Evidence map›Paper›PMID 27195797›Full record

ArticlePloS one2016

Hepatic Safety of Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate Fixed-Dose Single-Tablet Regimen in HIV-Infected Patients with Active Hepatitis C Virus Infection: The hEPAtic Study.

Karin Neukam, Nuria Espinosa, Antonio Collado, Marcial Delgado-Fernández, Patricia Jiménez-Aguilar, Antonio Rivero-Juárez, Victor Hontañón-Antoñana, Ana Gómez-Berrocal, Josefa Ruiz-Morales, Dolores Merino and 10 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 36% 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, 10 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
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

20 authors at 16 institutions in 1 country.

Karin NeukamUnit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
Nuria EspinosaService of Infectious Diseases, Hospital Universitario Virgen del Rocío, Seville, Spain.
Antonio ColladoUnit of Infectious Diseases, Hospital Torrecárdenas, Almeria, Spain.
Marcial Delgado-FernándezUnit of Infectious Diseases, Hospital Regional de Málaga. Malaga, Spain.
Patricia Jiménez-AguilarUnit of Infectious Diseases, Hospital Universitario Puerto Real, Puerto Real, Spain.
Antonio Rivero-JuárezUnit of Infectious Diseases, Hospital Universitario Reina Sofía, Instituto de Investigación Biomédica de Córdoba (IMIBIC), Cordoba, Spain.
Victor Hontañón-AntoñanaHIV Unit, Service of Internal Medicine, Hospital Universitario La Paz/IdiPAZ, Madrid, Spain.
Ana Gómez-BerrocalService of Internal/Infectious Medicine, Hospital Universitario de la Princesa, Madrid, Spain.
Josefa Ruiz-MoralesUnit of Infectious Diseases, Hospital Universitario Virgen de la Victoria, Malaga, Spain.
Dolores MerinoUnit of Infectious Diseases, Complejo Hospitalario de Huelva, Huelva, Spain.
Ana CarreroUnit of Infectious Diseases/HIV, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Francisco TéllezUnit of Infectious Diseases, Hospital La Línea, AGS Campo de Gibraltar, La Linea de la Concepcion, Spain.
María José RíosUnit of Infectious Diseases, Hospital Virgen Macarena, Seville, Spain.
José Hernández-QueroUnit of Infectious Diseases, Hospital Universitario San Cecilio, Granada, Spain.
María de Lagarde-SebastiánHIV Unit. Hospital Universitario 12 de Octubre, Madrid, Spain.
Inés Pérez-CamachoTropical Medicine Unit, Hospital Poniente, El Ejido, Spain.
Francisco Vera-MéndezInfectious Medicine Section, Hospital Universitario Santa Lucia, Cartagena, Spain.
Juan MacíasUnit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
Juan A PinedaUnit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
hEPAtic Study Group
Hospital Universitario de Valme · ESComplejo Hospitalario Torrecárdenas · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital de Poniente · ESHospital General Universitario Gregorio Marañón · ESHospital Regional Universitario de Málaga · ESHospital Universitario 12 De Octubre · ESHospital Universitario de La Princesa · ESHospital Universitario La Paz · ESHospital Universitario Puerto Real · ESHospital Universitario Virgen del Rocío · ESHospital Universitario Virgen Macarena · ESInstituto de Investigación Biosanitaria de Granada · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ESSanta Lucía University General Hospital · ESUniversidad de Huelva · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to evaluate the frequency of transaminase elevations (TE) and total bilirubin elevations (TBE) during the first year of therapy with a single tablet regimen including RPV/FTC/TDF (EPA) in HIV/hepatitis C virus (HCV)-coinfected subjects in clinical practice.

methodsIn a retrospective analysis, HIV/HCV-coinfected subjects who started EPA at 17 centres throughout Spain were included as cases. Subjects who started an antiretroviral therapy (ART) other than EPA during the study period at the same hospitals were randomly selected as controls in a 1:2 ratio. Primary outcome variables were grade (G) 3-4 TE and G4 TBE.

resultsOf the 519 subjects included, 173 individuals started EPA. Nine (5.2%) subjects of the EPA group and 49 (14.2%) controls were naïve to ART. The median (Q1-Q3) follow-up was 11.2 (9.7-13.9) months. TE was observed in 2 [1.2%; 95% confidence interval (CI): 0.14%-4.1%] subjects receiving EPA and 11 (3.2%; 95%CI: 1.6%-5.6%) controls (p = 0.136), all events were G3. No patient discontinued ART due to TE. One (0.6%; 95%CI: 0.01%-3.1%) subject on EPA and 8 (2.3%; 95%CI: 1%-4.5%) subjects in the control group developed TBE (p = 0.141), without developing any other hepatic event during follow-up. Three (2.3%) subjects with cirrhosis versus 10 (3.1%) without cirrhosis showed G3-4 TE (p = 0.451).

conclusionThe frequency of severe liver toxicity in HIV/HCV-coinfected subjects receiving EPA under real-life conditions is very low, TE were generally mild and did not lead to drug discontinuation. All these data suggest that EPA can be safely used in this particular subpopulation.

Indexed as

AdultAnti-Retroviral AgentsAntiviral AgentsBilirubinCase-Control StudiesCoinfectionDrug Therapy, CombinationEmtricitabineFemaleFibrosisHepacivirusHepatitis CHIV InfectionsHospitalizationHumansLiverAnti-Retroviral AgentsAntiviral AgentsBilirubinEmtricitabineRilpivirineTabletsTenofovirTransaminases

Identifiers

PMID27195797
PMCPMC4873169
OpenAlexW2397231263

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.