Airoldi Monica, Zaccarelli Mauro, Bisi Luca, Bini Teresa, Antinori Andrea, Mussini Cristina, Bai Francesca, Orofino Giancarlo, Sighinolfi Laura, Gori Andrea, Suter Fredy, Maggiolo Franco
Division of Infectious Diseases, Ospedali Riuniti, Bergamo;
Patient Prefer Adherence. 2010 May 13;4:115-25. doi: 10.2147/ppa.s10330.
The aim of the ADONE (ADherence to ONE pill) study was to verify the effect of a reduced number of pills on adherence and quality of life (QoL) in HIV-infected patients on highly active antiretroviral therapy (HAART).
Prospective, multicenter, study.
Patients chronically treated with emtricitabine (FTC) + tenofovir (TDF) + efavirenz (EFV) or lamivudine (3TC) +TDF +EFV and with a HIV-RNA < 50 copies/mL were switched to the single-pill fixed-dose regimen (FDR) of FTC +TDF +EFV. Data were collected with SF-36 using visual analog scales. Results of the final (6 months) primary as-treated analysis are reported.
212 patients (77.4% males) of mean age 45.8 years were enrolled; 202 completed the study. One month post switch to FDR the adherence rate increased significantly to 96.1% from a baseline value of 93.8% (P < 0.01). The increase was steadily maintained throughout the study (96.2% at 6 months). QoL improved over time from 68.8% to 72.7% (P = 0.042) as well, and was significantly associated with the perception of health status, presence of adverse events (AEs) and number of reported AEs (P < 0.0001). QoL significantly influenced adherence (P < 0.0001). During FDR use the mean CD4 count increased from 556 to 605 cells/muL (P < 0.0001). At the end of follow-up 98% of patients maintained HIV-RNA level < 50 copies/mL and 100% <400 copies/mL. Four patients stopped therapy because they were lost to follow-up and 6 because of AEs (insomnia/nervousness 4, allergy 1, difficulties swallowing pills 1).
By substituting a one-pill once-a-day HAART, we observed an improvement of both adherence and QoL while maintaining high virologic and immunologic efficacy. HAART simplicity is an added value that favors adherence and may improve long-term success.
ADONE（坚持服用单片药物）研究的目的是验证在接受高效抗逆转录病毒治疗（HAART）的HIV感染患者中，减少药片数量对依从性和生活质量（QoL）的影响。
前瞻性、多中心研究。
长期接受恩曲他滨（FTC）+替诺福韦（TDF）+依非韦伦（EFV）或拉米夫定（3TC）+TDF+EFV治疗且HIV-RNA＜50拷贝/mL的患者换用FTC+TDF+EFV单片固定剂量方案（FDR）。使用视觉模拟量表通过SF-36收集数据。报告最终（6个月）实际治疗分析的结果。
纳入212例患者（77.4%为男性），平均年龄45.8岁；202例完成研究。换用FDR后1个月，依从率从基线值（93.8%）显著提高至96.1%（P＜0.01）。在整个研究过程中该增幅持续保持（6个月时为96.2%）。生活质量也随时间从68.8%提高至72.7%（P=0.042），且与健康状况感知、不良事件（AE）的存在及报告的AE数量显著相关（P＜0.0001）。生活质量显著影响依从性（P＜0.0001）。在使用FDR期间，平均CD4细胞计数从556增至605个/μL（P＜0.0001）。随访结束时，98%的患者HIV-RNA水平维持在＜50拷贝/mL，100%维持在＜400拷贝/mL。4例患者因失访停止治疗，6例因AE（失眠/紧张4例、过敏1例、吞咽药片困难1例）停止治疗。
通过改用每日一次的单片HAART，我们观察到依从性和生活质量均得到改善，同时维持了较高的病毒学和免疫学疗效。HAART的简化是有利于依从性且可能改善长期治疗效果的一个附加价值。
