Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia ; I. Javakhishvili Tbilisi State University Faculty of Medicine, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
AIDS Res Ther. 2014 Jul 7;11:18. doi: 10.1186/1742-6405-11-18. eCollection 2014.
Data on the effectiveness of second-line antiretroviral therapy (ART) in resource-limited countries of Eastern Europe is limited. Objective of this study was to evaluate virological outcomes of second-line ART in Georgia.
We conducted retrospective analysis using routinely available program data. Study included adult HIV-infected patients with confirmed HIV drug resistance, who were switched to second-line ART from August 2005 to December 2010. Patients were followed until July 1, 2011. Primary outcome was achievement of viral suppression. Demographic, clinical, laboratory and adherence data were abstracted from medical and program records. Adherence was expressed as percentage based on medication refill data, and was calculated as days supply of medications dispensed divided by days between prescription fills. Predictors of primary outcome were assessed in modified Poisson regression analysis.
A total of 84 patients were included in the study. Among them 71.4% were men and 62% had history of IDU. All patients were receiving non-nucleoside reverse transcriptase based regimen as initial ART. The mean 6-month adherence prior to virologic failure was 75%, with 31% of patients showing 100% adherence. All patients were switched to protease inhibitor based regimens. Patients were followed for median 27 months. Over this period 9 (10.7%) patients died. Among 80 patients remaining alive at least 6 month after ART regimen switch, 72 (90%) patients ever reached undetectable viral load. The mean first 6-month adherence on second-line treatment was 81%, with 47.5% of patients showing 100% adherence. The proportion of patients achieving viral suppression after 6, 12, 24 and 36 months of second-line ART did not vary significantly ranging from 79 to 83%. Percentage of IDUs achieving viral suppression ranged from 75% and 83%. Factors associated with failure to achieve viral suppression at 6-months of second-line ART were: adherence <80% (Risk ratio [RR] 5.09, 95% CI: 1.89-13.70) and viral load >100,000 at the time of treatment failure (RR 3.39, 95% CI: 1.46-7.89).
The study demonstrated favourable virological outcomes of the second-line ART in Georgia. Majority of patients, including IDUs, achieved sustained virological response over 36 month period. The findings highlight the need of improving adherence.
东欧资源有限国家的二线抗逆转录病毒疗法（ART）疗效数据有限。本研究旨在评估格鲁吉亚二线 ART 的病毒学疗效。
我们使用常规获得的项目数据进行回顾性分析。研究包括从 2005 年 8 月至 2010 年 12 月从一线 ART 转换为二线 ART 的确诊 HIV 耐药的成年 HIV 感染者。患者随访至 2011 年 7 月 1 日。主要结局是病毒抑制的实现。从医疗和项目记录中提取人口统计学、临床、实验室和治疗依从性数据。基于药物补充数据来表示治疗依从性，计算为配药天数除以处方补充天数的药物供应天数。采用改良泊松回归分析评估主要结局的预测因素。
共纳入 84 例患者。其中 71.4%为男性，62%有吸毒史。所有患者最初均接受非核苷类逆转录酶抑制剂为基础的方案进行治疗。在病毒学失败前的 6 个月平均治疗依从率为 75%，其中 31%的患者依从率为 100%。所有患者均转为基于蛋白酶抑制剂的方案。中位随访时间为 27 个月。在此期间，9 名（10.7%）患者死亡。在至少 6 个月后 ART 方案转换后仍存活的 80 名患者中，72 名（90%）患者的病毒载量始终未检出。二线治疗的前 6 个月平均首次治疗依从率为 81%，其中 47.5%的患者依从率为 100%。在二线 ART 治疗的 6、12、24 和 36 个月后达到病毒抑制的患者比例无显著差异，范围为 79%至 83%。吸毒者达到病毒抑制的比例为 75%至 83%。与二线 ART 治疗 6 个月时未能达到病毒抑制相关的因素包括：依从性<80%（风险比 [RR] 5.09，95%CI：1.89-13.70）和治疗失败时病毒载量>100,000（RR 3.39，95%CI：1.46-7.89）。
该研究表明格鲁吉亚二线 ART 的病毒学疗效良好。大多数患者，包括吸毒者，在 36 个月的时间内均实现了持续的病毒学反应。研究结果强调需要提高治疗依从性。
