Evidence map›Paper›PMID 25808940›Full record

Trial reportThe patient2015

Patient-Reported Outcomes After a Switch to a Single-Tablet Regimen of Rilpivirine, Emtricitabine, and Tenofovir DF in HIV-1-Positive, Virologically Suppressed Individuals: Additional Findings From a Randomized, Open-Label, 48-Week Trial.

Jason Brunetta, Santiago Moreno Guillén, Andrea Antinori, Patrick Yeni, Barbara Wade, Margaret Johnson, Peter Shalit, Ramin Ebrahimi, Bethsheba Johnson, Ivan Walker and 1 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The patient, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 25% 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

8 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Accumulated pre-switch resistance to more recently introduced one-pill-once-a-day antiretroviral regimens impacts HIV-1 virologic outcome.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2018
    Article
  6. Observational
  7. Article
  8. 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 at 6 institutions in 6 countries.

Jason BrunettaFaculty of Medicine, University of Toronto, Toronto, ON, Canada, jbrunetta@mlmedical.com.
Santiago Moreno Guillén
Andrea Antinori
Patrick Yeni
Barbara Wade
Margaret Johnson
Peter Shalit
Ramin Ebrahimi
Bethsheba Johnson
Ivan Walker
Shampa De-Oertel
Gilead Sciences (United States) · USHôpital Bichat-Claude-Bernard · FRHospital Universitario Ramón y Cajal · ESIstituti di Ricovero e Cura a Carattere Scientifico · ITUniversity College London · GBUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatient-reported outcomes (PROs) can provide important information about treatment tolerability in HIV-1-infected patients.

objectiveThe aim of this study was to evaluate PROs following switching from a boosted protease inhibitor-based regimen to the single-tablet regimen (STR) of rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) in the 48-week open-label Switching Boosted PI to Rilpivirine in Combination with Truvada as a Single-Tablet Regimen (SPIRIT) trial.

methodsIn the open-label SPIRIT trial, patients were randomized to receive an STR of RPV/FTC/TDF (n = 317) for 48 weeks or stay on their baseline regimen of a ritonavir-boosted protease inhibitor and two nucleoside/nucleotide analog reverse transcriptase inhibitors (PI + RTV + 2NRTIs, n = 159) for 24 weeks before switching to RPV/FTC/TDF for another 24 weeks. PRO assessments included the HIV Treatment Satisfaction Questionnaire (TSQ) and the HIV Symptom Index Questionnaire (SIQ).

resultsAt week 24, the mean HIV TSQ improvement from baseline was significantly greater in the RPV/FTC/TDF group than the PI + RTV + 2NRTIs group (p < 0.001). On the HIV SIQ, the percentage of patients reporting a shift from 'symptom' to 'no symptom' was significantly greater with RPV/FTC/TDF treatment compared with PI + RTV + 2NRTIs for all items (all p ≤ 0.01), with total within-group occurrence of 13/20 symptoms significantly decreasing from baseline for RPV/FTC/TDF patients. In the delayed switch group, significantly fewer patients reported diarrhea and sleep problems at week 48 vs. week 24.

conclusionsThese data suggest that switching to the STR RPV/FTC/TDF from a PI-based multi-pill regimen is associated with greater patient-reported treatment satisfaction and improved tolerability in HIV-1-infected, virologically suppressed individuals.

Indexed as

Patient Outcome AssessmentAdultAnti-HIV AgentsDrug CombinationsEmtricitabineFemaleHIV InfectionsHumansMaleMedication AdherenceMiddle AgedPatient SatisfactionRilpivirineTenofovirAnti-HIV AgentsDrug CombinationsEmtricitabineRilpivirineTenofovir

Identifiers

PMID25808940
PMCPMC4445257
OpenAlexW2074595878

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.