Evidence map›Paper›PMID 28477212›Full record

ArticleInfection2017

Efficacy and tolerability of switching to a dual therapy with darunavir/ritonavir plus raltegravir in HIV-infected patients with HIV-1 RNA ≤50 cp/mL.

Giordano Madeddu, Stefano Rusconi, Alessandro Cozzi-Lepri, Simona Di Giambenedetto, Stefano Bonora, Alessia Carbone, Andrea De Luca, Nicola Gianotti, Antonio Di Biagio, Andrea Antinori and 1 more

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Article in Infection, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Dual therapy with raltegravir plus a fixed dose combination of darunavir/ritonavir in people living with HIV in Argentina.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2021
    Article
  4. Article
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

11 authors.

Giordano MadedduDepartment of Clinical and Experimental Medicine, Unit of Infectious Diseases, University of Sassari, Viale San Pietro 8, 07100, Sassari, Italy. giordano@uniss.it.ORCID http://orcid.org/0000-0001-6099-2273
Stefano RusconiInfectious Diseases Unit, DIBIC Luigi Sacco, University of Milan, Milan, Italy.
Alessandro Cozzi-LepriDepartment of Infection and Population Health, Division of Population Health, Hampstead Campus, University College London, London, UK.
Simona Di GiambenedettoCatholic University of the Sacred Heart, Milan, Unit of Infectious Diseases, Agostino Gemelli Polyclinic Foundation, Rome, Italy.
Stefano BonoraUnit of Infectious Diseases, Department of Medical Sciences, University of Turin, Turin, Italy.
Alessia CarboneInfectious Diseases Department, San Raffaele Scientific Institute, Università vita e salute, Milan, Italy.
Andrea De LucaDivision of Infectious Diseases, Department of Medical Biotechnologies, University of Siena and Siena University Hospital, Siena, Italy.
Nicola GianottiInfectious Diseases Department, San Raffaele Scientific Institute, Università vita e salute, Milan, Italy.
Antonio Di BiagioUnit of Infectious Diseases, IRCCS San Martino Hospital-IST, Genoa, Italy.
Andrea AntinoriClinical Department, National Institute of Infectious Diseases 'Lazzaro Spallanzani', Rome, Italy.
Icona Foundation Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNucleos(t)ide reverse transcriptase inhibitors (NRTI) toxicity may represent a threat for long-term success of combined antiretroviral therapy. Some studies have suggested a possible improvement of NRTI-related toxicity after switching to NRTI-sparing regimens.

objectivesWe aimed to explore the efficacy and tolerability of switching to darunavir/ritonavir (DRV/r) plus raltegravir (RAL) while having a viral load (VL) ≤50 copies/mL in the clinical setting. STUDY

designTreatment-experienced HIV 1-infected patients enrolled in the ICONA Foundation Study cohort were included if they switched their current regimen to DRV/r + RAL with a HIV-RNA ≤50 copies/mL. Different definitions of virological failure (VF) and treatment failure (TF) were employed. Kaplan-Meier curves and Cox regression models were performed to estimate time to event probability.

resultsWe included 72 HIV-infected patients, 22 (31%) of these were female, 31 (43%) men who have sex with men (MSM) amd 15 (21%) had hepatitis co-infections. Median age was 44 (IQR: 35-50) years amd CD4 count was 389 (IQR 283-606) cells/mmc. Median follow-up time for TF was 24 (IQR 9-31) months. Twenty-five discontinuations occurred (60% simplifications); only 2 (8%) were toxicity-driven (lipid elevations). The probability of VF (confirmed VL >50 copies/mL) was estimated at 7% [95% confidence interval (CI) 1-13%] by 12 and 9% (95% CI 2-16%) by 24 months. When considering TF, we found a probability of stop/intensification/single VL > 200 copies/mL of 13% (95% CI 1-17%) and 22% (95% CI 11-33%) by 12 and 24 months. Female gender (adjusted relative hazard, ARH = 0.10; 95% CI 0.01-0.74; p = 0.024) and older age (AHR = 0.50 per 10 years older; 95% CI 0.25-0.99; p = 0.045) were associated with a lower risk of TF. A previous PI failure was strongly associated with TF (AHR = 52.6, 95% CI 3.6-779; p = 0.004).

conclusionsDRV/r + RAL is a valuable NRTI-sparing option, especially in female and older patients, with a relatively low risk of VF and good tolerability after 2 years since start in an ART-experienced population. However, previous PI-failure should be a limiting factor for this strategy.

Indexed as

Viral LoadAdultAnti-HIV AgentsCohort StudiesDarunavirDrug Therapy, CombinationFemaleHIV-1HIV InfectionsHumansItalyMaleMiddle AgedRaltegravir PotassiumRitonavirRNA, ViralAnti-HIV AgentsDarunavirRaltegravir PotassiumRitonavirRNA, ViralAntiretroviral therapyDarunavir/ritonavirEfficacyNRTI-sparing regimenRaltegravirTolerability

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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.