Citation: | MO Jinrong, ZHOU Qiaoyu, LIAO Jiong, LIAN Xiaoming. Efficacy and safety of Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets in treatment-naive acquired immune deficiency syndrome patients[J]. Journal of Clinical Medicine in Practice, 2024, 28(12): 100-106. DOI: 10.7619/jcmp.20233952 |
To evaluate the efficacy and safety of Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets in initial treatment of acquired immune deficiency syndrome (AIDS) patients.
A total of 80 treatment-naive AIDS patients were selected as research subjects and randomly divided into control group and observation group, with 40 patients in each group. The control group was treated with free antiviral drugs (tenofovir + lamivudine + efavirenz), while the observation group was treated with Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets. The CD4+ count, human immunodeficiency virus (HIV) viral load, and biochemical indicators were compared between the two groups before treatment and at 3, 6, 9, and 12 months after treatment. The adherence, adverse reactions, and quality of life were also compared between the two groups.
During the treatment, six patients in the observation group and 9 patients in the control group had no compliance. With the extension of treatment time, the CD4+ level in both groups gradually increased, and the HIV viral load gradually decreased (P < 0.05). After 3, 6, 9, and 12 months of treatment, the CD4+ levels in the observation group were higher than those in the control group, and the HIV viral loads were lower than those in the control group (P < 0.05). With the extension of treatment time, the levels of alanine aminotransferase, aspartate aminotransferase, urea, creatinine, and uric acid in the control group gradually increased, and the random blood glucose levels after 3, 6, 9, and 12 months of treatment in the control group were higher than those before treatment (P < 0.05). After 3, 6, 9, and 12 months of treatment, the levels of alanine aminotransferase, aspartate aminotransferase, urea, creatinine, uric acid, and random blood glucose in the observation group were lower than those in the control group (P < 0.05). The incidence of adverse reactions in the observation group was 2.94% (1/34), which was lower than 90.00% (36/40) in the control group (corrected χ2=55.718, P < 0.001). With the extension of treatment time, the scores of various dimensions of quality of life in both groups gradually increased, and the scores of various dimensions of quality of life after treatment in the observation group were higher than those in the control group (P < 0.05).
Compared with the free antiviral drug regimen, Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets shows better efficacy in the treatment of AIDS-naive patients, which can significantly increase the CD4+ level, and reduce the HIV viral load. Besides, it has high safety, and can significantly improve their quality of life.
[1] |
闫翔宇, 李永杰, 肖冬, 等. 我国参与艾滋病防治社会组织相关工作情况调查[J]. 中国艾滋病性病, 2021, 27(9): 1000-1003. https://www.cnki.com.cn/Article/CJFDTOTAL-XBYA202109024.htm
|
[2] |
HUANG S Z, YANG C X, XIN J Y, et al. Outcomes of methadone maintenance therapy combined with rilpivirine/efavirenz in treatment-naive HIV-infected patients[J]. Curr HIV Res, 2021, 19(4): 368-376. doi: 10.2174/1570162X19666210423123958
|
[3] |
ORKIN C, SQUIRES K E, MOLINA J M, et al. Doravirine/lamivudine/tenofovir disoproxil fumarate (TDF) versus efavirenz/emtricitabine/TDF in treatment-naive adults with human immunodeficiency virus type 1 infection: week 96 results of the randomized, double-blind, phase 3 DRIVE-AHEAD noninferiority trial[J]. Clin Infect Dis, 2021, 73(1): 33-42. doi: 10.1093/cid/ciaa822
|
[4] |
LI G D, WANG Y L, CLERCQ E D. Approved HIV reverse transcriptase inhibitors in the past decade[J]. Acta Pharm Sin B, 2022, 12(4): 1567-1590. doi: 10.1016/j.apsb.2021.11.009
|
[5] |
SUÁREZ-GARCÍA I, ALEJOS B, HERNANDO V, et al. Effectiveness and tolerability of dolutegravir/lamivudine for the treatment of HIV-1 infection in clinical practice[J]. J Antimicrob Chemother, 2023, 78(6): 1423-1432. doi: 10.1093/jac/dkad102
|
[6] |
乌建平, 杨柳清, 周恒忠. 预防医学[M]. 5版. 北京: 北京大学医学出版社, 2020: 101-105.
|
[7] |
张阳, 武玉欣, 曲波, 等. SF-36量表在医学生生命质量评价中的应用[J]. 中国卫生统计, 2013, 30(3): 468-468. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGWT201901027.htm
|
[8] |
HUANG Y S, CHENG C Y, LIOU B H, et al. Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide as maintenance treatment in HIV/HBV-coinfected patients[J]. J Acquir Immune Defic Syndr, 2021, 86(4): 473-481. doi: 10.1097/QAI.0000000000002589
|
[9] |
付志鹏, 康东伟, 刘新泳, 等. 基于靶标的抗艾滋病药物研究新进展[J]. 药学进展, 2020, 44(9): 681-697. https://www.cnki.com.cn/Article/CJFDTOTAL-YXJZ202009007.htm
|
[10] |
邓永岳, 吴守丽, 邱丽君, 等. 应用高通量测序方法研究CRF01-AE亚型HIV-1毒株耐药突变的分子进化规律[J]. 实用临床医药杂志, 2021, 25(19): 1-6. doi: 10.7619/jcmp.20211220
|
[11] |
ADAMS J L, CHOI Y C, WEST M, et al. Changes in neurocognitive assessment scores after initiating dolutegravir- versus elvitegravir-based antiretroviral therapy[J]. AIDS Care, 2021, 33(11): 1507-1513. doi: 10.1080/09540121.2020.1837337
|
[12] |
杜小莉, 曹雅睿, 李太生. 利用药代动力学/药效动力学优化中国艾滋病患者的药物治疗方案[J]. 药学进展, 2021, 45(6): 413-418. https://www.cnki.com.cn/Article/CJFDTOTAL-YXJZ202106004.htm
|
[13] |
黄春玲. 四川省遂宁市新报告的艾滋病病毒感染者及艾滋病患者晚发现情况分析[J]. 实用临床医药杂志, 2020, 24(19): 15-17, 21. doi: 10.7619/jcmp.202019005
|
[14] |
NELSON M, WINSTON A, HILL A, et al. Efficacy, safety and central nervous system effects after switch from efavirenz/tenofovir/emtricitabine to doravirine/tenofovir/lamivudine[J]. AIDS, 2021, 35(5): 759-767. doi: 10.1097/QAD.0000000000002804
|
[15] |
HUANG W C, HUANG C K, HUANG S H, et al. Therapeutic drug monitoring study on the switch from coformulated 600-mg efavirenz, tenofovir disoproxil fumarate, and emtricitabine to coformulated 400-mg efavirenz, tenofovir disoproxil fumarate, and lamivudine among HIV-positive patients with viral suppression[J]. J Microbiol Immunol Infect, 2021, 54(5): 944-951. doi: 10.1016/j.jmii.2020.06.010
|
[16] |
贾思思, 黄普超, 马晓艳, 等. 信迪利单抗联合化疗方案对小细胞肺癌患者生活质量及免疫功能的影响[J]. 罕少疾病杂志, 2022, 29(7): 33-35. https://www.cnki.com.cn/Article/CJFDTOTAL-HSJB202207012.htm
|
[17] |
MAX B, DEMARAIS P. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide discontinuation and return to normal weight[J]. Int J STD AIDS, 2021, 32(1): 92-95. doi: 10.1177/0956462420964341
|
[18] |
KIRKEGAARD-KLITBO D M, THOMSEN M T, GELPI M, et al. Hepatic steatosis associated with exposure to elvitegravir and raltegravir[J]. Clin Infect Dis, 2021, 73(3): e811-e814.
|
[19] |
CAMARA-CISSE M, DJOHAN Y F, TONI T D, et al. Determination of reverse transcriptase inhibitor resistance mutations in HIV-1 infected children in Côte d′Ivoire[J]. Genome, 2021, 64(4): 347-354.
|
[20] |
PEREZ-VALERO I, LLIBRE J M, CASTAGNA A, et al. Switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in adults with HIV and M184V/I mutation[J]. J Acquir Immune Defic Syndr, 2021, 86(4): 490-495.
|