Practice Center Blondelstrasse (PZB), Blondelstr. 9, 52062 Aachen, Germany.
Infection. 2010 Apr;38(2):108-16. doi: 10.1007/s15010-009-9249-x. Epub 2010 Mar 29.
The RAINBOW survey is a multinational observational study assessing the tolerability and efficacy of ritonavir-boosted saquinavir (SQV/r), using the 500-mg film-coated SQV formulation, in routine clinical practice. This analysis presents data from the German subgroup of antiretroviral therapy (ART)-naïve and pretreated but protease inhibitor (PI)-naïve patients.
This was a multicenter, prospective, open-label, 48-week observational cohort study. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 48. Efficacy assessments included changes in the proportion of patients with HIV-1 RNA <50 and <400 copies/ml, and changes in CD4 cell count from baseline to week 48.
The analysis included 275 ART-naïve and 179 pretreated but PI-naïve patients. The proportion of ART-naïve patients achieving <50 copies/ml by 48 weeks was 53.1% by intent-to-treat (ITT) analysis and 67.3% using last observation carried forward (LOCF) analysis. In pretreated but PI-naïve patients, the proportions achieving <50 copies/ml by 48 weeks were 53.1% (ITT) and 70.4% (LOCF). The median increase in CD4 count at week 48 was +174 cells/mm3 (interquartile range [IQR] 86, 265) in the ART-naïve group and +100 cells/mm3 (IQR 0, 209) in the pretreated but PI-naïve group (p < 0.01 for both; LOCF). Drug-related adverse events were reported in 7.6% of ART-naïve and 2.8% of pretreated but PI-naïve patients. Treatment with SQV/r was stopped in 21.5% of ART-naïve and 17.9% of pretreated but PI-naïve patients (due to side effects in 3.3% and 2.8%, respectively). There were no clinically relevant changes in liver enzyme levels. Overall, the total cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein levels increased to week 48, although the levels remained within normal ranges in the majority of patients.
The results of this observational cohort study of treatment with the 500-mg tablet formulation of SQV are consistent with high efficacy and tolerability results seen in controlled studies of SQV/r. This analysis confirms that SQV/r is effective and well tolerated in ART-naïve and pretreated but PI-naïve patients in 'real-world' clinical settings.
RAINBOW 研究是一项多中心、观察性研究，评估了在常规临床实践中使用利托那韦增强的沙奎那韦（SQV/r）[500mg 薄膜包衣制剂]的耐受性和疗效。本分析介绍了来自德国的、初治且未接受过蛋白酶抑制剂（PI）治疗的患者的亚组数据。
这是一项多中心、前瞻性、开放性、48 周观察性队列研究。耐受性评估包括从基线到第 48 周时肝酶和血脂水平的变化。疗效评估包括治疗后 HIV-1 RNA<50 拷贝/ml 和<400 拷贝/ml 的患者比例以及 CD4 细胞计数从基线到第 48 周的变化。
分析纳入了 275 例初治和 179 例经治但未接受过 PI 治疗的患者。根据意向治疗（ITT）分析，初治患者在第 48 周时达到 HIV-1 RNA<50 拷贝/ml 的比例为 53.1%，采用最后观察到的结果（LOCF）分析时为 67.3%。在经治但未接受过 PI 治疗的患者中，第 48 周时达到 HIV-1 RNA<50 拷贝/ml 的比例分别为 53.1%（ITT）和 70.4%（LOCF）。初治患者在第 48 周时 CD4 计数中位数增加了 174 个细胞/mm3（四分位距 [IQR] 86，265），而经治但未接受过 PI 治疗的患者增加了 100 个细胞/mm3（IQR 0，209）（均<0.01；LOCF）。初治和经治但未接受过 PI 治疗的患者分别有 7.6%和 2.8%报告了药物相关不良事件。由于不良反应，分别有 21.5%和 17.9%的初治和经治但未接受过 PI 治疗的患者停止了 SQV/r 治疗（分别为 3.3%和 2.8%）。肝酶水平无临床相关变化。总体而言，总胆固醇、甘油三酯、低密度脂蛋白和高密度脂蛋白水平升高至第 48 周，但在大多数患者中仍处于正常值范围内。
这项使用 SQV 500mg 片剂的观察性队列研究结果与 SQV/r 的对照研究中观察到的高疗效和耐受性结果一致。该分析证实，在“真实世界”临床环境中，SQV/r 对初治和经治但未接受过 PI 治疗的患者是有效且耐受良好的。
