Brunetta Jason, Moreno Guillén Santiago, Antinori Andrea, Yeni Patrick, Wade Barbara, Johnson Margaret, Shalit Peter, Ebrahimi Ramin, Johnson Bethsheba, Walker Ivan, De-Oertel Shampa
Faculty of Medicine, University of Toronto, Toronto, ON, Canada,
Patient. 2015 Jun;8(3):257-67. doi: 10.1007/s40271-015-0123-2.
Patient-reported outcomes (PROs) can provide important information about treatment tolerability in HIV-1-infected patients.
The aim of this study was to evaluate PROs following switching from a boosted protease inhibitor-based regimen to the single-tablet regimen (STR) of rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) in the 48-week open-label Switching Boosted PI to Rilpivirine in Combination with Truvada as a Single-Tablet Regimen (SPIRIT) trial.
In the open-label SPIRIT trial, patients were randomized to receive an STR of RPV/FTC/TDF (n = 317) for 48 weeks or stay on their baseline regimen of a ritonavir-boosted protease inhibitor and two nucleoside/nucleotide analog reverse transcriptase inhibitors (PI + RTV + 2NRTIs, n = 159) for 24 weeks before switching to RPV/FTC/TDF for another 24 weeks. PRO assessments included the HIV Treatment Satisfaction Questionnaire (TSQ) and the HIV Symptom Index Questionnaire (SIQ).
At week 24, the mean HIV TSQ improvement from baseline was significantly greater in the RPV/FTC/TDF group than the PI + RTV + 2NRTIs group (p < 0.001). On the HIV SIQ, the percentage of patients reporting a shift from 'symptom' to 'no symptom' was significantly greater with RPV/FTC/TDF treatment compared with PI + RTV + 2NRTIs for all items (all p ≤ 0.01), with total within-group occurrence of 13/20 symptoms significantly decreasing from baseline for RPV/FTC/TDF patients. In the delayed switch group, significantly fewer patients reported diarrhea and sleep problems at week 48 vs. week 24.
These data suggest that switching to the STR RPV/FTC/TDF from a PI-based multi-pill regimen is associated with greater patient-reported treatment satisfaction and improved tolerability in HIV-1-infected, virologically suppressed individuals.
患者报告的结局（PROs）可为HIV-1感染患者的治疗耐受性提供重要信息。
本研究的目的是在一项为期48周的开放标签试验“从增强型蛋白酶抑制剂方案转换为rilpivirine/恩曲他滨/替诺福韦酯富马酸盐（RPV/FTC/TDF）单一片剂方案（STR）的转换增强型PI至rilpivirine联合Truvada作为单一片剂方案（SPIRIT）”中，评估从基于增强型蛋白酶抑制剂的方案转换为RPV/FTC/TDF单一片剂方案后的PROs。
在开放标签的SPIRIT试验中，患者被随机分配接受RPV/FTC/TDF的STR（n = 317）治疗48周，或继续使用其基线方案，即利托那韦增强型蛋白酶抑制剂和两种核苷/核苷酸类似物逆转录酶抑制剂（PI + RTV + 2NRTIs，n = 159）治疗24周，然后转换为RPV/FTC/TDF再治疗24周。PRO评估包括HIV治疗满意度问卷（TSQ）和HIV症状指数问卷（SIQ）。
在第24周时，RPV/FTC/TDF组的HIV TSQ从基线的平均改善显著大于PI + RTV + 2NRTIs组（p < 0.001）。在HIV SIQ上，与PI + RTV + 2NRTIs相比，接受RPV/FTC/TDF治疗的患者报告从“有症状”转变为“无症状”的百分比在所有项目上均显著更高（所有p≤0.01），RPV/FTC/TDF患者组内20种症状中共有13种从基线显著减少。在延迟转换组中，与第24周相比，第48周报告腹泻和睡眠问题的患者明显减少。
这些数据表明，从基于PI的多片方案转换为STR RPV/FTC/TDF与HIV-1感染、病毒学抑制的个体中患者报告的治疗满意度更高和耐受性改善相关。
