Evidence map›Paper›PMID 31714950›Full record

ArticlePloS one2019

Real-world evidence of the effectiveness of ombitasvir-paritaprevir/r ± dasabuvir ± ribavirin in patients monoinfected with chronic hepatitis C or coinfected with human immunodeficiency virus-1 in Spain.

José Manuel Sousa, Mercedes Vergara, Federico Pulido, Gloria Sánchez Antolín, Lander Hijona, Fernando Carnicer, Diego Rincón, Javier Salmerón, Beatriz Mateos-Muñoz, Antoni Jou and 30 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 29% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. 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

40 authors at 20 institutions in 1 country.

José Manuel SousaHepatology Department, Hospital Universitario Virgen del Rocío, Sevilla, Sevilla, Spain.
Mercedes VergaraHepatology Unit, Digestive Disease Department, Parc Taulí Sabadell Hospital Universitari, Sabadell, Barcelona, Spain, CIBERehd, Instituto Carlos III, Madrid, Spain.
Federico PulidoHIV Unit, Hospital Universitario 12 de Octubre, imas12, Universidad Complutense de Madrid (UCM), Madrid, Spain.
Gloria Sánchez AntolínHepatology Department, Hospital Universitario Río Hortega, Valladolid, Valladolid, Spain.
Lander HijonaHepatology Department, Hospital Universitario Araba, Vitoria-Gasteiz, Álava, Spain.
Fernando CarnicerHepatology Department, Hospital General Universitario de Alicante, Alicante, Alicante, Spain.
Diego RincónHepatology Department, Hospital General Universitario Gregorio Marañón, CIBERehd and (UCM), Madrid, Spain.
Javier SalmerónHepatology Department, Complejo Hospitalario Universitario de Granada, Granada, Granada, Spain.
Beatriz Mateos-MuñozHepatology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Antoni JouHIV Clinical Unit, Internal Medicine Department and Fundació de la Lluita contra la SIDA, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Barcelona, Spain.
Benjamín Polo-LorduyHepatology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Ángel RubínHepatology Department, Hospital Universitario y Politécnico de La Fe, Valencia, Valencia, Spain.
Ana EscardaHepatology Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
Patricia AguilarDigestive System Clinical Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía/Córdoba University, Córdoba, Spain.
Teresa Aldámiz-EchevarríaInfectious Diseases-HIV, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Madrid, Spain.
Luisa García-BueyHepatology Department, Hospital Universitario de La Princesa, Madrid, Spain.
José A CarriónLiver Section, Gastroenterology Department, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), UAB (Universitat Autonoma de Barcelona) Barcelona, Spain.ORCID 0000-0001-7191-6081
Manuel Hernández-GuerraHepatology Department, Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife, Spain.
Sonia Chimeno-HernándezHepatology Department, Hospital Arnau de Vilanova, Valencia, Valencia, Spain.
Nuria EspinosaClinical Unit of Infectious Diseases, Microbiology and Preventive Medicine, Infectious Diseases Research Group, Institute of Biomedicine of Seville (IBiS), University of Seville/CSIC,Sevilla, Spain.
Rosa Mª MorillasLiver Section, Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, IGTP, Badalona, Barcelona, Spain, and CIBEREHD.ORCID 0000-0001-9117-5049
Raúl J AndradeUnidad de Gestión Clínica de Aparato Digestivo, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas CIBERehd, Málaga, Spain.
Manuel DelgadoHepatology Department, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
Adolfo GallegoHepatology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Barcelona, Spain.
Marta MagazHepatology Department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
José María Moreno-PlanasDigestive System Department, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
Ángel EstébanezHepatology Department, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain.
Mikel RicoInfectious Diseases Unit, Hospital Universitario La Paz, Madrid, Spain.
Fernando MenéndezHepatology Department, Hospital Universitario Basurto, Bilbao, Vizcaya, Spain.
Blanca SampedroHepatology Department, Hospital Galdakao, Galdakao, Vizcaya, Spain.
Luís MoranoInfectious Diseases Unit, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain.ORCID 0000-0002-0560-3260
Sonia IzquierdoHepatology Department, Hospital Clínico San Carlos, Madrid, Spain.
José Manuel ZozayaHepatology Department, Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain.
Manuel RodríguezLiver Unit, Division of Gastroenterology & Hepatology. Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain.
Senador Morán-SánchezHepatology Department, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain.
Sara LorenteHepatology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Zaragoza, Spain.
Ignacio Martín-GranizoDepartment of Gastroenterology, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain.
Miguel Ángel Von-WichmannInfectious Diseases Unit, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain.
Marcial DelgadoInfectious Diseases Unit, Hospital Regional Universitario de Málaga, Málaga, Spain.
Amanda ManzanaresAbbVie Spain, S.L.U., Madrid, Spain.ORCID 0000-0003-1536-3560
Hospital General Universitario Gregorio Marañón · ESHospital Regional Universitario de Málaga · ESUniversitat Autònoma de Barcelona · ESUniversity Hospital Complex Of Vigo · ESAbbVie (Spain) · ESCentro de Investigación Biomédica en Red · ESComplejo Hospitalario de Navarra · ESComplejo Hospitalario Universitario de Albacete · ESComplejo Hospitalario Universitario de Granada · ESCorporació Sanitària Parc Taulí · ESDonostiako Unibertsitate Ospitalea · ESHospital Arnau de Vilanova · ESHospital Clínico San Carlos · ESHospital Clínico Universitario Lozano Blesa · ESHospital de Basurto · ESHospital de Galdakao · ESHospital de Sant Pau · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital Universitari Germans Trias i Pujol · ESHospital Universitari i Politècnic La Fe · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimWe describe the effectiveness and safety of the interferon-free regimen ombitasvir/paritaprevir/ritonavir plus dasabuvir with or without ribavirin (OBV/PTV/r ± DSV ± RBV) in a nationwide representative sample of the hepatitis C virus (HCV) monoinfected and human immunodeficiency virus-1/hepatitis C virus (HIV/HCV) coinfected population in Spain. MATERIAL AND

methodsData were collected from patients infected with HCV genotypes 1 or 4, with or without HIV-1 coinfection, treated with OBV/PTV/r ± DSV ± RBV at 61 Spanish sites within the initial implementation year of the first government-driven "National HCV plan." Effectiveness was assessed by sustained virologic response at post-treatment week 12 (SVR12) and compared between monoinfected and coinfected patients using a non-inferiority margin of 5% and a 90% confidence interval (CI). Sociodemographic and clinical characteristics or patients and adverse events (AEs) were also recorded.

resultsOverall, 2,408 patients were included in the intention-to-treat analysis: 386 (16%) were patients with HIV/HCV. Patient selection reflected the real distribution of patients treated in each participating region in Spain. From the total population, 96.6% (95% CI, 95.8-97.3%) achieved SVR12. Noninferiority of SVR12 in coinfected patients was met, with a difference between monoinfected and coinfected patients of -2.2% (90% CI, -4.5% - 0.2%). Only genotype 4 was associated with non-response to OBV/PTV/r ± DSV ± RBV treatment (p<0.001) in the multivariate analysis. Overall, 286 patients (11.9%) presented AEs potentially related to OBV/PTV/r ± DSV, whereas 347 (29.0%) presented AEs potentially related to ribavirin and 61 (5.1%) interrupted ribavirin.

conclusionsOur results confirm that OBV/PTV/r ± DSV ± RBV is effective and generally well tolerated in a representative sample of the HCV monoinfected and HCV/HIV coinfected population in Spain within the experience of a national strategic plan to tackle HCV.

Indexed as

2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesDrug Therapy, CombinationFemaleFollow-Up StudiesHepatitis C, ChronicHIV-1HIV InfectionsHumansLactams, MacrocyclicLogistic ModelsMacrocyclic CompoundsMale2-NaphthylamineAnilidesAntiviral AgentsCarbamatesCyclopropanesdasabuvirLactams, MacrocyclicMacrocyclic CompoundsombitasvirparitaprevirProlineRibavirinSulfonamidesUracilValine

Identifiers

PMID31714950
PMCPMC6850697
OpenAlexW2989509614

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.