Di Benedetto Nicolás, Montero-Alonso Marta, Blanes Marino, Lacruz José, Cuellar Sandra, Calabuig Eva, López José, Salavert Miguel
Nicolás Di Benedetto, Unidad de Enfermedades Infecciosas. Hospital Universitario y Politécnico La Fe. Av. Fernando Abril Martorell, 106. 46026. Valencia, Spain.
Rev Esp Quimioter. 2015 Oct;28(5):235-41.
Boosted protease inhibitor monotherapy may offer antiviral efficacy while reducing drug interactions, costs and toxicity. The aim of this study was to assess the efficacy of darunavir/ritonavir (DRV/r) and lopinavir/ritonavir (LPV/r) monotherapy in a real life setting.
A retrospective analysis of all HIV infected patients, who had initiated DRV/r or LPV/r monotherapy, was performed. Patients whose HIV viral load had remained undetectable for at least two consecutive follow-up visits and who had no neurocognitive disorder or hepatitis B co-infection, were included.
Sixty patients were included. The median (IQR) time to follow-up was 66 (33-118) weeks. The proportions (CI95%) of patients with virological failure were 6.3% (1.7- 20.2) and 25.0% (12.7-43.4), respectively, in the DRV/r and LPV/r groups (p= 0.0424). The proportions (CI95%) of patients with therapeutic success were 90.6% (80.5-100) in the DRV/r group and 60.7% (42.6-78.8) in the LPV/r group (p=0.0063). No protease inhibitor mutations were detected. During the follow-up, 6 patients with dyslipidemia normalized their lipid values. The median monthly cost was 410 (IQR 242-416) euros per person lower for the monotherapy than for the combined antiretroviral therapy.
Boosted protease inhibitor monotherapy was effective in a real life setting. This study showed differences in favour of DRV/r as compared with LPV/r in terms of therapeutic success; however prospective studies are needed to confirm these results. Finally, although this study was not specifically designed to detect benefits in terms of costs and lipid profile, it shows evidence of a positive impact of monotherapy in these fields.
增强型蛋白酶抑制剂单药治疗可能在提供抗病毒疗效的同时减少药物相互作用、成本和毒性。本研究的目的是评估在现实生活环境中达芦那韦/利托那韦（DRV/r）和洛匹那韦/利托那韦（LPV/r）单药治疗的疗效。
对所有开始接受DRV/r或LPV/r单药治疗的HIV感染患者进行回顾性分析。纳入那些HIV病毒载量在至少连续两次随访中一直未检测到且没有神经认知障碍或乙肝合并感染的患者。
纳入60例患者。随访的中位（四分位间距）时间为66（33 - 118）周。DRV/r组和LPV/r组病毒学失败患者的比例（95%置信区间）分别为6.3%（1.7 - 20.2）和25.0%（12.7 - 43.4）（p = 0.0424）。DRV/r组治疗成功患者的比例（95%置信区间）为90.6%（'80.5 - 100），LPV/r组为60.7%（42.6 - 78.8）（p = 0.0063）。未检测到蛋白酶抑制剂突变。随访期间，6例血脂异常患者的血脂值恢复正常。单药治疗的人均每月成本比联合抗逆转录病毒治疗低410（四分位间距242 - 416）欧元。
增强型蛋白酶抑制剂单药治疗在现实生活环境中是有效的。本研究显示，在治疗成功方面，与LPV/r相比，DRV/r更具优势；然而，需要前瞻性研究来证实这些结果。最后，尽管本研究并非专门设计用于检测成本和血脂方面的益处，但它显示了单药治疗在这些领域产生积极影响的证据。
