase 2 open label study

Janssen, Harry L.A.; Lampertico, Pietro; Chen, Chi-Yi; Heo, Jeong; Fournier, Claire; Ahn, Sang Hoon; Tsang, Tak Yin Owen; Coffin, Carla S.; Reggiani, Giulio Marchesini; Huang, Yi Hsiang; Hui, Aric Josun; Elkhashab, Magdy; Chen, Chien‐Hung; Jafri, Syed Mohammed Raza; Mo, Shuyuan; Suri, Vithika; Flaherty, John F.; Gaggar, Anuj; Subramanian, Mani; Agarwal, Kosh; Chuang, Wan‐Long; Gane, Edward; Lim, Young‐Suk

doi:10.1016/s0168-8278(20)32176-0

Cited by 2 publications

(20 citation statements)

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“…93 Recently released phase II study results of week 48, after switching from TDF to TAF in patients with advance kidney disease and hemodialysis, showed stabilization of eGFR and markers of renal tubular function. 83 Similar results have been recently suggested after switching from ETV in patients with renal failure. A retrospective study of 313 patients treated with ETV or NA combination concluded that eGFR significantly improved after switching to TAF in patients with chronic kidney disease (adjusted slope coefficient difference: 2.75 ml/min per 1.73 m 2 per 48 weeks; p = 0.001).…”

Section: Not Reportedsupporting

confidence: 80%

“…81 Table 1 summarizes the safety and monitoring of CHB patients under the recommended NAs in special situations. [82][83][84][85][86][87][88] Kidney-related side effects Both TDF and ETV are metabolized through the kidney and must be adjusted in glomerular filtrate rates (GFRs) under 50 ml/min per 1.73 m 2 , while TAF is not approved in GFR below 15 ml/min per m 2 . However, TDF kidney toxicity mechanisms are not based on glomerular function but in tubular-cell damage caused by high intracellular TDF concentrations.…”

Section: Safetymentioning

confidence: 99%

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Long-term efficacy and safety of nucleos(t)ides analogues in patients with chronic hepatitis B

Roade

Riveiro‐Barciela

Esteban

et al. 2021

Therapeutic Advances in Infection

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Nucleos(t)ide analogues with high barrier to resistance are regarded as the principal therapeutic option for chronic hepatitis B (CHB). Treatment with entecavir (ETV), tenofovir disoproxil (TDF) and the later released tenofovir alafenamide (TAF) is highly effective at controlling hepatitis B virus (HBV) infection and, in the vast majority of patients, is well tolerated. No significant differences in viral suppression have been described among the different regimens, although an earlier achievement in biochemical response has been suggested first under TDF and recently under TAF. High barrier to resistance NAs rarely achieve hepatitis B surface antigen sero-clearance, and therefore should be maintained life-long in most cases. This has increased concerns about treatment-related toxicity, especially in patients under TDF with additional risk factors for kidney and bone impairment. TAF has shown a better bone and kidney safety profile than TDF, although it is not yet available worldwide due to its higher cost. Emergence of adverse events should be monitored since treatment-switch to ETV/TAF seems to be effective and safe in HBV mono-infected subjects. Finally, although an effective antiviral treatment leads to a clear improvement in clinical outcome of CHB patients; the risk of developing hepatocellular carcinoma (HCC) is not completely avoided with viral suppression. Whether tenofovir-based regimens provide any additional benefit over ETV in HCC prevention remains unclear and requires further investigation.

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Section: Not Reportedsupporting

confidence: 80%

Section: Safetymentioning

confidence: 99%

Long-term efficacy and safety of nucleos(t)ides analogues in patients with chronic hepatitis B

Roade

Riveiro‐Barciela

Esteban

et al. 2021

Therapeutic Advances in Infection

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“…However, it is necessary to acknowledge that ‘other NA’ populations represent a diverse group. Changes in lipids and renal and bone safety in patients with prior TDF were reported in some studies 63‐65,68,72 . One study included TDF‐treated patients with resistance to adefovir and/or ETV who continued on TDF or switched to TAF.…”

Section: Discussion and Clinical Implicationsmentioning

confidence: 99%

“…A cross‐sectional study performed in two European hospitals estimated that two‐thirds of patients who could benefit from switching to ETV or TAF based on EASL guideline criteria remained on TDF 76 . Several studies have evaluated TAF switching in special patient populations, such as those with CKD, hepatic impairment, liver fibrosis or transplantation 44,51,52,54,63‐65,70,71 . Pregnant women and children are also important patient populations to consider with respect to NA treatment.…”

Section: Discussion and Clinical Implicationsmentioning

confidence: 99%

“…Current data suggest that switching these patients to TAF may help avoid poor long‐term outcomes. Improvements or maintenance in virological outcomes upon switching from other NAs or combinations of NAs to TAF have been reported 59,60,63‐65,67‐71 . TDF and/or ETV were the most commonly reported prior NAs, but several studies included a high proportion of patients treated with other prior NAs 59,60,63‐65,69 .…”

Section: Discussion and Clinical Implicationsmentioning

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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Safety and efficacy of switching to tenofovir alafenamide (TAF) in virally suppressed chronic hepatitis B (CHB) patients with renal impairment: week 48 results from a phase 2 open label study

Cited by 2 publications

References 0 publications

Long-term efficacy and safety of nucleos(t)ides analogues in patients with chronic hepatitis B

Long-term efficacy and safety of nucleos(t)ides analogues in patients with chronic hepatitis B

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

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