Troya Jesús, Ryan Pablo, Ribera Esteban, Podzamczer Daniel, Hontañón Victor, Terrón Jose Alberto, Boix Vicente, Moreno Santiago, Barrufet Pilar, Castaño Manuel, Carrero Ana, Galindo María José, Suárez-Lozano Ignacio, Knobel Hernando, Raffo Miguel, Solís Javier, Yllescas María, Esteban Herminia, González-García Juan, Berenguer Juan, Imaz Arkaitz
Hospital Universitario Infanta Leonor, Madrid, Spain.
Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
PLoS One. 2016 Oct 11;11(10):e0164455. doi: 10.1371/journal.pone.0164455. eCollection 2016.
Based on data from clinical practice, we evaluated the effectiveness and safety of switching to abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV) treatment in virologically suppressed HIV-1-infected patients.
We performed a multicenter, non-controlled, retrospective study of HIV-1-infected patients who switched treatment to ABC/3TC+RPV. Patients had an HIV-RNA <50 copies/mL for at least 24 weeks prior to changing treatments. The primary objective was HIV-1 RNA <50 copies/mL at week 48. Effectiveness was analyzed by intention-to-treat (ITT), missing = failure and on-treatment (OT) analyses. The secondary objectives analyzed were adverse effects changes in renal, hepatic or lipid profiles, changes in CD4+ cell count and treatment discontinuations.
Of the 205 patients included, 75.6% were men and the median age was 49. At baseline, before switching to ABC/3TC+RPV, median time since HIV diagnosis was 13.1 years, median time with undetectable HIV-1 RNA was 6.2 years and median time of previous antiretroviral regimen was 3.1 years (48.3% patients were taking efavirenz and ABC/3TC was the most frequent backbone coformulation in 69.7% of patients). The main reasons for switching were drug toxicity/poor tolerability (60.5%) and simplification (20%). At week 48, the primary objective was achieved by 187 out of 205 (91.2%) patients by ITT analysis, and 187 out of 192 (97.4%) patients by OT analysis. The CD4+ lymphocyte count and CD4+ percentage increased significantly from baseline to week 48 by a median of 48 cells/μL (-50 to 189) and 1.2% (-1.3% to 4.1%), respectively, P<0.001. Thirty-eight adverse events (AE) were detected in 32 patients. Of these, 25 had no clear association with treatment. Three patients interrupted therapy due to AE. We observed a decrease in all lipid parameters, P<0.001, and a slight improvement in the glomerular filtration rate, P<0.01. Therapy was considered to have failed in 18 patients owing to virological failure (5 [2.4%]), toxicity/poor tolerability (4 [2%]), clinical decision (3 [1.5%]), loss to follow-up (3 [1.5%]), death (1 [0.5%]), and no clinical data (2 [1%]).
The results of this study confirms that ABC/3TC+RPV is an effective, safe, and cost-effective option for the treatment of patients with virologically stable HIV-1 infection.
基于临床实践数据，我们评估了在病毒学抑制的HIV-1感染患者中换用阿巴卡韦/拉米夫定加rilpivirine（ABC/3TC+RPV）治疗的有效性和安全性。
我们对换用ABC/3TC+RPV治疗的HIV-1感染患者进行了一项多中心、非对照、回顾性研究。患者在改变治疗前至少24周HIV-RNA<50拷贝/mL。主要目标是在第48周时HIV-1 RNA<50拷贝/mL。通过意向性分析（ITT）、缺失值=失败分析和治疗中分析（OT）来分析有效性。分析的次要目标包括不良反应、肾、肝或血脂谱的变化、CD4+细胞计数的变化以及治疗中断情况。
纳入的205例患者中，75.6%为男性，中位年龄为49岁。在基线时，即换用ABC/3TC+RPV之前，自HIV诊断以来的中位时间为13.1年，HIV-1 RNA检测不到的中位时间为6.2年，先前抗逆转录病毒治疗方案的中位时间为3.1年（48.3%的患者正在服用依非韦伦，69.7%的患者中ABC/3TC是最常见的主干复方制剂）。换用治疗的主要原因是药物毒性/耐受性差（60.5%）和简化治疗方案（20%）。在第48周时，通过ITT分析，205例患者中有187例（91.2%）达到主要目标，通过OT分析，192例患者中有187例（97.4%）达到主要目标。从基线到第48周，CD4+淋巴细胞计数和CD4+百分比分别显著增加，中位增加量分别为48个细胞/μL（-50至189）和1.2%（-1.3%至4.1%），P<0.001。在32例患者中检测到38例不良事件（AE）。其中，25例与治疗无明确关联。3例患者因AE中断治疗。我们观察到所有血脂参数均下降，P<0.001，肾小球滤过率略有改善，P<0.01。由于病毒学失败（5例[2.4%]）、毒性/耐受性差（4例[2%]）、临床决策（3例[1.5%]）、失访（3例[1.5%]）、死亡（1例[0.5%]）和无临床数据（2例[1%]），18例患者被认为治疗失败。
本研究结果证实，ABC/3TC+RPV是治疗病毒学稳定的HIV-1感染患者的一种有效、安全且具有成本效益的选择。
