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  • IDDF2019-ABS-0168 Bone and renal safety are improved in chronic hbv patients 1 year after switching to tenofovir alafenamide (TAF) from tenofovir disoproxil fumarate (TDF)

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Clinical Hepatology
IDDF2019-ABS-0168 Bone and renal safety are improved in chronic hbv patients 1 year after switching to tenofovir alafenamide (TAF) from tenofovir disoproxil fumarate (TDF)
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  1. Henry Lik Yuen Chan1,
  2. Wai Kay Seto2,
  3. Maria Buti3,
  4. Namiki Izumi4,
  5. Young-Suk Lim5,
  6. Jia-Horng Kao6,
  7. Adrian Streinu-Cercel7,
  8. Elena Nurmukhametova8,
  9. Xiaoli Ma9,
  10. Fehmi Tabak10,
  11. Maciej Jablkowski11,
  12. Vithika Suri12,
  13. John Flaherty12,
  14. Audrey Lau12,
  15. Anuj Gaggar12,
  16. Shuyuan Mo12,
  17. Abhijit Chowdhury13,
  18. Scott Fung14,
  19. Wan-Long Chuang15,
  20. Edward Gane16
  1. 1Institute of Digestive Disease, State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong
  2. 2Queen Mary Hospital, Hong Kong
  3. 3Vall d’Hebron Barcelona Campus Hospitalari, Barcelona, Spain
  4. 4Japanese Red Cross Musashino Hospital, Tokyo, Japan
  5. 5Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, South
  6. 6Graduate Institute of Clinical Medicine, National Taiwan University Hospital, Taipei, Taiwan
  7. 7Institutul National de Boli Infectioase ‘Prof.Dr. Matei Bals,’ Bucharest, Romania
  8. 8Infectious Clinical Hospital #1 of Moscow Healthcare Department, Russia
  9. 9PC, Bryn Mawr, PA, USA
  10. 10Istanbul Üniversitesi Cerrahpaşa Tıp Fakültesi Hastanesi, Istanbul, Turkey
  11. 11Oddzial Obserwacyjno-Zakazny, Poland
  12. 12Gilead Sciences, Inc., Foster City, CA, USA
  13. 13School of Digestive and Liver Diseases, Institute of Post Graduate Medical Education and Research, Kolkata, India
  14. 14University of Toronto, Ontario, Canada
  15. 15Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan
  16. 16Auckland Clinical Studies, Auckland, New Zealand

Abstract

Background TAF has shown efficacy non-inferior to that of TDF at Week 96 with less bone and renal effects. Following implementation of a protocol amendment to extend double-blind (DB) treatment for an additional year, 50% of patients were able to continue on DB treatment while the remainder had already rolled-over to open-label (OL) TAF at Week 96. Here we compared the efficacy and safety from Week 96 to 144 in patients randomized to TDF in whom treatment was either continued or switched to TAF at Week 96.

Methods In 2 identically-designed studies, 1298 HBeAg-negative and HBeAg-positive CHB patients (873 TAF, 425 TDF) were randomized and treated. In the TDF group, 211 remained on TDF (DB TDF) while 180 patients were switched to OL TAF (TDF→TAF) at Week 96. Safety assessments including changes in bone (hip and spine BMD) and renal (CrCl by Cockcroft-Gault [eGFRCG], serum creatinine) parameters, viral suppression, and biochemical responses were assessed in all patients from Week 96 to Week 144.

Results Patient characteristics were similar for those who continued TDF and those switched to TAF. In the TDF→TAF group, improvements in eGFRCG were observed, while those remaining on DB TDF showed a continued decrease in eGFRCG at Week 144 (table 1). Similarly, significant improvements in hip and spine BMD were seen over 1 year in TDF→TAF patients while those remaining on TDF either had continued BMD declines or smaller increases (figure 1). High rates of virologic suppression (HBV DNA <29 IU/mL) were maintained in both groups (TDF→TAF 84% and DB TDF 88%; M=F), while a greater rate of ALT normalization (by 2018 AASLD criteria) was seen in TDF→TAF patients at 1 year following switch (45% vs 29%; M=F).

View this table:
Abstract IDDF2019-ABS-0168 Table 1

Efficacy and safety renal and bone results from week 96 to week 144

Abstract IDDF2019-ABS-0168 Figure 1
Abstract IDDF2019-ABS-0168 Figure 1

Conclusions Virologic control was maintained and ALT normalization was increased following switch from TDF to TAF. However, compared to those remaining on TDF for an additional year, patients switched to TAF had improved bone and renal safety.

https://doi.org/10.1136/gutjnl-2019-IDDFAbstracts.277

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