Sonenthal Paul D, Ratshaa Bakgaki, Chimbengo Gilbert, Rantleru Tumelo, Ngoni Thelma, Barenbaum Sarah, Platoff Rebecca, Steenhoff Andrew P, Gross Robert
Botswana-University of Pennsylvania Partnership, Gaborone, Botswana; Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA; Center for Pharmacoepidemiology Research and Training, University of Pennsylvania, Philadelphia, PA, USA.
Pharmacoepidemiol Drug Saf. 2014 Jul;23(7):773-7. doi: 10.1002/pds.3615. Epub 2014 Mar 24.
We aimed to identify modifiable, routinely available patient characteristics associated with adverse experiences potentially attributable to efavirenz-based regimens in patients in Botswana.
HIV-infected treatment naïve individuals starting a standard antiretroviral regimen including two nucleoside analog reverse transcriptase inhibitors and efavirenz in Botswana were enrolled in a prospective cohort. Adverse experiences were measured at 1 and 6 months using the efavirenz checklist, a 35-item instrument developed by the AIDS Clinical Trials Group.
We enrolled 232 patients from 11 March 2010 to 17 March 2011. One hundred ninety-six were included in the month 1 analyses. Of the 196 included in the month 1 analyses, 157 (80%) completed the 6-month follow-up. Median efavirenz checklist score was 6 (interquartile range (IQR): 2-15) at month 1 and 1 (IQR: 0-5) at month 6. The median change in efavirenz checklist score from month 1-6 was -4 (IQR: -11 to -1), representing an improvement. Depressive symptoms, low CD4 count and less alcohol use were associated with improvement in adverse experiences over time. Low weight was associated with increased extent of adverse experiences at month 1 and 6. There was no confounding or effect modification.
Clinicians may want to consider more intensive and tailored adverse experience education and management in patients based on depressive symptoms, CD4 count, and weight. Further assessment of the mechanism of the effect of alcohol use on adverse experiences, including analysis of CYP2B6 genotype and plasma efavirenz concentrations, is warranted.
我们旨在确定博茨瓦纳患者中与基于依非韦伦的治疗方案可能导致的不良经历相关的可改变的、常规可得的患者特征。
在博茨瓦纳，开始使用包括两种核苷类逆转录酶抑制剂和依非韦伦的标准抗逆转录病毒治疗方案的初治HIV感染个体被纳入一个前瞻性队列。使用依非韦伦检查表在1个月和6个月时测量不良经历，该检查表是由艾滋病临床试验组开发的一个包含35个条目的工具。
我们在2010年3月11日至2011年3月17日期间招募了232名患者。196名患者被纳入1个月时的分析。在1个月时分析的196名患者中，157名（80%）完成了6个月的随访。依非韦伦检查表的中位得分在1个月时为6（四分位间距（IQR）：2 - 15），在6个月时为1（IQR：0 - 5）。依非韦伦检查表得分从1个月到6个月的中位变化为 - 4（IQR： - 11至 - 1），表明有所改善。抑郁症状、低CD4细胞计数和较少饮酒与不良经历随时间的改善相关。低体重与1个月和6个月时不良经历的程度增加相关。没有混杂或效应修饰。
临床医生可能希望根据抑郁症状、CD4细胞计数和体重，对患者进行更强化和针对性的不良经历教育及管理。有必要进一步评估饮酒对不良经历影响的机制，包括分析CYP2B6基因型和血浆依非韦伦浓度。
