Analysis of the Virological Failure Rates and Influencing Factors of ART Regimens Containing Integrase Inhibitors: A Retrospective Analysis from the Real World in Chongqing

Objective: To assess the virological failure (VF) rate and determinants in treatment-naïve HIV patients using regimens with second-generation integrase inhibitors (INSTIs) in regions characterized by delayed diagnosis and advanced AIDS. Methods: We collected data from HIV-naïve patients who began antiretroviral therapy (ART) at Chongqing Public Health Medical Center between January 2018 and January 2023. Patients receiving second-generation INSTIs in their ART regimen were selected for study. Demographic information, clinical comorbidities, and laboratory test results before and after treatment, along with treatment compliance data, were gathered to calculate the VF rate. Independent risk factors for VF were analyzed via univariate and multivariate methods. Results: A total of 1,215 treatment-naïve HIV-infected individuals were screened for ART via a second-generation INSTIs regimen. Among them, 819 (67.41%) had baseline CD4+ T lymphocyte counts less than 200/µL, and 424 (34.90%) had baseline HIV RNA levels exceeding 500,000 copies/ml. The VF rate was 6.34% (77/1,215) at 48 weeks posttreatment. Univariate analysis revealed that baseline CD4+ T lymphocytes <200/µL, baseline HIV RNA >500,000 copies/ml, coinfection with opportunistic infections, occurrence of low-level viremia (LLV), and poor drug adherence were risk factors for VF. Multivariate analysis confirmed that a baseline CD4+ T lymphocyte count <200/µL, LLV, and poor drug adherence were independent risk factors for VF. Among the 77 patients who experienced VF, 23 underwent HIV gene resistance testing, revealing integrase drug resistance mutations in 3 patients (13.04%). By December 2024, 58 of the 77 VF patients achieved successful virologic suppression (16 maintained the original regimen), 8 had HIV RNA levels between 50 and 200 copies/ml, and 11 had levels >200 copies/ml. Conclusion: In real-world scenarios where HIV is detected and treated late, second-generation INSTIs exhibit a high rate of VF However, the incidence of integrase drug resistance mutations among patients experiencing VF is low. Many patients achieve successful virologic suppression through enhanced adherence education while continuing their original regimen. Patients with a baseline CD4+ T lymphocyte count less than 200/µL, LLV, and poor drug adherence are at an elevated risk for treatment failure and warrant particular attention.