Amjad Waseem, Zhang Talan, Maheshwari Anurag, Thuluvath Paul J
Institute of Digestive Heath and Liver Diseases, Mercy Medical Center, Baltimore, MD, USA.
University of Maryland School of Medicine, Baltimore, MD, USA.
J Clin Exp Hepatol. 2022 Mar-Apr;12(2):329-335. doi: 10.1016/j.jceh.2021.08.013. Epub 2021 Aug 20.
BACKGROUND & OBJECTIVES: There are reports of worsening renal functions with sofosbuvir, but there are no comparative data of different direct-acting antivirals (DAAs) on serum creatinine. In this retrospective cohort analysis, we examined the treatment effect of two commonly used regimens, sofosbuvir/ledipasvir (SOF/LDV) and glecaprevir/pibrentasvir (GLE/PIB), on serum creatinine.
We included all patients treated with SOF/LDV (n = 825) and GLE/PIB (n = 116) between December 1, 2014, and December 31, 2018. An increase of serum creatinine ≥0.3 mg/dL was considered clinically significant. The change of creatinine values from pretreatment to posttreatment between two treatment groups was tested in unadjusted and adjusted generalized linear model, and risk factors associated with creatinine change were assessed. In addition, GLE/PIB-treated patients were matched 1:2 to SOF/LDV-treated patients using propensity scores, and then serum creatinine changes were compared.
The mean baseline creatinine was higher in the GLE/PIB group vs. SOF/LDV group (1.39 ± 1.86 vs. 0.91 ± 0.24, = 0.007). When compared to baseline, serum creatinine at posttreatment week 4 was significantly higher in SOF/LDV group (0.97 ± 0.4 vs.0.91 ± 0.24, < 0.001), but there was no significant change in the GLE/PIB group (1.41 ± 1.73 vs. 1.39 ± 1.86, = 0.52). Overall, there was no significant change in serum creatinine between posttreatment week 4 and week 24 ( = 0.6). Clinically significant increase in serum creatinine was seen in 6% (46/825) of SOF/LDV and 7% (8/116) of GLE/PIB ( = 0.6). The unadjusted and adjusted models indicated that the changes in creatinine from baseline to posttreatment week 4 and week 24 were not associated with the type of DAA combination.
Treatment of chronic hepatitis C infection with both SOF/LDV and GLE/PIB regimens may result in an increase of creatinine, and 6-7% will have an increase in serum creatinine of ≥0.3 mg/dL. The increase in creatinine, however, is unrelated to the type of DAA combination.
有报告称索磷布韦可导致肾功能恶化，但尚无不同直接作用抗病毒药物（DAA）对血清肌酐影响的比较数据。在这项回顾性队列分析中，我们研究了两种常用方案，即索磷布韦/来迪帕司韦（SOF/LDV）和格卡瑞韦/哌仑他韦（GLE/PIB）对血清肌酐的治疗效果。
我们纳入了2014年12月1日至2018年12月31日期间接受SOF/LDV（n = 825）和GLE/PIB（n = 116）治疗的所有患者。血清肌酐升高≥0.3mg/dL被认为具有临床意义。在未调整和调整后的广义线性模型中测试两个治疗组从治疗前到治疗后肌酐值的变化，并评估与肌酐变化相关的危险因素。此外，使用倾向评分将接受GLE/PIB治疗的患者与接受SOF/LDV治疗的患者按1:2进行匹配，然后比较血清肌酐变化。
GLE/PIB组的平均基线肌酐高于SOF/LDV组（1.39±1.86 vs. 0.91±0.24，P = 0.007）。与基线相比，SOF/LDV组治疗后第4周的血清肌酐显著升高（0.97±0.4 vs. 0.91±0.24，P < 0.001），但GLE/PIB组无显著变化（1.41±1.73 vs. 1.39±1.86，P = 0.52）。总体而言，治疗后第4周和第24周血清肌酐无显著变化（P = 0.6）。SOF/LDV组6%（46/825）和GLE/PIB组7%（8/116）出现血清肌酐临床显著升高（P = 0.6）。未调整和调整后的模型表明，从基线到治疗后第4周和第24周肌酐的变化与DAA组合类型无关。
使用SOF/LDV和GLE/PIB方案治疗慢性丙型肝炎感染可能导致肌酐升高，6%-7%的患者血清肌酐升高≥0.3mg/dL。然而，肌酐升高与DAA组合类型无关。
