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低剂量的地瑞纳韦也可有效抑制HIV患者的病情

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近日,来自西班牙的研究人员表示,600mg剂量的地瑞纳韦或许和批准的800mg剂量一样都可以有效抑制HIV患者的病情,该研究发表于the Journal of Antimicrobial Chemotherapy杂志上。

 近日,一项发表于国际杂志the Journal of Antimicrobial Chemotherapy上的论文中,来自西班牙的研究人员表示,600mg剂量的地瑞纳韦或许和批准的800mg剂量一样都可以有效抑制HIV患者的病情。

  研究者Jose及其同事对100名抑制性HIV感染病人进行了一项随机实验,对比了600mg剂量同800mg剂量地瑞纳韦在治疗患者疾病上的有效性、安全性、药代动力学及经济影响的差异。结果显示,在48周时,94%的600mg剂量组患者及96%的800mg剂量组患者机体中的HIV-1 RNA水平均下降到了50拷贝/mL。

  研究者表示,不一致依从性或许是五分之四的HIV患者RNA升高的主要原因,但在整个研究过程中并未出现耐药性的突变。在试验中平均的波谷浓度(Mean trough concentrations)在600mg组(2.19mg/L)和800mg组(2.21 mg/L)中并无明显不同;在花费方面,600mg剂量组患者平均每年花费为33038美元,而800mg剂量组患者每年平均花费为40311美元,前者比后者低了大约7273美元,而节省下的这些开销每年可以为6位病人进行600mg剂量的免费抗逆转录病毒疗法。

  最后研究者Massimiliano Lanzafame指出,我们认为需要对首次利用地瑞纳韦进行抗病毒疗法的病人或正在进行抗病毒疗法但机体中没有特殊性耐药突变的患者采取一种新型的剂量标准,这样或许可以在更好地改善患者病情的同时,也能更好的改善患者的经济状况。(转化医学网360zhyx.com)

  以上为转化医学网原创翻译整理,谢绝转载。如需转载,请联系 info@360zhyx.com
转化医学网推荐的原文摘要:

Reduced darunavir dose is as effective in maintaining HIV suppression as the standard dose in virologically suppressed HIV-infected patients: a randomized clinical trial
J. Antimicrob. Chemother. doi: 10.1093/jac/dku516
José Moltó1,2,*, Marta Valle2,3, Elena Ferrer4, Pere Domingo5, Adrian Curran2,6, José Ramón Santos1, María Gracia Mateo5, María Silvana Di Yacovo4, Cristina Miranda1, Daniel Podzamczer4 and Bonaventura Clotet1,2,7,8 on behalf of the DRV600 Study Group†
Objectives Maximizing ART efficiency is of growing interest. This study assessed the efficacy, safety, pharmacokinetics and economics of a darunavir dose-reduction strategy.

Methods This was a multicentre, randomized, open-label clinical trial in HIV-infected patients with plasma HIV-1 RNA <50 copies/mL while receiving triple ART including 800 mg of darunavir once daily. Participants were randomized to continue 800 mg of darunavir (DRV800) or to 600 mg of darunavir (DRV600), both once daily. Treatment failure was defined as two consecutive HIV-1 RNA determinations >50 copies/mL or discontinuation of study treatment by week 48. The study was registered at https://www.clinicaltrialsregister.eu (trial number 2011-006272-39).

Results Fifty participants were allocated to each arm. The mean (SD) CD4+ T cell count at baseline was 562 (303) cells/mm3 and HIV-1 RNA had been <50 copies/mL for a median (IQR) of 106.9 (43.4–227.9) weeks before enrolment. At week 48 no treatment failure had occurred in 45/50 (90%) DRV600 patients and in 47/50 (94%) DRV800 patients (difference –4%; 95% CI lower limit, –12.9%). When only patients with virological data were considered, that endpoint was met by 45/48 (94%) in the DRV600 arm and 47/49 (96%) in the DRV800 arm (difference –2.2%; 95% CI lower limit, –9.6%). Darunavir exposure was similar in the two arms. The average reduction in annual cost per successfully treated DRV600-arm patient was US$7273.

Conclusions The efficacy of a darunavir daily dose of 600 mg seemed to be similar to the efficacy of the standard 800 mg dose in virologically suppressed HIV-infected patients on triple ART. This strategy can potentially translate to substantial savings in the cost of care of HIV-infected patients.



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