Nozza Silvia, Galli Laura, Bigoloni Alba, Gianotti Nicola, Spagnuolo Vincenzo, Carbone Alessia, Chiappetta Stefania, Ripa Marco, Tambussi Giuseppe, Lazzarin Adriano, Castagna Antonella
Department of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy.
New Microbiol. 2014 Apr;37(2):145-51. Epub 2014 Apr 1.
Aim of this study was to report the 204-week efficacy and safety results of a novel PI- and NRTI-sparing regimen for salvage therapy including maraviroc, raltegravir, etravirine in 28 failing HIV-infected patients with R5-tropic virus. The trend of laboratory parameters was tested by ANOVA for repeated measures and Greenhouse-Geisser probabilities were reported. Results were described as median (Q1-Q3) values. Twenty-six (93%) out of 28 patients completed 204 weeks of treatment. Virological success (HIV-RNA<50 copies/mL) at week 204 was 96%. CD4+ counts significantly increased [244 (158-213) cells/mm3, p<0.0001] from baseline [247 (68-355) cells/mm(3)] as well as CD4+ percentage. Four serious adverse events (1 death due to Hodgkins's lymphoma, 1 anal cancer, 1 Hodgkins's lymphoma, 1 recurrence of mycobacterial spondylodiscitis) were observed; three events led to transitory discontinuation of the antiretroviral therapy due to drug-drug interaction. BMI (p<0.0001) and waist circumference (p<0.0001) significantly increased over 204 weeks. An amelioration was also observed in relation to haemoglobin (p=0.0006), platelets (p<0.0001), white blood cell (p=0.013), neutrophils (p=0.301), lymphocytes (p=0.207) and creatinine (p<0.0001). In highly treatment-experienced patients the maraviroc, raltegravir and etravirine combination is associated with a good long-term efficacy and safety profile.
本研究的目的是报告一种新型的无需蛋白酶抑制剂（PI）和核苷类逆转录酶抑制剂（NRTI）的挽救治疗方案在28例R5嗜性病毒感染且治疗失败的HIV患者中的204周疗效和安全性结果。该方案包括马拉维罗、拉替拉韦和依曲韦林。实验室参数的趋势通过重复测量方差分析进行检验，并报告Greenhouse-Geisser概率。结果以中位数（Q1-Q3）值描述。28例患者中有26例（93%）完成了204周的治疗。第204周时病毒学成功（HIV-RNA<50拷贝/mL）率为96%。CD4+细胞计数从基线时的[247（68-355）个细胞/mm³]显著增加至[244（158-213）个细胞/mm³，p<0.0001]，CD4+百分比也显著增加。观察到4例严重不良事件（1例因霍奇金淋巴瘤死亡、1例肛门癌、1例霍奇金淋巴瘤、1例分枝杆菌性脊椎间盘炎复发）；3例事件因药物相互作用导致抗逆转录病毒治疗暂时中断。在204周内，体重指数（p<0.0001）和腰围（p<0.0001）显著增加。血红蛋白（p=0.0006）、血小板（p<0.0001）、白细胞（p=0.013）、中性粒细胞（p=0.301）、淋巴细胞（p=0.207）和肌酐（p<0.0001）也有改善。在治疗经验丰富的患者中，马拉维罗、拉替拉韦和依曲韦林联合使用具有良好的长期疗效和安全性。
