Efficacy and Safety of Albuvirtide Plus Dolutegravir or Dolutegravir/Lamivudine in Hospitalized People with Advanced AIDS: A Retrospective Real-World Study.

Abstract

Hospitalized people with advanced AIDS require potent, safe antiretroviral therapy (ART) with minimal drug interactions. This real-world retrospective cohort study aims to evaluate the efficacy and safety of albuvirtide (ABT) plus dolutegravir (DTG), with or without lamivudine (3TC), in this vulnerable population. We retrospectively analyzed clinical data from treatment-naïve (TN) and treatment-experienced (TE) hospitalized people with AIDS who received an ABT-based regimen for at least 24 weeks at the Chengdu Public Health Clinical Medical Center between July 2021 and July 2023. The primary outcome was the virological suppression rate (HIV-1 RNA <50 copies/mL) at week 24. A total of 174 patients (112 TN, 62 TE) were included, with 90.23% presenting with opportunistic infections. At week 24, the overall virological suppression rate was 79.89% (139/174). The suppression rate was 75.89% in TN patients and 87.10% in TE patients. From baseline, the median CD4 count increased by 115.50 cells/μL in the TN group and 89.00 cells/μL in the TE group (both p < .05). Treatment-related adverse events (AEs) occurred in only 5.17% of patients, all were mild-to-moderate, and no injection-site reactions were reported. No significant differences in efficacy or safety were found between the ABT + DTG and ABT + DTG/3TC regimens. In a real-world setting, ABT-based regimens containing DTG (with or without 3TC) demonstrated high efficacy and excellent safety in hospitalized people with advanced AIDS, supporting its use in this difficult-to-treat population.