Evidence map›Paper›PMID 31451115›Full record

Observational studyAIDS research and therapy2019

Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA).

Lucia Taramasso, Elena Ricci, Antonio Cascio, Laura Valsecchi, Barbara Menzaghi, Nicola Squillace, Paolo Maggi, Giuseppe Vittorio De Socio, Chiara Dentone, Giordano Madeddu and 6 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in AIDS research and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Observational
  2. Article
  3. Observational
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

16 authors.

Lucia TaramassoDepartment of Health Science (DISSAL), Infectious Disease Clinic, University of Genova, Genoa, Italy. taramasso.lucia@gmail.com.ORCID 0000-0002-6622-6358
Elena RicciDipartimento Donna-Bambino-Neonato, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Antonio CascioDepartment of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE) - Infectious Disease Unit, Policlinico "P. Giaccone", University of Palermo, Palermo, Italy.
Laura ValsecchiInfectious Disease Unit (I Divisione), ASST Fatebenefratelli Sacco, Milan, Italy.
Barbara MenzaghiInfectious Disease Unit, ASST della Valle Olona, Busto Arsizio, Italy.
Nicola SquillaceInfectious Disease Unit, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.
Paolo MaggiInfectious Diseases Clinic University of Campania "Luigi Vanvitelli", Neaples, Italy.
Giuseppe Vittorio De SocioInfectious Disease Unit, Santa Maria Hospital, Perugia, Italy.
Chiara DentoneInfectious Disease Unit, Sanremo Hospital, Sanremo, Italy.
Giordano MadedduUnit of Infectious Diseases, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
Giovanni F PellicanòUnit of Infectious Diseases, Department of Human Pathology of the Adult and the Developmental Age "G. Barresi", University of Messina, Messina, Italy.
Leonardo CalzaDepartment of Medical and Surgical Sciences, Unit of Infectious Diseases, 'Alma Mater Studiorum' University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Goffredo AngioniInfectious Disease Unit, SS Trinità Hospital, Cagliari, Italy.
Paolo BonfantiInfectious Disease Unit, Ospedale A. Manzoni, Lecco, Italy.
Antonio Di BiagioInfectious Diseases Clinic, Policlinico Hospital San Martino, Genoa, Italy.
CISAI Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStudy aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting.

methodsMulticentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables.

resultsA total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up.

conclusionsDRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Indexed as

AdultAnti-Retroviral AgentsCobicistatDarunavirDrug Therapy, CombinationFemaleHIV-1HIV InfectionsHumansMaleMiddle AgedProspective StudiesViral LoadAnti-Retroviral AgentsCobicistatDarunavirAdverse eventsCISAIDarunavir/cobicistatDualDurabilityTolerability

Identifiers

PMID31451115
PMCPMC6710858

What OpenQuestion holds

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Registered trials

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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.