Early virologic and immunologic outcomes of albuvirtide-based regimens in treatment-naïve adults with advanced HIV disease and ultra-high viral loads: a multicenter retrospective cohort study

Advanced HIV-1 infection with ultra-high viral loads (> 500,000 copies/mL) represents a high-risk clinical presentation characterized by extreme viremia and profound immunosuppression. This clinical setting requires prompt initiation of effective antiretroviral therapy to achieve early control of plasma viremia. We evaluated the early virologic and immunologic outcomes and safety of albuvirtide (ABT)-based regimens in this high-risk cohort. We conducted a multicenter, retrospective study analyzing real-world data from 25 clinical centers in China. The cohort comprised treatment-naïve adults with baseline HIV-1 RNA > 500,000 copies/mL and CD4+ T-cell counts < 200 cells/µL who initiated ABT-based therapy. The primary endpoint was the proportion of patients achieving virologic suppression at Week 12. Secondary endpoints included the magnitude of viral decline, immunologic recovery, and safety. The primary descriptive analysis was conducted among participants with an evaluable Week-12 virologic assessment. A conservative non-responder-imputation sensitivity analysis including all treatment initiators classified participants without an evaluable Week-12 viral-load measurement as non-responders. Among 358 eligible patients who initiated ABT-based therapy, 287 had an evaluable Week-12 virologic outcome, of whom 132 (46.0%) were classified as CDC stage C3. The median baseline viral load was 1,060,000 (IQR: 696,000–2,205,000) copies/mL and the median CD4+ T-cell count was 48 (IQR: 25–100) cells/µL. At Week 12, 40.4% (116/287) achieved HIV-1 RNA < 50 copies/mL and 76.3% (219/287) achieved < 200 copies/mL. In the conservative sensitivity analysis including all 358 treatment initiators, corresponding suppression rates were 32.4% (116/358) and 61.2% (219/358), respectively. The median change from baseline in HIV-1 RNA was − 4.3 log₁₀ copies/mL, and CD4+ T-cell counts increased over 12 weeks. Among the 287 participants included in the 12-week safety analysis, 45 (15.7%) had at least one recorded Grade 1 or 2 laboratory abnormality. No Grade 3 laboratory abnormalities, serious adverse events, adverse event-related treatment discontinuations or regimen switches, or deaths were recorded. Among treatment-naïve adults with ultra-high HIV-1 viral loads and advanced immunosuppression, ABT-based regimens were associated with early reductions in HIV-1 RNA and increases in CD4+ T-cell counts over 12 weeks. These observational findings warrant further evaluation in prospective comparative studies. Not applicable. ABT-based regimens were associated with early declines in HIV-1 RNA in treatment-naïve adults with baseline HIV-1 RNA > 500,000 copies/mL. Among Week-12 evaluable participants, 40.4% achieved HIV-1 RNA < 50 copies/mL and 76.3% achieved < 200 copies/mL. Among Week-12 evaluable participants, CD4+ T-cell counts increased by a mean of 122.5 cells/µL over 12 weeks. Among the 287 Week-12 evaluable participants included in the 12-week safety analysis, Forty-five participants (15.7%) had at least one recorded Grade 1 or 2 laboratory abnormality; no Grade 3 laboratory abnormalities, serious adverse events, adverse event-related treatment discontinuations or regimen switches, or deaths were recorded. Conservative non-responder imputation in all 358 treatment initiators yielded suppression rates of 32.4% (< 50 copies/mL) and 61.2% (< 200 copies/mL), supporting cautious interpretation of evaluable-cohort estimates.