Department of Medicine, Indiana University, School of Medicine, Indianapolis, IN, USA.
J Acquir Immune Defic Syndr. 2010 Feb;53(2):254-9. doi: 10.1097/QAI.0b013e3181b8f26e.
To describe first change or discontinuation in combination antiretroviral treatment (cART) among previously treatment naive, HIV-infected adults in a resource-constrained setting.
The United States Agency for International Development-Academic Model Providing Access to Healthcare Partnership has enrolled >90,000 HIV-infected patients at 18 clinics throughout western Kenya. Patients in this analysis were aged > or =18 years, previously antiretroviral treatment naive, and initiated to cART between January 2006 and November 2007, with at least 1 follow-up visit. A treatment change or discontinuation was defined as change of regimen including single drug substitutions or a complete halting of cART.
There were 14,162 patients eligible for analysis and 10,313 person-years of follow-up, of whom 1376 changed or stopped their cART. Among these, 859 (62%) changed their regimen (including 514 patients who had a single drug substitution) and 517 (38%) completely discontinued cART. The overall incidence rate (IR) of cART changes or stops per 100 person-years was 13.3 [95% confidence interval (CI): 12.7-14.1]. The incidence was much higher in the first year of post-cART initiation (IR: 25.0, 95% CI: 23.6-26.3) compared with the second year (IR: 2.4, 95% CI: 2.0-2.8). The most commonly cited reason was toxicity (46%). In multivariate regression, individuals were more likely to discontinue cART if they were World Health Organization stage III/IV [adjusted hazard ratio (AHR): 1.37, 95% CI: 1.11-1.69] or were receiving a zidovudine-containing regimen (AHR: 4.44, 95% CI: 3.35-5.88). Individuals were more likely to change their regimen if they were aged > or =38 years (AHR: 1.44, 95% CI: 1.23-1.69), had to travel more than 1 hour to clinic (AHR: 1.34, 95% CI: 1.15-1.57), had a CD4 at cART initiation < or =111 cells/mm3 (AHR: 1.51, 95% CI: 1.29-1.77), or had been receiving a zidovudine-containing regimen (AHR: 3.73, 95% CI: 2.81-4.95). Those attending urban clinics and those receiving stavudine-containing regimens were less likely to experience either a discontinuation or a change of their cART.
These data suggest a moderate incidence of cART changes and discontinuations among this large population of adults in western Kenya. Mostly occurring within 12 months of cART initiation, and primarily due to toxicity, older individuals, those with more advanced disease, and those using zidovudine are at higher risk of experiencing a change or a discontinuation in their cART.
描述在资源有限环境下，先前未经治疗的 HIV 感染成年患者中，联合抗逆转录病毒治疗（cART）的首次改变或停止。
美国国际开发署学术模型提供医疗保健合作关系已经在肯尼亚西部的 18 个诊所登记了超过 90000 名 HIV 感染患者。本分析中的患者年龄≥18 岁，先前未经抗逆转录病毒治疗，并且在 2006 年 1 月至 2007 年 11 月期间接受了 cART 治疗，至少有 1 次随访。治疗改变或停止被定义为方案改变，包括单药替代或完全停止 cART。
共有 14162 名患者符合分析条件，随访 10313 人年，其中 1376 名患者改变或停止了他们的 cART。其中，859 名（62%）改变了治疗方案（包括 514 名接受单一药物替代的患者），517 名（38%）完全停止了 cART。每 100 人年 cART 改变或停止的总发生率（IR）为 13.3%（95%可信区间：12.7-14.1）。在 cART 开始后的第一年（IR：25.0，95%可信区间：23.6-26.3），与第二年（IR：2.4，95%可信区间：2.0-2.8）相比，发生率要高得多。最常被引用的原因是毒性（46%）。在多变量回归中，如果患者处于世界卫生组织（WHO）III/IV 期（调整后的危险比[AHR]：1.37，95%可信区间：1.11-1.69）或接受包含齐多夫定的方案（AHR：4.44，95%可信区间：3.35-5.88），则更有可能停止 cART。如果患者年龄≥38 岁（AHR：1.44，95%可信区间：1.23-1.69）、需要到诊所就诊的时间超过 1 小时（AHR：1.34，95%可信区间：1.15-1.57）、cART 开始时 CD4 细胞计数≤111 个/毫米 3（AHR：1.51，95%可信区间：1.29-1.77）或接受包含齐多夫定的方案（AHR：3.73，95%可信区间：2.81-4.95），则更有可能改变治疗方案。在城市诊所就诊和接受司他夫定方案的患者，经历 cART 停药或改变的可能性较低。
这些数据表明，在肯尼亚西部的这一大群成年人中，cART 的改变和停药发生率适中。大多数发生在 cART 开始后的 12 个月内，主要由于毒性、年龄较大、疾病进展较严重以及使用齐多夫定的患者，更有可能经历 cART 的改变或停药。
