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Abstract：
BACKGROUND: The effectiveness of post-exposure prophylaxis (PEP) depends on participants adherence, making it crucial to assess and compare regimen options to enhance human immunodeficiency virus (HIV) prophylaxis strategies. However, no prospective study in China has shown that the completion rate and adherence of single-tablet regimens in HIV PEP are higher than those of multi-tablet preparations. Therefore, this study aimed to assess the completion rate and adherence of two HIV PEP regimens.
METHODS: In this single-center, prospective, open-label cohort study, we included 179 participants from May 2022 to March 2023 and analyzed the differences in the 28-day medication completion rate, adherence, safety, tolerance, and effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and tenofovir disoproxil fumarate, emtricitabine, and dolutegravir (TDF/FTC + DTG).
RESULTS: The PEP completion rate and adherence were higher in the BIC/FTC/TAF group than in the TDF/FTC + DTG group (completion rate: 97.8% vs. 82.6%, P = 0.009; adherence: 99.6 ± 2.82% vs. 90.2 ± 25.29%, P = 0.003). The incidence of adverse reactions in the BIC/FTC/TAF and TDF/FTC + DTG groups was 15.2% and 10.3% (P = 0.33), respectively. In the TDF/FTC + DTG group, one participant stopped PEP owing to adverse reactions (1.1%). No other participants stopped PEP due to adverse events.
CONCLUSIONS: BIC/FTC/TAF and TDF/FTC + DTG have good safety and tolerance as PEP regimens. BIC/FTC/TAF has a higher completion rate and increased adherence, thus, is recommended as a PEP regimen. These findings emphasize the importance of regimen choice in optimizing PEP outcomes.
BACKGROUND: The study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2200059994(2022-05-14), https://www.chictr.org.cn/bin/project/edit?pid=167391 ).
METHODS: In this single-center, prospective, open-label cohort study, we included 179 participants from May 2022 to March 2023 and analyzed the differences in the 28-day medication completion rate, adherence, safety, tolerance, and effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and tenofovir disoproxil fumarate, emtricitabine, and dolutegravir (TDF/FTC + DTG).
RESULTS: The PEP completion rate and adherence were higher in the BIC/FTC/TAF group than in the TDF/FTC + DTG group (completion rate: 97.8% vs. 82.6%, P = 0.009; adherence: 99.6 ± 2.82% vs. 90.2 ± 25.29%, P = 0.003). The incidence of adverse reactions in the BIC/FTC/TAF and TDF/FTC + DTG groups was 15.2% and 10.3% (P = 0.33), respectively. In the TDF/FTC + DTG group, one participant stopped PEP owing to adverse reactions (1.1%). No other participants stopped PEP due to adverse events.
CONCLUSIONS: BIC/FTC/TAF and TDF/FTC + DTG have good safety and tolerance as PEP regimens. BIC/FTC/TAF has a higher completion rate and increased adherence, thus, is recommended as a PEP regimen. These findings emphasize the importance of regimen choice in optimizing PEP outcomes.
BACKGROUND: The study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2200059994(2022-05-14), https://www.chictr.org.cn/bin/project/edit?pid=167391 ).
摘要：
背景：暴露后预防（PEP）的有效性取决于参与者的依从性，这使得评估和比较方案选择对增强人类免疫缺陷病毒（HIV）预防策略至关重要。然而,在中国,没有前瞻性研究显示HIVPEP中单片方案的完成率和依从性高于多片制剂.因此,本研究旨在评估两种HIVPEP方案的完成率和依从性.
方法：在这个单中心，prospective,开放标签队列研究，我们纳入了2022年5月至2023年3月的179名参与者，并分析了28天药物完成率的差异，坚持,安全,容忍度,和比替格拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）和富马酸替诺福韦酯的有效性，恩曲他滨,和dolutegravir（TDF/FTC+DTG）。
结果：BIC/FTC/TAF组的PEP完成率和依从性高于TDF/FTC+DTG组（完成率：97.8%vs.82.6%,P=0.009；依从性：99.6±2.82%vs.90.2±25.29%，P=0.003)。BIC/FTC/TAF和TDF/FTC+DTG组的不良反应发生率分别为15.2%和10.3%(P=0.33)。分别。在TDF/FTC+DTG组中，1名参与者因不良反应停止PEP(1.1%).没有其他参与者因不良事件而停止PEP。
结论：BIC/FTC/TAF和TDF/FTC+DTG作为PEP方案具有良好的安全性和耐受性。BIC/FTC/TAF的完成率更高，依从性更高，因此，建议作为PEP方案。这些发现强调了方案选择在优化PEP结果中的重要性。
背景：该研究已在中国临床试验注册中心注册（注册号：ChiCTR2200059994（2022-05-14），https://www.chictr.org.cn/bin/project/edit?pid=167391)。
方法：在这个单中心，prospective,开放标签队列研究，我们纳入了2022年5月至2023年3月的179名参与者，并分析了28天药物完成率的差异，坚持,安全,容忍度,和比替格拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）和富马酸替诺福韦酯的有效性，恩曲他滨,和dolutegravir（TDF/FTC+DTG）。
结果：BIC/FTC/TAF组的PEP完成率和依从性高于TDF/FTC+DTG组（完成率：97.8%vs.82.6%,P=0.009；依从性：99.6±2.82%vs.90.2±25.29%，P=0.003)。BIC/FTC/TAF和TDF/FTC+DTG组的不良反应发生率分别为15.2%和10.3%(P=0.33)。分别。在TDF/FTC+DTG组中，1名参与者因不良反应停止PEP(1.1%).没有其他参与者因不良事件而停止PEP。
结论：BIC/FTC/TAF和TDF/FTC+DTG作为PEP方案具有良好的安全性和耐受性。BIC/FTC/TAF的完成率更高，依从性更高，因此，建议作为PEP方案。这些发现强调了方案选择在优化PEP结果中的重要性。
背景：该研究已在中国临床试验注册中心注册（注册号：ChiCTR2200059994（2022-05-14），https://www.chictr.org.cn/bin/project/edit?pid=167391)。
