一项针对开始抗逆转录病毒治疗的个体，比较单类四联疗法方案与两类三联疗法方案的开放标签随机对照试验性研究。

An open-label, randomized comparative pilot study of a single-class quadruple therapy regimen versus a 2-class triple therapy regimen for individuals initiating antiretroviral therapy.

作者信息

Moyle Graeme, Higgs Christopher, Teague Alastair, Mandalia Sundhiya, Nelson Mark, Johnson Margaret, Fisher Martin, Gazzard Brian

机构信息

Chelsea and Westminster Hospital, London, UK.

出版信息

Antivir Ther. 2006;11(1):73-8.

PMID:16518962

Abstract

OBJECTIVE

To examine the antiviral potency and tolerability profile of a single-class four drug (quadruple) nucleoside reverse transcriptase inhibitor (NRTI) regimen compared with a 2-class standard-of-care regimen.

METHODOLOGY

A three-centre, randomized, open-label comparative pilot study of zidovudine/lamivudine/efavirenz (triple) versus abacavir/lamivudine/zidovudine/tenofovir (quadruple) therapy in HIV-1-infected, treatment-naive individuals. Both regimens were taken without regard to food and consisted of a twice-daily regimen and 3 pills/day. The study power was based on time-weighted average changes in HIV-1 RNA load.

RESULTS

A total of 114 individuals (56 triple, 57 quadruple) received at least one dose of medication. Patients were well matched at baseline for viral load (mean 5.26 log10 versus 5.13 log10, respectively) and CD4 cell count (median 193 versus 153 cells/mm3, respectively). The two regimens performed similarly with regards to all endpoints. At week 48, by intention-to-treat, missing=failure analysis, 68% of triple- and 67% of quadruple-drug treated patients had an HIV-1 RNA <50copies/ml (P>0.05). On-treatment analysis showed 40/40 (100%) of triple- and 39/40 (97.5%) of quadruple-drug treated patients (P=0.996) had responded to <50copies/ml. No unexpected adverse events were reported. Changes in total cholesterol and triglycerides were modest but significantly favoured the quadruple therapy regimen at multiple time points.

CONCLUSION

This pilot study suggests a quadruple NRTI-based regimen provides similar antiviral potency, tolerability and administrative characteristics to a 2-class triple therapy regimen. These findings should be confirmed in a more fully powered study. Potent quadruple NRTI-based regimens may have advantages for some individuals with regards to salvageability, tolerability and drug interactions.

摘要

目的

比较单类四联核苷类逆转录酶抑制剂（NRTI）方案与两类标准治疗方案的抗病毒效力和耐受性。

方法

一项在三个中心开展的随机、开放标签的比较性初步研究，纳入未接受过治疗的HIV-1感染者，比较齐多夫定/拉米夫定/依非韦伦（三联）与阿巴卡韦/拉米夫定/齐多夫定/替诺福韦（四联）治疗。两种方案均不受饮食影响，采用每日两次给药方案，每天服用3片药。研究效能基于HIV-1 RNA载量的时间加权平均变化。

结果

共有114名个体（56名接受三联治疗，57名接受四联治疗）接受了至少一剂药物治疗。患者在基线时的病毒载量（分别为平均5.26 log10和5.13 log10）和CD4细胞计数（分别为中位数193和153个细胞/mm3）匹配良好。两种方案在所有终点方面表现相似。在第48周，根据意向性分析，缺失=失败分析，接受三联治疗的患者中有68%、接受四联治疗的患者中有67%的HIV-1 RNA<50拷贝/ml（P>0.05）。治疗中分析显示，接受三联治疗的患者中有40/40（100%）、接受四联治疗的患者中有39/40（97.5%）的HIV-1 RNA<50拷贝/ml（P=0.996）。未报告意外不良事件。总胆固醇和甘油三酯的变化较小，但在多个时间点上四联治疗方案明显更具优势。