Safety and Efficacy of Albuvirtide and Dolutegravir for HIV Post-Exposure Prophylaxis in MSM Population: A Prospective Controlled Study
Background: There are no prospective clinical studies of adherence and tolerance to HIV post-exposure prophylaxis (PEP) in Men who have sex with men (MSM) in China. The simplified two-drug regimen can reduce adverse drug reactions and drug interactions Thus, We aimde to explore the efficacy, safety, and adherence of the simplified regimen of Albuvirtide (ABT) + Dolutegravir (DTG) for HIV PEP in the MSM population.
Methods: A prospective, open-label, single-center, cohort study was conducted, enrolling participants who received PEP for HIV at the Chengdu Public Health Clinical Medical Center from June 2021 to December 2023 and met the inclusion criteria. Participants were divided into two groups based on their preference: the study group received ABT + DTG for PEP, while the control group received TDF/3TC or TDF/FTC + DTG. All enrolled participants received PEP within 72 h after exposure and continued for 28 days, and were followed up for 12 weeks
展开剩余51%Results: A total of 120 MSM participants were enrolled and stratified into two groups: the study group and the control group, with 60 and 60 participants in each group, respectively. Baseline characteristics were similar between groups (P > 0.05). The overall completion rate for 28 days of treatment among all 120 participants was 91.67%, with the study group showing a higher completion rate than the control group (96.67% vs. 86.67%, P = 0.048). No serious adverse events occurred in either of the two groups of subjects. The total incidence of clinical adverse events in the digestive system was lower in the study group than that in the control group(13.33% vs. 36.67%, P = 0.003). All participants in both groups had negative HIV screening antibody results during the study period.
Conclusion: The ABT+DTG simplified regimen for PEPin MSM populations showed no cases of treatment failure and demonstrated good adherence and safety.
Keywords: HIV post-exposure prophylaxis; men who have sex with men (MSM); efficacy; safety; adherence.
项目基金：四川省科技计划项目（2021YJ0155）；四川省临床重点专科建设项目（2023AGRKP001）；
中国临床试验注册中心，注册号：ChiCTR2100046125
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