A phase 3 study comparing tenofovir alafenamide (TAF) to tenofovir disoproxil fumarate (TDF) in patients with HBeAg-positive, chronic hepatitis B (CHB): efficacy and safety results at week 96

Agarwal, Kosh; Fung, Scott; Seto, Wai‐Kay; Lim, Young‐Suk; Gane, Ed; Janssen, H.L.; Sharma, Mithun; Chuang, Wan‐Long; Bae, Ho; Yoon, K.T.; Flaherty, J.F.; Lau, Audrey H.; Gaggar, Anuj; Suri, Vithika; Cathcart, A.; Lin, Lung–Huang; Subramanian, G. Mani; Shalimar, S.; Furusyo, Norihiro; Buti, Marı́a; Chan, Henry Lik‐Yuen

doi:10.1016/s0168-8278(17)31347-8

Cited by 21 publications

(27 citation statements)

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“…In patients with HBeAg-positive CHB, the rates of virologic response on TAF were 64% at week 48 and 75% at week 96 74,75 HBeAg loss and anti-HBe seroconversion were achieved in 14% and 10% of patients at week 48 and 22% and 18% at week 96, respectively. In the same study, ALT normalisation rates at week 96 by traditional values were higher in patients treated with TAF than TDF (75% vs. 68%), whereas only 1% of patients cleared HBsAg.…”

Section: Hbsagmentioning

confidence: 97%

“…In the same study, ALT normalisation rates at week 96 by traditional values were higher in patients treated with TAF than TDF (75% vs. 68%), whereas only 1% of patients cleared HBsAg. [74][75][76] In HBeAg-negative CHB patients, TAF achieved virologic response in 94% of patients at week 48, 76 which was maintained in most cases at week 96 (90%). Only one TAF treated HBeAg-negative CHB patient (\1%) cleared HBsAg by week 96.…”

Section: Hbsagmentioning

confidence: 99%

“…[74][75][76][77]88 In both groups of patients there was a significant difference in markers reflecting renal and bone function at week 48. A significant difference was noted in decrease of eGFR in both studies: À0.6 ml/min vs. À5.…”

Section: Monitoring Of Patients Treated With Etv Tdf or Taf Recommenmentioning

confidence: 99%

See 2 more Smart Citations

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,207

3,081

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Section: Hbsagmentioning

confidence: 97%

Section: Hbsagmentioning

confidence: 99%

See 1 more Smart Citation

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Lampertico¹,

Agarwal²,

Berg³

et al. 2017

Journal of Hepatology

4,207

3,081

View full text Add to dashboard Cite

“…7 With the similarly potent viral suppression, 32 TAF was shown to have better renal and bone safety profile compared to TDF. 3,4 At week 96 of two Phase three studies of total 1298 patients, TAF-treated patients had smaller declines in eGFR (À2.4 mL/min) than TDF-treated patients (À6.7 mL/min; P = 0.008).…”

Section: 24mentioning

confidence: 99%

“…33 Fewer TAF recipients experienced a decline in eGFR >25% (10% vs 18%; P = 0.002) or had a confirmed eGFR of <50 mL/min (0% vs 2%; P = 0.004). 32 Patients on TDF at risk of development and/or with underlying renal (as well as bone) disease should be considered for a switch to ETV or TAF, depending on previous lamivudine exposure. 7 …”

Section: 24mentioning

confidence: 99%

Review article: long‐term safety of oral anti‐viral treatment for chronic hepatitis B

Wong

Seto

Wong

et al. 2018

Aliment Pharmacol Ther

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SummaryBackgroundSafety profile of nucleos(t)ide analogues is an important issue in view of its widespread use for decades in patients with chronic hepatitis B (CHB).AimTo review and evaluate the latest evidence on the safety profiles of the six approved nucleoside analogues.MethodsRelevant articles related to nucleoside analogue safety were selected for review following extensive language‐ and date‐unrestricted, electronic searches of the literature.ResultsNephrotoxicity has been well reported in patients receiving older generations of nucleotide analogues, namely adefovir dipivoxil and tenofovir disoproxil fumarate (TDF). Yet risks of renal failure and renal replacement therapy were similar in patients treated with nucleoside analogues versus nucleotide analogues in real‐life setting. Bone toxicity is closely related to nucleoside analogue effect on renal proximal tubular and phosphaturia. Real‐life data demonstrated increased risk of hip fracture in patients receiving adefovir but not TDF. The newly approved tenofovir alafenamide (TAF) has improved renal and bone safety profiles compared to TDF. Long‐term use of nucleoside analogues eg entecavir does not increase the risk of other cancers. Muscular toxicity may be seen in telbivudine‐treated patients so regular monitoring is advised. Peripheral neuropathy and lactic acidosis are rare adverse events. Latest international guidelines support the use of TDF, telbivudine and lamivudine during pregnancy; breastfeeding is not contraindicated during TDF therapy.ConclusionsLong‐term safety profile of nucleoside analogues is now better defined with more data from large real‐life cohorts and clinical trials with long‐term follow‐up. The new nucleotide analogue, TAF is now available with favourable renal and bone safety profiles.

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Update on prevention, diagnosis, and treatment of chronic hepatitis B

et al. 2018

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A phase 3 study comparing tenofovir alafenamide (TAF) to tenofovir disoproxil fumarate (TDF) in patients with HBeAg-positive, chronic hepatitis B (CHB): efficacy and safety results at week 96

Cited by 21 publications

References 0 publications

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection

Review article: long‐term safety of oral anti‐viral treatment for chronic hepatitis B

Update on prevention, diagnosis, and treatment of chronic hepatitis B

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