Rajasekaran Sikhamani, Jeyaseelan Lakshmanan, Vijila Sundaraj, Gomathi Chandrahasan, Raja Krishnaraj
Government Hospital of Thoracic Medicine, Tambaram Sanatorium, Chennai-600047, India.
AIDS. 2007 Jul;21 Suppl 4:S47-53. doi: 10.1097/01.aids.0000279706.24428.78.
To study the incidence and risk factors for failure of treatment with antiretroviral therapy among adults in the national treatment program in India, and to estimate the possible number of persons living with human immunodeficiency virus (HIV) who will need a second-line treatment regimen in the next 3 and 3.5 years.
Data of a cohort of HIV-positive adult patients, who were enrolled in the government-sponsored antiretroviral therapy program, were obtained from the electronic medical record system of the largest HIV care center in India and subjected to analysis.
Treatment failure defined by the World Health Organization criteria, assessed immunologically on the basis of CD4 T cell count, with a minimum period of 12 months of follow-up and with a minimum of two CD4 T cell follow-up measures.
The cumulative incidence of treatment failure in the 1370 adult patients included in the study was 3.9% (95% confidence interval [CI] 2.9 to 4.9). Men had a 3.5 (1.6 to 7.4) times significantly greater risk of treatment failure. Patients who had negative changes in absolute lymphocyte count, hemoglobin concentration and body weight had 3.1 (1.6 to 6.2), 3.2 (1.6 to 6.2), and 3.5 (1.9 to 6.4) times significantly greater risk of treatment failure. In India, after 2007, by 2, 3, and 3.5 years, respectively, an estimated 16 000, 35 000, and 51 000 patients receiving antiretroviral therapy are likely to require second-line treatment.
Monitoring of hemoglobin concentration, absolute lymphocyte count, and body weight during follow-up emerged as inexpensive predictors of treatment failure in a resource-poor setting. A significant number of patients will need second-line therapy as a result of failure of their first-line antiretroviral therapy regimen in 3 and 3.5 years in India, and therefore the development of an appropriate policy for second-line drugs is urgently needed.
研究印度国家治疗项目中成人抗逆转录病毒治疗失败的发生率及危险因素，并估计未来3年和3.5年可能需要二线治疗方案的人类免疫缺陷病毒（HIV）感染者人数。
从印度最大的HIV护理中心的电子病历系统中获取参加政府资助的抗逆转录病毒治疗项目的HIV阳性成年患者队列的数据，并进行分析。
根据世界卫生组织标准定义的治疗失败，基于CD4 T细胞计数进行免疫学评估，随访期至少12个月且至少进行两次CD4 T细胞随访测量。
纳入研究的1370例成年患者中，治疗失败的累积发生率为3.9%（95%置信区间[CI] 2.9至4.9）。男性治疗失败的风险显著高出3.5（1.6至7.4）倍。绝对淋巴细胞计数、血红蛋白浓度和体重出现负变化的患者，治疗失败的风险分别显著高出3.1（1.6至6.2）倍、3.2（1.6至6.2）倍和3.5（1.9至6.4）倍。在印度，2007年后，分别在2年、3年和3.5年后，估计有16000例、35000例和51000例接受抗逆转录病毒治疗的患者可能需要二线治疗。
在资源匮乏的环境中，随访期间监测血红蛋白浓度、绝对淋巴细胞计数和体重可成为治疗失败的廉价预测指标。在印度，由于一线抗逆转录病毒治疗方案在3年和3.5年内失败，大量患者将需要二线治疗，因此迫切需要制定关于二线药物的适当政策。
