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Available online 3 April 2025
Electrocardiographic alterations during direct-acting antiviral therapy against hepatitis C virus
Alteraciones electrocardiográficas durante el tratamiento antiviral de acción directa contra el virus de la hepatitis C
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Olga Neva López-Garcíaa,b, Daniel García-Arribasb,c,
Corresponding author
dgarribas@salud.madrid.org

Corresponding author.
, Carmen Olmosb,c, María José Devesa Medinaa,b, Javier Higueras Nafríab,c, Sonia Izquierdo Rubioa,b, Francisca Cuenca Alarcóna,b, Maite Maroto Castellanosa,b, Ana Fernández-Vegab,c, Alejandro Cruz-Utrillab,c, Pablo Martínez-Vivesb,c, Enrique Reya,b
a Servicio de Aparato Digestivo, Hospital Clínico San Carlos, Madrid, Spain
b Instituto de Investigación Sanitaria San Carlos, Madrid, Spain
c Instituto Cardiovascular, Hospital Clínico San Carlos, Madrid, Spain
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Figures (2)
Tables (3)
Table 1. Basal characteristics of all patients and patients with and without sofosbuvir.
Tables
Table 2. Comparison of the measurements in the 3 ECG in groups without and with sofosbuvir.
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Table 3. QTc subgroup analysis. Variation of QTc depending on concomitant treatment, genotype and grade of liver fibrosis.
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Abstract
Introduction and objectives

QTc interval alterations have been described in patients receiving sofosbuvir. Our objective was to evaluate the effect of anti-hepatitis C virus drugs on the human cardiac conduction system.

Methods

We included all patients with hepatitis C virus infection that started treatment with direct-acting antivirals in a tertiary hospital between May 2016 and March 2017. Three electrocardiograms were performed in them: before starting treatment; during treatment; and at least 3 weeks after finished treatment. Heart rate, PR, QRS, and QTc intervals were compared between patients with and without sofosbuvir. Patients were followed for a mean time of 41.9 weeks.

Results

A total of 101 patients were studied, 61 received treatment with sofosbuvir and 40 without sofosbuvir. No differences were found between the 2 groups regarding heart rate, and PR intervals. There was a statistically significant enlargement of QTc in patients with sofosbuvir at the fourth week of treatment (415.3ms vs 420.8ms) that returned to baseline values once finalized (411.1ms; P=.029). These differences were not observed in patients without sofosbuvir.

Conclusions

We observed a statistically significant prolongation of the QTc interval at the fourth week of treatment in patients with sofosbuvir, which returned to baseline levels once the treatment was finished. Further prospective studies are needed to assess the clinical relevance of these findings.

Keywords:
Viral hepatitis C
Electrocardiogram
Drug-induced long QT syndrome
Sofosbuvir
Abbreviations:
DAA
ECG
HCV
QTc
Resumen
Introducción y objetivos

Se han descrito alteraciones del intervalo QTc en pacientes en tratamiento con sofosbuvir. Nuestro objetivo fue evaluar el efecto de los fármacos contra el virus de la hepatitis C sobre el sistema de conducción cardiaca humana.

Métodos

Incluimos a todos los pacientes con infección por VHC que iniciaron tratamiento con antivirales de acción directa en un hospital terciario entre mayo de 2016 y marzo de 2017. Se les realizaron 3 electrocardiogramas: antes de iniciar el tratamiento, durante el tratamiento y al menos 3semanas después de finalizar el tratamiento. Se compararon la frecuencia cardiaca y los intervalos PR, QRS y QTc entre pacientes con y sin sofosbuvir. Se siguió a los pacientes durante un tiempo medio de 41,9semanas.

Resultados

Se estudió a 101 pacientes, de los que 61 recibieron tratamiento con sofosbuvir y 40 sin sofosbuvir. No se encontraron diferencias entre los 2 grupos en cuanto a la frecuencia cardiaca y los intervalos PR. Se observó un aumento estadísticamente significativo del intervalo QTc en los pacientes con sofosbuvir en la cuarta semana de tratamiento (415,3ms frente a 420,8ms), que volvió a los valores basales una vez finalizado el tratamiento (411,1ms; p=0,029). Estas diferencias no se observaron en los pacientes sin sofosbuvir.

Conclusiones

Observamos una prolongación estadísticamente significativa del intervalo QTc en la cuarta semana de tratamiento en los pacientes con sofosbuvir, que volvió a los niveles basales una vez finalizado el tratamiento. Se necesitan más estudios prospectivos para evaluar la relevancia clínica de estos hallazgos.

Palabras clave:
Hepatitis C
Electrocardiograma
Síndrome de QTc adquirido por fármacos
Sofosbuvir

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