Arai Taeang, Atsukawa Masanori, Tsubota Akihito, Ikegami Tadashi, Shimada Noritomo, Kato Keizo, Abe Hiroshi, Okubo Tomomi, Itokawa Norio, Kondo Chisa, Mikami Shigeru, Asano Toru, Chuganji Yoshimichi, Matsuzaki Yasushi, Toyoda Hidenori, Kumada Takashi, Iio Etsuko, Tanaka Yasuhito, Iwakiri Katsuhiko
Department of Internal Medicine, Division of Gastroenterology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.
Hepatol Res. 2018 Jun;48(7):549-555. doi: 10.1111/hepr.13058. Epub 2018 Feb 21.
The aim of this study was to clarify the effects and safety of ombitasvir/paritaprevir/ritonavir (OBT/PTV/r) therapy in genotype 1b chronic hepatitis C patients with non-dialysis chronic kidney disease (CKD).
This retrospective, multicenter study of 12-week OBT/PTV/r therapy included genotype 1b patients with non-dialysis CKD. Chronic kidney disease was defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m . Virologic responses and treatment-emergent adverse events (TEAEs) in patients with CKD were compared with those in patients without CKD.
Two hundred and thirty-five patients with a median age of 67 years (range, 27-89 years) were enrolled, consisting of 181 patients without CKD and 54 patients with CKD. Overall, the rates of rapid virologic response (RVR), end of treatment response (ETR), and sustained virologic response (SVR) were 78.7%, 98.7%, and 98.7%, respectively. Among the 181 non-CKD patients, the rates were 77.3% (140/181), 98.9% (179/181), and 98.9% (179/181), respectively. Among the 54 CKD patients, the rates were 83.3% (45/54), 98.1% (53/54), and 98.1% (53/54), respectively. There were no significant differences in the virologic response rates between the two groups (P = 0.449 for RVR, 0.545 for ETR, and 0.545 for SVR). In the CKD group, the eGFR level did not significantly change throughout the treatment period. There was no significant difference in the incidence of TEAEs or treatment discontinuation due to TEAEs between the two groups.
The present study showed that the effects and safety of OBV/PTV/r therapy in genotype 1b chronic hepatitis C patients with non-dialysis CKD were not inferior to those in patients without CKD.
本研究旨在阐明奥比他韦/帕利哌韦/利托那韦（OBT/PTV/r）疗法对1b型慢性丙型肝炎合并非透析慢性肾脏病（CKD）患者的疗效及安全性。
这项关于OBT/PTV/r 12周疗法的回顾性多中心研究纳入了1b型非透析CKD患者。慢性肾脏病定义为估算肾小球滤过率（eGFR）<60 mL/min/1.73 m²。将CKD患者的病毒学应答和治疗期间出现的不良事件（TEAE）与非CKD患者进行比较。
共纳入235例患者，中位年龄67岁（范围27 - 89岁），其中181例非CKD患者，54例CKD患者。总体而言，快速病毒学应答（RVR）、治疗结束时应答（ETR）和持续病毒学应答（SVR）率分别为78.7%、98.7%和98.7%。181例非CKD患者中，上述比率分别为77.3%（140/181）、98.9%（179/181）和98.9%（179/181）。54例CKD患者中，上述比率分别为83.3%（45/54）、98.1%（53/54）和98.1%（53/54）。两组间病毒学应答率无显著差异（RVR的P = 0.449，ETR的P = 0.545，SVR的P = 0.545）。在CKD组，整个治疗期间eGFR水平无显著变化。两组间TEAE的发生率或因TEAE导致的治疗中断情况无显著差异。
本研究表明，OBV/PTV/r疗法对1b型慢性丙型肝炎合并非透析CKD患者的疗效及安全性不低于非CKD患者。
