Efficacy and safety of switching to raltegravir plus atazanavir dual therapy in pretreated HIV-1-infected patients over 144 weeks: a cohort study.

Pierre Gantner, Christine Koeppel, Marialuisa Partisani, Marie-Laure Batard, Claudine Bernard-Henry, Christine Cheneau, Erik De Mautort, Michele Priester, Patrice Muret, Charlotte Sueur, Samira Fafi-Kremer, David Rey
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引用次数: 8

Abstract

Background: To decrease drug burden among HIV-1-positive adults, we need a new gold standard for antiretroviral therapy maintenance strategies.

Methods: This retrospective study aimed to assess efficacy in maintenance strategy of atazanavir (ATV) and raltegravir (RAL) dual therapy. The proportion of patients with HIV-1 RNA < 40 copies/ml at specific time points was recorded. Immunological response, safety, and pharmacokinetics were assessed.

Results: Overall, 39 patients were switched to a RAL/ATV (n = 32) or RAL/ATV plus ritonavir (n = 7) regimen. Almost all patients (95%) received RAL twice daily. Most patients (70%) received a 400 mg ATV dosing per day, once (26%) or twice daily (44%). The percentages of virological success at weeks 24, 48, 96, and 144 were 92% (95% confidence interval (CI), 83-10), 86% (95% CI, 74-98), 70% (95% CI, 52-88), and 63% (95% CI, 42-84), respectively. Overall, 12 (31%) patients stopped dual therapy: 7 patients because of adverse events, mostly clinical myositis (n = 3). Confirmed virological failure occurred in three patients; two of them developed RAL resistance patterns. A significant increase in the CD4+/CD8 + T-cell ratio was observed at week 48 (p < 0.005). Only grade 1-2 adverse events were observed. Trough plasma levels presented a wide variability. Suggested trough concentrations were achieved in 79% and 94% of patients for ATV and RAL, respectively. An unboosted 400 mg per day ATV dosing seemed to be appropriate, regarding the targeted levels achieved and the lack of grade 3 or 4 hyperbilirubinemia.

Conclusions: We demonstrated, on a 3-year follow-up, the efficacy and safety of RAL plus ATV maintenance dual therapy.

转换为雷替格拉韦加阿扎那韦双药治疗144周以上hiv -1感染患者的疗效和安全性:一项队列研究
背景:为了减少hiv -1阳性成人的药物负担,我们需要一个新的抗逆转录病毒治疗维持策略的黄金标准。方法:回顾性研究阿扎那韦(ATV)和雷替格拉韦(raltegravir)双重治疗的维持策略的疗效。记录特定时间点HIV-1 RNA < 40拷贝/ml的患者比例。对免疫反应、安全性和药代动力学进行了评估。结果:总体而言,39例患者切换到RAL/ATV (n = 32)或RAL/ATV加利托那韦(n = 7)方案。几乎所有患者(95%)每天接受两次RAL治疗。大多数患者(70%)每天服用400mg ATV,每天一次(26%)或两次(44%)。24周、48周、96周和144周病毒学成功率分别为92%(95%可信区间(CI) 83-10)、86% (95% CI, 74-98)、70% (95% CI, 52-88)和63% (95% CI, 42-84)。总体而言,12例(31%)患者停止了双重治疗:7例患者因不良事件,主要是临床肌炎(n = 3)。3例患者确诊病毒学失败;其中2例出现RAL抗性模式。CD4+/CD8 + t细胞比值在第48周显著升高(p < 0.005)。仅观察到1-2级不良事件。谷血浆水平表现出广泛的变异性。建议的谷浓度分别在79%的ATV和94%的RAL患者中达到。考虑到达到的目标水平和缺乏3级或4级高胆红素血症,每日400毫克不加药的ATV剂量似乎是合适的。结论:在3年的随访中,我们证明了RAL + ATV维持双重治疗的有效性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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