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.

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.