Saumoy Maria, Llibre Josep M, Terrón Alberto, Knobel Hernando, Arribas José Ramón, Domingo Pere, Arroyo-Manzano David, Rivero Antonio, Moreno Santiago, Podzamczer Daniel
1 HIV and STD Unit, Infectious Diseases Service, Bellvitge University Hospital , Bellvitge Biomedical Research Institute, Hospitalet de Llobregat, Spain .
2 Hospital Universitari Germans Trias i Pujol , Badalona, Spain .
AIDS Res Hum Retroviruses. 2017 Jan;33(1):29-32. doi: 10.1089/AID.2015.0386. Epub 2016 Dec 20.
To assess the efficacy and safety of maraviroc (MVC) administered once-daily in routine clinical practice. A retrospective multicenter study (27 centers in Spain) was conducted. Data were collected from the records of patients starting a regimen with MVC. Laboratory and clinical data were recorded every 3 months the first year and every 6 months thereafter. Data are presented as median and interquartile range. Among 667 patients treated with MVC, 142 (21.3%) received MVC once-daily: 108 (76.1%), 150 mg and 34 (23.9%), and 300 mg. Age was 47 (42-45) years, there were 76.1% men, and 81 (57%) patients had baseline HIV-RNA <50 copies/mL. Viral tropism was R5 in 118 (83.1%) patients. Reasons for prescribing MVC: salvage therapy (36.6%), drug toxicity (31.2%), simplification (16.9%), and immunodiscordant response (7.1%). Median follow-up was 13 (9-16) months. In 95.8%, a PI/r was part of the regimen (67% on dual therapy). At months 12 and 24, 73.3% and 68.2% of patients had HIV-RNA <50 copies/mL, respectively (p = .041 and p < .001 vs. baseline). CD4 cell count increased by a median of 52 (-36,135) and 84 (-9.5,180) cells/mm at 12 and 24 months, respectively (p < .001 and p = .039 vs. baseline). Twenty-five (17.6%) patients discontinued MVC: virologic failure (6), medical decision (5), and other reasons (14). Two patients presented grade 3 adverse events (hypertransaminasemia, hypertriglyceridemia) without the need for MVC withdrawal, whereas MVC was discontinued in two patients due to gastrointestinal toxicity. In routine clinical practice, MVC once-daily combined with at least PI/r was virologically effective and well tolerated in a high percentage of pretreated patients.
评估在常规临床实践中每日一次服用马拉维若（MVC）的疗效和安全性。开展了一项回顾性多中心研究（西班牙的27个中心）。从开始使用MVC治疗方案的患者记录中收集数据。第一年每3个月记录一次实验室和临床数据，此后每6个月记录一次。数据以中位数和四分位间距表示。在667例接受MVC治疗的患者中，142例（21.3%）每日一次服用MVC：108例（76.1%）服用150mg，34例（23.9%）服用300mg。年龄为47（42 - 45）岁，男性占76.1%，81例（57%）患者基线HIV-RNA<50拷贝/mL。118例（83.1%）患者的病毒嗜性为R5。开具MVC的原因：挽救治疗（36.6%）、药物毒性（31.2%）、简化治疗方案（16.9%）和免疫不一致反应（7.1%）。中位随访时间为13（9 - 16）个月。95.8%的患者治疗方案中包含蛋白酶抑制剂/利托那韦（PI/r）（67%接受双重治疗）。在第12个月和第24个月时，分别有73.3%和68.2%的患者HIV-RNA<50拷贝/mL（与基线相比，p = 0.041和p<0.001）。在第12个月和第24个月时，CD4细胞计数分别中位数增加52（-36,135）和84（-9.5,180）个细胞/mm³（与基线相比，p<0.001和p = 0.039）。25例（17.6%）患者停用MVC：病毒学失败（6例）、医疗决策（5例）和其他原因（14例）。2例患者出现3级不良事件（高转氨酶血症、高甘油三酯血症），无需停用MVC，而2例患者因胃肠道毒性停用MVC。在常规临床实践中，每日一次服用MVC联合至少一种PI/r对大部分接受过治疗的患者在病毒学方面有效且耐受性良好。
