Evidence map›Paper›PMID 32266663›Full record

ArticleThe patient2020

Patient-Reported Outcomes in an Observational Cohort of HIV-1-Infected Adults on Darunavir/Cobicistat-Based Regimens: Beyond Viral Suppression.

Andrea Antinori, Maria V Cossu, Barbara Menzaghi, Gaetana Sterrantino, Nicola Squillace, Valentina Di Cristo, Annamaria Cattelan, Emanuele Focà, Antonella Castagna, Giancarlo Orofino and 14 more

Erratum issuedOpen access · hybridAbstract read
In one paragraph

Article in The patient, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.1field-weighted citation impact, top 46% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 20 institutions in 1 country.

Andrea AntinoriHIV/AIDS Department, National Institute for Infectious Diseases "Lazzaro Spallanzani"-IRCCS, Rome, Italy.
Maria V Cossu1st Division of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Barbara MenzaghiInfectious Diseases, Azienda Socio-Sanitaria Territoriale della Valle Olona-Busto Arsizio, Busto Arsizio, Italy.
Gaetana SterrantinoDivision of Tropical and Infectious Disease, Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.
Nicola SquillaceClinic of Infectious Diseases, "San Gerardo" Hospital, ASST Monza, Monza, Italy.
Valentina Di CristoDIBIC Luigi Sacco, Division of Infectious Diseases, University of Milan, Milan, Italy.
Annamaria CattelanDivision of Infectious and Tropical Diseases, Azienda Ospedaliero-Universitaria di Padova, Padua, Italy.
Emanuele FocàDepartment of Infectious and Tropical Diseases, University of Brescia and Spedali Civili General Hospital, Brescia, Italy.
Antonella CastagnaDepartment of Infectious Diseases, IRCSS San Raffaele Scientific Institute, Milan, Italy.
Giancarlo OrofinoUnit of Infectious Diseases, Amedeo di Savoia Hospital, Turin, Italy.
Daniela ValentiFROM Research Foundation, Papa Giovanni XXIII Hospital, Bergamo, Italy.
Gabriella D'EttoreDepartment of Public Health and Infectious Disease, Sapienza University, Rome, Italy.
Lucia ApreaVIII Divisione di Malattie Infettive, A.O.R.N. Cotugno, Naples, Italy.
Sergio FerraraDepartment of Clinical and Experimental Medicine, Infectious Diseases Unit, University of Foggia, Foggia, Italy.
Maria E LocatelliUOC Malattie Infettive, ARNAS "Garibaldi", Catania, Italy.
Giordano MadedduUnit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
Emanuele PontaliInfectious Diseases, E.O. Ospedali Galliera, Genoa, Italy.
Paolo ScerboUnit of Infectious Diseases, "Pugliese-Ciaccio" Hospital, Catanzaro, Italy.
Barbara RossettiInfectious Diseases Unit, Siena University Hospital, Siena, Italy.
Alessia UgliettiMedical Affairs Department, Infectious Diseases, Janssen-Cilag SpA, Via Michelangelo Buonarroti, 23, Cologno Monzese, 20093, Milan, Italy.
Roberta TerminiMedical Affairs Department, Infectious Diseases, Janssen-Cilag SpA, Via Michelangelo Buonarroti, 23, Cologno Monzese, 20093, Milan, Italy.
Francesco RucciDepartment of Oncology and Onco-Hematology, Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, Milan, Italy.
Andrea GoriInfectious Diseases Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Daniela MancusiMedical Affairs Department, Infectious Diseases, Janssen-Cilag SpA, Via Michelangelo Buonarroti, 23, Cologno Monzese, 20093, Milan, Italy. dmancusi@its.jnj.com.
Janssen (Italy) · ITASST Fatebenefratelli Sacco · ITAzienda Ospedaliera di Padova · ITAzienda Ospedaliera Pugliese Ciaccio · ITAzienda Ospedaliera San Gerardo · ITEnte Ospedaliero Ospedali Galliera · ITIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani · ITLuigi Sacco Hospital · ITOspedale Amedeo di Savoia · ITOspedale D. Cotugno · ITOspedale di Circolo di Busto Arsizio · ITOspedale Garibaldi · ITOspedale Papa Giovanni XXIII · ITUniversity of Brescia · ITUniversity of Florence · ITUniversity of Foggia · ITUniversity of Milan · ITUniversity of Milano-Bicocca · ITUniversity of Sassari · ITUniversity of Siena · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis prospective, multicenter, non-interventional cohort study enrolling human immunodeficiency virus (HIV)-1-infected, virally suppressed adult outpatients in Italy aimed to describe results obtained from patient-reported outcome questionnaires regarding treatment satisfaction and symptom perceptions in HIV-1-positive patients who switched to cobicistat-boosted darunavir antiretroviral regimens, coming from ritonavir-boosted protease inhibitors.

methodsPatients entered this study between June 2016 and February 2017, once their treating physician had considered them eligible for cobicistat-boosted darunavir-based treatment as per clinical practice. Patients' satisfaction regarding regimen and current symptom burdens were assessed using two previously validated, patient-reported outcome questionnaires: HIV Treatment Satisfaction Questionnaire (HIV-TSQ) and HIV Symptoms Distress Module (HIV-SDM). These questionnaires were administered at prespecified time-points: enrollment (Visit 1), 4-8 weeks later (Visit 2), and 48 ± 6 weeks after study enrollment (Visit 4). Data of patient-reported outcome total scores for both questionnaires are presented as median with 25th-75th percentiles. Questionnaires scores were analyzed overall and stratified by gender when applicable. A p value of less than 0.05 was considered statistically significant. A sensitivity analysis was conducted to evaluate the role of lost to follow-up, using the "last observation carried forward" method.

resultsA total of 348 patients were enrolled in this study; 296 patients (208 male and 88 female) provided both evaluable HIV-TSQ and HIV-SDM at enrollment and at 4-8 weeks, while 250 patients (174 male and 76 female) provided questionnaire data at enrollment and at 48 ± 6 weeks. The total scores of HIV-TSQ showed improvements in patient satisfaction in the overall population both at Visit 2 and Visit 4 (p < 0.001, sign test) and also when stratified by gender throughout the study period. In addition, the overall burden of symptoms, as shown by the HIV-SDM scores, decreased.

conclusionsSwitching to a cobicistat-boosted darunavir-based therapy led to overall increased patient satisfaction and reduced symptom burden when compared with previous regimens. The use of patient-reported outcomes in clinical daily practice could provide a useful tool towards achieving guideline goals to achieve "fourth 90", having 90% of virally suppressed patients with a good health-related quality of life.

Indexed as

Drug Therapy, CombinationPatient Reported Outcome MeasuresAdultAnti-HIV AgentsCobicistatCohort StudiesDarunavirFemaleHIV InfectionsHIV Protease InhibitorsHumansItalyMaleMiddle AgedPatient SatisfactionProspective StudiesAnti-HIV AgentsCobicistatDarunavirHIV Protease Inhibitors

Identifiers

PMID32266663
PMCPMC7210246
OpenAlexW3014402556

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.