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.
Cabotegravir
HIV-1
Long-acting
Patient-reported outcome
Quality of life
Rilpivirine
Journal
AIDS and behavior
ISSN: 1573-3254
Titre abrégé: AIDS Behav
Pays: United States
ID NLM: 9712133
Informations de publication
Date de publication:
08 Oct 2024
08 Oct 2024
Historique:
accepted:
24
08
2024
medline:
8
10
2024
pubmed:
8
10
2024
entrez:
7
10
2024
Statut:
aheadofprint
Résumé
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. SOLAR (NCT04542070; registrado el 09-09-2020) es un estudio de fase IIIb que ha demostrado la eficacia virológica no inferior de cambiar a cabotegravir+rilpivirina de acción prolongada (CAB+RPV LA) administrado cada 2 meses frente a continuar con la administración oral diaria de bictegravir/emtricitabina/tenofovir alafenamida (BIC/FTC/TAF) durante 12 meses. Los participantes fueron asignados de forma aleatoria (2:1) al grupo de cambio a CAB+RPV LA o de continuación con BIC/FTC/TAF. Los parámetros declarados por los pacientes incluían la preferencia del tratamiento, la satisfacción del tratamiento (versión del estado del cuestionario de satisfacción del tratamiento de VIH de 12 preguntas), la aceptación de las inyecciones (cuestionario de percepción de las inyecciones [dominio de aceptación]) y tres preguntas individuales que analizaban los problemas psicológicos relacionados con el tratamiento del VIH (miedo a la revelación, ansiedad relacionada con el cumplimiento terapéutico y recordatorio del estado del VIH). De los 670 participantes, 447 participantes cambiaron a CAB+RPV LA y 223 continuaron con BIC/FTC/TAF. En general, el 18 % eran mujeres, el promedio de edad era de 37 años y el 31 % no eran blancos. En el mes 12, el tratamiento con CAB+RPV LA aumentó considerablemente la satisfacción del tratamiento frente al BIC/FTC/TAF (cambio [intervalo de confianza (IC) del 95 %] medio: +3.36 [2.59; 4.13] frente a –1.59 [–2.71; –0.47]; p<0.001). En el mes 12, una mayor proporción de participantes del grupo de CAB+RPV LA declararon mejoras en todos los problemas psicológicos relacionados con las preguntas sobre el tratamiento del VIH en comparación con los participantes del grupo de BIC/FTC/TAF. Los participantes que indicaron ≥ 1 problema psicológico en el inicio experimentaron una mejora importante estadísticamente y significativa clínicamente con respecto a la satisfacción del tratamiento al cabo de 12 meses del cambio a CAB+RPV LA frente a la continuación con BIC/FTC/TAF (diferencia ajustada [IC del 95 %]: 7.96 [5.65; 10.26]; p<0.001). La mayoría de encuestados (el 90 %, 382/425) preferían CAB+RPV LA frente a BIC/FTC/TAF (el 5 %, 21/425). El cambio a CAB+RPV LA se asoció a un aumento considerable de la satisfacción del tratamiento y al alivio del miedo a la revelación, la ansiedad en torno al cumplimiento terapéutico y el recordatorio del estado del VIH.
Autres résumés
Type: Publisher
(spa)
SOLAR (NCT04542070; registrado el 09-09-2020) es un estudio de fase IIIb que ha demostrado la eficacia virológica no inferior de cambiar a cabotegravir+rilpivirina de acción prolongada (CAB+RPV LA) administrado cada 2 meses frente a continuar con la administración oral diaria de bictegravir/emtricitabina/tenofovir alafenamida (BIC/FTC/TAF) durante 12 meses. Los participantes fueron asignados de forma aleatoria (2:1) al grupo de cambio a CAB+RPV LA o de continuación con BIC/FTC/TAF. Los parámetros declarados por los pacientes incluían la preferencia del tratamiento, la satisfacción del tratamiento (versión del estado del cuestionario de satisfacción del tratamiento de VIH de 12 preguntas), la aceptación de las inyecciones (cuestionario de percepción de las inyecciones [dominio de aceptación]) y tres preguntas individuales que analizaban los problemas psicológicos relacionados con el tratamiento del VIH (miedo a la revelación, ansiedad relacionada con el cumplimiento terapéutico y recordatorio del estado del VIH). De los 670 participantes, 447 participantes cambiaron a CAB+RPV LA y 223 continuaron con BIC/FTC/TAF. En general, el 18 % eran mujeres, el promedio de edad era de 37 años y el 31 % no eran blancos. En el mes 12, el tratamiento con CAB+RPV LA aumentó considerablemente la satisfacción del tratamiento frente al BIC/FTC/TAF (cambio [intervalo de confianza (IC) del 95 %] medio: +3.36 [2.59; 4.13] frente a –1.59 [–2.71; –0.47]; p<0.001). En el mes 12, una mayor proporción de participantes del grupo de CAB+RPV LA declararon mejoras en todos los problemas psicológicos relacionados con las preguntas sobre el tratamiento del VIH en comparación con los participantes del grupo de BIC/FTC/TAF. Los participantes que indicaron ≥ 1 problema psicológico en el inicio experimentaron una mejora importante estadísticamente y significativa clínicamente con respecto a la satisfacción del tratamiento al cabo de 12 meses del cambio a CAB+RPV LA frente a la continuación con BIC/FTC/TAF (diferencia ajustada [IC del 95 %]: 7.96 [5.65; 10.26]; p<0.001). La mayoría de encuestados (el 90 %, 382/425) preferían CAB+RPV LA frente a BIC/FTC/TAF (el 5 %, 21/425). El cambio a CAB+RPV LA se asoció a un aumento considerable de la satisfacción del tratamiento y al alivio del miedo a la revelación, la ansiedad en torno al cumplimiento terapéutico y el recordatorio del estado del VIH.
Identifiants
pubmed: 39375290
doi: 10.1007/s10461-024-04490-0
pii: 10.1007/s10461-024-04490-0
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Trickey A, Zhang L, Sabin CA, Sterne JAC. Life expectancy of people with HIV on long-term antiretroviral therapy in Europe and North America: a cohort study. Lancet Healthy longev. 2022;3:S2.
doi: 10.1016/S2666-7568(22)00063-0
Ryan White HIV/AIDS Program: Annual Client-Level Data Report 2021. Available from: https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2021.pdf . Accessed Jun 2024.
Lazarus JV, Safreed-Harmon K, Barton SE, Costagliola D, Dedes N, Del Amo VJ, et al. Beyond viral suppression of HIV—the new quality of life frontier. BMC Med. 2016;14:94.
doi: 10.1186/s12916-016-0640-4
pubmed: 27334606
pmcid: 4916540
UNAIDS. Global AIDS Strategy 2021–2026: End Inequalities End AIDS. 2021. Available from: https://www.unaids.org/sites/default/files/media_asset/global-AIDS-strategy-2021-2026_en.pdf . Accessed Jun 2024.
de Los RP, Okoli C, Castellanos E, Allan B, Young B, Brough G, et al. Physical, emotional, and psychosocial challenges associated with daily dosing of HIV medications and their impact on indicators of quality of life: findings from the positive perspectives study. AIDS Behav. 2021;25:961–72.
doi: 10.1007/s10461-020-03055-1
de Los Rios P, Okoli C, Punekar Y, Allan B, Muchenje M, Castellanos E, et al. Prevalence, determinants, and impact of suboptimal adherence to HIV medication in 25 countries. Prev Med. 2020;139:106182.
doi: 10.1016/j.ypmed.2020.106182
D’Amico R, Margolis DA. Long-acting injectable therapy: an emerging paradigm for the treatment of HIV infection. Curr Opin HIV AIDS. 2020;15:13–8.
doi: 10.1097/COH.0000000000000606
pubmed: 31764197
Thoueille P, Choong E, Cavassini M, Buclin T, Decosterd LA. Long-acting antiretrovirals: a new era for the management and prevention of HIV infection. J Antimicrob Chemother. 2022;77:290–302.
doi: 10.1093/jac/dkab324
pubmed: 34499731
Mantsios A, Murray M, Karver TS, Davis W, Margolis D, Kumar P, et al. “I feel empowered”: women’s perspectives on and experiences with long-acting injectable antiretroviral therapy in the USA and Spain. Cult Health Sex. 2021;23:1066–78.
doi: 10.1080/13691058.2020.1752397
pubmed: 32436478
U.S. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV 2022. Available from: https://clinicalinfo.hiv.gov/en/guidelines . Accessed Jun 2024.
Gandhi RT, Bedimo R, Hoy JF, Landovitz RJ, Smith DM, Eaton EF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2022 recommendations of the international antiviral society-USA panel. JAMA. 2023;329:63–84.
doi: 10.1001/jama.2022.22246
pubmed: 36454551
European AIDS Clinical Society. EACS Guidelines Version 12.0. October 2023. Available at https://www.eacsociety.org/media/guidelines-12.0.pdf . Accessed Nov 2023.
Orkin C, Arasteh K, Górgolas Hernández-Mora M, Pokrovsky V, Overton ET, Girard PM, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. 2020;382:1124–35.
doi: 10.1056/NEJMoa1909512
pubmed: 32130806
Orkin C, Oka S, Philibert P, Brinson C, Bassa A, Gusev D, et al. Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study. Lancet HIV. 2021;8:e185–96.
doi: 10.1016/S2352-3018(20)30340-4
pubmed: 33794181
Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021;396:1994–2005.
doi: 10.1016/S0140-6736(20)32666-0
pubmed: 33308425
Overton ET, Richmond G, Rizzardini G, Thalme A, Girard PM, Wong A, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection: 152-week results from ATLAS-2M, a randomized, open-label, Phase 3b, noninferiority study. Clin Infect dis. 2023;76:1646–54.
doi: 10.1093/cid/ciad020
pubmed: 36660819
pmcid: 10156123
Swindells S, Andrade-Villanueva JF, Richmond GJ, Rizzardini G, Baumgarten A, Masiá M, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. 2020;382:1112–23.
doi: 10.1056/NEJMoa1904398
pubmed: 32130809
Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, et al. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022;36:185–94.
doi: 10.1097/QAD.0000000000003025
pubmed: 34261093
Ramgopal MN, Castagna A, Cazanave C, Diaz-Brito V, Dretler R, Oka S, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023;10:e566-77.
doi: 10.1016/S2352-3018(23)00136-4
pubmed: 37567205
World Medical Association. World medical association declaration of helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–4.
doi: 10.1001/jama.2013.281053
Woodcock A, Bradley C. Validation of the revised 10-item HIV treatment satisfaction questionnaire status version and new change version. Value Health. 2006;9:320–33.
doi: 10.1111/j.1524-4733.2006.00121.x
pubmed: 16961550
Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017;390:1499–510.
doi: 10.1016/S0140-6736(17)31917-7
pubmed: 28750935
Chounta V, Byrnes HF, Henry-Szatkowski M, Browning D, Donatti C, Lambert J. Psychometric validation of the perception of injection (PIN) questionnaire using data from two phase III, open-label, active-controlled, non-inferiority studies in people living with HIV. Adv Ther. 2023;40:5300–14.
doi: 10.1007/s12325-023-02656-1
pubmed: 37776478
pmcid: 10611592
Sedaghat AR. Understanding the minimal clinically important difference (MCID) of patient-reported outcome measures. Otolaryngol Head Neck Surg. 2019;161:551–60.
doi: 10.1177/0194599819852604
pubmed: 31159641
Kerrigan D, Mantsios A, Gorgolas M, Montes M-L, Pulido F, Brinson C, et al. Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS ONE. 2018;13:e0190487.
doi: 10.1371/journal.pone.0190487
pubmed: 29304154
pmcid: 5755771
Dang BN, Westbrook RA, Black WC, Rodriguez-Barradas MC, Giordano TP. Examining the link between patient satisfaction and adherence to HIV care: a structural equation model. PLoS ONE. 2013;8:e54729.
doi: 10.1371/journal.pone.0054729
pubmed: 23382948
pmcid: 3559888
Nega J, Taye S, Million Y, Rodrigo C, Eshetie S. Antiretroviral treatment failure and associated factors among HIV patients on first-line antiretroviral treatment in Sekota, northeast Ethiopia. AIDS Res Ther. 2020;17:39.
doi: 10.1186/s12981-020-00294-z
pubmed: 32650796
pmcid: 7350666
Ahmed M, Merga H, Jarso H. Predictors of virological treatment failure among adult HIV patients on first-line antiretroviral therapy in Woldia and Dessie hospitals, Northeast Ethiopia: a case-control study. BMC Infect Dis. 2019;19:305.
doi: 10.1186/s12879-019-3924-4
pubmed: 30943903
pmcid: 6448227
Turan B, Budhwani H, Fazeli PL, Browning WR, Raper JL, Mugavero MJ, et al. How Does Stigma Affect People Living with HIV? The Mediating Roles of Internalized and Anticipated HIV Stigma in the Effects of Perceived Community Stigma on Health and Psychosocial Outcomes. AIDS Behav. 2017;21:283–91.
doi: 10.1007/s10461-016-1451-5
pubmed: 27272742
pmcid: 5143223
Philbin MM, Bergen S, Parish C, Kerrigan D, Kinnard EN, Reed S, et al. Long-acting injectable ART and PrEP among women in six cities across the United States: a qualitative analysis of who would benefit the most. AIDS Behav. 2022;26:1260–9.
doi: 10.1007/s10461-021-03483-7
pubmed: 34648131
Jenny Scherzer SN, Celia Jonsson-Oldenbüttel, Christoph Wyen, Stefan Esser, Gordon Weinberg, Anja Potthoff, Ivanka Krznaric, Bernd Westermayer, Katharina Bernhardt, Patricia de los Rios, editor Perceptions of Cabotegravir + Rilpivirine Long-Acting (CAB + RPV LA) From People Living With HIV (PLHIV) in the CARLOS Study. 12th IAS Conference on HIV Science; 2023; Brisbane, Australia.
Hsu RK, Phoenix J, Sinclair GI, Gupta SK, Puga A, Nguyen K, et al. 1288.US Healthcare Provider Perspectives on the initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Open forum Infect Dis. 2022.
John M, Williams L, Nolan G, Bonnet M, Allen A, Castley A, et al. 2023 Implementation of long-acting cabotegravir and rilpivirine in vulnerable populations with complex needs: primary 48-week results of JABS. 12th IAS Conference on HIV Science.