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与依法韦仑相比,马拉维若联合齐多夫定/拉米夫定的疗效和安全性:MERIT研究的96周结果

Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study.

作者信息

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

机构信息

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, CIFBIOTEC Medica Sur, Tlalpan, Mexico.

出版信息

HIV Clin Trials. 2010 May-Jun;11(3):125-32. doi: 10.1310/hct1103-125.

Abstract

BACKGROUND

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.

METHODS

Week 96 efficacy (post hoc, n = 614) and safety (n = 721) were assessed.

RESULTS

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.

CONCLUSION

Week 96 data confirm week 48 observations in MERIT.

摘要

背景

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。

方法

评估了第96周的疗效(事后分析,n = 614)和安全性(n = 721)。

结果

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。

结论

第96周的数据证实了MERIT研究中第48周的观察结果。

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