Faculty of Health Sciences, University of Namibia, Windhoek, Namibia.
Strathclyde University, Karolinska Institute, Sefako Makgatho University of Health Sciences, Ga-Rankuwa, South Africa.
Pharmacol Res Perspect. 2023 Feb;11(1):e00681. doi: 10.1002/prp2.681.
Prescription of tenofovir disoproxil fumarate (TDF) for patients with baseline creatinine clearances (CrCl) <60 mL/min is said to increase risk of further decline in CrCl. Study objectives were to assess incidence of improvement and predictors thereof; to assess incidence of decline and transition to lower stages of CrCl; and comparison of declines between patients with a baseline CrCl < 60mL/min (group-I) and ≥ 60 mL/min (group-II). The study was retrospective, included patients 16 yrs or older who received TDF-containing ART. Improvement and decline were defined as ≥ 25% increase or decrease in CrCl, respectively. Binary logistic regression was performed to identify predictors of improvement. Groups I and II had 2862 and 7526 patients, respectively. In group-I, improvement in CrCl was observed in 40.1% (n = 1146), and was associated with stage IV of CrCl (adjusted Odds Ratio [aOR]=13.4 [95% CI: 6.7 - 26.9, P < .001]); male gender (aHR = 1.8 [95% CI: 1.5 - 2.2, P < .001]); and a poor HIV-status (aHR = 1.2 [95% CI: 1.0 - 1.4], P = .033). In group-I and group-II, respectively, decline occurred in 2.3% and 13.0%, (P < .001); transition to lower stages occurred in 1.0% and 25.2% (P < .001); and migration to stage IV CrCl occurred in 1.0% and 0.5% (P < .001). Improvement was more likely than decline in group-I patients. Although, group-I patients were more likely to experience new onset severe reduced CrCl than group-II patients, the proportions were extremely low. TDF should not be withheld from HIV-positive patients with a baseline CrCl < 60 mL/min.
替诺福韦二吡呋酯(TDF)处方给基线肌酐清除率(CrCl)<60 mL/min 的患者据说会增加 CrCl 进一步下降的风险。研究目的是评估改善的发生率及其预测因素;评估下降的发生率和向 CrCl 较低阶段的转变;以及比较基线 CrCl<60mL/min 的患者(组 I)和≥60mL/min 的患者(组 II)之间的下降。该研究是回顾性的,纳入了接受 TDF 含 ART 的 16 岁或以上的患者。改善和下降分别定义为 CrCl 增加或减少≥25%。使用二元逻辑回归来确定改善的预测因素。组 I 和 II 分别有 2862 名和 7526 名患者。在组 I 中,CrCl 的改善在 40.1%(n=1146)中观察到,与 CrCl 的第四阶段相关(调整后的优势比[aOR]=13.4[95%CI:6.7-26.9,P<.001]);男性(aHR=1.8[95%CI:1.5-2.2,P<.001]);和较差的 HIV 状况(aHR=1.2[95%CI:1.0-1.4],P=0.033)。在组 I 和组 II 中,分别下降了 2.3%和 13.0%(P<.001);向较低阶段的转变发生在 1.0%和 25.2%(P<.001);向第四阶段 CrCl 的迁移发生在 1.0%和 0.5%(P<.001)。组 I 患者改善的可能性大于下降。尽管组 I 患者比组 II 患者更有可能出现新的严重 CrCl 降低,但比例极低。对于基线 CrCl<60mL/min 的 HIV 阳性患者,不应拒绝 TDF。