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[西班牙艾滋病研究与治疗学会(Gesida)和西班牙国家艾滋病防治计划秘书处(SPNS)关于人类免疫缺陷病毒感染成人联合抗逆转录病毒治疗的共识文件(2012年1月)]

[Consensus document of Gesida and Spanish Secretariat for the National Plan on AIDS (SPNS) regarding combined antiretroviral treatment in adults infected by the human immunodeficiency virus (January 2012)].

出版信息

Enferm Infecc Microbiol Clin. 2012 Jun;30(6):e1-89. doi: 10.1016/j.eimc.2012.03.006. Epub 2012 May 23.

Abstract

This consensus document has been prepared by a panel consisting of members of the AIDS Study Group (Gesida) and the Spanish Secretariat for the National Plan on AIDS (SPNS) after reviewing the efficacy and safety results of clinical trials, cohort and pharmacokinetic studies published in medical journals, or presented in medical scientific meetings. Gesida has prepared an objective and structured method to prioritise combined antiretroviral treatment (cART) in naïve patients. Recommendations strength (A, B, C) and the evidence which supports them (I, II, III) are based on a modification of the Infectious Diseases Society of America criteria. The current antiretroviral treatment (ART) of choice for chronic HIV infection is the combination of three drugs. ART is recommended in patients with symptomatic HIV infection, in pregnancy, in serodiscordant couples with high transmission risk, hepatitis B fulfilling treatment criteria, and HIV nephropathy. Guidelines on ART treatment in patients with concurrent diagnosis of HIV infection and an opportunistic type C infection are included. In asymptomatic patients ART is recommended on the basis of CD4 lymphocyte counts, plasma viral load and patient co-morbidities, as follows: 1) therapy should be started in patients with CD4 counts <350 cells/μL; 2) when CD4 counts are between 350 and 500 cells/μL, therapy will be recommended and only delayed if patient is reluctant to take it, the CD4 are stabilised, and the plasma viral load is low; 3) therapy could be deferred when CD4 counts are above 500 cells/μL, but should be considered in cases of cirrhosis, chronic hepatitis C, high cardiovascular risk, plasma viral load >10(5) copies/mL, proportion of CD4 cells <14%, and in people aged >55 years. ART should include 2 reverse transcriptase inhibitors nucleoside analogues and a third drug (non-analogue reverse transcriptase inhibitor, ritonavir boosted protease inhibitor or integrase inhibitor). The panel has consensually selected and given priority to using the Gesida score for some drug combinations, some of them co-formulated. The objective of ART is to achieve an undetectable viral load. Adherence to therapy plays an essential role in maintaining antiviral response. Therapeutic options are limited after ART failures, but an undetectable viral load may be possible nowadays. Adverse events are a fading problem of ART. Guidelines in acute HIV infection, in women, in pregnancy, and to prevent mother-to-child transmission and pre- and post-exposition prophylaxis are commented upon. Management of hepatitis B or C co-infection, other co-morbidities, and the characteristics of ART in HIV-2 infection are included.

摘要

这份共识文件由艾滋病研究小组(Gesida)和西班牙国家艾滋病计划秘书处(SPNS)的成员组成的小组编写,该小组在审查了医学期刊上发表的或在医学科学会议上展示的临床试验、队列研究和药代动力学研究的疗效和安全性结果之后完成编写。Gesida制定了一种客观且结构化的方法,用于对初治患者的联合抗逆转录病毒治疗(cART)进行优先排序。推荐强度(A、B、C)及其支持证据(I、II、III)基于对美国传染病学会标准的修改。目前慢性HIV感染的抗逆转录病毒治疗(ART)选择是三种药物联合使用。对于有症状的HIV感染患者、孕妇、具有高传播风险的血清学不一致的夫妇、符合治疗标准的乙型肝炎患者以及HIV肾病患者,推荐进行ART治疗。其中还包括了HIV感染与机会性C型感染并存患者的ART治疗指南。对于无症状患者,根据CD4淋巴细胞计数、血浆病毒载量和患者合并症情况推荐进行ART治疗,具体如下:1)CD4计数<350个细胞/μL的患者应开始治疗;2)当CD4计数在350至500个细胞/μL之间时,推荐进行治疗,若患者不愿接受治疗、CD4计数稳定且血浆病毒载量较低,则可延迟治疗;3)CD4计数高于500个细胞/μL时,治疗可推迟,但在肝硬化、慢性丙型肝炎、心血管风险高、血浆病毒载量>10⁵拷贝/mL、CD4细胞比例<14%以及年龄>55岁的人群中应考虑进行治疗。ART应包括2种核苷类似物逆转录酶抑制剂和第三种药物(非核苷类逆转录酶抑制剂、利托那韦增强的蛋白酶抑制剂或整合酶抑制剂)。该小组已就某些药物组合(其中一些是复方制剂)达成共识,选择并优先使用Gesida评分。ART的目标是使病毒载量检测不到。坚持治疗在维持抗病毒反应中起着至关重要的作用。ART治疗失败后治疗选择有限,但如今有可能实现病毒载量检测不到。不良事件是ART中一个逐渐减少的问题。文中还对急性HIV感染、女性、孕妇以及预防母婴传播和暴露前及暴露后预防的指南进行了评论。其中包括了乙型或丙型肝炎合并感染的管理、其他合并症以及HIV-2感染中ART的特点。

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