Efficacy of Efavirenz-Based Regimen in Antiretroviral-Naïve Patients with HIV-1 V179D/E Mutations in Shanghai, China

Zhenyan Wang; Min Zhang; Jiangrong Wang; Li Liu; Jun Chen; Renfang Zhang; Yang Tang; Yinzhong Shen; Tangkai Qi; Wei Song; Jianjun Sun; Shuibao Xu; Junyang Yang; Hongzhou Lu

doi:10.1007/s40121-022-00723-8

Efficacy of Efavirenz-Based Regimen in Antiretroviral-Naïve Patients with HIV-1 V179D/E Mutations in Shanghai, China

Infect Dis Ther. 2023 Jan;12(1):245-255. doi: 10.1007/s40121-022-00723-8. Epub 2022 Nov 28.

Authors

Zhenyan Wang^#¹, Min Zhang^#², Jiangrong Wang³, Li Liu³, Jun Chen³, Renfang Zhang³, Yang Tang³, Yinzhong Shen³, Tangkai Qi³, Wei Song³, Jianjun Sun³, Shuibao Xu³, Junyang Yang³, Hongzhou Lu⁴

Affiliations

¹ Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China. wangzhenyan@shaphc.org.
² Clinical Laboratory, Shanghai Public Health Clinical Center, Shanghai, China.
³ Department of Infection and Immunity, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jinshan District, Shanghai, 201508, China.
⁴ Shenzhen Key Laboratory of Pathogen and Immunity, National Clinical Research Center for Infectious Disease, State Key Discipline of Infectious Disease, The Third People's Hospital of Shenzhen, Second Hospital Affiliated to Southern University of Science and Technology, Shenzhen, 518112, Guangdong, China.

^# Contributed equally.

Abstract

Introduction: This study aimed to evaluate the prevalence of HIV-1 mutation V179D/E and the effect of V179D/E on the virological response to first-line efavirenz-based regimens among antiretroviral treatment (ART)-naïve patients.

Methods: An ambispective cohort study was conducted. All ART-naïve patients who underwent baseline genotypic resistance testing between January 2019 and November 2021 were included in the analysis of the prevalence of the V179D/E mutation. Then, patients with identified V179D/E received the efavirenz-based regimen or the protease inhibitor (PI)/integrase strand transfer inhibitor (INSTI)-based regimen. The virological and immunological outcomes at week 48 were compared between the two groups.

Results: HIV-1 mutation V179D/E was identified in 252 out of 2568 ART-naïve patients, with a prevalence of 9.8% in Shanghai, China. A total of 206 participants were included in the efficacy analysis. Forty-six patients with altered ART regimens or incomplete follow-up data were excluded from the analysis. The baseline characteristics were comparable between the efavirenz group (n = 109) and the PI/INSTI group (n = 97). At week 48, a total of 96 participants (88.1%) in the efavirenz group and 92 participants (94.8%) in the PI/INSTI group had a viral load lower than 50 copies/mL (chi-square test, p = 0.086). In both groups, a lower proportion of participants achieved virological suppression among participants with a baseline viral load of at least 100,000 copies/mL compared with those with lower than 100,000 copies/mL (66.7% vs. 96.1% in the efavirenz group, p < 0.001; 87.1% vs. 98.4% in the PI/INSTI group, p = 0.039). The median increase from baseline in the CD4 count at week 48 was significantly greater in the PI/INSTI group (192 cells/μL) than in the efavirenz group (154 cells/μL) (p = 0.029).

Conclusion: There is a high prevalence of V179D/E in ART-naïve patients with HIV-1 in Shanghai, China. The first-line efavirenz-based regimen may be not suitable for patients with HIV-1 mutation V179D/E, especially for those with a baseline viral load of at least 100,000 copies/mL. The study was registered at the Chinese Clinical Trial Registry (ChiCTR2000034787).

Keywords: Antiretroviral; Efavirenz; HIV; Integrase strand transfer inhibitor; Mutation; Protease inhibitor; V179D; V179E.

Abstract

Grants and funding