Rajesh Radhakrishnan, Vidyasagar Sudha, Varma Danturulu Muralidhar, Naik Anand, Hegde Brahmavar Mohandas, Guddattu Vasudeva, Kamath Asha
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India.
Int J Risk Saf Med. 2013 Jan 1;25(1):53-65. doi: 10.3233/JRS-130580.
There are no studies performed in India on the safety of highly active antiretroviral therapy (HAART) combinations which focus on the base-line CD4+ T-cell count. Further, no data on risk factors for Adverse drug reactions (ADRs) to HAART and there is a lack of data on CD4+ T-cell count recovery after HAART.
The aim of this study was to assess risk factors for ADRs to HAART. We also compared the efficacy of HAART combinations with respect to base-line CD4+ T-cell count and CD4+ T-cell counts recovery in Indian HIV positive patients.
A prospective active surveillance study was adopted at the Antiretroviral Therapy (ART) Centre, District Government Hospital, Udupi, India. HIV-infected patients were intensively monitored to identify risk factors associated with ADRs to HAART from August 2009 to May 2012. The study protocol was approved by the University ethics committee. Baseline CD4+ T-cell count before initiation of HAART and thereafter at every six months of regular follow-up up to 24 months duration was included for comparison. Multivariate logistic regression analysis was used to identify predictors of high risk factors of ADRs. CD4+ T-cell count recovery after HAART from base-line CD4+ T-cell count in different HAART groups was analyzed by test of between-subject effects. P-value <0.05 was considered as statistically significant.
A total of 1982 HIV positive patients were enrolled with 1181 (59.6%) males, and 801 (40.4%) females. On multivariate logistic regression analysis, four factors were found to be predictors of high-risk factors for ADRs to HAART: 1) CD4+ T-cell counts, 2) female gender, 3) polypharmacy and 4) opportunistic infections. Between HAART groups, a mean increase of 98 cells/μl of CD4+ T-cell counts recovery was seen in the 3TC + NVP + D4T group (p < 0.001) at 24 months of regular follow-up.
In India, Clinician should take into consideration all possible risk factors associated with the use of HAART in order to avoid and minimize ADRs. As initial CD4+ T-cell count and age of patient decides the rise of CD4+ T-cell counts with HAART. HAART should be initiated at the earliest age in order to attain maximum CD4+ T-cell counts recovery.
在印度，尚未有针对以基线CD4+T细胞计数为重点的高效抗逆转录病毒疗法（HAART）组合安全性的研究。此外，关于HAART药物不良反应（ADR）的危险因素尚无数据，且缺乏HAART治疗后CD4+T细胞计数恢复情况的数据。
本研究旨在评估HAART药物不良反应的危险因素。我们还比较了HAART组合在印度HIV阳性患者中，相对于基线CD4+T细胞计数和CD4+T细胞计数恢复情况的疗效。
在印度乌度皮地区政府医院的抗逆转录病毒治疗（ART）中心采用前瞻性主动监测研究。从2009年8月至2012年5月，对HIV感染患者进行密切监测，以确定与HAART药物不良反应相关的危险因素。研究方案经大学伦理委员会批准。纳入HAART治疗开始前以及之后每六个月定期随访直至24个月期间的基线CD4+T细胞计数进行比较。采用多因素逻辑回归分析确定ADR高风险因素的预测指标。通过组间效应检验分析不同HAART组中HAART治疗后相对于基线CD4+T细胞计数的CD4+T细胞计数恢复情况。P值<0.05被认为具有统计学意义。
共纳入1982例HIV阳性患者，其中男性1181例（59.6%），女性801例（40.4%）。多因素逻辑回归分析发现，有四个因素是HAART药物不良反应高风险因素的预测指标：1）CD4+T细胞计数，2）女性性别，3）联合用药，4）机会性感染。在HAART组之间，在24个月的定期随访中，3TC+NVP+D4T组的CD4+T细胞计数恢复平均增加98个细胞/μl（p<0.001）。
在印度，临床医生应考虑与使用HAART相关的所有可能危险因素，以避免和减少ADR。由于初始CD4+T细胞计数和患者年龄决定了HAART治疗后CD4+T细胞计数的上升情况，因此应尽早开始HAART治疗，以实现最大程度的CD4+T细胞计数恢复。
