Enferm Infecc Microbiol Clin. 2009 Apr;27(4):222-35. doi: 10.1016/j.eimc.2008.11.002. Epub 2009 Feb 26.
This consensus document is an update of antiretroviral therapy recommendations for adult patients with human immunodeficiency virus (HIV) infection.
To formulate these recommendations, a panel comprised 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 current understanding of the pathophysiology of HIV infection, and the efficacy and safety results from clinical trials, cohort studies, and pharmacokinetic studies published in biomedical journals or presented at scientific meetings over the last 2 years. Three levels of evidence were defined according to the data source: randomized studies (level A), cohort or case-control studies (level B), and expert opinion (level C). The decision to recommend, consider, or not recommend antiretroviral therapy (ART) was established in each situation.
The current treatment of choice for chronic HIV infection is a combination of 3 drugs from 2 different classes; that is, 2 nucleoside or nucleotide analogs (NRTI) plus 1 non-nucleoside (NNRTI) or 1 boosted protease inhibitor (PI/r). ART initiation is recommended in patients with symptomatic HIV infection. In asymptomatic patients, initiation of ART is recommended on the basis of CD4 lymphocyte counts, plasma viral load and the patient's comorbid conditions, as follows: a) therapy should be started in patients with CD4 counts of <350 cells/microl; b) when CD4 count is between 350 and 500 cells/microl, therapy should be started in patients with chronic hepatitis C or cirrhosis, coinfection with hepatitis B requiring treatment, high cardiovascular risk, HIV nephropathy, HIV viral load >10(5)copies/ml, or<14% CD4 cells; c) therapy should be deferred when CD4 count is >500 cells/microl, but can be considered if any of the previous circumstances concur. 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 undetectable viral load may be possible with new drugs, even in highly drug-experienced patients. Genotype studies are useful in these situations. Drug toxicity from ART therapy is losing importance as benefits exceed adverse effects.
CD4 cell count, viral load, and patient comorbidities are the most important reference factors to consider when initiating ART in asymptomatic patients. The large number of available drugs, the increasing sensitivity of tests to monitor viral load, and the ability to determine viral resistance is leading to a more individualized therapy approach, with the goal of achieving undetectable viral load in any circumstance. The complete version of the recommendations can be found on the Gesida (http://www.gesida.seimc.org) or PNS (http://www.msc.es/ciudadanos/enfLesiones/enfTransmisibles/sida/home.htm) web sites.
本共识文件是对成人人类免疫缺陷病毒(HIV)感染患者抗逆转录病毒治疗建议的更新。
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)成员组成的小组回顾了当前对HIV感染病理生理学认识的进展,以及过去两年在生物医学期刊上发表或在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及安全性结果。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)以及专家意见(C级)。针对每种情况确定了推荐、考虑或不推荐抗逆转录病毒治疗(ART)的决定。
目前慢性HIV感染的首选治疗方法是使用来自2种不同类别的三种药物联合治疗;即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感染患者,建议启动ART。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的合并症情况建议启动ART,如下:a)CD4计数<350个细胞/微升的患者应开始治疗;b)当CD4计数在350至500个细胞/微升之间时,患有慢性丙型肝炎或肝硬化、需要治疗的乙型肝炎合并感染、高心血管风险、HIV肾病、HIV病毒载量>10⁵拷贝/毫升或CD4细胞<14%的患者应开始治疗;c)当CD4计数>500个细胞/微升时,治疗应推迟,但如果出现上述任何情况,则可考虑开始治疗。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,但即使是对多种药物耐药的患者,使用新药也可能使病毒载量检测不到。在这些情况下,基因型研究很有用。由于益处超过不良反应,ART治疗的药物毒性已不再重要。
在无症状患者中启动ART时,CD4细胞计数、病毒载量和患者合并症是最重要的参考因素。大量可用药物、监测病毒载量检测的敏感性增加以及确定病毒耐药性的能力导致了更个体化的治疗方法,目标是在任何情况下都使病毒载量检测不到。建议的完整版本可在Gesida(http://www.gesida.seimc.org)或PNS(http://www.msc.es/ciudadanos/enfLesiones/enfTransmisibles/sida/home.htm)网站上找到。