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  3. 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

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

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Mussini C.
  • Cazanave C.
  • Adachi E.
  • Eu B.
  • Crofoot G.
  • Chounta V.
  • Kolobova I.
  • Sutton K.
  • Sutherland-Phillips D.
  • Urbaityte R.
  • Ehmann A.
  • Scherzer J.
  • de los Rios P.
  • D’Amico R.
  • Spreen W.
  • van Wyk J.

Grupos

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. © The Author(s) 2024.

Datos de la publicación

ISSN/ISSNe:
1090-7165, 1573-3254

AIDS AND BEHAVIOR  SPRINGER/PLENUM PUBLISHERS

Tipo:
Article
Páginas:
64-76
PubMed:
39375290
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
1,704 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • Adult; Alanine; Amides; Anti-HIV Agents; Diketopiperazines; Drug Combinations; Emtricitabine; Female; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, 4 or More Rings; HIV Infections; Humans; Male; Medication Adherence; Middle Aged; Patient Reported Outcome Measures; Patient Satisfaction; Piperazines; Pyridones; Rilpivirine; Tenofovir; Treatment Outcome; Viral Load; alanine; amide; anti human immunodeficiency virus agent; bictegravir; cabotegravir; emtricitabine; fused heterocyclic rings; piperazine derivative; piperazinedione; pyridone derivative; rilpivirine; tenofovir; tenofovir alafenamide; adult; clinical trial; comparative study; controlled study; drug combination; drug therapy; female; human; Human immunodeficiency virus infection; male; medication compliance; middle aged; patient satisfaction; patient-reported outcome; phase 3 clinical trial; psychology; randomized controlled trial; treatment outcome; virus load

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