Department of Pharmacy Services, Complejo Hospitalario de Navarra, C/Irunlarrea 3, 31008, Pamplona, Spain.
Int J Clin Pharm. 2012 Dec;34(6):911-6. doi: 10.1007/s11096-012-9692-5. Epub 2012 Sep 25.
Previous studies have evaluated the simplification of HIV treatment with ritonavir-boosted protease inhibitor monotherapy, demonstrating acceptable efficacy and advantages such as avoidance of the adverse effects of reverse transcriptase inhibitors. To achieve the best results, patients should be appropriately selected for this therapy.
The purpose of this study was to estimate the proportion of HIV patients suitable for boosted protease inhibitor monotherapy according to clinical trial criteria. Setting The study was conducted in the outpatient hospital pharmacy service of the Complejo Hospitalario de Navarra in northern Spain.
A retrospective analysis was performed on data from 635 adults on antiretroviral therapy. The eligibility criteria were: (1) >18 years of age; (2) prior triple-drug antiretroviral regimen; (3) durability of current treatment >18 months; (4) viral load <400 copies/mL over the 18 months before evaluation and <50 copies/mL over the last 6 months; (5) CD4 count ≥250 cells/μL; (6) CD4 count nadir >100 cells/μL; (7) no previous virological failure under prior protease inhibitor-based regimen; (8) absence of co-infection with hepatitis B virus; (9) absence of HIV-related neurological disease; and (10) adherence >95 %. The average cost of the current treatment was calculated for patients who met all criteria, as well as the potential economic impact of simplification to monotherapy.
Number of patients meeting all criteria for simplification to monotherapy according to clinical trial standards.
One hundred and three patients (16.5 %) met the clinical trial criteria for protease inhibitor monotherapy. One hundred and fifty patients (24 %) failed to fulfil only one of the conditions. Fifty-four percent of the patients who met all of the criteria had been treated for more than 10 years. The average saving per patient per year was
This treatment strategy represents a realistic, albeit minority, option. Fulfilment of the above conditions should be the basis for simplification to protease inhibitor monotherapy, though the final decision depends on clinical criteria and patient preferences assessed by the attending physician. Further studies are needed to confirm long-term safety and efficacy.
先前的研究已经评估了简化 HIV 治疗方案，即使用利托那韦增效蛋白酶抑制剂单药治疗，证明其具有可接受的疗效，并且避免了逆转录酶抑制剂的不良反应等优势。为了达到最佳效果，应该对患者进行适当的选择。
本研究旨在根据临床试验标准，评估适合接受增效蛋白酶抑制剂单药治疗的 HIV 患者的比例。
本研究在西班牙北部纳瓦拉综合医院的门诊药房进行。
对 635 名接受抗逆转录病毒治疗的成年人进行回顾性分析。入选标准为：（1）年龄>18 岁；（2）有过三联抗逆转录病毒治疗方案；（3）目前的治疗方案持续时间>18 个月；（4）在评估前的 18 个月内病毒载量<400 拷贝/ml，且过去 6 个月内病毒载量<50 拷贝/ml；（5）CD4 计数≥250 个/μL；（6）CD4 计数最低点>100 个/μL；（7）既往蛋白酶抑制剂治疗方案无病毒学失败；（8）无乙型肝炎病毒合并感染；（9）无 HIV 相关神经疾病；（10）依从性>95%。对符合所有标准的患者计算了目前治疗方案的平均费用，以及简化为单药治疗的潜在经济影响。
根据临床试验标准，简化为单药治疗的患者符合所有标准的人数。
103 名患者（16.5%）符合蛋白酶抑制剂单药治疗的临床试验标准。150 名患者（24%）仅不符合其中一项条件。54%符合所有标准的患者治疗时间超过 10 年。每名患者每年的平均节省费用为
这种治疗策略是现实的，尽管是少数选择。符合上述条件应是简化为蛋白酶抑制剂单药治疗的基础，但最终决策取决于临床标准和经治医生评估的患者偏好。需要进一步研究以确认长期安全性和疗效。
