Norio Itokawa1, Masanori Atsukawa1,2, Akihito Tsubota3, Koichi Takaguchi4, Makoto Nakamuta5, Atsushi Hiraoka6, Keizo Kato7, Hiroshi Abe7, Shigeru Mikami8, Noritomo Shimada9, Makoto Chuma10, Nozaki Akito10, Haruki Uojima11, Chikara Ogawa12, Toru Asano13, Joji Tani14, Asahiro Morishita14, Tomonori Senoh4, Naoki Yamashita5, Tsunekazu Oikawa15, Yoshihiro Matsumoto16, Mai Koeda1, Yuji Yoshida1, Tomohide Tanabe2, Tomomi Okubo1, Taeang Arai2, Korenobu Hayama2, Ai-Nakagawa Iwashita2, Chisa Kondo2, Toshifumi Tada17, Hidenori Toyoda17, Takashi Kumada18, Katsuhiko Iwakiri2. 1. Department of Internal Medicine, Division of Gastroenterology Nippon Medical School Chiba Hokusoh Hospital Chiba Japan. 2. Department of Internal Medicine, Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan. 3. Core Research Facilities The Jikei University School of Medicine Tokyo Japan. 4. Department of Hepatology Kagawa Prefectural Central Hospital Takamatsu Japan. 5. Department of Gastroenterology National Hospital Organization Kyushu Medical Center Fukuoka Japan. 6. Gastroenterology Center Ehime Prefectural Central Hospital Matsuyama Japan. 7. Division of Gastroenterology and Hepatology Shinmatusdo Central General Hospital Matsudo Japan. 8. Department of Internal Medicine, Division of Gastroenterology Kikkoman General Hospital Noda Japan. 9. Department of Internal Medicine, Division of Gastroenterology and Hepatology Otakanomori Hospital Chiba Japan. 10. Gastroenterological Center Yokohama City University Medical Center Yokohama Japan. 11. Department of Gastroenterology Kitasato University School of Medicine Kanagawa Japan. 12. Department of Gastroenterology and Hepatology Takamatsu Red Cross Hospital Takamatsu Japan. 13. Department of Internal Medicine, Division of Gastroenterology and Hepatology Tokyo Metropolitan Bokutoh Hospital Tokyo Japan. 14. Department of Gastroenterology Kagawa University Graduate School of Medicine Kagawa Japan. 15. Department of Gastroenterology and Hepatology The Jikei University School of Medicine Tokyo Japan. 16. Department of Gastroenterology and Hepatology Jikei University School of Medicine Kashiwa Hospital Chiba Japan. 17. Department of Gastroenterology Ogaki Municipal Hospital Gifu Japan. 18. Department of Nursing Ogaki Women's College Gifu Japan.
Abstract
BACKGROUND AND AIM: Although tenofovir alafenamide (TAF), as well as entecavir (ETV), is widely used as first-line treatment for patients with chronic hepatitis B, there are only a few studies comparing sequential therapy from ETV to TAF and continuous ETV monotherapy in patients with maintained virologic response to ETV. METHODS: In a retrospective multicenter study, we investigated the efficacy and safety of sequential therapy from ETV to TAF (ETV-TAF group) and compared them with continuous ETV monotherapy (ETV group), using propensity score matching, in chronic hepatitis B patients. RESULTS: From 442 patients, we analyzed 142 patients from each group comprising 71 patients matched for several data, including age, HBV genotype, hepatitis B envelope antigen, cirrhosis, alanine aminotransferase, platelet count, prior ETV monotherapy period, and hepatitis B surface antigen (HBsAg) change during prior ETV monotherapy. In the ETV-TAF group, HBsAg levels significantly decreased from baseline to 48 weeks after switching to TAF (-0.02 log IU/mL, P = 0.038). HBcrAg levels also significantly decreased after switching to TAF (-0.1 log IU/mL, P = 0.004). However, there were no significant differences in the reduction of HBsAg and HBcrAg levels between the ETV-TAF and ETV groups. There was no significant difference in the change of estimated glomerular filtration rate levels from baseline to 48 weeks between the two groups. CONCLUSIONS: The present study indicated that the efficacy, especially of the HBsAg-reducing action, and safety of sequential therapy from ETV to TAF were similar to those of continuous ETV monotherapy among chronic hepatitis B patients with maintained virologic response to ETV.
BACKGROUND AND AIM: Although tenofovir alafenamide (TAF), as well as entecavir (ETV), is widely used as first-line treatment for patients with chronic hepatitis B, there are only a few studies comparing sequential therapy from ETV to TAF and continuous ETV monotherapy in patients with maintained virologic response to ETV. METHODS: In a retrospective multicenter study, we investigated the efficacy and safety of sequential therapy from ETV to TAF (ETV-TAF group) and compared them with continuous ETV monotherapy (ETV group), using propensity score matching, in chronic hepatitis B patients. RESULTS: From 442 patients, we analyzed 142 patients from each group comprising 71 patients matched for several data, including age, HBV genotype, hepatitis B envelope antigen, cirrhosis, alanine aminotransferase, platelet count, prior ETV monotherapy period, and hepatitis B surface antigen (HBsAg) change during prior ETV monotherapy. In the ETV-TAF group, HBsAg levels significantly decreased from baseline to 48 weeks after switching to TAF (-0.02 log IU/mL, P = 0.038). HBcrAg levels also significantly decreased after switching to TAF (-0.1 log IU/mL, P = 0.004). However, there were no significant differences in the reduction of HBsAg and HBcrAg levels between the ETV-TAF and ETV groups. There was no significant difference in the change of estimated glomerular filtration rate levels from baseline to 48 weeks between the two groups. CONCLUSIONS: The present study indicated that the efficacy, especially of the HBsAg-reducing action, and safety of sequential therapy from ETV to TAF were similar to those of continuous ETV monotherapy among chronic hepatitis B patients with maintained virologic response to ETV.
Authors: Jing-He Yan; Marc Bifano; Steven Olsen; Robert A Smith; Duxi Zhang; Dennis M Grasela; Frank LaCreta Journal: J Clin Pharmacol Date: 2006-11 Impact factor: 3.126