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Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China
The World Health Organization guidelines recommend lopinavir/ritonavir (LPV/r) as a second-line antiretroviral therapy (ART) for HIV-infected adults in middle-income and low-income countries as a protease inhibitor boost based on clinical trials; however, the real-world safety and efficacy remain un...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6917650/ https://www.ncbi.nlm.nih.gov/pubmed/31920648 http://dx.doi.org/10.3389/fphar.2019.01455 |
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author | Huang, Xiaojie Xu, Liumei Sun, Lijun Gao, Guiju Cai, Weiping Liu, Yanfen Ding, Haibo Wei, Hongxia Ma, Ping Wang, Min Liu, Shuiqing Chen, Yaokai Chen, Xiaohong Zhao, Qingxia Yu, Jianhua Song, Yuxia Chen, Hui Wu, Hao Qin, Shanfang Li, Linghua |
author_facet | Huang, Xiaojie Xu, Liumei Sun, Lijun Gao, Guiju Cai, Weiping Liu, Yanfen Ding, Haibo Wei, Hongxia Ma, Ping Wang, Min Liu, Shuiqing Chen, Yaokai Chen, Xiaohong Zhao, Qingxia Yu, Jianhua Song, Yuxia Chen, Hui Wu, Hao Qin, Shanfang Li, Linghua |
author_sort | Huang, Xiaojie |
collection | PubMed |
description | The World Health Organization guidelines recommend lopinavir/ritonavir (LPV/r) as a second-line antiretroviral therapy (ART) for HIV-infected adults in middle-income and low-income countries as a protease inhibitor boost based on clinical trials; however, the real-world safety and efficacy remain unknown. Therefore, we conducted a large-scale, multicenter retrospective cohort study to evaluate the efficacy and safety of LPV/r-based ART among HIV-infected adults in China in whom first-line therapy failed. The data were obtained from a national database covering 17 clinics in China for six years of follow-up from 2009 to 2016. Failure of first-line treatment was determined according to a viral load at least 400 copies/ml at week 48, non-completers at week 48 for any reason, and those who switched ART before week 48 for any reason such as side effects. Treatment effectiveness was assessed by the rate of CD4(+)T cell recovery, defined as >500 cells/mm(3), and the proportion of patients achieving viral suppression, defined as <400 or <50 copies/ml according to the methods used during treatment. Safety was assessed by rates of LPV/r-related adverse events (AEs), including lipid disorder, severe abnormal liver function, myelosuppression, and renal function. Between 2009 and 2016, 1196 participants (median, 36 years old; IQR, 30–43 years) were ultimately enrolled. All patients had been on LPV/r-based second-line ART treatment for more than one year after failure of any first-line ART regimen. Overall CD4(+)T cell counts increased from 138 cells/mm(3) to 475 cells/mm(3) and 37.2% of all participants reached CD4 recovery. Viral suppression rates dramatically increased at the end of the first year (<400 copies/ml, 88.8%; <50 copies/ml, 76.7%) and gradually increased during follow-up (<400 copies/ml, 95.8%; <50 copies/ml, 94.4%). The most frequently reported AEs were LPV/r-induced lipid disorders with no obvious increase on LDL-C at follow-up visits. This is the first real-world LPV/r-based second-line treatment study to cover such a large population in China. These results provide strong clinical evidence that LPV/r-based second-line ART is effective in increasing CD4(+)T cell counts and viral suppression rates with tolerable side effects in HIV-infected adults in China in whom first-line treatment had failed. |
format | Online Article Text |
id | pubmed-6917650 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-69176502020-01-09 Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China Huang, Xiaojie Xu, Liumei Sun, Lijun Gao, Guiju Cai, Weiping Liu, Yanfen Ding, Haibo Wei, Hongxia Ma, Ping Wang, Min Liu, Shuiqing Chen, Yaokai Chen, Xiaohong Zhao, Qingxia Yu, Jianhua Song, Yuxia Chen, Hui Wu, Hao Qin, Shanfang Li, Linghua Front Pharmacol Pharmacology The World Health Organization guidelines recommend lopinavir/ritonavir (LPV/r) as a second-line antiretroviral therapy (ART) for HIV-infected adults in middle-income and low-income countries as a protease inhibitor boost based on clinical trials; however, the real-world safety and efficacy remain unknown. Therefore, we conducted a large-scale, multicenter retrospective cohort study to evaluate the efficacy and safety of LPV/r-based ART among HIV-infected adults in China in whom first-line therapy failed. The data were obtained from a national database covering 17 clinics in China for six years of follow-up from 2009 to 2016. Failure of first-line treatment was determined according to a viral load at least 400 copies/ml at week 48, non-completers at week 48 for any reason, and those who switched ART before week 48 for any reason such as side effects. Treatment effectiveness was assessed by the rate of CD4(+)T cell recovery, defined as >500 cells/mm(3), and the proportion of patients achieving viral suppression, defined as <400 or <50 copies/ml according to the methods used during treatment. Safety was assessed by rates of LPV/r-related adverse events (AEs), including lipid disorder, severe abnormal liver function, myelosuppression, and renal function. Between 2009 and 2016, 1196 participants (median, 36 years old; IQR, 30–43 years) were ultimately enrolled. All patients had been on LPV/r-based second-line ART treatment for more than one year after failure of any first-line ART regimen. Overall CD4(+)T cell counts increased from 138 cells/mm(3) to 475 cells/mm(3) and 37.2% of all participants reached CD4 recovery. Viral suppression rates dramatically increased at the end of the first year (<400 copies/ml, 88.8%; <50 copies/ml, 76.7%) and gradually increased during follow-up (<400 copies/ml, 95.8%; <50 copies/ml, 94.4%). The most frequently reported AEs were LPV/r-induced lipid disorders with no obvious increase on LDL-C at follow-up visits. This is the first real-world LPV/r-based second-line treatment study to cover such a large population in China. These results provide strong clinical evidence that LPV/r-based second-line ART is effective in increasing CD4(+)T cell counts and viral suppression rates with tolerable side effects in HIV-infected adults in China in whom first-line treatment had failed. Frontiers Media S.A. 2019-12-11 /pmc/articles/PMC6917650/ /pubmed/31920648 http://dx.doi.org/10.3389/fphar.2019.01455 Text en Copyright © 2019 Huang, Xu, Sun, Gao, Cai, Liu, Ding, Wei, Ma, Wang, Liu, Chen, Chen, Zhao, Yu, Song, Chen, Wu, Qin and Li http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Huang, Xiaojie Xu, Liumei Sun, Lijun Gao, Guiju Cai, Weiping Liu, Yanfen Ding, Haibo Wei, Hongxia Ma, Ping Wang, Min Liu, Shuiqing Chen, Yaokai Chen, Xiaohong Zhao, Qingxia Yu, Jianhua Song, Yuxia Chen, Hui Wu, Hao Qin, Shanfang Li, Linghua Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China |
title | Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China |
title_full | Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China |
title_fullStr | Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China |
title_full_unstemmed | Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China |
title_short | Six-Year Immunologic Recovery and Virological Suppression of HIV Patients on LPV/r-Based Second-Line Antiretroviral Treatment: A Multi-Center Real-World Cohort Study in China |
title_sort | six-year immunologic recovery and virological suppression of hiv patients on lpv/r-based second-line antiretroviral treatment: a multi-center real-world cohort study in china |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6917650/ https://www.ncbi.nlm.nih.gov/pubmed/31920648 http://dx.doi.org/10.3389/fphar.2019.01455 |
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