Innovative Albuvirtide-Based Combination Regimen in Critically Ill HIV-1-Infected Patients: Evidence of Viral Suppression and Safety Outcomes

Background To control HIV-1 viral load, reduce drug resistance, and maintain optimal immune function, albuvirtide (ABT) combined with antiretroviral therapy (ART) is used in designated AIDS hospitals in China. However, the standard weekly 320-mg ABT injection regimen poses adherence-related challenges. This study aimed to evaluate the safety and efficacy of an optimized ABT regimen in HIV-1-infected patients. Methods Twenty HIV-1-infected patients received ABT 320 mg intravenously for three consecutive days every four weeks, alongside their baseline ART regimens. Peripheral blood samples were collected to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), triglyceride (TAG), cholesterol, CD4 ⁺ T-cell counts, and HIV-RNA levels, and ABT concentrations (pre-dose and 2 hours after dose). Results All patients maintained high adherence and reported reduced psychological burden. No drug-related adverse events (e.g., injection-site reactions, hepatotoxicity, nephrotoxicity) were observed. Laboratory parameters remained stable, with no significant changes from baseline ( P  > 0.05). Pharmacokinetic analysis demonstrated sustained therapeutic exposure, with mean trough concentrations of 4.71 mg/L, 3.83 mg/L, and 4.53 mg/L at Weeks 4, 8, and 12, respectively exceeding 50× the IC₉₀. The mean viral load decreased from 1.65 log ₁₀ copies/mL at baseline to 0.59 log ₁₀ copies/mL at Week 12 (mean reduction: 1.06 log₁₀ copies/mL; P  = 0.0007). Among patients with baseline HIV-RNA > 20 copies/mL, the viral load decreased from 2.55 to 1.43 log ₁₀ copies/mL. Although both CD4 ⁺ and CD8 ⁺ T-cell counts increased, the changes were not statistically significant. Conclusion The innovative ABT regimen, administered every four weeks, demonstrated effective viral suppression and a favorable safety and tolerability profile. Sustained plasma drug concentrations above the PA-IC₉₀ support its potential as a promising long-acting antiretroviral agent with improved patient adherence and applicability for managing HIV-1. These findings suggest that this approach may offer a promising therapeutic option for treatment-refractory HIV-1 populations.