Podzamczer D, Rozas N, Domingo P, Miralles C, den Eynde E Van, Romero A, Deig E, Knobel H, Pasquau J, Antela A, Clotet B, Geijo P, de Castro E Rodríguez, Casado M A, Muñoz A, Casado A
Hospital Universitari de Bellvitge, Barcelona, Spain.
Hospital de la Santa Creu y Sant Pau, Barcelona, Spain.
Curr HIV Res. 2018;16(6):425-435. doi: 10.2174/1570162X17666190212163518.
To investigate the impact of switching from stable Combined Antiretroviral Therapy (cART) to single-tablet regimen (RPV/FTC/TDF=EVIPLERA® /COMPLERA®) on patient- reported outcomes in HIV-infected adults who cannot tolerate previous cART, in a real-world setting.
PRO-STR is a 48-week observational, prospective, multicenter study. Presence and magnitude of symptoms (main endpoint), health-related quality-of-life (HRQoL), adherence, satisfaction with treatment and patient preferences were assessed.
Three hundred patients with 48-week follow-up, who switched to EVIPLERA® (mean age: 46.6 years; male: 74.0%; 74.7% switched from a non-nucleoside reverse-transcriptase-inhibitor, 25.3% from a protease inhibitor + ritonavir) were included. There was no statistical difference in median CD4+ cell count (baseline: 678.5 cells/mm3; 48-week: 683.0 cells/mm3) neither in virological suppression (≤50 copies/mL) (baseline: 98.3%; 48-week: 95.3%). The most frequent reasons for switching were neuropsychiatric (62.3%), gastrointestinal (19.3%) and biochemical/metabolic (19.3%) events. Only 7.7% of patients permanently discontinued therapy. At 48-week, all outcomes showed an improvement compared to baseline. Overall, there was a significant decrease (pvalue≤ 0.05) in number and magnitude of symptoms, while HRQoL, satisfaction and adherence improved significantly. Most patients prefered EVIPLERA® than previous cART. According to the type of intolerance, HRQoL was improved, but only significantly in patients with neuropsychiatric and gastrointestinal symptoms. Adherence improved significantly in patients with metabolic disturbances and satisfaction with EVIPLERA® was higher in the three groups.
Switching to EVIPLERA® from non-nucleoside reverse-transcriptase-inhibitor or protease inhibitor-based regimens due to toxicity, improved the presence/magnitude of symptoms, HRQoL, and preference with treatment. EVIPLERA® maintained a virological response, CD4+ cell count and maintained or improved adherence.
在真实世界环境中，研究无法耐受既往联合抗逆转录病毒疗法（cART）的HIV感染成人从稳定的cART转换为单片复方制剂（RPV/FTC/TDF = 艾维雷韦/克比司特/替诺福韦酯片®/康普来®）对患者报告结局的影响。
PRO-STR是一项为期48周的观察性、前瞻性、多中心研究。评估症状的存在情况及严重程度（主要终点）、健康相关生活质量（HRQoL）、依从性、治疗满意度和患者偏好。
纳入了300例接受48周随访的患者，他们转换为艾维雷韦/克比司特/替诺福韦酯片®（平均年龄：46.6岁；男性：74.0%；74.7%从非核苷类逆转录酶抑制剂转换而来，25.3%从蛋白酶抑制剂+利托那韦转换而来）。CD4+细胞计数中位数（基线：678.5个细胞/mm³；48周：683.0个细胞/mm³）以及病毒学抑制（≤50拷贝/mL）情况（基线：98.3%；48周：95.3%）均无统计学差异。转换的最常见原因是神经精神方面（62.3%）、胃肠道方面（19.3%）和生化/代谢方面（19.3%）的事件。仅7.7%的患者永久停药。在48周时，与基线相比所有结局均有改善。总体而言，症状的数量和严重程度显著降低（p值≤0.05），而HRQoL、满意度和依从性显著改善。大多数患者更喜欢艾维雷韦/克比司特/替诺福韦酯片®而非既往的cART。根据不耐受类型，HRQoL有所改善，但仅在有神经精神和胃肠道症状的患者中显著改善。代谢紊乱患者的依从性显著提高，三组患者对艾维雷韦/克比司特/替诺福韦酯片®的满意度均较高。
因毒性从基于非核苷类逆转录酶抑制剂或蛋白酶抑制剂的方案转换为艾维雷韦/克比司特/替诺福韦酯片®，改善了症状的存在情况/严重程度、HRQoL和治疗偏好。艾维雷韦/克比司特/替诺福韦酯片®维持了病毒学应答、CD4+细胞计数，并维持或改善了依从性。
