Gathe Joseph, Arribas Jose R, Van Lunzen Jan, Garner Will, Speck Rebecca M, Bender Randall, Shreay Sanatan, Nguyen Thai
Therapeutic Concepts, PA, Houston, TX, USA.
Hospital La Paz, IdiPaz, Madrid, Spain.
Patient. 2015 Oct;8(5):445-54. doi: 10.1007/s40271-015-0137-9.
Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®)) is a recommended integrase inhibitor-based regimen in treatment guidelines from the US Department of Health and Human Services and the British HIV Association. The purpose of this analysis was to determine the change in patient-reported symptoms over time among HIV-infected adults who switch to Stribild(®) versus those continuing on a protease inhibitor (PI) with FTC/TDF.
A secondary analysis was conducted on the STRATEGY-PI study (GS-US-236-0115, ClinicalTrials.gov NCT01475838), a randomized, open-label, phase 3b trial of HIV-infected adults taking a PI with FTC/TDF who were randomly assigned (2:1) either to Stribild(®) (switch) or continuation of their existing regimen (no-switch). Logistic regressions and longitudinal modeling were conducted to evaluate the relationship of treatment with bothersome symptoms.
At week 4 as compared with baseline, the switch group experienced a statistically significantly lower prevalence in five symptoms (diarrhea/loose bowels, bloating/pain/gas in stomach, pain/numbness/tingling in hands/feet, nervous/anxious, and trouble remembering). The lower prevalence of diarrhea/loose bowels, bloating/pain/gas in stomach, and pain/numbness/tingling in hands/feet observed at week 4 was maintained over time. While there were no significant differences between groups in the prevalence of sad/down/depressed and problems with sex at week 4 or week 48, longitudinal models indicated the switch group had a statistically significantly decreased prevalence in both symptoms from week 4 to week 48. As compared with the no-switch group, higher levels of satisfaction with treatment were experienced by patients in the switch group at the first follow-up visit and at week 24.
In this study sample, a switch from a ritonavir-boosted PI, FTC, and TDF regimen to coformulated EVG/COBI/FTC/TDF was associated with more treatment satisfaction and a reduction in the prevalence of patient-reported diarrhea/loose bowel symptoms, which was maintained over the 48-week study period.
复方埃替拉韦、考比司他、恩曲他滨和替诺福韦酯（EVG/COBI/FTC/TDF；捷扶康（Stribild®））是美国卫生与公众服务部及英国HIV协会治疗指南中推荐的基于整合酶抑制剂的治疗方案。本分析的目的是确定换用捷扶康（Stribild®）的HIV感染成人与继续使用含FTC/TDF的蛋白酶抑制剂（PI）的成人相比，患者报告的症状随时间的变化情况。
对STRATEGY-PI研究（GS-US-236-0115，ClinicalTrials.gov NCT01475838）进行二次分析，这是一项针对正在服用含FTC/TDF的PI的HIV感染成人的随机、开放标签3b期试验，这些成人被随机分配（2:1）至捷扶康（Stribild®）组（换药组）或继续其现有治疗方案（未换药组）。进行逻辑回归和纵向建模以评估治疗与困扰症状之间的关系。
与基线相比，在第4周时，换药组有5种症状的患病率在统计学上显著降低（腹泻/大便稀溏、胃部腹胀/疼痛/胀气、手脚疼痛/麻木/刺痛、紧张/焦虑、记忆困难）。第4周时观察到的腹泻/大便稀溏、胃部腹胀/疼痛/胀气以及手脚疼痛/麻木/刺痛的较低患病率随时间持续存在。虽然在第4周或第48周时，两组在悲伤/情绪低落/抑郁和性功能问题的患病率方面无显著差异，但纵向模型表明，从第4周到第48周，换药组这两种症状的患病率在统计学上显著降低。与未换药组相比，换药组患者在首次随访和第24周时对治疗的满意度更高。
在本研究样本中，从利托那韦增强的PI、FTC和TDF方案换用复方EVG/COBI/FTC/TDF与更高的治疗满意度以及患者报告的腹泻/大便稀溏症状患病率降低相关，这种降低在48周的研究期间持续存在。
