Enferm Infecc Microbiol Clin. 2007 Jan;25(1):32-53. doi: 10.1157/13096750.
This consensus document is an update of antiretroviral therapy (ART) recommendations for adult patients infected with the human immunodeficiency virus (HIV-1).
To formulate these recommendations, a panel composed of members of the Grupo de Estudio de Sida (GESIDA; AIDS Study Group) and the Plan Nacional sobre el Sida (PNS; Spanish AIDS Plan) reviewed the advances in the current understanding of the pathophysiology of HIV, the safety and efficacy findings from clinical trials, and the results from cohort and pharmacokinetic studies published in biomedical journals or presented at scientific meetings over the last years. Three levels of evidence were defined according to the source of the data: randomized studies (level A), cohort or case-control studies (level B), and expert opinion (level C). The decision to recommend, consider or not recommend ART was established in each situation.
Currently, the treatment of choice for chronic HIV infection is the combination of three drugs of two different classes, including 2 nucleosides or nucleotide analogs (NRTI) plus 1 non-nucleoside (NNRTI) or 1 boosted protease inhibitor (PI/r). Initiation of ART is recommended in patients with symptomatic HIV infection. In asymptomatic patients, initiation of ART is recommended on the basis of CD4+ lymphocyte counts and plasma viral load, as follows: 1) therapy should be started in patients with CD4+ counts of < 200 cells/microl; 2) therapy should be started in most patients with CD4+ counts of 200-350 cells/microl, although it can be delayed when CD41 count persists at around 350 cells/microL and viral load is low, and 3) initiation of therapy can be delayed in patients with CD4+ counts of > 350 cells/microL. The initial objective of ART is to achieve an undetectable viral load. Adherence to therapy plays an essential role in maintaining the antiviral response. Therapeutic options are limited with the development of cross resistance and ART failure. Genotype studies are useful in these cases. More information regarding the studies analyzed and the panel recommendations for adherence, toxicity, treatment during pregnancy, patients with hepatitis B or C virus co-infection, and post-exposure prophylaxis can be accessed at www.gesida.seimc.org.
CD4+ lymphocyte count is the most important reference factor for initiating ART in asymptomatic patients. The large number of available drugs, the increased sensitivity of tests to monitor viral load, and the ability to determine viral resistance is leading to a more individualized approach to therapy.
本共识文件是对成人人类免疫缺陷病毒(HIV-1)感染者抗逆转录病毒治疗(ART)建议的更新。
为制定这些建议,由西班牙艾滋病研究小组(GESIDA)和西班牙国家艾滋病计划(PNS)成员组成的专家小组回顾了近年来对HIV病理生理学的最新认识进展、临床试验的安全性和有效性结果,以及发表在生物医学期刊上或在科学会议上展示的队列研究和药代动力学研究结果。根据数据来源定义了三个证据级别:随机研究(A级)、队列或病例对照研究(B级)和专家意见(C级)。在每种情况下确定推荐、考虑或不推荐ART的决定。
目前,慢性HIV感染的首选治疗方法是两种不同类别三种药物的联合使用,包括2种核苷或核苷酸类似物(NRTI)加1种非核苷(NNRTI)或1种增强型蛋白酶抑制剂(PI/r)。对于有症状的HIV感染者,建议开始ART治疗。对于无症状患者,根据CD4+淋巴细胞计数和血浆病毒载量建议开始ART治疗,如下:1)CD4+计数<200个细胞/微升的患者应开始治疗;2)大多数CD4+计数为200 - 350个细胞/微升的患者应开始治疗,尽管当CD4+计数持续在350个细胞/微升左右且病毒载量较低时可以延迟治疗;3)CD4+计数>350个细胞/微升的患者可以延迟开始治疗。ART的初始目标是实现病毒载量检测不到。坚持治疗在维持抗病毒反应中起着至关重要的作用。随着交叉耐药性的发展和ART治疗失败,治疗选择受到限制。在这些情况下,基因型研究很有用。有关分析的研究以及专家小组关于依从性、毒性、孕期治疗、乙型或丙型肝炎病毒合并感染患者以及暴露后预防的建议的更多信息可访问www.gesida.seimc.org。
CD4+淋巴细胞计数是无症状患者开始ART治疗的最重要参考因素。可用药物数量众多、监测病毒载量的检测灵敏度提高以及确定病毒耐药性的能力导致治疗方法更加个体化。