Efficacy and Tolerability of Lopinavir/Ritonavir- and Efavirenz-Based Initial Antiretroviral Therapy in HIV-1-Infected Patients in a Tertiary Care Hospital in Beijing, China
Efficacy and Tolerability of Lopinavir/Ritonavir- and Efavirenz-Based Initial Antiretroviral Therapy in HIV-1-Infected Patients in a Tertiary Care Hospital in Beijing, China
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DOI：
10.3389/fphar.2019.01472
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发表时间：
2019-12
影响因子：
5.6
通讯作者：
B. Su;Yin Wang;Ruifeng Zhou;Taiyi Jiang;Hongwei Zhang;Zai-cun Li;An Liu;Y. Shao;Wei Hua;Tong Zhang;Hao Wu;Shenghua He;Lili Dai;Lijun Sun
中科院分区：
文献类型：
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作者：
B. Su;Yin Wang;Ruifeng Zhou;Taiyi Jiang;Hongwei Zhang;Zai-cun Li;An Liu;Y. Shao;Wei Hua;Tong Zhang;Hao Wu;Shenghua He;Lili Dai;Lijun Sun
背景：洛匹那韦/利托那韦(LPV/r)是中国的主要抗逆转录病毒疗法，但基于LPV/r的一线方案在治疗人类免疫缺陷病毒1型(HIV-1)感染的初治患者中的疗效鲜为人知。这项研究旨在评估LPV/r联合拉米夫定和替诺福韦或齐多夫定作为HIV-1感染者初始抗逆转录病毒治疗的疗效和不良反应事件，这些患者不能服用EFV(EFV)或对EFV过敏。方法：我们对2012年7月至2017年1月在中国国家免费抗逆转录病毒治疗计划登记的患者进行了回顾性研究，并在北京的一家三级保健医院中国进行了随访。主要结果是在治疗6个月和24个月时，艾滋病毒-1RNA≤40拷贝/毫升的受试者所占比例。我们评估了免疫学反应和不良事件。结果：总共有4862名患者参加了这项研究，每个研究组有237名患者符合分析条件。在前6个月，基于LPV/r方案的病毒学抑制效果好于基于EFV的方案(P<；0.05，93.80%比87.80%)。两组的病毒抑制率持续增加，直到12个月，此后保持稳定，直到24个月。多水平分析显示，LPV/R组的患者比EFV组的患者更有可能随着时间的推移表现出CD4T细胞计数的改善(P<；0.001)。LPV/r组14例(5.91%)和EFV组3例(1.20%)发生3~4级实验室不良反应。结论：LPV/r方案对中国初治HIV-1感染者是有效且耐受性良好的。
Background: Lopinavir/ritonavir (LPV/r) is a major antiretroviral treatment in China, but little is known about the performance of first-line LPV/r-based regimen in treatment-naïve patients with human immunodeficiency virus type 1 (HIV-1) infection. This study aims to assess the efficacy and adverse effect events of LPV/r plus lamivudine and tenofovir or zidovudine as an initial antiretroviral treatment in HIV-1-infected individuals for whom cannot take efavirenz (EFV) or is allergic to EFV. Methods: We performed a retrospective study of patients registering with the China’s National Free Antiretroviral Treatment Program from July 2012 to January 2017, followed at a tertiary care hospital in Beijing, China. The primary outcome was the proportion of subjects with HIV-1 RNA ≤40 copies/ml at 6 and 24 months of treatment. We assessed the immunological response and adverse events. Results: In total, 4,862 patients were enrolled in the study and 237 were eligible for analysis in each study arm. During the first six months, virological suppression was better with the LPV/r-based regimen than with the EFV-based regimen (93.80 vs 87.80% for P < 0.05). Viral suppression rates continued to increase until 12 months, remain steady thereafter until 24 months, for both groups. The multilevel analysis revealed that patients in the LPV/r group were more likely to display improvements in CD4 T-cell count over time than those in the EFV group (P < 0.001). Grade 3 or 4 laboratory adverse events were observed in 14 patients (5.91%) from the LPV/r group and three patients (1.20%) in EFV group. Conclusion: Our findings demonstrate that LPV/r-containing regimens are effective and well-tolerated in Chinese treatment-naïve patients with HIV-1 infection.