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首页> 外文期刊>AIDS care. >Patient-reported outcomes in the single-tablet regimen (STaR) trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate in antiretroviral treatment-naive adults infected with HIV-1 through 48 weeks of treatment
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Patient-reported outcomes in the single-tablet regimen (STaR) trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate in antiretroviral treatment-naive adults infected with HIV-1 through 48 weeks of treatment

机译：利匹韦林/恩曲他滨/替诺福韦富马酸替莫索韦富马酸单药方案研究（STaR）的患者在抗逆转录病毒治疗未感染HIV-1的成人中治疗48周，结果与依法韦仑/恩曲他滨/替诺福韦富马酸二吡呋酯相比

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This 96-week, randomized, open-label study was designed to assess the efficacy and safety of two single-tablet regimens in treatment naive HIV-1-infected adults: rilpivirine (RPV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and efavirenz (EFV) + FTC/TDF. Assessments included patient-reported Medication Adherence Self-Report Inventory, SF-12v2 Quality of Life assessment, HIV Treatment Satisfaction Questionnaire, and HIV Symptom Index Questionnaire through Week 48. Additional evaluations included study drug discontinuations due to treatment-emergent adverse events (TEAEs). A total of 786 participants (n=394 RPV/FTC/TDF, n=392 EFV/FTC/TDF) were included. Fewer RPV/FTC/TDF-treated than EFV/FTC/TDF-treated participants discontinued study drug due to TEAEs (2.5% vs. 8.7%), with 41% (14/34) TEAE-related discontinuations in the EFV/FTC/TDF group occurring within the first four weeks of treatment. Treatment adherence and satisfaction remained high through Week 48 and quality of life improved from baseline in both groups. There were no significant between-group differences in virologic success (HIV-1 RNA <50 copies/mL) regardless of adherence (<95% or >= 95%). Significant between-group differences favouring RPV/FTC/TDF were observed for the HIV SIQ symptoms of difficulty falling or staying asleep (p = .022) and diarrhea or loose bowel movements (p = .002). In conclusion, 48-week treatment with RPV/FTC/TDF or EFV/FTC/TDF was associated with high adherence, high treatment satisfaction, and improved quality of life. TEAE-related discontinuations and patient-reported symptoms indicate that RPV/FTC/TDF may be somewhat better tolerated than EFV/FTC/TDF.
机译：这项为期96周的随机，开放标签研究旨在评估两种单片方案在未经HIV-1感染的成人中的治疗效果和安全性：利比韦林（RPV）+恩曲他滨/替诺福韦富马酸替诺福韦（FTC / TDF）依法韦仑（EFV）+ FTC / TDF。评估包括患者报告的用药依从性自我报告清单，SF-12v2生活质量评估，HIV治疗满意度问卷以及至48周的HIV症状指数问卷。其他评估包括由于治疗紧急不良事件（TEAE）而停药的研究。总共包括786名参与者（n = 394 RPV / FTC / TDF，n = 392 EFV / FTC / TDF）。接受RPV / FTC / TDF治疗的RAE / FTC / TDF治疗的参与者因TEAE停药的比例比EFV / FTC / TDF治疗的参与者少（2.5％对8.7％），其中EFV / FTC / TEAE相关停药的比例为41％（14/34） TDF组在治疗的前四周内发生。整个第48周，治疗依从性和满意度一直很高，两组的生活质量均较基线水平有所改善。不论是否依从（<95％或> = 95％），病毒学成功率（HIV-1 RNA <50拷贝/ mL）之间均无显着的组间差异。对于HIV SIQ症状，难以入睡或入睡（p = .022）和腹泻或排便不畅（p = .002），观察到两组之间存在明显的利于RPV / FTC / TDF的差异。总之，使用RPV / FTC / TDF或EFV / FTC / TDF进行的48周治疗具有较高的依从性，较高的治疗满意度和改善的生活质量。与TEAE相关的停药和患者报告的症状表明，RPV / FTC / TDF的耐受性可能比EFV / FTC / TDF更好。

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