Efficacy and effect on lipid profiles of switching to ainuovirine-based regimen versus continuing efavirenz-based regimen in people with HIV-1: 24-week results from a real-world, retrospective, multi-center cohort study

Author:

Wang Chunmei1,Yu Xiaoli2,Ke Yingchun3,Fu Yanhua4,Luo Yanhe2,Li Ying5,Bi Yanmei1,Chen Xingqiong6,Li Linghua3,Zhao Xiuhong1,Chen Zhong5ORCID

Affiliation:

1. Department of Dermatology, Shandong Public Health Clinical Center, Shandong University, Jinan, Shandong, China

2. Department of Infection and Immunology with Chinese Integrative Medicine, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China

3. Infectious Disease Center, Guangzhou Eighth People’s Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China

4. Department of Infectious Disease, GuiYang Public Health Clinical Center, Guiyang, Guizhou, China

5. Department of Infection and Immunology, The First Hospital of Changsha City, Xiangya School of Medicine of Central South University, Changsha, Hunan, China

6. Department of Outpatient, Yunnan Provincial Infectious Disease Hospital, Kunming, Yunnan, China

Abstract

ABSTRACT Ainuovirine (ANV), a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI), was approved in China in 2021. In a previous randomized phase 3 trial, ANV demonstrated non-inferior efficacy relative to efavirenz (EFV) and was associated with lower rates of dyslipidemia. In this study, we aimed to explore lipid changes in treatment-experienced people with human immunodeficiency virus (HIV)-1 (PWH) switching to ANV from EFV in real world. At week 24, 96.65% of patients in the ANV group and 93.25% in the EFV group had HIV-1 RNA levels below the limit of quantification (LOQ). Median changes from baseline in CD4 +T cell counts (37.0 vs 36.0 cells/µL, P = 0.886) and CD4+/CD8 +ratio (0.03 vs 0.10, P = 0.360) were similar between the two groups. The ANV group was superior to the EFV group in mean changes in total cholesterol (TC, −0.06 vs 0.26 mmol/L, P = 0.006), triglyceride (TG, −0.6 vs 0.14 mmol/L, P < 0.001), high-density lipoprotein cholesterol (HDL-C, 0.09 vs 0.08 mmol/L, P = 0.006), and low-density lipoprotein cholesterol (LDL-C, −0.18 vs 0.29 mmol/L, P < 0.001) at week 24. We also observed that a higher proportion of patients demonstrated improved TC (13.55% vs 4.45%, P = 0.015) or LDL-C (12.93% vs 6.89%, P = 0.017), and a lower proportion of patients showed worsened LDL-C (5.57% vs 13.52%, P = 0.017) with ANV than with EFV at week 24. In conclusion, we observed good efficacy and favorable changes in lipids in switching to ANV from EFV in treatment-experienced PWH in real world, indicating a promising switching option for PWH who may be more prone to metabolic or cardiovascular diseases.

Publisher

American Society for Microbiology

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