Sierra-Madero Juan, Di Perri Giovanni, Wood Robin, Saag Michael, Frank Ian, Craig Charles, Burnside Robert, McCracken Jennifer, Pontani Dennis, Goodrich James, Heera Jayvant, Mayer Howard
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, CIFBIOTEC Medica Sur, Tlalpan, Mexico.
HIV Clin Trials. 2010 May-Jun;11(3):125-32. doi: 10.1310/hct1103-125.
The MERIT study evaluated maraviroc versus efavirenz, both with zidovudine/lamivudine, in treatment-naïve patients with CCR5-tropic (R5) HIV-1. Post hoc analyses previously assessed week 48 outcomes in patients rescreened with R5 virus by a more sensitive tropism assay.
Week 96 efficacy (post hoc, n = 614) and safety (n = 721) were assessed.
Proportions of subjects <50 copies/mL (58.8% maraviroc, 62.7% efavirenz) and time to loss of virologic response (TLOVR) responders (<50 copies/mL: 60.5% vs 60.7%) were similar. Maraviroc recipients had greater CD4 increases (+ 212 vs + 171 cells/mm(3)) and fewer adverse event discontinuations (6.1% vs 15.5%), malignancies, and category C events.
Week 96 data confirm week 48 observations in MERIT.
MERIT研究评估了马拉维罗与依非韦伦(两者均联合齐多夫定/拉米夫定)在初治的CCR5嗜性(R5)HIV-1患者中的疗效。事后分析先前评估了通过更敏感的嗜性检测重新筛查出R5病毒的患者在第48周时的结局。
评估了第96周的疗效(事后分析,n = 614)和安全性(n = 721)。
病毒载量<50拷贝/毫升的受试者比例(马拉维罗为58.8%,依非韦伦为62.7%)以及病毒学应答丧失时间(TLOVR)的应答者比例(<50拷贝/毫升:60.5%对60.7%)相似。接受马拉维罗治疗的患者CD4增加更多(+212对+171个细胞/立方毫米),因不良事件停药的情况更少(6.1%对15.5%),恶性肿瘤和C类事件也更少。
第96周的数据证实了MERIT研究中第48周的观察结果。