Safety and Virological Outcomes of a Modified Albuvirtide Intensification Regimen with Standard ART in People with HIV.

BACKGROUND: To control HIV-1 viral load 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 explored the safety and virological outcomes of a modified ABT intensification regimen in people with HIV. METHODS: This single-arm, uncontrolled prospective cohort enrolled 20 people with HIV who received intravenous ABT 320 mg for three consecutive days every four weeks while continuing their baseline ART regimens. Peripheral blood samples were collected to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), triglyceride (TAG), cholesterol, CD4+ T-cell counts, HIV-RNA levels, and plasma ABT concentrations. RESULTS: No adverse events considered related to ABT were observed in this cohort. 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, each exceeding 50-fold the IC9 0. During follow-up, mean HIV-RNA decreased from 1.65 log10 copies/mL at baseline to 0.59 log10 copies/mL at Week 12 (mean reduction: 1.06 log1 0 copies/mL; P = 0.0007). Among patients with baseline HIV-RNA above 20 copies/mL, the viral load decreased from 2.55 to 1.43 log10 copies/mL. CONCLUSION: Preliminary results demonstrate that 4-week ABT antiviral intensification regimen is feasible and exhibits potential antiviral activity.