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Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK study

机译：雷格列韦在不同人群的HIV感染患者中的安全性，耐受性和有效性：REALMRK研究的48周结果

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The racial diversity and gender distribution of HIV-infected patients make it essential to confirm the safety and efficacy of raltegravir in these populations. A multicenter, open-label, single-arm observational study was conducted in a diverse cohort of HIV-infected patients (goals: ≥25% women; ≥50% blacks in the United States), enrolling treatment-experienced patients failing or intolerant to current antiretroviral therapy (ART) and treatment-naive patients (limited to ≤20%). All patients received raltegravir 400 mg b.i.d. in a combination antiretroviral regimen for up to 48 weeks. A total of 206 patients received study treatment at 34 sites in the United States, Brazil, Dominican Republic, Jamaica, and South Africa: 97 (47%) were female and 153 (74%) were black [116 (56%) in the United States]. Of these, 185 patients were treatment experienced: 97 (47%) were failing and 88 (43%) were intolerant to current therapy; 21 patients (10%) were treatment naive. Among treatment-intolerant patients, 55 (63%) had HIV-1 RNA<50 copies/ml at baseline. Overall, 15% of patients discontinued: 13% of men, 18% of women, 14% of blacks, and 17% of nonblacks. At week 48, HIV RNA was <50 copies/ml in 60/94 (64%) patients failing prior therapy, 61/80 (76%) patients intolerant to prior therapy, and 16/21 (76%) treatment-naive patients. Response rates were similar for men vs. women and black vs. nonblack patients. Drug-related clinical adverse events were reported by 8% of men, 18% of women, 14% of blacks, and 9% of nonblacks. After 48 weeks of treatment in a diverse cohort of HIV-infected patients, raltegravir was generally safe and well tolerated with potent efficacy regardless of gender or race.
机译：HIV感染患者的种族多样性和性别分布，因此必须确定这些人群中raltegravir的安全性和有效性。一项多中心，开放性，单臂观察性研究在不同的艾滋病毒感染患者队列中进行（目标：美国≥25％的女性;黑人≥50％的黑人），接受治疗经历失败或不耐受的患者当前的抗逆转录病毒疗法（ART）和未接受过治疗的患者（限于≤20％）。所有患者均接受raltegravir 400 mg b.i.d.联合抗逆转录病毒疗法长达48周。在美国，巴西，多米尼加共和国，牙买加和南非的34个地点，共有206位患者接受了研究治疗：97位（47％）是女性，153位（74％）是黑人[116位（56％）美国]。其中，有185名患者经历过治疗：97名（47％）失败，88名（43％）不耐受目前的治疗; 21例患者（占10％）未接受过治疗。在不耐受治疗的患者中，有55名（63％）的HIV-1 RNA在基线时<50拷贝/ ml。总体而言，有15％的患者停药：男性13％，女性18％，黑人14％和非黑人17％。在第48周时，先前治疗失败的60/94（64％）患者，对先前治疗不耐受的61/80（76％）患者和未经治疗的16/21（76％）患者的HIV RNA <50拷贝/ ml 。男性与女性以及黑人与非黑人患者的反应率相似。据报告，与药物相关的临床不良事件有8％的男性，18％的女性，14％的黑人和9％的非黑人。在各种HIV感染患者队列中治疗48周后，无论性别或种族，raltegravir通常都是安全的且具有良好的耐受性。

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