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) ove...
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| Veröffentlicht in: | AIDS and behavior 2025, Vol.29 (1), p.64-76 |
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| creator | Mussini, Cristina Cazanave, Charles Adachi, Eisuke Eu, Beng Alonso, Marta Montero Crofoot, Gordon Chounta, Vasiliki Kolobova, Irina Sutton, Kenneth Sutherland-Phillips, Denise Urbaityte, Rimgaile Ehmann, Alice Scherzer, Jenny de los Rios, Patricia D’Amico, Ronald Spreen, William van Wyk, Jean |
| description | 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 |
| doi_str_mv | 10.1007/s10461-024-04490-0 |
| format | Article |
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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.</description><identifier>ISSN: 1090-7165</identifier><identifier>ISSN: 1573-3254</identifier><identifier>EISSN: 1573-3254</identifier><identifier>DOI: 10.1007/s10461-024-04490-0</identifier><identifier>PMID: 39375290</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Acceptability ; Antiretroviral drugs ; Anxiety ; Clinical outcomes ; Disclosure ; Emtricitabine ; Fear ; Health Psychology ; HIV ; Human immunodeficiency virus ; Infectious Diseases ; Medicine ; Medicine & Public Health ; Original Paper ; Patients ; Psychological distress ; Public Health ; Questionnaires ; Satisfaction ; Statistical analysis ; Tenofovir ; Treatment compliance</subject><ispartof>AIDS and behavior, 2025, Vol.29 (1), p.64-76</ispartof><rights>The Author(s) 2024</rights><rights>2024. The Author(s).</rights><rights>Copyright Springer Nature B.V. Jan 2025</rights><rights>The Author(s) 2024 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2710-835baa56242ec64d4a4b35f054f2279c53f92699e736d117374bb2ac8c9749a43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10461-024-04490-0$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10461-024-04490-0$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,33751,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39375290$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mussini, Cristina</creatorcontrib><creatorcontrib>Cazanave, Charles</creatorcontrib><creatorcontrib>Adachi, Eisuke</creatorcontrib><creatorcontrib>Eu, Beng</creatorcontrib><creatorcontrib>Alonso, Marta Montero</creatorcontrib><creatorcontrib>Crofoot, Gordon</creatorcontrib><creatorcontrib>Chounta, Vasiliki</creatorcontrib><creatorcontrib>Kolobova, Irina</creatorcontrib><creatorcontrib>Sutton, Kenneth</creatorcontrib><creatorcontrib>Sutherland-Phillips, Denise</creatorcontrib><creatorcontrib>Urbaityte, Rimgaile</creatorcontrib><creatorcontrib>Ehmann, Alice</creatorcontrib><creatorcontrib>Scherzer, Jenny</creatorcontrib><creatorcontrib>de los Rios, Patricia</creatorcontrib><creatorcontrib>D’Amico, Ronald</creatorcontrib><creatorcontrib>Spreen, William</creatorcontrib><creatorcontrib>van Wyk, Jean</creatorcontrib><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</title><title>AIDS and behavior</title><addtitle>AIDS Behav</addtitle><addtitle>AIDS Behav</addtitle><description>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.</description><subject>Acceptability</subject><subject>Antiretroviral drugs</subject><subject>Anxiety</subject><subject>Clinical outcomes</subject><subject>Disclosure</subject><subject>Emtricitabine</subject><subject>Fear</subject><subject>Health Psychology</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Infectious Diseases</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Paper</subject><subject>Patients</subject><subject>Psychological distress</subject><subject>Public Health</subject><subject>Questionnaires</subject><subject>Satisfaction</subject><subject>Statistical analysis</subject><subject>Tenofovir</subject><subject>Treatment compliance</subject><issn>1090-7165</issn><issn>1573-3254</issn><issn>1573-3254</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>BHHNA</sourceid><recordid>eNp9Uk1vEzEQXSEQLYU_wAFZ4oKElvhrd-sTClGBSqlSpUEcLa93Nusqa29tb6TcuPIXOfJLcJq2fBw4WB7PvPdmxnpZ9pLgdwTjahII5iXJMeU55lzgHD_KjklRsZzRgj9OMU7JipTFUfYshGuMsSgr8TQ7YoJVBRX4OPtx3g_ebaEHGwMyFl2qaFKcL2FwPkKDFmPUroeApm0EjwhFF87GLiDXogtlbASrrAa06sCrYYe-mtihmapdhLVXW-N_fvv-Np2l2QwmPY0FNHd2nU91NHaNZq4flE-NbokfjL7nTc766I02UdWJM1mBda1LeTTdqDY17U0D-4ljB-iyUwEQq9HVYj5doqs4Nrvn2ZNWbQK8uLtPsi8fz1azz_l88el8Np3nmlYE56esqJUqSsop6JI3XPGaFS0ueEtpJXTBWkFLIaBiZUNIxSpe11TpUy0qLhRnJ9n7g-4w1j00Ov2eVxs5eNMrv5NOGfl3xZpOrt1W7sVEapsU3twpeHczQoiyN0HDZqMsuDFIRggnBS7LPfT1P9BrN3qb9kuotERJSrJH0QNKexeCh_ZhGoLl3jvy4B2ZvCNvvSNxIr36c48Hyr1ZEoAdACGV7Br8797_kf0FFSLUXg</recordid><startdate>2025</startdate><enddate>2025</enddate><creator>Mussini, Cristina</creator><creator>Cazanave, Charles</creator><creator>Adachi, Eisuke</creator><creator>Eu, Beng</creator><creator>Alonso, Marta Montero</creator><creator>Crofoot, Gordon</creator><creator>Chounta, Vasiliki</creator><creator>Kolobova, Irina</creator><creator>Sutton, Kenneth</creator><creator>Sutherland-Phillips, Denise</creator><creator>Urbaityte, Rimgaile</creator><creator>Ehmann, Alice</creator><creator>Scherzer, Jenny</creator><creator>de los Rios, Patricia</creator><creator>D’Amico, Ronald</creator><creator>Spreen, William</creator><creator>van Wyk, Jean</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T2</scope><scope>7U3</scope><scope>7U9</scope><scope>BHHNA</scope><scope>C1K</scope><scope>H94</scope><scope>K7.</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>2025</creationdate><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</title><author>Mussini, Cristina ; Cazanave, Charles ; Adachi, Eisuke ; Eu, Beng ; Alonso, Marta Montero ; Crofoot, Gordon ; Chounta, Vasiliki ; Kolobova, Irina ; Sutton, Kenneth ; Sutherland-Phillips, Denise ; Urbaityte, Rimgaile ; Ehmann, Alice ; Scherzer, Jenny ; de los Rios, Patricia ; D’Amico, Ronald ; Spreen, William ; van Wyk, Jean</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2710-835baa56242ec64d4a4b35f054f2279c53f92699e736d117374bb2ac8c9749a43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Acceptability</topic><topic>Antiretroviral drugs</topic><topic>Anxiety</topic><topic>Clinical outcomes</topic><topic>Disclosure</topic><topic>Emtricitabine</topic><topic>Fear</topic><topic>Health Psychology</topic><topic>HIV</topic><topic>Human immunodeficiency virus</topic><topic>Infectious Diseases</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Paper</topic><topic>Patients</topic><topic>Psychological distress</topic><topic>Public Health</topic><topic>Questionnaires</topic><topic>Satisfaction</topic><topic>Statistical analysis</topic><topic>Tenofovir</topic><topic>Treatment compliance</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mussini, Cristina</creatorcontrib><creatorcontrib>Cazanave, Charles</creatorcontrib><creatorcontrib>Adachi, Eisuke</creatorcontrib><creatorcontrib>Eu, Beng</creatorcontrib><creatorcontrib>Alonso, Marta Montero</creatorcontrib><creatorcontrib>Crofoot, Gordon</creatorcontrib><creatorcontrib>Chounta, Vasiliki</creatorcontrib><creatorcontrib>Kolobova, Irina</creatorcontrib><creatorcontrib>Sutton, Kenneth</creatorcontrib><creatorcontrib>Sutherland-Phillips, Denise</creatorcontrib><creatorcontrib>Urbaityte, Rimgaile</creatorcontrib><creatorcontrib>Ehmann, Alice</creatorcontrib><creatorcontrib>Scherzer, Jenny</creatorcontrib><creatorcontrib>de los Rios, Patricia</creatorcontrib><creatorcontrib>D’Amico, Ronald</creatorcontrib><creatorcontrib>Spreen, William</creatorcontrib><creatorcontrib>van Wyk, Jean</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Social Services Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Sociological Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Criminal Justice (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>AIDS and behavior</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mussini, Cristina</au><au>Cazanave, Charles</au><au>Adachi, Eisuke</au><au>Eu, Beng</au><au>Alonso, Marta Montero</au><au>Crofoot, Gordon</au><au>Chounta, Vasiliki</au><au>Kolobova, Irina</au><au>Sutton, Kenneth</au><au>Sutherland-Phillips, Denise</au><au>Urbaityte, Rimgaile</au><au>Ehmann, Alice</au><au>Scherzer, Jenny</au><au>de los Rios, Patricia</au><au>D’Amico, Ronald</au><au>Spreen, William</au><au>van Wyk, Jean</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>AIDS and behavior</jtitle><stitle>AIDS Behav</stitle><addtitle>AIDS Behav</addtitle><date>2025</date><risdate>2025</risdate><volume>29</volume><issue>1</issue><spage>64</spage><epage>76</epage><pages>64-76</pages><issn>1090-7165</issn><issn>1573-3254</issn><eissn>1573-3254</eissn><abstract>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.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>39375290</pmid><doi>10.1007/s10461-024-04490-0</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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| source | Sociological Abstracts; SpringerLink Journals - AutoHoldings |
| subjects | Acceptability Antiretroviral drugs Anxiety Clinical outcomes Disclosure Emtricitabine Fear Health Psychology HIV Human immunodeficiency virus Infectious Diseases Medicine Medicine & Public Health Original Paper Patients Psychological distress Public Health Questionnaires Satisfaction Statistical analysis Tenofovir Treatment compliance |
| 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 |
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