Evidence map›Paper›PMID 37112915›Full record

ArticleViruses2023

Efficacy and Safety of Two-Drug Regimens with Dolutegravir plus Rilpivirine or Lamivudine in HIV-1 Virologically Suppressed People Living with HIV.

Carlos Dueñas-Gutiérrez, Luis Buzón, Roberto Pedrero-Tomé, José A Iribarren, Ignacio De Los Santos, Sara De la Fuente, Guillermo Pousada, Miguel Angel Moran, Estela Moreno, Eva Ferreira and 2 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Viruses, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Observational
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. 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

12 authors at 11 institutions in 1 country.

Carlos Dueñas-GutiérrezInfectious Diseases Division, Hospital Universitario Clínico de Valladolid, 47003 Valladolid, Spain.ORCID 0000-0002-8943-1231
Luis BuzónInfectious Diseases Division, Hospital Universitario de Burgos, 09006 Burgos, Spain.ORCID 0000-0003-4847-8014
Roberto Pedrero-ToméInfanta Leonor University Hospital Research and Innovation Foundation, 28031 Madrid, Spain.ORCID 0000-0003-0318-2981
José A IribarrenInfectious Diseases Department, Hospital Universitario de Donostia, 20014 San Sebastián, Spain.
Ignacio De Los SantosInfectious Diseases Division, Hospital Universitario de La Princesa, 28006 Madrid, Spain.ORCID 0000-0001-7073-5211
Sara De la FuenteInfectious Diseases Division, Hospital Universitario Puerta de Hierro, 28222 Madrid, Spain.ORCID 0000-0002-5835-5782
Guillermo PousadaInfectious Diseases Division, Hospital Universitario de Txagorritxu, 01009 Vitoria, Spain.ORCID 0000-0002-2466-8094
Miguel Angel MoranInfectious Diseases Division, HospitalÁlvaro Cunqueiro, 36312 Vigo, Spain.
Estela MorenoInfectious Diseases Division, Complejo Hospitalario de Navarra, 31008 Pamplona, Spain.
Eva FerreiraInfectious Diseases Division, Hospital de Segovia, 47002 Segovia, Spain.
Julia GómezInfectious Diseases Division, Hospital Universitario de Salamanca, 37007 Salamanca, Spain.
Jesús TroyaInternal Medicine Department, Hospital Universitario Infanta Leonor, 28031 Madrid, Spain.ORCID 0000-0001-7323-114X
Hospital Universitario Infanta Leonor · ESBiogipuzkoa Health Research Institute · ESComplejo Hospitalario de Navarra · ESComplejo Hospitalario de Salamanca · ESHospital Clínico Universitario de Valladolid · ESHospital General De Segovia · ESHospital Txagorritxu · ESHospital Universitario de Burgos · ESHospital Universitario de La Princesa · ESHospital Universitario Puerta de Hierro Majadahonda · ESUniversity Hospital Complex Of Vigo · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe high effectiveness and safety of the two-drug (2DRs) strategy using dolutegravir (DTG) plus lamivudine (3TC) have led to international guidelines recommending their use for treatment-naive HIV patients. In virologically suppressed patients, de-escalating from 3DRs to DTG plus either rilpivirine (RPV) or 3TC has shown high rates of virological suppression.

objectivesThis study aimed to compare the real-life data of two multicenter Spanish cohorts of PLWHIV treated with DTG plus 3TC (SPADE-3) or RPV (DORIPEX) as a switch strategy, not only in terms of virological suppression, safety, and durability but also in terms of immune restoration. The primary endpoint was the percentage of patients with virological suppression on DTG plus 3TC and DTG plus RPV at weeks 24 and 48. The secondary outcomes included the proportion of patients who experienced the protocol-defined loss of virological control by week 48; changes in immune status in terms of CD4+ and CD8+ T lymphocyte counts and the CD4+/CD8+ ratio; the rate, incidence, and reasons for discontinuation of treatment over the 48-week study period; and safety profiles at weeks 24 and 48.

methodsWe conducted a retrospective, observational, multicenter study of 638 and 943 virologically suppressed HIV-1-infected patients in two cohorts who switched to 2DRs with DTG plus RPV or DTG plus 3TC.

resultsThe most frequent reasons for starting DTG-based 2DRs were treatment simplification/pill burden or drug decrease. The virological suppression rates were 96.9%, 97.4%, and 99.1% at weeks 24, 48, and 96, respectively. The proportion of patients with virological failure over the 48-week study period was 0.01%. Adverse drug reactions were uncommon. Patients treated with DTG+3TC increased CD4, CD8, and CD4/CD8 parameters at 24 and 48 weeks.

conclusionsWe conclude that DTG-based 2DRs (combined with 3TC or RPV) in clinical practice were effective and safe as a switching strategy, with a low VF and high viral suppression rates. Both regimens were well tolerated, and ADR rates were low, including neurotoxicity and induced treatment discontinuations.

Indexed as

Anti-HIV AgentsDrug-Related Side Effects and Adverse ReactionsHIV-1HIV InfectionsHIV SeropositivityDolutegravirHeterocyclic Compounds, 3-RingHumansLamivudineRetrospective StudiesRilpivirineAnti-HIV AgentsDolutegravirHeterocyclic Compounds, 3-RingLamivudineRilpivirine2DRHIV/AIDSvirologically suppressed patients

Identifiers

PMID37112915
PMCPMC10145987
OpenAlexW4363678409

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.