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

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.

Factors associated with CD4 cell count recovery among males and females with advanced HIV disease

“…The median (IQR) age of the participants was 37 (32-43) years. Women were younger than men [median (IQR) age 35 (30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41) vs. 39 (34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45), P < 0.0001]. The median (IQR) CD4 þ cell count and log 10 viral load (VL) at study entry was 31 (14-55) cells/ml and 5.43 (5.09-5.82) copies/ml respectively and was the same between male and female participants (P > 0.05).…”

“…A recent study by Chan et al showed that DTG-based ART compared to EFV-based ART was associated with greater increments of CD4 þ and CD8 þ cell count among individuals with acute HIV infection following a 96 week post-ART treatment [39]. Two recent studies concluded that, use of DTG-based regimens compared to a NNRTI-based regimen were a better option to attain better CD4 þ cell count among treatment naive patients with advanced HIV infection [40,41]. As DTG is being rolled out in LMICs, more studies are warranted to assess whether these factors associated with immune reconstitution persist on a DTGbased ART.…”

Active HIV infection and current effectiveness rate of dolutegravir-based treatment among people living with HIV in Gabon

“…But this could also be due to a regular supply of antiretroviral drugs observed during the study period. Several studies carried out around the world and particularly in countries with limited resources have shown that DTG still retains its effectiveness even if some resistance mutations are already observable in PLHIV on a global scale (13,(28)(29)(30)(31) .…”

Comparative Safety and Changes in Immunologic and Virologic Parameters of Dolutegravir versus Efavirenz-Based Antiretroviral Therapies Among HIV Patients: A Retrospective Cohort Study

“…Moreover, the survival rate and safety results from this 48-week retrospective study were poorer compared with other similar studies conducted for the same duration. [32][33][34][35] Unlike the many reference trials discussed here, the demographics, type of patients (ART-exposed and ART-naïve HIV-infected patients), and clinical characteristics at baseline were not balanced between the treatment groups. The proportion of patients who were female, with initial VL ≥1000 copies/ mL, baseline CD4 + T-cell count <200 cells/mm 3 , bed-ridden functional status, longer treatment duration, and young median age were higher in the EFV-based compared to the DTG-based regimen.…”