Klinikum der Johann-Wolfgang-Goethe-Universität, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany.
Eur J Med Res. 2010 Sep 24;15(9):369-76. doi: 10.1186/2047-783x-15-9-369.
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 protease inhibitor (PI)-pretreated, but SQV-naive patients.
multicenter, prospective, open-label, 48 week cohort study. Efficacy assessments included the proportion of patients with HIV-1 RNA <50 and <400 copies/mL and changes in CD4 cell count from baseline to week 48. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 48.
a total of 426 patients were included in the analysis. The proportion of patients with HIV RNA levels <50 copies/mL at week 48 was 60.3 % (compared with 31.7% at switch to SQV/r) (intent-to-treat, last observation carried forward analysis). After 48 weeks, median CD4 count increased by +61 cells/mm3 from baseline (p<0.01) and 60.3% of patients achieved HIV-1 RNA <50 copies/mL. Median changes in fasting triglyceride levels (stratified according to baseline level) at week 48 were: +14 mg/dL (IQR -8; 57) for patients with baseline triglyceride <200 mg/dL; -50 mg/dL (IQR -139; 0) for baseline triglyceride 200-750 mg/dL, and -656 mg/dL (IQR -1024; 0) for baseline triglyceride >750 mg/dL (p<0.01 for all). Median changes in fasting total cholesterol (TC) levels (stratified according to baseline) were +16 mg/dL (IQR -3; 43) for patients with baseline TC <200 mg/dL (p<0.01), -3 mg/dL (IQR -25; 25) for baseline TC 200-300 mg/dL (p = 0.4), and -47 mg/dL (IQR -87; -4) for baseline TC >300 mg/dL (p<0.01). No significant changes in liver enzymes or bilirubin were observed. SQV treatment was discontinued in 22% of patients, 6% due to side effects.
these data confirm the efficacy and tolerability of SQV/r in PI-experienced, SQV-naive patients treated in a real-life clinical setting. Of particular relevance are the improvements in triglycerides and TC levels observed in patients with baseline grade III-IV elevations.
RAINBOW 研究是一项多中心观察性研究，评估了利托那韦增强的沙奎那韦（SQV/r）在常规临床实践中的耐受性和疗效，使用的是 500mg 薄膜包衣 SQV 制剂。本分析报告了蛋白酶抑制剂（PI）预处理但 SQV 初治患者的德国亚组数据。
多中心、前瞻性、开放性、48 周队列研究。疗效评估包括 HIV-1 RNA<50 和<400 拷贝/ml 的患者比例，以及从基线到第 48 周 CD4 细胞计数的变化。耐受性评估包括从基线到第 48 周肝酶和血脂水平的变化。
共纳入 426 例患者进行分析。第 48 周时 HIV RNA 水平<50 拷贝/ml 的患者比例为 60.3%（与换用 SQV/r 时的 31.7%相比）（意向治疗，最后观察到的向前分析）。48 周后，中位 CD4 计数从基线增加了+61 个细胞/mm3（p<0.01），60.3%的患者达到了 HIV-1 RNA<50 拷贝/ml。根据基线水平分层，第 48 周时空腹甘油三酯水平的中位数变化为：基线甘油三酯<200mg/dL 的患者为+14mg/dL（IQR-8；57）；基线甘油三酯 200-750mg/dL 的患者为-50mg/dL（IQR-139；0）；基线甘油三酯>750mg/dL 的患者为-656mg/dL（IQR-1024；0）（所有 p<0.01）。根据基线水平分层，空腹总胆固醇（TC）水平的中位数变化为：基线 TC<200mg/dL 的患者为+16mg/dL（IQR-3；43）（p<0.01），基线 TC 200-300mg/dL 的患者为-3mg/dL（IQR-25；25）（p=0.4），基线 TC>300mg/dL 的患者为-47mg/dL（IQR-87；-4）（p<0.01）。未观察到肝酶或胆红素的显著变化。由于不良反应，22%的患者停止了 SQV 治疗，其中 6%的患者停止了治疗。
这些数据证实了 SQV/r 在 PI 经验丰富、SQV 初治患者中的疗效和耐受性，在基线 III-IV 级升高的患者中观察到甘油三酯和 TC 水平的改善尤为重要。
