Cristina Mussini, Charles Cazanave, Eisuke Adachi, Beng Eu, Marta Montero Alonso, Gordon Crofoot, Vasiliki Chounta, Irina Kolobova, Kenneth Sutton, Denise Sutherland-Phillips, Rimgaile Urbaityte, Alice Ehmann, Jenny Scherzer, Patricia de Los Rios, Ronald D'Amico, William Spreen, Jean van Wyk
{"title":"在 3b 期 SOLAR 研究中，与比特拉韦/恩曲他滨/替诺福韦-阿拉非那胺相比，卡博特拉韦+长效利匹韦林维持治疗 12 个月后患者报告的结果有所改善。","authors":"Cristina Mussini, Charles Cazanave, Eisuke Adachi, Beng Eu, Marta Montero Alonso, Gordon Crofoot, Vasiliki Chounta, Irina Kolobova, Kenneth Sutton, Denise Sutherland-Phillips, Rimgaile Urbaityte, Alice Ehmann, Jenny Scherzer, Patricia de Los Rios, Ronald D'Amico, William Spreen, Jean van Wyk","doi":"10.1007/s10461-024-04490-0","DOIUrl":null,"url":null,"abstract":"<p><p>SOLAR (NCT04542070; registered 2020-09-09) is a Phase 3b study that demonstrated the noninferior virological efficacy of switching to cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months vs. continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) over 12 months. Participants were randomised (2:1) to switch to CAB + RPV LA or to continue BIC/FTC/TAF. Patient-reported endpoints included treatment preference, treatment satisfaction (12-item HIV Treatment Satisfaction Questionnaire status version), acceptability of injections (Perception of Injection questionnaire [acceptability domain]) and three single-item questions exploring psychological challenges related to HIV treatment (fear of disclosure, adherence-related anxiety and reminder of HIV status). Of 670 participants, 447 participants switched to CAB + RPV LA and 223 continued BIC/FTC/TAF. Overall, 18% were female, median age was 37 years and 31% were non-White. At Month 12, CAB + RPV LA significantly improved treatment satisfaction vs. BIC/FTC/TAF (mean [95% confidence interval (CI)] change: + 3.36 [2.59, 4.13] vs. -1.59 [-2.71, -0.47]; p < 0.001). At Month 12, a higher proportion of CAB + RPV LA arm participants reported improvements across the psychological challenges related to HIV treatment questions compared with BIC/FTC/TAF participants. Participants indicating ≥ 1 psychological challenge at baseline experienced a statistically significant and clinically meaningful improvement in treatment satisfaction after 12 months of CAB + RPV LA vs. continuing BIC/FTC/TAF (adjusted difference [95% CI]: 7.96 [5.65, 10.26]; p < 0.001). Most (90%, 382/425) questionnaire respondents preferred CAB + RPV LA vs. BIC/FTC/TAF (5%, 21/425). Switching to CAB + RPV LA was associated with significantly improved treatment satisfaction and relief from the fear of disclosure, anxiety surrounding adherence and reminder of HIV status.</p>","PeriodicalId":7543,"journal":{"name":"AIDS and Behavior","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Improvements in Patient-Reported Outcomes After 12 Months of Maintenance Therapy With Cabotegravir + Rilpivirine Long-Acting Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in the Phase 3b SOLAR Study.\",\"authors\":\"Cristina Mussini, Charles Cazanave, Eisuke Adachi, Beng Eu, Marta Montero Alonso, Gordon Crofoot, Vasiliki Chounta, Irina Kolobova, Kenneth Sutton, Denise Sutherland-Phillips, Rimgaile Urbaityte, Alice Ehmann, Jenny Scherzer, Patricia de Los Rios, Ronald D'Amico, William Spreen, Jean van Wyk\",\"doi\":\"10.1007/s10461-024-04490-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>SOLAR (NCT04542070; registered 2020-09-09) is a Phase 3b study that demonstrated the noninferior virological efficacy of switching to cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months vs. continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) over 12 months. Participants were randomised (2:1) to switch to CAB + RPV LA or to continue BIC/FTC/TAF. Patient-reported endpoints included treatment preference, treatment satisfaction (12-item HIV Treatment Satisfaction Questionnaire status version), acceptability of injections (Perception of Injection questionnaire [acceptability domain]) and three single-item questions exploring psychological challenges related to HIV treatment (fear of disclosure, adherence-related anxiety and reminder of HIV status). Of 670 participants, 447 participants switched to CAB + RPV LA and 223 continued BIC/FTC/TAF. Overall, 18% were female, median age was 37 years and 31% were non-White. At Month 12, CAB + RPV LA significantly improved treatment satisfaction vs. BIC/FTC/TAF (mean [95% confidence interval (CI)] change: + 3.36 [2.59, 4.13] vs. -1.59 [-2.71, -0.47]; p < 0.001). At Month 12, a higher proportion of CAB + RPV LA arm participants reported improvements across the psychological challenges related to HIV treatment questions compared with BIC/FTC/TAF participants. Participants indicating ≥ 1 psychological challenge at baseline experienced a statistically significant and clinically meaningful improvement in treatment satisfaction after 12 months of CAB + RPV LA vs. continuing BIC/FTC/TAF (adjusted difference [95% CI]: 7.96 [5.65, 10.26]; p < 0.001). Most (90%, 382/425) questionnaire respondents preferred CAB + RPV LA vs. BIC/FTC/TAF (5%, 21/425). Switching to CAB + RPV LA was associated with significantly improved treatment satisfaction and relief from the fear of disclosure, anxiety surrounding adherence and reminder of HIV status.</p>\",\"PeriodicalId\":7543,\"journal\":{\"name\":\"AIDS and Behavior\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2024-10-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"AIDS and Behavior\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10461-024-04490-0\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"AIDS and Behavior","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10461-024-04490-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
摘要
SOLAR（NCT04542070；注册号 2020-09-09）是一项 3b 期研究，它证明了在 12 个月内改用卡博特拉韦+利匹韦林长效制剂（CAB + RPV LA）与继续每日口服比特拉韦/恩曲他滨/替诺福韦-阿拉非那胺（BIC/FTC/TAF）相比，前者的病毒学疗效优于后者。参与者被随机分配（2:1）转用 CAB + RPV LA 或继续使用 BIC/FTC/TAF。患者报告的终点包括治疗偏好、治疗满意度（12 项 HIV 治疗满意度问卷状态版）、注射可接受性（注射感知问卷[可接受性域]）和三个单项问题，这些问题探讨了与 HIV 治疗相关的心理挑战（害怕公开、与坚持治疗相关的焦虑和提醒 HIV 感染状况）。在 670 名参与者中，447 人改用 CAB + RPV LA，223 人继续使用 BIC/FTC/TAF。总体而言，18% 为女性，年龄中位数为 37 岁，31% 为非白人。第 12 个月时，CAB + RPV LA 与 BIC/FTC/TAF 相比显著提高了治疗满意度（平均[95% 置信区间 (CI)]变化：+ 3.36 [2.59+ 3.36 [2.59, 4.13] vs. -1.59 [-2.71, -0.47]; p
Improvements in Patient-Reported Outcomes After 12 Months of Maintenance Therapy With Cabotegravir + Rilpivirine Long-Acting Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in the Phase 3b SOLAR Study.
SOLAR (NCT04542070; registered 2020-09-09) is a Phase 3b study that demonstrated the noninferior virological efficacy of switching to cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months vs. continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) over 12 months. Participants were randomised (2:1) to switch to CAB + RPV LA or to continue BIC/FTC/TAF. Patient-reported endpoints included treatment preference, treatment satisfaction (12-item HIV Treatment Satisfaction Questionnaire status version), acceptability of injections (Perception of Injection questionnaire [acceptability domain]) and three single-item questions exploring psychological challenges related to HIV treatment (fear of disclosure, adherence-related anxiety and reminder of HIV status). Of 670 participants, 447 participants switched to CAB + RPV LA and 223 continued BIC/FTC/TAF. Overall, 18% were female, median age was 37 years and 31% were non-White. At Month 12, CAB + RPV LA significantly improved treatment satisfaction vs. BIC/FTC/TAF (mean [95% confidence interval (CI)] change: + 3.36 [2.59, 4.13] vs. -1.59 [-2.71, -0.47]; p < 0.001). At Month 12, a higher proportion of CAB + RPV LA arm participants reported improvements across the psychological challenges related to HIV treatment questions compared with BIC/FTC/TAF participants. Participants indicating ≥ 1 psychological challenge at baseline experienced a statistically significant and clinically meaningful improvement in treatment satisfaction after 12 months of CAB + RPV LA vs. continuing BIC/FTC/TAF (adjusted difference [95% CI]: 7.96 [5.65, 10.26]; p < 0.001). Most (90%, 382/425) questionnaire respondents preferred CAB + RPV LA vs. BIC/FTC/TAF (5%, 21/425). Switching to CAB + RPV LA was associated with significantly improved treatment satisfaction and relief from the fear of disclosure, anxiety surrounding adherence and reminder of HIV status.
期刊介绍：
AIDS and Behavior provides an international venue for the scientific exchange of research and scholarly work on the contributing factors, prevention, consequences, social impact, and response to HIV/AIDS. This bimonthly journal publishes original peer-reviewed papers that address all areas of AIDS behavioral research including: individual, contextual, social, economic and geographic factors that facilitate HIV transmission; interventions aimed to reduce HIV transmission risks at all levels and in all contexts; mental health aspects of HIV/AIDS; medical and behavioral consequences of HIV infection - including health-related quality of life, coping, treatment and treatment adherence; and the impact of HIV infection on adults children, families, communities and societies. The journal publishes original research articles, brief research reports, and critical literature reviews. provides an international venue for the scientific exchange of research and scholarly work on the contributing factors, prevention, consequences, social impact, and response to HIV/AIDS. This bimonthly journal publishes original peer-reviewed papers that address all areas of AIDS behavioral research including: individual, contextual, social, economic and geographic factors that facilitate HIV transmission; interventions aimed to reduce HIV transmission risks at all levels and in all contexts; mental health aspects of HIV/AIDS; medical and behavioral consequences of HIV infection - including health-related quality of life, coping, treatment and treatment adherence; and the impact of HIV infection on adults children, families, communities and societies. The journal publishes original research articles, brief research reports, and critical literature reviews.5 Year Impact Factor: 2.965 (2008) Section ''SOCIAL SCIENCES, BIOMEDICAL'': Rank 5 of 29 Section ''PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH'': Rank 9 of 76
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