Eiichi Ogawa1, Makoto Nakamuta2, Toshimasa Koyanagi3, Aritsune Ooho4, Norihiro Furusyo5, Eiji Kajiwara6, Kazufumi Dohmen7, Akira Kawano8, Takeaki Satoh9, Kazuhiro Takahashi10, Koichi Azuma11, Nobuyuki Yamashita12, Naoki Yamashita2, Rie Sugimoto13, Hiromasa Amagase14, Masami Kuniyoshi15, Yasunori Ichiki16, Chie Morita17, Masaki Kato18,19, Shinji Shimoda20, Hideyuki Nomura21, Jun Hayashi22. 1. Department of General Internal Medicine, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan. e.ogawa.a65@m.kyushu-u.ac.jp. 2. Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization, Fukuoka, Japan. 3. Department of Medicine, Fukuoka City Hospital, Fukuoka, Japan. 4. Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu, Japan. 5. General Internal Medicine, Taihaku Avenue Clinic, Fukuoka, Japan. 6. Kajiwara Clinic, Kitakyushu, Japan. 7. Department of Internal Medicine, Chihaya Hospital, Fukuoka, Japan. 8. Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. 9. Center for Liver Disease, Kokura Medical Center, National Hospital Organization, Kitakyushu, Japan. 10. Department of Medicine, Hamanomachi Hospital, Fukuoka, Japan. 11. Department of Medicine, Kyushu Central Hospital, Fukuoka, Japan. 12. The Center for Liver Disease, Shin-Kokura Hospital, Kitakyushu, Japan. 13. Department of Gastroenterology, Kyushu Cancer Center, Fukuoka, Japan. 14. Amagase Clinic, Kitakyushu, Japan. 15. Department of Gastroenterology, Kyushu Rosai Hospital, Kitakyushu, Japan. 16. Department of Internal Medicine, JCHO Kyushu Hospital, Kitakyushu, Japan. 17. Department of Internal Medicine, Kyushu Railway Memorial Hospital, Kitakyushu, Japan. 18. Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 19. Graduate School of Nutritional Sciences, Nakamura Gakuen University, Fukuoka, Japan. 20. Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 21. Department of Internal Medicine, Haradoi Hospital, Fukuoka, Japan. 22. Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan.
Abstract
BACKGROUND AND AIMS: Outcome data of sequential hepatitis B virus treatment with tenofovir alafenamide (TAF) are limited. We aimed to assess the effectiveness and renal safety of TAF in chronic hepatitis B (CHB) patients who were previously treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), or a nucleos(t)ide analogue (NA) combination. METHODS: This multicenter, retrospective, cohort study included 458 consecutive CHB patients who switched to TAF monotherapy after at least 2 years of treatment with another NA. The longitudinal virological/laboratory responses were evaluated up to 96 weeks after switchover. Chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2. RESULTS: The proportions of complete viral suppression (CVS) (HBV DNA < 20 IU/mL) at week 96 were 99.0%, 98.5%, and 98.4% in the prior ETV (n = 198), TDF (n = 137), and NA combination (n = 123) groups, respectively. Almost all patients with HBV DNA of 20-2000 IU/mL at baseline achieved CVS at week 96. On multivariable generalized estimated equation analysis, a low quantitative hepatitis surface antigen (qHBsAg) level at baseline was associated with a lower follow-up qHBsAg level (coefficient 0.81, p < 0.001). The eGFR showed greater improvement in patients with CKD compared to those without (coefficient 21.7, p < 0.001). However, the increase of eGFR reached a peak between weeks 24 and 48. CONCLUSIONS: Based on this longitudinal data analysis up to 96 weeks, sequential NA therapy with a switch to TAF is a good option to achieve high viral suppression and renal safety.
BACKGROUND AND AIMS: Outcome data of sequential hepatitis B virus treatment with tenofovir alafenamide (TAF) are limited. We aimed to assess the effectiveness and renal safety of TAF in chronic hepatitis B (CHB) patients who were previously treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), or a nucleos(t)ide analogue (NA) combination. METHODS: This multicenter, retrospective, cohort study included 458 consecutive CHB patients who switched to TAF monotherapy after at least 2 years of treatment with another NA. The longitudinal virological/laboratory responses were evaluated up to 96 weeks after switchover. Chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2. RESULTS: The proportions of complete viral suppression (CVS) (HBV DNA < 20 IU/mL) at week 96 were 99.0%, 98.5%, and 98.4% in the prior ETV (n = 198), TDF (n = 137), and NA combination (n = 123) groups, respectively. Almost all patients with HBV DNA of 20-2000 IU/mL at baseline achieved CVS at week 96. On multivariable generalized estimated equation analysis, a low quantitative hepatitis surface antigen (qHBsAg) level at baseline was associated with a lower follow-up qHBsAg level (coefficient 0.81, p < 0.001). The eGFR showed greater improvement in patients with CKD compared to those without (coefficient 21.7, p < 0.001). However, the increase of eGFR reached a peak between weeks 24 and 48. CONCLUSIONS: Based on this longitudinal data analysis up to 96 weeks, sequential NA therapy with a switch to TAF is a good option to achieve high viral suppression and renal safety.