Abdel Alem Shereen, El Garhy Naeema, El Khateeb Engy, Khalil Mahmoud, Cordie Ahmed, Elsharkawy Aisha, Fouad Rabab, Esmat Gamal, Abdelbary Mohammad Salah
Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo University, Cairo 11562, Egypt.
Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Cairo 11562, Egypt.
Trans R Soc Trop Med Hyg. 2023 Apr 3;117(4):285-296. doi: 10.1093/trstmh/trac107.
Sofosbuvir (SOF) is authorized for hepatitis C virus (HCV) patients. The nephrotoxicity of SOF on HCV mono-infected and HCV-human immunodeficiency virus (HIV) individuals receiving antiretroviral therapy (ART) remains controversial.
A prospective study including 159 HCV mono-infected and 124 HCV-HIV individuals (47 were ART naïve and 77 were tenofovir [TDF]-based ART) who presented with an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2 at baseline and were treated with SOF-daclatasvir for 12 weeks. The eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation over the study period.
HCV patients had a progressive decline in median levels of eGFR compared with HCV-HIV patients who were ART naïve and those receiving TDF-based ART during and after discontinuing SOF-DAC treatment (96, 109 and 114 at baseline vs 94, 117 and 108 at the end of treatment [EOT]) vs 95, 114 and 115 ml/min/1.73 m2 at 12 weeks after treatment [SVR12], respectively). Moreover, the rate of eGFR stage worsening was more pronounced in HCV mono-infected compared with HCV-HIV individuals who were ART naïve and those receiving TDF-based ART (21.4% vs 8.5% and 14.3% at EOT; 21.4% vs 2.1% and 6.5% at SVR12, respectively). Multivariable regression analysis showed that baseline variables were not independent predictors of eGFR stage worsening either at EOT or SVR12.
Because the changes in eGFR were minimal and not of clinical significance, and TDF was not associated with an increase in renal dysfunction, SOF-based direct-acting antivirals could be safely used in HCV mono-infected and HCV-HIV individuals, even in those on TDF-based ART.
索磷布韦(SOF)已被批准用于丙型肝炎病毒(HCV)患者。SOF对接受抗逆转录病毒治疗(ART)的HCV单一感染患者及HCV-人类免疫缺陷病毒(HIV)合并感染患者的肾毒性仍存在争议。
一项前瞻性研究纳入了159例HCV单一感染患者和124例HCV-HIV合并感染患者(47例未接受过ART,77例接受基于替诺福韦[TDF]的ART),这些患者基线时估计肾小球滤过率(eGFR)≥30 ml/min/1.73 m²,并接受索磷布韦-达卡他韦治疗12周。在研究期间使用慢性肾脏病流行病学合作组方程估算eGFR。
与未接受过ART的HCV-HIV合并感染患者以及接受基于TDF的ART的HCV-HIV合并感染患者相比,HCV单一感染患者在停止索磷布韦-达卡他韦治疗期间及之后,eGFR的中位数水平呈逐渐下降趋势(基线时分别为96、109和114,治疗结束时[EOT]分别为94、117和108),而治疗后12周[持续病毒学应答12周(SVR12)]时分别为95、114和115 ml/min/1.73 m²)。此外,与未接受过ART的HCV-HIV合并感染患者以及接受基于TDF的ART的HCV-HIV合并感染患者相比,HCV单一感染患者的eGFR分期恶化率更为明显(EOT时分别为21.4% vs 8.5%和14.3%;SVR12时分别为21.4% vs 2.1%和6.5%)。多变量回归分析显示,基线变量在EOT或SVR12时均不是eGFR分期恶化的独立预测因素。
由于eGFR的变化极小且无临床意义,并且TDF与肾功能障碍增加无关,基于索磷布韦的直接抗病毒药物可安全用于HCV单一感染患者及HCV-HIV合并感染患者,即使是接受基于TDF的ART的患者。