Macías J, Recio E, Márquez M, García C, Jiménez P, Merino D, Muñoz L, Pasquau J, Ojeda G, Bancalero P, Chueca N, Pineda J A
Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain; Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain.
HIV Med. 2014 Aug;15(7):417-24. doi: 10.1111/hiv.12129. Epub 2014 Feb 24.
Nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens may be needed in patients with NRTI toxicity. Maraviroc (MVC) plus ritonavir-boosted darunavir (DRV-r) or atazanavir is associated with slightly lower response rates than triple therapy in drug-naïve patients. No information is available on these combinations in pretreated patients. The aim of this study was to assess the efficacy and safety of MVC plus DRV/r once-daily (qd) in HIV-infected pretreated patients.
A retrospective cohort study including patients starting MVC 150 mg plus DRV/r 800/100 mg qd, with CCR5 tropism and no resistance mutations for DRV/r, was performed. The primary efficacy endpoint was the achievement of plasma HIV RNA < 50 HIV-1 RNA copies/mL after 48 weeks. The frequency of serious adverse effects was investigated.
Sixty patients were recruited to the study, of whom 48 (80%) had HIV RNA < 50 copies/mL at baseline. Reasons for starting MVC plus DRV/r were: adverse effects in 38 individuals (63%), simplification in 15 (25%) and virological failure in seven (12%). The main analysis (intention to treat, noncompleter = failure) showed that 47 patients (78%) achieved HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). On-treatment analysis showed that 42 (86%) of 49 patients presented HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). Median (interquartile range) CD4 cell counts increased from 491 (301-729) to 561 (367-793) cells/μL at 48 weeks (P = 0.013). Only one patient discontinued therapy because of adverse effects.
Most individuals starting MVC plus DRV/r qd because of simplification or adverse effects maintained HIV suppression after 48 weeks of follow-up.
核苷类逆转录酶抑制剂（NRTI）毒性患者可能需要采用不含NRTI的治疗方案。在初治患者中，马拉维罗（MVC）联合利托那韦增强的达芦那韦（DRV-r）或阿扎那韦的治疗有效率略低于三联疗法。目前尚无关于这些联合用药方案在经治患者中的相关信息。本研究旨在评估MVC联合DRV/r每日一次（qd）用于HIV感染经治患者的疗效和安全性。
开展一项回顾性队列研究，纳入开始服用MVC 150mg联合DRV/r 800/100mg qd、具有CCR5嗜性且对DRV/r无耐药突变的患者。主要疗效终点为48周后血浆HIV RNA＜50拷贝/mL。调查严重不良反应的发生频率。
60例患者纳入本研究，其中48例（80%）基线时HIV RNA＜50拷贝/mL。开始MVC联合DRV/r治疗的原因有：38例（63%）出现不良反应，15例（25%）为简化治疗方案，7例（12%）为病毒学失败。主要分析（意向性分析，未完成治疗者视为治疗失败）显示，47例患者（78%）在48周时HIV RNA＜50拷贝/mL（与基线进行配对比较，P = 1.0）。治疗中分析显示，49例患者中有42例（86%）在48周时HIV RNA＜50拷贝/mL（与基线进行配对比较，P = 1.0）。48周时CD4细胞计数中位数（四分位间距）从491（301 - 729）个/μL增至561（367 - 793）个/μL（P = 0.013）。仅1例患者因不良反应停药。
多数因简化治疗方案或不良反应开始服用MVC联合DRV/r qd的患者在随访48周后维持了HIV抑制状态。
