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. 2023 Jan 9:13:1033098.
doi: 10.3389/fimmu.2022.1033098. eCollection 2022.

A retrospective clinical study of dolutegravir- versus efavirenz-based regimen in treatment-naïve patients with advanced HIV infection in Nanjing, China

Mingli Zhong  1 , Mengqing Li  1 , Mingxue Qi  2 , Yifan Su  2 , Nawei Yu  2 , Ru Lv  2 , Zi Ye  2 , Xiang Zhang  2 , Xinglian Xu  2 , Cong Cheng  2 , Chen Chen  2 , Hongxia Wei  1
Affiliations

A retrospective clinical study of dolutegravir- versus efavirenz-based regimen in treatment-naïve patients with advanced HIV infection in Nanjing, China

Mingli Zhong et al. Front Immunol. .

Abstract

Currently, there are limited data related to the efficacy and safety of ART regimens, as well as factors influencing immune recovery in antiretroviral therapy (ART)-naïve patients with advanced HIV infection, especially in China. We designed a single-center, retrospective cohort study from March 1, 2019, to May 31, 2022, at The Second Hospital of Nanjing, China. ART-naïve adults with advanced HIV infection (CD4+ T-cell count < 200 cells/μL) who met the study criteria were included. The plasma viral load (VL), CD4+ T-cell count, CD4/CD8 ratio, treatment discontinuation, and immune reconstitution inflammatory syndrome (IRIS) events were collected to compare the efficacy and safety of the dolutegravir (DTG) and the efavirenz (EFV) regimens. Factors of immune recovery were analyzed using the Cox regression model. Study enrolled 285 ART-naïve adults with advanced HIV-1 infection, of which 95 (33.3%) started regimens including DTG and 190 (66.7%) were treated with EFV. After ART initiation, the proportion of patients with HIV-1 RNA < 50 copies/mL was higher (22.5% versus 6.5%, P < 0.001) in those on DTG-based regimens at month 1, but no significant difference at other follow-up points. Compared to the baseline, the median CD4+ T-cell count and CD4/CD8 ratio increased significantly during follow-up both in the EFV and the DTG groups. However, the CD4+ T-cell count increased greater in patients on DTG-based regimens at months 6, 12, 24, and 36 (P < 0.05). A total of 52 (18.2%) patients discontinued treatment, with no significant difference between ART regimens in treatment discontinuation rates. Only 7 patients reported IRIS, without significant difference between ART regimens (P=0.224). Overall, 34.0% (97/285) achieved a CD4+ T-cell count ≥ 350 cells/μL during follow-up. Age (P < 0.001), baseline CD4+ T-cell count (P < 0.001), baseline VL (P < 0.001) and ART regimens (P = 0.019) were associated with the CD4+ T-cell count ≥ 350 cells/μL after adjusting for potential confounders. Among ART-naïve adults with advanced HIV infection, it appeared that DTG-based regimens were better options for initial therapy compared to regimens including EFV; in addition, ART regimens, age, baseline VL and CD4+ T-cell count were associated with immune recovery.

Keywords: IRIS - immune reconstitution inflammatory syndrome; advanced HIV infection; antiretroviral therapy; dolutegravir; efavirenz; immune recovery.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Study process. ART, antiretroviral therapy; PLWH, people living with HIV; NVP, nevirapine; LPV/r, lopinave/litonawe; RAL, raltegravir; EVG/c/F/TAF, elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; EFV, efavirenz; DTG, dolutegravir; eGFR, estimated glomerular filtration rate; ALT, alanine transaminase; AST, aspartate transaminase.
Figure 2
Figure 2
Proportion of patients with virological suppression at 6 different follow-up points according to antiretroviral regimens. (A) Proportion of virological suppression in all patients. (B) Proportion of virological suppression in patients with a baseline VL ≥ 100,000 copies/mL. BL, baseline; VL, viral load; EFV, efavirenz; DTG, dolutegravir. ***P<0.001.
Figure 3
Figure 3
Changes in median CD4+ T-cell count and CD4/CD8 ratio of patients during the follow-up period according to antiretroviral regimens. (A) Median CD4+ T-cell count change from baseline in all patients. (B) Median CD4+ T-cell count change from baseline in patients with baseline CD4+ T-cell count ≤ 50 cells/μL. (C) Median CD4/CD8 ratio change from baseline in all patients. (D) Median CD4/CD8 ratio change from baseline in patients with baseline CD4/CD8 ratio ≤ 0.1. The numbers in the table below the figure were the median change of CD4+ T-cell count or CD4/CD8 ratio from baseline. BL, baseline; EFV, efavirenz; DTG, dolutegravir. *P<0.05; **P<0.01.
Figure 4
Figure 4
Effects of regimens and baseline CD4+ T-cell count on the cumulative probability of CD4+ T-cell count ≥ 350 cells/μL. (A) Different regimens on CD4+ T-cell count ≥ 350 cells/μL. (B) Baseline CD4+ T-cell count-stratified results on CD4+ T-cell count ≥ 350 cells/μL. EFV, efavirenz; DTG, dolutegravir.
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Grants and funding

This work was supported by the 2020 Annual Medical Research Project of Jiangsu Commission of Health to Hongxia Wei [Grant# ZDA 2020014], and the 2022 Annual Key Project supported by Medical Science and Technology Development Foundation, Nanjing Department of Health, awarded to Hongxia Wei (Grant# ZKX 22040).