Mindie H Nguyen1, Masanori Atsukawa2, Toru Ishikawa3, Satoshi Yasuda4, Keisuke Yokohama5, Huy N Trinh6, Taeang Arai2, Shinya Fukunishi7, Eiichi Ogawa8, Yao-Chun Hsu9, Mayumi Maeda1, Hansen Dang1, Cheng-Hao Tseng9, Hirokazu Takahashi10,11, Dae Won Jun12, Tsunamasa Watanabe13, Makoto Chuma14, Akito Nozaki14, Norifumi Kawada15, Ramsey Cheung1,16, Masaru Enomoto15, Koichi Takaguchi17, Hidenori Toyoda4. 1. Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, California, USA. 2. Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan. 3. Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan. 4. Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan. 5. 2nd Department of Internal Medicine, Osaka Medical College, Osaka, Japan. 6. San Jose Gastroenterology, San Jose, California, USA. 7. Premier Development Research of Medicine, Osaka Medical College, Osaka, Japan. 8. Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan. 9. Division of Gastroenterology and Hepatology, Department of Internal Medicine, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan. 10. Liver Center, Saga University Hospital, Saga, Japan. 11. Division of Metabolism and Endocrinology, Saga University, Faculty of Medicine, Saga, Japan. 12. Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, South Korea. 13. Division of Gastroenterology and Hepatology, St. Marianna University School of Medicine, Kawasaki, Japan. 14. Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan. 15. Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan. 16. Division of Gastroenterology & Hepatology, The Palo Alto Veterans Affairs Health Care System, Palo Alto, California, USA. 17. Department of Hepatology, Kagawa Prefectural Central Hospital, Kagawa, Japan.
Abstract
INTRODUCTION: Entecavir (ETV) and tenofovir alafenamide (TAF) are both first-line hepatitis B virus (HBV) therapies, but ETV-to-TAF switch outcome data are limited. We aimed to assess outcomes up to 96 weeks after ETV-to-TAF switch. METHODS: ETV-treated (≥12 months) chronic hepatitis B patients switched to TAF in routine practice at 15 centers (United States, Korea, Japan, and Taiwan) were included. Primary outcome was complete viral suppression (CVS) rate (HBV DNA <20 IU/mL). RESULTS: We analyzed 425 eligible patients (mean age 60.7 ± 13.2 years, 60% men, 90.8% Asian, 20.7% with diabetes, 27% with hypertension, 14.8% with cirrhosis, 8.3% with hepatocellular carcinoma, and mean ETV duration before switch 6.16 ± 3.17 years). The mean baseline estimated glomerular filtration rate (eGFR) was 89 ± 19 (chronic kidney disease [CKD] stages: 55.6% stage 1, 35.7% stage 2, and 8.8% stages 3-5). CVS rate increased from 91.90% at switch (from 90.46% 24 weeks before switch) to 95.57% and 97.21% at 48 and 96 weeks after (P = 0.03 and 0.02, respectively). Over the 96 weeks after switch, mean HBV DNA (P < 0.001) but not alanine aminotransferase or CKD stage decreased. Between switch and 96-week follow-up, 11% (26/235) of CKD stage 1 patients migrated to stage 2 and 8% (12/151) of stage 2 patients to stages 3-5, whereas 18% (27/151) from stage 2 to 1, and 19% (7/37) from stages 3-5 to 2. On multivariable generalized estimated equation analysis adjusted for age, sex, hypertension, diabetes, and cirrhosis, baseline eGFR, age (P < 0.001), and CKD stages 2 and 3-5 (vs 1) (both P < 0.001) were associated with lower follow-up eGFR. DISCUSSION: After an average of 6 years on ETV, CVS increased from 91.9% at TAF switch to 97.2% at 96 weeks later.
INTRODUCTION:Entecavir (ETV) and tenofovir alafenamide (TAF) are both first-line hepatitis B virus (HBV) therapies, but ETV-to-TAF switch outcome data are limited. We aimed to assess outcomes up to 96 weeks after ETV-to-TAF switch. METHODS:ETV-treated (≥12 months) chronic hepatitis Bpatients switched to TAF in routine practice at 15 centers (United States, Korea, Japan, and Taiwan) were included. Primary outcome was complete viral suppression (CVS) rate (HBV DNA <20 IU/mL). RESULTS: We analyzed 425 eligible patients (mean age 60.7 ± 13.2 years, 60% men, 90.8% Asian, 20.7% with diabetes, 27% with hypertension, 14.8% with cirrhosis, 8.3% with hepatocellular carcinoma, and mean ETV duration before switch 6.16 ± 3.17 years). The mean baseline estimated glomerular filtration rate (eGFR) was 89 ± 19 (chronic kidney disease [CKD] stages: 55.6% stage 1, 35.7% stage 2, and 8.8% stages 3-5). CVS rate increased from 91.90% at switch (from 90.46% 24 weeks before switch) to 95.57% and 97.21% at 48 and 96 weeks after (P = 0.03 and 0.02, respectively). Over the 96 weeks after switch, mean HBV DNA (P < 0.001) but not alanine aminotransferase or CKD stage decreased. Between switch and 96-week follow-up, 11% (26/235) of CKD stage 1 patients migrated to stage 2 and 8% (12/151) of stage 2 patients to stages 3-5, whereas 18% (27/151) from stage 2 to 1, and 19% (7/37) from stages 3-5 to 2. On multivariable generalized estimated equation analysis adjusted for age, sex, hypertension, diabetes, and cirrhosis, baseline eGFR, age (P < 0.001), and CKD stages 2 and 3-5 (vs 1) (both P < 0.001) were associated with lower follow-up eGFR. DISCUSSION: After an average of 6 years on ETV, CVS increased from 91.9% at TAF switch to 97.2% at 96 weeks later.