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

Frontiers in Pharmacology

Shuiqing Liu¹  Yaokai Chen²  Xiaohong Chen³  Qingxia Zhao⁴  Jianhua Yu⁵  Yuxia Song⁶  Hui Chen⁷  Shanfang Qin⁸  Hao Wu⁹  Xiaojie Huang⁹  Lijun Sun⁹  Yanfen Liu^1,10  Guiju Gao^1,11  Liumei Xu^1,12  Hongxia Wei^1,13  Ping Ma^1,14  Linghua Li^1,15  Weiping Cai^1,15  Min Wang^1,16  Haibo Ding^1,17 

[1] 0Department of Infectious Diseases, Guiyang Public Health Clinical Center, Guiyang, China;1Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, China;2Department of Infectious Diseases, the Fourth Affiliated Hospital of Harbin Medical University, Harbin, China;3Department of Infectious Diseases, Henan Infectious Disease Hospital, Zhengzhou, China;4Department of Infectious Diseases, XIXI Hospital of Hangzhou, Hangzhou, China;5Department of Infectious Diseases, Xinjiang Uygur Autonomous Region Sixth People’s Hospital, Xinjiang, China;6School of Biomedical Engineering, Capital Medical University, Beijing, China;7Department of Infectious Diseases, Longtan Hospital of Guangxi Zhuang Autonomous Region, Liuzhou, China;Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing, China;Center for Infectious Diseases, the Fourth People's Hospital of Nanning, Nanning, China;Clinical and Research Center for Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, China;Department of Clinical AIDS Research, the Third People’s Hospital of Shenzhen, Shenzhen, China;Department of Infectious Disease, The Second Hospital of Nanjing, Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine, Nanjing, China;Department of Infectious Disease, the Affiliated Second Peoples’ Hospital of the Nankai University, Tianjin, China;InInfectious Diseases Center, Guangzhou Eighth People’s Hospital, Guangzhou Medical University, Guangzhou, China;Institute of HIV/ AIDS, The First Hospital of Changsha, Changsha, China;NHC Key Laboratory of AIDS Immunology (China Medical University), Department of Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China;

关键词: efficacy and safety;    ART-experienced;    second-line antiretroviral therapy;    human immunodeficiency virus;    lopinavir/ritonavir;   

DOI  :  10.3389/fphar.2019.01455

来源: DOAJ

【 摘 要 】

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/mm3, 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/mm3 to 475 cells/mm3 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.

【 授权许可】

Unknown