Evidence map›Paper›PMID 40063206›Full record

Trial reportAIDS and behavior2025

Participant-reported Outcomes from the CAPELLA Clinical Trial of Lenacapavir-based Regimens in Heavily Treatment-experienced Adults with HIV.

Moti Ramgopal, Dylan J Mezzio, Keith Dunn, Shan-Yu Liu, Damemarie Paul, Martin S Rhee, Antonella Castagna

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled 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 NCT04150068 (A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04150068 phase2 / phase3active not recruitingnot on this map

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

TypeinterventionalSponsorGilead SciencesRan2019 to 2027Enrolled72ConditionsHIV-1-infectionArmsOral Lenacapavir, Oral Lenacapavir Placebo, Subcutaneous Lenacapavir, Failing ARV Regimen, Optimized Background Regimen (OBR)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Moti RamgopalFlorida State University, Fort Pierce, FL, USA.
Dylan J MezzioGilead Sciences, Inc., Foster City, CA, USA.
Keith DunnGilead Sciences, Inc., Foster City, CA, USA.
Shan-Yu LiuGilead Sciences, Inc., Foster City, CA, USA.
Damemarie PaulGilead Sciences, Inc., Foster City, CA, USA.
Martin S RheeGilead Sciences, Inc., Foster City, CA, USA.
Antonella CastagnaUniversità Vita-Salute San Raffaele, Milan, Italy. castagna.antonella1@hsr.it.

Funding

Gilead Sciences NCT04150068
6 · The paper itself

Abstract

Lenacapavir, a first-in-class inhibitor of HIV-1 capsid function, can be administered twice yearly subcutaneously (SC). In the ongoing Phase 2/3 CAPELLA study (NCT04150068), the addition of SC lenacapavir to an optimized background regimen led to high rates of virologic suppression and was generally well tolerated. We describe participant-reported, health-related quality-of-life (HRQoL) outcomes with lenacapavir among heavily treatment-experienced people with HIV (PWH) from CAPELLA. Scores from EQ-5D-5L index and visual analogue scale (VAS), Short Form 36 (SF-36), HIV-Symptom Index (HIV-SI), and Numeric Pain Rating Scale (NPRS) at injection were collected. Mean baseline and week (W) 52 scores were: EQ-5D-5L index, 0.87 and 0.83; EQ-5D-5L VAS, 81 and 86; SF-36 physical component, 48.5 and 49.9; SF-36 mental component, 48.4 and 48.0. Scores remained stable over time (< 7% change), with values near US norms. For 15 of 20 HIV-SI symptoms, fewer participants reported them as bothersome at W52 than at baseline. Mean NPRS scores on injection were 3.9, 5.1, and 4.4 at first (W0), second (W26), and third injection (W52). Participants on lenacapavir-based regimens demonstrated stability or improvement in HRQoL and other outcomes, with fewer participants reporting bothersome HIV symptoms. These data can help clinicians address individuals' needs and medication preferences while achieving sustained virologic suppression in heavily treatment-experienced PWH.

Indexed as

Anti-HIV AgentsHIV InfectionsPatient Reported Outcome MeasuresQuality of LifeAcetamidesAdultFemaleHIV-1HumansIndazolesMaleMiddle AgedTreatment OutcomeViral LoadAcetamidesAnti-HIV AgentsIndazoleslenacapavirClinical trialHIVPatient-reported outcomesQuality of life

Identifiers

PMID40063206
PMCPMC12031994

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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.