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在接受替诺福韦和增效蛋白酶抑制剂治疗的 HCV/HIV 合并感染患者中,使用 Sofosbuvir/Ledipasvir 治疗慢性丙型肝炎期间肾小球滤过率的变化:一项观察性前瞻性研究。

Glomerular filtration rate change during chronic hepatitis C treatment with Sofosbuvir/Ledipasvir in HCV/HIV Coinfected patients treated with Tenofovir and a boosted protease inhibitor: an observational prospective study.

机构信息

Infectious Diseases Department, Centro Hospitalar do Porto, Largo do Prof. Abel Salazar, 4099-001, Porto, Portugal.

出版信息

BMC Infect Dis. 2018 Aug 3;18(1):364. doi: 10.1186/s12879-018-3278-3.

Abstract

INTRODUCTION

Concomitant use of ledipasvir and boosted protease inhibitors (PIs) may increase the risk of tenofovir (TDF) nephrotoxicity, since both these drugs increase TDF levels. Our aim was to evaluate glomerular filtration rate (eGFR) evolution during HCV treatment with sofosbuvir/ledipasvir (SOF/LDV) in HCV/HIV coinfected patients, according to their antiretroviral treatment (ARV).

METHODS

Observational prospective study of HCV/HIV coinfected patients treated with SOF/LDV. eGFR evolution was evaluated during and 12 weeks after HCV treatment. Patients were categorized in three groups based on ARV regimen: non TDF, non-boosted TDF and TDF + boosted PI.

RESULTS

We included 273 patients: 145 were receiving a non-TDF regimen, 78 a non-boosted TDF scheme and 50 were receiving TDF + boosted PI. We observed a statistically significant decrease in eGFR during treatment in all groups (non TDF p = 0.03, 95%CI [0.23-3.86], non-boosted TDF p < 0.01, 95%CI [3.36-7.44], TDF + PI p = 0.01, 95%CI [1.09-7.53]). The decrease was more pronounced in those receiving unboosted TDF (- 5.40 ml/min/1.73m), but differences in eGFR decrease between the three groups were small and not statistically different (p = 0.06). eGFR decrease was greater in patients treated for 24 weeks (p = 0.009) and in cirrhotic patients (p = 0.036). At the end of follow up a recovery of eGFR was observed in all groups.

CONCLUSION

We observed a significant decrease in eGFR during treatment in all study groups, that was small and reversible after SOF/LDV discontinuation. TDF was not associated with an increase in renal toxicity.

摘要

简介

拉替拉韦与增强型蛋白酶抑制剂(PI)联合使用可能会增加替诺福韦(TDF)肾毒性的风险,因为这两种药物都会增加 TDF 水平。我们的目的是评估 HCV/HIV 合并感染患者接受索非布韦/拉替拉韦(SOF/LDV)治疗期间肾小球滤过率(eGFR)的变化,根据他们的抗逆转录病毒治疗(ARV)方案进行分组。

方法

这是一项 HCV/HIV 合并感染患者接受 SOF/LDV 治疗的观察性前瞻性研究。在 HCV 治疗期间及治疗后 12 周评估 eGFR 的变化。根据 ARV 方案将患者分为三组:非 TDF 组、非增强型 TDF 组和 TDF+增强型 PI 组。

结果

我们纳入了 273 例患者:145 例患者正在接受非 TDF 方案治疗,78 例患者正在接受非增强型 TDF 方案治疗,50 例患者正在接受 TDF+增强型 PI 方案治疗。我们观察到所有组在治疗期间 eGFR 均有统计学显著下降(非 TDF 组 p=0.03,95%CI [0.23-3.86],非增强型 TDF 组 p<0.01,95%CI [3.36-7.44],TDF+PI 组 p=0.01,95%CI [1.09-7.53])。接受非增强型 TDF 治疗的患者 eGFR 下降更为明显(-5.40 ml/min/1.73m),但三组间 eGFR 下降的差异较小,且无统计学差异(p=0.06)。治疗 24 周的患者(p=0.009)和肝硬化患者(p=0.036)eGFR 下降更为明显。在随访结束时,所有组的 eGFR 均有所恢复。

结论

我们观察到所有研究组在治疗期间 eGFR 均有显著下降,但在 SOF/LDV 停药后下降较小且可恢复。TDF 与肾毒性增加无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4dba/6090809/d511e41723bf/12879_2018_3278_Fig1_HTML.jpg

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