Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C

• Published in: Journal of gastroenterology Vol. 51; no. 7; pp. 733 - 740
• Main Authors: Suda, Goki, Kudo, Mineo, Nagasaka, Atsushi, Furuya, Ken, Yamamoto, Yoshiya, Kobayashi, Tomoe, Shinada, Keisuke, Tateyama, Miki, Konno, Jun, Tsukuda, Yoko, Yamasaki, Kazushi, Kimura, Megumi, Umemura, Machiko, Izumi, Takaaki, Tsunematsu, Seiji, Sato, Fumiyuki, Terashita, Katsumi, Nakai, Masato, Horimoto, Hiromasa, Sho, Takuya, Natsuizaka, Mitsuteru, Morikawa, Kenichi, Ogawa, Koji, Sakamoto, Naoya
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-07-2016; Springer; Springer Nature B.V
• Subjects: Abdominal Surgery; Aged; Antiviral Agents - therapeutic use; Biliary Tract; Care and treatment; Colorectal Surgery; Drug Therapy, Combination; Female; Gastroenterology; Health aspects; Hemodialysis; Hepatitis C; Hepatitis C virus; Hepatitis C, Chronic - complications; Hepatitis C, Chronic - drug therapy; Hepatology; Humans; Imidazoles - therapeutic use; Infection; Infection control; Isoquinolines - therapeutic use; Kidneys; Liver; Liver cirrhosis; Male; Medical colleges; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Middle Aged; Original Article—Liver; Pancreas; Prognosis; Prospective Studies; Proteases; Renal Dialysis; Renal Insufficiency - complications; Renal Insufficiency - therapy; Sulfonamides - therapeutic use; Surgical Oncology; Transplantation; Daclatasvir; HCV; Asunaprevir; Hemodialysis
• ISSN: 0944-1174; 1435-5922
• DOI: 10.1007/s00535-016-1162-8

Background
HCV infection in chronic hemodialysis patients is high, has a poor prognosis and high risk of renal graft failure, and requires nosocomial infection control measures. However, options of anti-HCV therapy in such patients are limited and unsatisfactory. In this study, we report effectiveness and safety of HCV-NS5A-inhibitor daclatasvir (DCV) and protease-inhibitor asunaprevir (ASV) combination therapy for hemodialysis patients with HCV infection.
Methods
This study was registered at the UMIN Clinical Trials Registry as UMIN000016355. Thirty-four dialysis patients were treated with DCV/ASV combination therapy between January 2015 and November 2015. Of those, 21 patients who were followed more than 12 weeks after treatment ended were included. We evaluated the 12-week sustained virologic response (SVR12) and adverse events during treatment.
Results
Of the 21 patients, four had compensated liver cirrhosis and three had resistance-associated variant of NS5A (NS5A RAVs)-Y93H at baseline. Overall, total of 95.5 % (20/21) of the patients achieved SVR12. Of note, all patients with cirrhosis or NS5A RAVs achieved SVR12. One relapser patient at 4 weeks post-treatment had NS3 D168E RAVs at baseline. A total of 20 patients (95.5 %) completed the 24-week therapy. One patient discontinued treatment at week 12 due to ALT elevations and achieved SVR12.
Conclusions
DAV and ASV combination therapy for chronic hemodialysis patients with HCV infection was highly effective and well tolerated, even in elderly patients and patients with liver cirrhosis and NS5A-RAVs.