对于HIV-1得到抑制的患者，改用马拉维若与达芦那韦/利托那韦联合使用（均为每日一次），耐受性良好，但病毒学效果劣于标准抗逆转录病毒疗法：一项随机试验的48周结果
Switch to maraviroc with darunavir/r, both QD, in patients with suppressed HIV-1 was well tolerated but virologically inferior to standard antiretroviral therapy: 48-week results of a randomized trial.
作者信息
Rossetti Barbara, Gagliardini Roberta, Meini Genny, Sterrantino Gaetana, Colangeli Vincenzo, Re Maria Carla, Latini Alessandra, Colafigli Manuela, Vignale Francesca, Rusconi Stefano, Micheli Valeria, Di Biagio Antonio, Orofino Giancarlo, Ghisetti Valeria, Fantauzzi Alessandra, Vullo Vincenzo, Grima Pierfrancesco, Francisci Daniela, Mastroianni Claudio, Antinori Andrea, Trezzi Michele, Lisi Lucia, Navarra Pierluigi, Canovari Benedetta, D'Arminio Monforte Antonella, Lamonica Silvia, D'Avino Alessandro, Zazzi Maurizio, Di Giambenedetto Simona, De Luca Andrea
机构信息
Infectious Diseases Unit, Azienda Ospedaliera Universitaria Senese, Siena, Italy.
Clinic of Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.
出版信息
PLoS One. 2017 Nov 21;12(11):e0187393. doi: 10.1371/journal.pone.0187393. eCollection 2017.
OBJECTIVES
Primary study outcome was absence of treatment failure (virological failure, VF, or treatment interruption) per protocol at week 48.
METHODS
Patients on 3-drug ART with stable HIV-1 RNA <50 copies/mL and CCR5-tropic virus were randomized 1:1 to maraviroc with darunavir/ritonavir qd (study arm) or continue current ART (continuation arm).
RESULTS
In June 2015, 115 patients were evaluable for the primary outcome (56 study, 59 continuation arm). The study was discontinued due to excess of VF in the study arm (7 cases, 12.5%, vs 0 in the continuation arm, p = 0.005). The proportion free of treatment failure was 73.2% in the study and 59.3% in the continuation arm. Two participants in the study and 10 in the continuation arm discontinued therapy due to adverse events (p = 0.030). At VF, no emergent drug resistance was detected. Co-receptor tropism switched to non-R5 in one patient. Patients with VF reported lower adherence and had lower plasma drug levels. Femoral bone mineral density was significantly improved in the study arm.
CONCLUSION
Switching to maraviroc with darunavir/ritonavir qd in virologically suppressed patients was associated with improved tolerability but was virologically inferior to 3-drug therapy.
目的
主要研究结果是在第48周时根据方案无治疗失败（病毒学失败、VF或治疗中断）。
方法
接受三联抗逆转录病毒治疗且HIV-1 RNA稳定<50拷贝/mL且为CCR5嗜性病毒的患者按1:1随机分为接受马拉维罗与达芦那韦/利托那韦每日一次治疗组（研究组）或继续当前抗逆转录病毒治疗组（继续治疗组）。
结果
2015年6月，115例患者可对主要结果进行评估（研究组56例，继续治疗组59例）。由于研究组VF过多（7例，12.5%，而继续治疗组为0例，p = 0.005），该研究提前终止。研究组无治疗失败的比例为73.2%，继续治疗组为59.3%。研究组有2名参与者和继续治疗组有10名参与者因不良事件停止治疗（p = 0.030）。在出现VF时，未检测到新出现的耐药性。一名患者的共受体嗜性转换为非R5。出现VF的患者报告依从性较低且血浆药物水平较低。研究组股骨骨密度显著改善。
结论
在病毒学抑制的患者中换用每日一次的马拉维罗与达芦那韦/利托那韦治疗与耐受性改善相关，但在病毒学方面劣于三联药物治疗。
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