Infectious Diseases Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Vall d'Hebron Research Institute, Barcelona, Spain.
J Antimicrob Chemother. 2020 Jul 1;75(7):1955-1960. doi: 10.1093/jac/dkaa072.
The combination of boosted darunavir plus rilpivirine, once daily, could be a convenient, effective and well-tolerated two-drug regimen to achieve HIV suppression in HIV-infected patients.
Multicentre, retrospective cohort study in nine hospitals in Spain. All HIV-infected subjects starting boosted darunavir plus rilpivirine were included, irrespective of their viral load (VL). The primary objective was the percentage of patients with VL <50 copies/mL at 48 weeks. Secondary objectives included changes in CD4+ cell count, lipid profile and renal function.
Eighty-one of 84 patients reached Week 48. Fifty-nine (70.2%) patients had VL <50 copies/mL at baseline and the rest had a median VL of 202 (IQR 98-340) copies/mL. Subjects had a median of 21 years of infection with six prior regimens. The main reasons for starting boosted darunavir plus rilpivirine were simplification (44%), kidney or bone toxicity (28.6%) and virological failure (17.9%). Historical genotypes from 47 patients showed 41 (87.2%) patients with NRTI RAMs, 21 (44.7%) with NNRTI RAMs, 12 (25.5%) with primary PI RAMs and 7 (14.9%) with integrase strand transfer inhibitor (INSTI) RAMs. One patient had low-level resistance to boosted darunavir and five patients had some resistance to rilpivirine. At 48 weeks, 71 (87.7%) patients had VL <50 copies/mL. According to undetectable or detectable baseline VL, effectiveness was 91.1% or 80%, respectively. There were four virological failures with no emergence of new RAMs. Three of these patients resuppressed viraemia while maintaining the same regimen.
The combination of boosted darunavir plus rilpivirine has shown good effectiveness and tolerability in this cohort of pretreated patients with a long-lasting HIV infection, exposure to multiple antiretroviral regimens and prior HIV resistance.
每日一次的强化达芦那韦/利匹韦林方案，可能是一种方便、有效且耐受性良好的两药方案，可用于实现 HIV 感染者的病毒抑制。
这是一项在西班牙 9 家医院进行的多中心回顾性队列研究。所有开始强化达芦那韦/利匹韦林治疗的 HIV 感染者，无论其病毒载量（VL）如何，均被纳入研究。主要研究终点为治疗 48 周时 VL<50 拷贝/ml 的患者比例。次要研究终点包括 CD4+细胞计数、血脂谱和肾功能的变化。
84 例患者中有 81 例完成了 48 周随访。59 例（70.2%）患者基线时 VL<50 拷贝/ml，其余患者的中位 VL 为 202（IQR 98-340）拷贝/ml。患者的中位感染时间为 21 年，曾接受过 6 种治疗方案。开始强化达芦那韦/利匹韦林治疗的主要原因是方案简化（44%）、肾毒性或骨毒性（28.6%）和病毒学失败（17.9%）。47 例患者的既往基因型显示，41 例（87.2%）存在核苷逆转录酶抑制剂（NRTI）耐药相关突变、21 例（44.7%）存在非核苷逆转录酶抑制剂（NNRTI）耐药相关突变、12 例（25.5%）存在蛋白酶抑制剂（PI）耐药相关突变、7 例（14.9%）存在整合酶抑制剂耐药相关突变。1 例患者对强化达芦那韦存在低度耐药，5 例患者对利匹韦林存在一定程度耐药。治疗 48 周时，71 例（87.7%）患者的 VL<50 拷贝/ml。根据基线 VL 是否可检测到，疗效分别为 91.1%和 80%。有 4 例患者发生病毒学失败，但均未出现新的耐药突变。这 3 例患者在维持原方案的情况下再次抑制了病毒血症。
在这组具有长期 HIV 感染、暴露于多种抗逆转录病毒方案和既往 HIV 耐药的经治患者中，强化达芦那韦/利匹韦林联合方案显示出良好的疗效和耐受性。
