ArticleBMC infectious diseases2026
Safety and efficacy of albuvirtide and dolutegravir for HIV postexposure prophylaxis in men who have sex with men: a prospective non-randomized cohort study.
Article in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundOptimizing 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.
methodsWe 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.
resultsOf 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.
conclusionWhile 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).
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