Chisa Kondo1, Masanori Atsukawa1, Akihito Tsubota2, Noritomo Shimada3, Hiroshi Abe4, Toru Asano5, Kai Yoshizawa6, Tomomi Okubo1, Yoshimichi Chuganji5, Yoshio Aizawa7, Etsuko Iio8, Yasuhito Tanaka8, Katsuhiko Iwakiri9. 1. Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan. 2. Core Research Facilities for Basic Science, Jikei University School of Medicine, Nishi-Shimbashi, Minato-ku, Tokyo, Japan. 3. Division of Gastroenterology and Hepatology, Otakanomori Hospital, Toyosiki, Kashiwa, Chiba, Japan. 4. Division of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Shinmatsudo, Matsudo, Chiba, Japan. 5. Tokyo Metropolitan Bokutoh Hospital, Koutoubashi, Sumida, Tokyo, Japan. 6. Machida Municipal Hospital, Asahi-cho, Machida, Tokyo, Japan. 7. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Jikei University School of Medicine Katsushika Medical Center, Aoto, Katsushika-ku, Tokyo, Japan. 8. Department of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Kawasumi, Mizuho, Aichi, Nagoya, Japan. 9. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Sendagi, Bunkyo-ku, Tokyo, Japan.
Abstract
AIM: To evaluate the efficacy and safety of daclatasvir and asunaprevir combined therapy in genotype 1b chronic hepatitis C patients with non-dialysis chronic kidney disease (CKD). METHODS: In a multicenter collaborative study, 249 patients received 60 mg daclatasvir (NS5A inhibitor) once a day and 100 mg of asunaprevir (NS3/4A protease inhibitor) twice a day for 24 weeks between September 2014 and September 2015 and were subjected to this analysis. Virological response and adverse events in non-dialysis patients with CKD (stage 3-5, excluding 5D: dialysis), which was defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 , were compared with those in patients without CKD. RESULTS: Overall, the rates of rapid viral response, end-of-treatment response, and sustained virological response (SVR) were 76.7%, 91.2%, and 86.3%, respectively. Among 55 patients with CKD, the rapid viral response, end-of-treatment response, and SVR rates were 76.4%, 87.3%, and 83.6%, respectively. Among 194 patients without CKD, they were 76.8, 92.3, and 87.1%, respectively. There were no significant differences in the virological response rates between the two groups (P = 0.999, 0.282, and 0.509, respectively). The baseline estimated glomerular filtration rate did not affect the achievement of SVR. The incidence of adverse events in patients with and without CKD were 21.8% and 13.9%, respectively (not significant, P = 0.142). CONCLUSION: The efficacy and safety of daclatasvir and asunaprevir combined therapy in genotype 1b chronic hepatitis C patients with non-dialysis CKD are not inferior to those in patients without CKD.
AIM: To evaluate the efficacy and safety of daclatasvir and asunaprevir combined therapy in genotype 1b chronic hepatitis C patients with non-dialysis chronic kidney disease (CKD). METHODS: In a multicenter collaborative study, 249 patients received 60 mg daclatasvir (NS5A inhibitor) once a day and 100 mg of asunaprevir (NS3/4A protease inhibitor) twice a day for 24 weeks between September 2014 and September 2015 and were subjected to this analysis. Virological response and adverse events in non-dialysis patients with CKD (stage 3-5, excluding 5D: dialysis), which was defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 , were compared with those in patients without CKD. RESULTS: Overall, the rates of rapid viral response, end-of-treatment response, and sustained virological response (SVR) were 76.7%, 91.2%, and 86.3%, respectively. Among 55 patients with CKD, the rapid viral response, end-of-treatment response, and SVR rates were 76.4%, 87.3%, and 83.6%, respectively. Among 194 patients without CKD, they were 76.8, 92.3, and 87.1%, respectively. There were no significant differences in the virological response rates between the two groups (P = 0.999, 0.282, and 0.509, respectively). The baseline estimated glomerular filtration rate did not affect the achievement of SVR. The incidence of adverse events in patients with and without CKD were 21.8% and 13.9%, respectively (not significant, P = 0.142). CONCLUSION: The efficacy and safety of daclatasvir and asunaprevir combined therapy in genotype 1b chronic hepatitis C patients with non-dialysis CKD are not inferior to those in patients without CKD.