Gianotti Nicola, Poli Andrea, Nozza Silvia, Spagnuolo Vincenzo, Tambussi Giuseppe, Bossolasco Simona, Cinque Paola, Maillard Myriam, Cernuschi Massimo, Galli Laura, Lazzarin Adriano, Castagna Antonella
Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy;
Dipartimento di Malattie Infettive, San Raffaele Scientific Institute, Milan, Italy.
J Int AIDS Soc. 2015 Jul 30;18(1):20037. doi: 10.7448/IAS.18.1.20037. eCollection 2015.
Switching to a rilpivirine, tenofovir and emtricitabine (RTE) single-tablet regimen (STR) has been evaluated in a limited number of virologically suppressed patients. The aim of this study was to describe clinical outcomes in HIV-positive patients switched from a suppressive antiretroviral regimen to RTE STR in routine clinical practice.
In this retrospective study of antiretroviral-treated patients with <50 copies of HIV RNA/mL switched to RTE STR, virological failure (VF) was defined as two consecutive measurements of ≥50 copies/mL or a single measurement of ≥50 copies/mL followed by any change in treatment. Treatment failure (TF) was defined as VF or discontinuation of the STR for any reason. Univariate mixed-linear models were used to identify differences in laboratory parameters over time.
The analysis involved 307 patients (83% males) with a median age of 45.8 years (interquartile range (IQR 39.3-50.9), who were followed up for a median of 7.4 months (IQR 4.6-10.9). VF occurred in three patients (1%) switched from a protease inhibitor (PI)-based regimen, after a median of 2.6 months (IQR 1.6-3.0), and TF in 34 patients (11%) after a median of three months (IQR 1.4-5.8), 24 of whom (71%) were receiving a PI-based regimen at baseline. Overall, there was a slight but statistically significant improvement in the mean monthly change from baseline in CD4+ cell counts (p=0.027), the CD4+/CD8+ ratio (p=0.0001), and Hb (p=0.024), alanine amino transferase (ALT) (p=0.009), total bilirubin (p<0.0001), indirect bilirubin (p<0.0001), total cholesterol (p<0.0001) and triglyceride (p<0.0001) levels. There was also a slight but statistically significant increase in serum creatinine (p=0.0004), aspartate amino transferase (AST) (p=0.001) and liver fibrosis index (FIB-4) (p=0.002), and a decrease in eGFRcreat (p<0.0001) and high-density lipoprotein (HDL) cholesterol (p<0.0001) values. The study limitations include its retrospective design, the relatively short follow-up, and the absence of data concerning the severity of clinical adverse events; however, it does provide new information concerning the laboratory changes that occur in patients switching from PI-based or PI-sparing regimens to RTE STR.
The study findings confirm the efficacy and safety in clinical practice of switching to RTE STR in virologically suppressed patients receiving other antiretrovirals.
在少数病毒学抑制的患者中评估了换用rilpivirine、替诺福韦和恩曲他滨（RTE）单片复方制剂（STR）的情况。本研究的目的是描述在常规临床实践中从抑制性抗逆转录病毒方案换用RTE STR的HIV阳性患者的临床结局。
在这项对HIV RNA/mL低于50拷贝且换用RTE STR的抗逆转录病毒治疗患者的回顾性研究中，病毒学失败（VF）定义为连续两次测量≥50拷贝/mL或单次测量≥50拷贝/mL，随后进行任何治疗改变。治疗失败（TF）定义为VF或因任何原因停用STR。使用单变量混合线性模型确定实验室参数随时间的差异。
分析纳入了307例患者（83%为男性），中位年龄45.8岁（四分位间距（IQR）39.3 - 50.9），中位随访时间7.4个月（IQR 4.6 - 10.9）。从基于蛋白酶抑制剂（PI）的方案换用的3例患者（1%）发生VF，中位时间为2.6个月（IQR 1.6 - 3.0），34例患者（11%）发生TF，中位时间为3个月（IQR 1.4 - 5.8），其中24例（71%）基线时接受基于PI的方案。总体而言，CD4 +细胞计数从基线的平均每月变化（p = 0.027）、CD4+/CD8+比值（p = 0.0001）、血红蛋白（p = 0.024）、丙氨酸氨基转移酶（ALT）（p = 0.009）、总胆红素（p < 0.0001）、间接胆红素（p < 0.0001）、总胆固醇（p < 0.0001）和甘油三酯（p < 0.0001）水平有轻微但具有统计学意义的改善。血清肌酐（p = 0.0004）、天冬氨酸氨基转移酶（AST）（p = 0.001）和肝纤维化指数（FIB - 4）（p = 0.002）也有轻微但具有统计学意义的升高，估算肾小球滤过率（eGFRcreat）（p < 0.0001）和高密度脂蛋白（HDL）胆固醇（p < 0.0001）值降低。研究局限性包括其回顾性设计、相对较短的随访时间以及缺乏关于临床不良事件严重程度的数据；然而，它确实提供了有关从基于PI或不含PI的方案换用RTE STR的患者中发生的实验室变化的新信息。
研究结果证实了在接受其他抗逆转录病毒药物治疗且病毒学抑制的患者中换用RTE STR在临床实践中的有效性和安全性。
