Sise Meghan E, Backman Elke S, Wenger Julia B, Wood Brian R, Sax Paul E, Chung Raymond T, Thadhani Ravi, Kim Arthur Y
Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Harvard University, Boston, MA, United States of America.
Department of Pharmacy, Massachusetts General Hospital, Harvard University, Boston, MA, United States of America.
PLoS One. 2015 Apr 29;10(4):e0124139. doi: 10.1371/journal.pone.0124139. eCollection 2015.
Recent reports suggest that telaprevir, a protease inhibitor used to treat hepatitis C infection, is associated with decline in kidney function during therapy, particularly in patients with baseline renal impairment.
Patients treated with telaprevir in a single healthcare network were retrospectively reviewed. Kidney function was determined at baseline, during therapy, and twelve weeks and twelve months after telaprevir discontinuation. Significant creatinine rise during therapy was defined as an increase in serum creatinine ≥ 0.3mg/dL from baseline during treatment with telaprevir.
Between July 2011 to January 2013,seventy-eight patients began treatment. The majority completed the prescribed twelve weeks of telaprevir therapy; 32% discontinued due to side effects. The average rise in serum creatinine during therapy was 0.22mg/dL (standard deviation 0.22mg/dL). Thirty-one percent experienced a significant creatinine rise during therapy. Decline in estimated glomerular filtration rate (eGFR) was lower in those with baseline eGFR < 90 mL/min/1.73m2 compared to the group with baseline eGFR ≥ 90 mL/min/1.73m2 (12 vs. 18 mL/min/1.73m2, P = 0.047). Serum creatinine fully normalized by twelve weeks after cessation of telaprevir in 83% of patients, however experiencing a significant creatinine rise during telaprevir use was associated with a 6.6mL/min/1.73m2 decrease in estimated glomerular filtration rate at twelve months in an adjusted model.
Decline in kidney function during therapy with telaprevir is common and is not associated with baseline eGFR < 90mL/min/1.73m2 as previously reported.
近期报告表明,用于治疗丙型肝炎感染的蛋白酶抑制剂特拉匹韦在治疗期间与肾功能下降有关,尤其是在基线肾功能损害的患者中。
对在单一医疗网络中接受特拉匹韦治疗的患者进行回顾性研究。在基线、治疗期间以及特拉匹韦停药后12周和12个月时测定肾功能。治疗期间血清肌酐显著升高定义为在使用特拉匹韦治疗期间血清肌酐较基线水平升高≥0.3mg/dL。
2011年7月至2013年1月期间,78例患者开始治疗。大多数患者完成了规定的12周特拉匹韦治疗;32%因副作用停药。治疗期间血清肌酐平均升高0.22mg/dL(标准差0.22mg/dL)。31%的患者在治疗期间血清肌酐显著升高。与基线估算肾小球滤过率(eGFR)≥90 mL/min/1.73m²的组相比,基线eGFR < 90 mL/min/1.73m²的患者估算肾小球滤过率下降幅度较小(分别为12 vs. 18 mL/min/1.73m²,P = 0.047)。83%的患者在停用特拉匹韦后12周时血清肌酐完全恢复正常,然而,在调整模型中,在使用特拉匹韦期间血清肌酐显著升高与12个月时估算肾小球滤过率降低6.6mL/min/1.73m²相关。
特拉匹韦治疗期间肾功能下降很常见,且与先前报道的基线eGFR < 90mL/min/1.73m²无关。