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首页> 外文期刊>Current HIV Research >Saquinavir/Ritonavir Monotherapy as a New Nucleoside-Sparing Maintenance Strategy in Long-Term Virologically Suppressed HIVInfected Patients
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Saquinavir/Ritonavir Monotherapy as a New Nucleoside-Sparing Maintenance Strategy in Long-Term Virologically Suppressed HIVInfected Patients

机译：沙奎那韦/利托那韦单药治疗是长期病毒学抑制的HIV感染患者的一种新的保留核苷的维持策略

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Background: The high antiviral potency and low toxicity of saquinavir/ritonavir (SQV/r) prompted us to assess a viable strategy in chronic virologically suppressed HIV-infected patients.nnMethods: A randomized, multicenter pilot trial. Patients taking triple HAART with (VL < 50 copies/mL) and no history of virological failure with a protease inhibitor (PI) or PI-related resistance were assigned in a 2:1 ratio to receive SQV 1000 mg/ritonavir 100 mg BID (SQV/r group) or to continue with their habitual treatment (control group). Comparisons were performed using the Mann-Whitney test for medians, the t test or ANOVA for means, and the χ2 or Fisher's exact test for proportions.nnResults: 28 patients were randomized: 17 to the SQV/r group and 11 to the control group. Only 1 patient from the SQV/r group experienced virological failure at week 48. A similar mean increase was observed in CD4+ T-cell counts in both groups at week 48. Three patients (17.6%) from the SQV/r group prematurely interrupted the study for reasons other than virological failure. HDL cholesterol increased significantly at week 48 in the SQV/r group (from 41±11 mg/dL to 56±35, P=.026); patients in the control group showed a decrease in LDL cholesterol (from 129±37 mg/dL to 107±17, P=.028). The median (IQR) trough plasma concentrations of SQV were 760 ng/mL (379.5-1332.25 ng/mL). Three patients had saquinavir concentrations lower than 100 ng/mL.nnConclusion: SQV/r as monotherapy has proven to be a valid, safe, and economical option for virologically suppressed HIV-infected patients, especially in those who experience intolerance or toxicity with nucleoside analogs.
机译：背景：沙奎那韦/利托那韦（SQV / r）的高抗病毒效力和低毒性促使我们评估在慢性病毒学抑制的HIV感染患者中的可行策略。nn方法：一项随机，多中心的先导试验。服用三联HAART（VL <50拷贝/ mL）且无蛋白酶抑制剂（PI）或PI相关耐药性无病毒学失败史的患者，以2：1的比例接受SQV 1000 mg / ritonavir 100 mg BID（ SQV / r组）或继续进行习惯性治疗（对照组）。结果采用Mann-Whitney检验进行中位数比较，采用t检验或ANOVA进行均值比较，对比例进行χ2或Fisher精确检验.nn结果：随机分配28例患者：SQV / r组17例，对照组11例。 SQV / r组中只有1名患者在第48周出现病毒学衰竭。两组在第48周时CD4 + T细胞计数均观察到了相似的平均增长。SQV/ r组中的3名患者（17.6％）提前中断了治疗。进行除病毒学失败之外的其他原因的研究。 SQV / r组在第48周时HDL胆固醇显着增加（从41±11 mg / dL增至56±35，P = .026）；对照组患者的LDL胆固醇降低（从129±37 mg / dL降至107±17，P = .028）。 SQV的中值（IQR）谷血浆浓度为760 ng / mL（379.5-1332.25 ng / mL）。三名患者的沙奎那韦浓度低于100 ng / mL.nn结论：SQV / r已被证明对于病毒学抑制的HIV感染患者，尤其是对核苷类似物有不耐受或毒性的患者，单药治疗是一种有效，安全且经济的选择。

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