HIV-1感染晚期有抗逆转录病毒治疗经验患者中高效抗逆转录病毒治疗失败的临床结局及预测因素

Clinical outcome and predictive factors of failure of highly active antiretroviral therapy in antiretroviral-experienced patients in advanced stages of HIV-1 infection.

作者信息

d'Arminio Monforte A, Testa L, Adorni F, Chiesa E, Bini T, Moscatelli G C, Abeli C, Rusconi S, Sollima S, Balotta C, Musicco M, Galli M, Moroni M

机构信息

Institute of Infectious and Tropical Diseases, University of Milan, Italy.

出版信息

AIDS. 1998 Sep 10;12(13):1631-7. doi: 10.1097/00002030-199813000-00010.

DOI:10.1097/00002030-199813000-00010

PMID:9764782

Abstract

OBJECTIVE

To verify the effectiveness of highly active antiretroviral therapy (HAART) and to identify any factors predictive of clinical outcome in a clinical setting.

DESIGN

Observational study.

METHODS

Treatment failure (i.e., the occurrence of new or recurrent AIDS-defining events, death or any definitive discontinuation) and the course of CD4+ cell counts and HIV RNA copies were evaluated in 250 heavily pretreated HIV-infected patients starting HAART [153 with indinavir (IDV), 55 with ritonavir (RTV), 43 with saquinavir (SQV)]. Univariate and multivariate analyses were performed to identify predictors of worse outcome.

RESULTS

During a median follow-up of 8 months, 75 patients (30%) had treatment failure because of the occurrence of an AIDS-defining event or death (n = 24), inefficacy (n = 24), or severe intolerance (n = 27). Twenty new and six recurrent AIDS-defining events, and nine deaths occurred (six out of 20 AIDS-defining events and two out of nine deaths within 1 month of treatment). CD4+ counts were above 200 x 10(6)/l at AIDS diagnosis in only two patients. None of the SQV patients, 12 (7.8%) of the IDV patients, and 15 (27.3%) of the RTV-treated patients were considered non-compliant. The SQV-containing regimens independently correlated with treatment failure (relative risk, 2.46; 95% confidence interval, 1.20-5.03; versus IDV). Low compliance partially determined outcome in RTV-treated patients; both severe immunodepression and AIDS at baseline were predictive of treatment failure. There was a 10-fold increase in CD4+ cell counts in the patients treated with IDV and RTV; the best virological outcome occurred in IDV-treated patients, with 68.4% of patients showing undetectable HIV RNA copies after 6 months.

CONCLUSIONS

HAART was effective in 70% of patients; low compliance and previous AIDS diagnosis represented predictive factors of therapy failure.

摘要

目的

在临床环境中验证高效抗逆转录病毒疗法（HAART）的有效性，并确定任何可预测临床结局的因素。

设计

观察性研究。

方法

对250例开始接受HAART的经大量前期治疗的HIV感染患者评估治疗失败情况（即出现新的或复发的艾滋病定义事件、死亡或任何确定性停药）以及CD4 +细胞计数和HIV RNA拷贝数的变化过程[153例接受茚地那韦（IDV）治疗，55例接受利托那韦（RTV）治疗，43例接受沙奎那韦（SQV）治疗]。进行单因素和多因素分析以确定预后较差的预测因素。

结果

在中位随访8个月期间，75例患者（30%）因出现艾滋病定义事件或死亡（n = 24）、治疗无效（n = 24）或严重不耐受（n = 27）而治疗失败。发生了20例新的和6例复发的艾滋病定义事件，9例患者死亡（治疗后1个月内20例艾滋病定义事件中的6例和9例死亡中的2例）。仅2例患者在艾滋病诊断时CD4 +计数高于200×10⁶/L。接受SQV治疗的患者中无一例被认为不依从，接受IDV治疗的患者中有12例（7.8%），接受RTV治疗的患者中有15例（约27.3%）被认为不依从。含SQV的治疗方案与治疗失败独立相关（相对风险，2.46；95%置信区间，1.20 - 5.03；与IDV相比）。低依从性部分决定了接受RTV治疗患者的结局；基线时严重免疫抑制和艾滋病均为治疗失败的预测因素。接受IDV和RTV治疗的患者CD4 +细胞计数增加了10倍；接受IDV治疗的患者病毒学结局最佳，68.4%的患者在6个月后HIV RNA拷贝数检测不到。