Safety and efficacy of switching to 4-weekly albuvirtide plus daily dolutegravir in virologically suppressed HIV-1 adults: a 24-week study

Objectives: Albuvirtide (ABT) is a long-acting fusion inhibitor. This study assessed switching to ABT 640 mg every 4 weeks plus daily Dolutegravir (DTG) in virologically suppressed adults with HIV-1. Design and methods: In this open-label, single-arm study, 10 participants with HIV-1 RNA <50 copies/mL switched to ABT plus DTG for 24 weeks. Safety, pharmacokinetics, viral load, and CD4+ T cell counts were assessed. Results: No serious adverse events occurred. Albuvirtide's steady-state trough concentration was 31.1 times higher than PA-IC90. All participants maintained virological suppression. CD4+ T-cell counts increased significantly after 24 weeks (P = 0.0462). Conclusion: Switching to 4-weekly ABT plus daily DTG demonstrated good safety, favorable pharmacokinetics, maintained virological suppression, and improved immune recovery. These findings support ABT's potential as a long-acting agent for simplifying HIV treatment.