Safety and efficacy of albuvirtide and dolutegravir for HIV postexposure prophylaxis in men who have sex with men: a prospective non-randomized cohort study.

BACKGROUND

Optimizing HIV post-exposure prophylaxis (PEP) for men who have sex with men (MSM) necessitates balancing regimen efficacy with tolerability. While oral triple-therapy is standard, data regarding simplified, injectable-containing strategies to enhance adherence in this population remain limited.

METHODS

We conducted a prospective, non-randomized cohort study at the Chengdu Public Health Clinical Medical Center (June 2021–December 2023). Participants self-selected into two cohorts based on preference: the study group received injectable albuvirtide (ABT; administered on days 1 and 15) combined with daily oral dolutegravir (DTG), whereas the control group received a standard oral TDF-based triple-drug regimen (TDF/3TC or TDF/FTC + DTG). Participants initiated PEP within 72 h of exposure and continued for 28 days. Primary outcomes included the 28-day completion rate, adherence, and safety profile over a 12-week follow-up period.

RESULTS

Of 120 enrolled participants, the ABT + DTG cohort achieved a significantly higher 28-day completion rate compared to controls (96.67% vs. 86.67%, P = 0.048). Adherence metrics similarly favored the investigational arm (99.28% ± 3.93% vs. 92.68% ± 17.75%, P = 0.006). The study group exhibited a markedly lower incidence of overall clinical adverse events (13.33% vs. 36.67%, P = 0.003), driven primarily by a reduction in gastrointestinal toxicities. No severe adverse events, injection-site reactions, or HIV seroconversions occurred in either group.

CONCLUSION

While both regimens demonstrated high efficacy and safety, the ABT + DTG combination offered superior tolerability and adherence, characterized by minimal gastrointestinal impact. This simplified, injectable-containing strategy represents a promising, high-adherence PEP alternative for MSM, particularly those prone to regimen fatigue or gastrointestinal intolerance. CLINICAL REGISTRATION: Chinese Clinical Trial Registry ( https://www.chictr.org.cn/ ), Clinical trial number ChiCTR2100046125 (Date of Registration 2021/05/04).