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Original article
Uncorrected Proof. Available online 1 July 2024
Clinical profile of Spanish hepatitis C virus-infected treatment-naïve patients with compensated cirrhosis in the CREST study
Perfil clínico de los pacientes españoles con hepatitis C naïve con cirrosis compensada tratados en el estudio CREST
Francisco Jorqueraa,
Corresponding author
fjorquera@saludcastillayleon.es

Corresponding author.
, Francisco Ledesmab, Adriana Ahumadac, María Luisa Manzanod, Agustín Castiellae, Sara Lorentef, Mireia Miquelg,h,i, Zoe Mariñoj, José Castellotek, Eva Sanzl, Juan Urizm
a Complejo Asistencial Universitario de León, IBIOMED y CIBERehd, León, Spain
b Former Employee, AbbVie Spain, Madrid, Spain
c Hospital General Universitario Gregorio Marañón, Madrid, Spain
d Hospital Universitario 12 De Octubre, Madrid, Spain
e Hospital Universitario Donostia, San Sebastián, Spain
f Hospital Clínico Universitario Lozano Blesa, Universidad de Zaragoza, IIS Aragón, Zaragoza, Spain
g Hospital Universitario Parc Taulí, Institut d’Investigació i Innovació I3PT, Universidad Autónoma de Barcelona, Sabadell, Barcelona, Spain
h Universitat de Vic - Universitat Central de Catalunya (UVic-UCC), Vic, Barcelona, Spain
i CIBERehd, Instituto Carlos III, Madrid, Spain
j Hospital Clínic, IDIBAPS, CIBERehd, Universitat de Barcelona, Barcelona, Spain
k Hospital Universitario Bellvitge, IDIBELL, Universidad de Barcelona, Barcelona, Spain
l AbbVie Spain, Madrid, Spain
m Hospital Universitario de Navarra, IdiSNA, Pamplona, Spain
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Table 1. Demographic and baseline clinical characteristics.
Table 2. Comorbidities and drug use.
Table 3. Adverse events.
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Abstract
Background and aim of the study

There are still patients with hepatitis C in Spain who have yet to be diagnosed, but their clinical profile is unclear. In 2021, 21.93% of patients diagnosed had cirrhosis and were mostly treatment-naïve.

Methods

This sub-analysis describes the clinical profile of the 60 Spanish treatment-naïve patients with compensated cirrhosis who were included in the CREST study.

Major results

Sixty percent of patients were male, median age 56 years, and 33% had a history of drug use. Almost three-quarters (71.3%) had more than one comorbidity and 78.3% took concomitant medication. At treatment initiation, median platelet count was 139 × 103/µL and FibroScan® 17 kPa. No virological failure was observed and no patient discontinued treatment due to adverse events. No clinically significant changes were noted during or after treatment in the median platelet, albumin, bilirubin, and transaminase levels.

Conclusions

Treatment with glecaprevir/pibrentasvir for 8 weeks in this cohort of treatment-naïve patients with compensated cirrhosis in Spain was safe and effective. This information reinforces the use of this short antiviral regimen even when there is compensated cirrhosis, simplifying the approach to hepatitis C among those patients still to be diagnosed and treated in Spain.

Keywords:
Hepatitis C
Liver cirrhosis
Glecaprevir and pibrentasvir
Duration of therapy
Spain
Resumen
Antecedentes y propósito del estudio

En España quedan pacientes con hepatitis C por diagnosticar, pero se desconoce su perfil clínico. En 2021 el 21,93% de los pacientes diagnosticados tenían cirrosis y eran mayoritariamente naïve al tratamiento.

Métodos

En este subanálisis se describe el perfil clínico de los 60 pacientes españoles naïve con cirrosis compensada que se incluyeron en el estudio CREST.

Resultados principales

60% de los pacientes eran varones, la mediana de edad 56 años y 33% tenían historia de consumo de drogas. 71,3% tenían más de 1 comorbilidad y 78,3% tomaban alguna medicación concomitante. Al inicio del tratamiento, la mediana de plaquetas era 139 × 103/µL y la del FibroScan® 17 kPa. No hubo ningún fracaso virológico y ningún paciente interrumpió el tratamiento debido a acontecimientos adversos. No se apreciaron cambios clínicamente significativos ni durante ni después del tratamiento en las medianas de plaquetas, albúmina, bilirrubina ni de transaminasas.

Conclusiones

El tratamiento con Glecaprevir/Pibrentasvir durante 8 semanas en esta cohorte de pacientes naïve al tratamiento con cirrosis compensada en España se mostró seguro y efectivo. Esta información refuerza el uso de esta pauta antiviral corta incluso en presencia de cirrosis compensada, simplificando el abordaje de la hepatitis C entre aquellos pacientes que aún quedan por diagnosticar y tratar en España.

Palabras clave:
Hepatitis C
Cirrosis hepática
Glecaprevir y pibrentasvir
Duración de la terapia
España

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