Galindo Jaime, Amariles Pedro, Mueses-Marín Héctor F, Hincapié Jaime A, González-Avendaño Sebastián, Galindo-Orrego Ximena
Grupo Educación y Salud en VIH/SIDA, Corporación de Lucha Contra el Sida, Santiago de Cali, Colombia.
Grupo Promoción y Prevención Farmacéutica, Universidad de Antioquia (UdeA), Calle 70 No 52-21, Medellín, Colombia.
BMC Infect Dis. 2016 Oct 3;16(1):532. doi: 10.1186/s12879-016-1871-x.
Generic drug policies are often associated with concerns about the quality and effectiveness of these products. Phase IV clinical trials may be a suitable design to assess the effectiveness and safety of generic drugs. The objective of this study was to describe the effectiveness and the safety of the generic abacavir/lamivudine and efavirenz in treatment-naïve HIV-infected patients.
A monocentric, nonrandomized, open-label, phase IV study in treatment naïve HIV-infected patients 18 years or older with indication to receive abacavir/lamivudine and efavirenz were recruited from a program that provides comprehensive outpatient consultation and continuing care. The primary end-point was to achieve viral load <40 copies/mL at 12 months after baseline to assess effectiveness. Secondary end-point of the study were 1) to asses increasing in T-CD4 lymphocytes levels as accompaniment to asses effectiveness, and 2) to assess both gastrointestinal, skin, and central nervous system symptoms, and lipid profile, cardiovascular risk, renal, and hepatic function as safety profile. Data were determined at baseline, 3, 6, and 12 months. Close clinical monitoring and pharmaceutical care were used for data collection. Wilcoxon matched-pairs signed-rank test was used to compare proportions or medians.
Sixty patients were invited to participate in the study; 42 were enrolled and 33 completed the follow-up. Of the nine patients excluded from the study, only one was withdrawn due to adverse events. At 12 months, 31 of 42 patients (73.8 % in intention-to-treat analysis) achieved a viral load of HIV1 RNA <40 copies/mL. There was a significant increase (172 cells/mm) in the median for CD4 T lymphocyte count. The adverse events were mild and met the safety profile for this antiretroviral regimen, mainly of central nervous system symptoms, skin rash, lipid abnormalities, and an increase of 2 % in the median of the percentage of cardiovascular risk.
The clinical outcomes of generic version of abacavir/lamivudine and efavirenz in HIV treatment naïve patients showed the expected safety and effectiveness profile of proprietary ARV drugs.
Registro Público Cubano de Ensayos Clínicos (RPCEC) ID: RPCEC00000202 . Registered 19 November 2015.
仿制药政策常常引发对这些产品质量和有效性的担忧。IV期临床试验可能是评估仿制药有效性和安全性的合适设计。本研究的目的是描述初治HIV感染患者中仿制药阿巴卡韦/拉米夫定和依非韦伦的有效性和安全性。
一项单中心、非随机、开放标签的IV期研究，从一个提供全面门诊咨询和持续护理的项目中招募18岁及以上有指征接受阿巴卡韦/拉米夫定和依非韦伦的初治HIV感染患者。主要终点是在基线后12个月时病毒载量<40拷贝/mL以评估有效性。该研究的次要终点是：1）评估T-CD4淋巴细胞水平的升高以辅助评估有效性；2）评估胃肠道、皮肤和中枢神经系统症状以及血脂谱、心血管风险、肾功能和肝功能作为安全性指标。在基线、3个月、6个月和12个月时确定数据。通过密切临床监测和药学监护来收集数据。采用Wilcoxon配对符号秩检验来比较比例或中位数。
邀请了60名患者参与研究；42名患者入组，33名完成随访。在被排除出研究的9名患者中，只有1名因不良事件退出。在12个月时，42名患者中的31名（意向性分析中为73.8%）HIV-1 RNA病毒载量<40拷贝/mL。CD4 T淋巴细胞计数中位数有显著增加（172个细胞/mm³）。不良事件较轻，符合该抗逆转录病毒治疗方案的安全性特征，主要为中枢神经系统症状、皮疹、血脂异常以及心血管风险百分比中位数增加2%。
初治HIV患者中阿巴卡韦/拉米夫定和依非韦伦仿制药的临床结果显示出与专利抗逆转录病毒药物预期的安全性和有效性特征。
古巴临床研究公共注册库（RPCEC）编号：RPCEC00000202。于2015年11月19日注册。
