Safety, pharmacokinetics, and efficacy of albuvirtide administered by intravenous bolus every 4 weeks in combination with oral dolutegravir in virologically suppressed adults living with HIV: A 24-week study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Albuvirtide (ABT), China's first domestically developed long-acting HIV-1 fusion inhibitor, shows significant potential for simplifying antiretroviral therapy when used in combination with dolutegravir (DTG). METHODS: This single-center, open-label, single-arm pilot study enrolled nine virologically suppressed people living with HIV. Participants received ABT 640 mg via intravenous bolus every 4 weeks plus a daily oral dose of DTG 50 mg for 24 weeks. The primary endpoints were the virologic failure rate and pharmacokinetic (PK) interactions. RESULTS: All nine participants completed the 24-week study with no virologic failures. A statistically significant increase in CD4+ T cell count was observed (median change +66 cells/µl, P = 0.045). The PK profile was favorable, with the steady-state ABT trough concentrations being approximately 27-fold the required inhibitory concentration, and no clinically significant PK interactions were noted. Treatment-emergent adverse events were mild to moderate, most commonly laboratory abnormalities and transient cardiac events, with no discontinuations due to AEs. CONCLUSION: In this small-sample, open-label study, the combination of 4-weekly ABT with daily DTG demonstrated excellent short-term efficacy, a favorable safety profile, and desirable pharmacokinetic properties over 24 weeks. These preliminary findings support further investigation of this novel long-acting regimen in larger, controlled clinical trials.
Authors: Yanhua Fu, Xiaoxin Xie, Lin Gan, Xiaoyan Yang, Yebing Song, Chunli Song, Fangfang Sun, Lei Guo, Hai Long
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,900
OpenAlex ID: W4415592280