Evidence map›Paper›PMID 39375290›Full record

Trial reportAIDS and behavior2025

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.

Cristina Mussini, Charles Cazanave, Eisuke Adachi, Beng Eu, Marta Montero Alonso, Gordon Crofoot, Vasiliki Chounta, Irina Kolobova, Kenneth Sutton, Denise Sutherland-Phillips and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
In one paragraph

Trial report in AIDS and behavior, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04542070 (A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04542070 phase3completednot on this map

A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed

TypeinterventionalSponsorViiV HealthcareRan2020 to 2023Enrolled687ConditionsHIV InfectionsArmsCabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets, Rilpivirine Injectable Suspension (RPV LA), BIKTARVY Tablets (BIK)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Cristina MussiniUniversity of Modena and Reggio Emilia, Modena, Italy.
Charles CazanaveDepartment of Infectious Diseases, Pellegrin Hospital, University Hospital of Bordeaux, Bordeaux, France.
Eisuke AdachiThe Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Beng EuPrahran Market Clinic, Melbourne, VIC, Australia.
Marta Montero AlonsoUnit of Infectious Diseases, La Fe University and Polytechnic Hospital, Valencia, Spain.
Gordon CrofootThe Crofoot Research Center, Houston, TX, USA.
Vasiliki ChountaViiV Healthcare, 410 Blackwell Street, Durham, NC, 27701, USA.
Irina KolobovaViiV Healthcare, 410 Blackwell Street, Durham, NC, 27701, USA. Irina.x.kolobova@viivhealthcare.com.
Kenneth SuttonViiV Healthcare, 410 Blackwell Street, Durham, NC, 27701, USA.
Denise Sutherland-PhillipsViiV Healthcare, 410 Blackwell Street, Durham, NC, 27701, USA.
Rimgaile UrbaityteGSK, London, UK.
Alice EhmannGSK, Ballston Spa, NY, USA.
Jenny ScherzerViiV Healthcare, Munich, Germany.
Patricia de Los RiosViiV Healthcare, 410 Blackwell Street, Durham, NC, 27701, USA.
Ronald D'AmicoViiV Healthcare, 410 Blackwell Street, Durham, NC, 27701, USA.
William SpreenViiV Healthcare, 410 Blackwell Street, Durham, NC, 27701, USA.
Jean van WykViiV Healthcare, Brentford, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Anti-HIV AgentsEmtricitabineHIV InfectionsPatient Reported Outcome MeasuresPyridonesRilpivirineTenofovirAdenineAdultAmidesDiketopiperazinesDrug CombinationsDrug Therapy, CombinationFemaleHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsAdenineAmidesAnti-HIV AgentsbictegravircabotegravirDiketopiperazinesDrug CombinationsEmtricitabineHeterocyclic Compounds, 3-RingHeterocyclic Compounds, 4 or More RingsPiperazinesPyridonesRilpivirineTenofovirCabotegravirHIV-1Long-actingPatient-reported outcomeQuality of lifeRilpivirine

Identifiers

PMID39375290
PMCPMC11739242

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.