Brown Patrick R, Sadiq Omar, Weick Alexander, Lenhart Adrienne, Elbatta Mohammad, Fernandez Christopher, Kutait Anas, Pompa Robert, Jafri Syed-Mohammed
Department of Internal Medicine Henry Ford Hospital Detroit MI.
Department of Gastroenterology Henry Ford Hospital Detroit MI.
Hepatol Commun. 2018 Sep 24;2(10):1172-1178. doi: 10.1002/hep4.1243. eCollection 2018 Oct.
Ledipasvir-sofosbuvir, a once-a-day, oral combination pill, was approved in 2014 for the treatment of chronic hepatitis C infection. Initial trials did not comment on nephrotoxicity; however, recent data suggest a risk of acute kidney injury (AKI) with the use of the medication. We assessed the rates of AKI in patients undergoing ledipasvir-sofosbuvir in a large, urban tertiary care center. This single-center retrospective observation study included all patients undergoing therapy from October 1, 2014, to October 1, 2015. Rates of AKI, defined by more than a 0.3 mg/dL increase in serum creatinine level, were calculated. Patients were followed 12 weeks after therapy to assess for sustained viral response as well as to assess for improvement of AKI after completion of therapy, defined by less than 0.2 mg/dL above baseline serum creatinine. In total, 197 patients were included in the final analysis who had completed ledipasvir-sofosbuvir therapy and completed laboratory values. Among the patients treated, 38 (19%) had AKI during therapy. An additional 4 (2%) had AKI at the end of therapy. Of the 38 patients who experienced AKI, 20 (53%) had improvement in serum creatinine to less than 0.2 mg/dL above their baseline. When comparing for chronic kidney disease (CKD) stage, those with CKD I or II experienced AKI 17% of the time compared with 47% of the time in CKD III or worse ( = 0.005). AKI was seen in nearly one-fifth of our patients, and patients with CKD stage III or worse are at increased risk. Although ledipasvir-sofosbuvir is generally safe in the general population, close monitoring of renal function is recommended.
来迪派韦-索磷布韦是一种每日服用一次的口服复方药丸，于2014年被批准用于治疗慢性丙型肝炎感染。最初的试验未对肾毒性进行评论；然而，最近的数据表明使用该药物有急性肾损伤（AKI）的风险。我们在一家大型城市三级医疗中心评估了接受来迪派韦-索磷布韦治疗的患者的急性肾损伤发生率。这项单中心回顾性观察研究纳入了2014年10月1日至2015年10月1日期间所有接受治疗的患者。计算血清肌酐水平升高超过0.3mg/dL所定义的急性肾损伤发生率。治疗后对患者随访12周，以评估持续病毒学应答以及治疗完成后急性肾损伤的改善情况，改善定义为血清肌酐比基线水平升高小于0.2mg/dL。最终分析共纳入197例完成来迪派韦-索磷布韦治疗并完成实验室检查值的患者。在接受治疗的患者中，38例（19%）在治疗期间发生急性肾损伤。另外4例（2%）在治疗结束时发生急性肾损伤。在发生急性肾损伤的38例患者中，20例（53%）的血清肌酐改善至比基线水平升高小于0.2mg/dL。比较慢性肾脏病（CKD）分期时，CKD I或II期患者发生急性肾损伤的时间为17%，而CKD III期或更严重患者为47%（P = 0.005）。近五分之一的患者出现急性肾损伤，CKD III期或更严重的患者风险增加。虽然来迪派韦-索磷布韦在一般人群中通常是安全的，但建议密切监测肾功能。
