Tratamiento de hepatitis C con antivirales pangenotípicos de acción directa: Interacciones farmacológicas en pacientes que consumen drogas y tratados con antipsicóticos Hepatitis C therapy with pangenotypic direct-acting antivirals: Drug-drug interactions in drug-using HCV patients and antipsychotic-treated HCV patients

Autores/as

  • Juan Turnes
  • Antonio García-Herola Sección de Aparato Digestivo. Hospital Marina Baixa de Villajoyosa (Alicante)
  • Marinela Méndez Medical Affairs, Gilead Sciences S.L., Madrid
  • Cándido Hernández Global Medical Affairs, Gilead Sciences Europe Ltd
  • Alfonsina Trento Health Economics and Outcomes Research, Atrys Health, Barcelona
  • Ramón Morillo-Verdugo Farmacia Hospitalaria, Hospital de Valme, AGS Sur de Sevilla
  • Francisco Pascual Socidrogalcohol, Barcelona
  • Ignacio Hernández Atrys Health https://orcid.org/0009-0000-2231-4228

DOI:

https://doi.org/10.20882/adicciones.2296

Palabras clave:

Virus de la Hepatitis C, Interacciones farmacológicas, Antipsicóticos, Antivirales de acción directa, Usuarios de drogas Hepatitis C Virus, People Who Use Drugs, Drug-Drug Interactions, Antipsychotic Medication, Direct-Acting Antivirals.

Resumen

Los usuarios de drogas (UD) tienen un alto riesgo de infección por el virus de la hepatitis C (VHC), y muchos pacientes con VHC presentan trastornos psiquiátricos que requieren medicación del sistema nervioso, incluidos antipsicóticos. Estos medicamentos pueden interactuar con los antivirales de acción directa (AAD), produciendo interacciones farmacológicas (IF). En este estudio, nos centramos en las potenciales IF entre AAD y medicaciones concomitantes utilizadas en estos pacientes, así como en los eventos adversos (EA) asociados e intervenciones clínicas en España. El estudio, basado en registros electrónicos de BIG-PAC®, analizó a adultos tratados con glecaprevir/pibrentasvir (GLE/PIB) o sofosbuvir/velpatasvir (SOF/VEL) entre 2017 y 2020. Se incluyeron 1.620 pacientes con VHC, 985 UD y 187 usuarios de antipsicóticos, de los cuales el 75% también eran UD. En la cohorte UD, las comorbilidades cardiovasculares fueron más frecuentes; el 22,7% presentaba riesgo de IF con medicación cardiovascular, mayor con GLE/PIB que con SOF/VEL (36,8% vs.13,7%, p<0,001). Los EA cardiovasculares fueron más frecuentes en GLE/PIB. En la cohorte de antipsicóticos, quetiapina fue el más prescrito (26,2%), seguida de paliperidona (17,6%) y olanzapina (17,1%). El 51% de los tratados con GLE/PIB presentó riesgo de IF, frente al 23% con SOF/VEL (p<0,001). Se reportaron dos EA en GLE/PIB: un paciente con quetiapina (<300 mg/día) presentó síntomas extrapiramidales y otro con paliperidona sufrió sedación, que requirió suspensión o ajuste. Los resultados subrayan el riesgo de IF en estas cohortes, especialmente en pacientes con GLE/PIB, destacando la necesidad de un seguimiento clínico estrecho para optimizar la seguridad del tratamiento. Se utilizaron registros médicos electrónicos (BIG-PAC®) para evaluar a pacientes con VHC tratados entre 2017-2020. Se incluyeron 1.620 pacientes con VHC, 985 tenían TCS y 187 usaban antipsicóticos; el 75% de estos también sufrían TCS. En la cohorte TCS, las comorbilidades cardiovasculares fueron más frecuentes; el 22,7% estuvo en riesgo de IF relacionados con medicación cardiovascular, el 36,8% con GLE/PIB y el 13,7% con SOF/VEL (p<0.001). Los EA cardiovasculares fueron más comunes con GLE/PIB. En la cohorte de antipsicóticos, la quetiapina fue el más prescrito (26,2%), seguida de paliperidona (17,6%) y olanzapina (17,1%). El 51% de los tratados con GLE/PIB tuvo riesgo de IF, frente al 23% con SOF/VEL (p<0.001). Se reportaron dos EA en el grupo de GLE/PIB (n=37): un paciente con quetiapina (<300 mg/día) experimentó síntomas extrapiramidales, y otro con paliperidona sufrió sedación, que requirió suspensión o ajuste de dosis. Los resultados subrayan el riesgo de IF en estas cohortes, especialmente con GLE/PIB, destacando la necesidad de un seguimiento clínico estrecho para optimizar la seguridad del tratamiento.
People who use drugs (PWUD) are at high risk of hepatitis C virus (HCV) infection, and HCV patients often have psychiatric disorders requiring nervous system drugs, including antipsychotics. These medicines can interact with HCV treatment-related metabolic pathways producing DDIs (drug-drug interactions). This analysis focused on potential DDIs between direct-acting antivirals (DAAs) and concomitant medications used in PWUD/antipsychotics-treated HCV patients, alongside associated adverse events (AEs) and clinical interventions in Spain. Electronic medical records (BIG-PAC® database) were used to analyse adult HCV patients treated with glecaprevir/pibrentasvir (GLE/PIB) or sofosbuvir/velpatasvir (SOF/VEL) between 2017-2020. The study included 1,620 HCV patients, 985 identified as PWUD and 187 as antipsychotic users, 75% of whom were also PWUD. In the PWUD cohort, cardiovascular (CV) comorbidities were the most frequent; 22.7% patients were at risk of DDIs with CV, with the risk being higher in GLE/PIB-treated (36.8%) versus SOF/VEL (13.7%) (p<0.001). Cardiovascular AEs were more common in the GLE/PIB group. In the antipsychotic cohort, quetiapine was the most prescribed antipsychotic comedication (26.2%), followed by paliperidone (17.6%) and olanzapine (17.1%). Fifty-one per cent of those on GLE/PIB were at risk of DDIs versus 23% on SOF/VEL (p<0.001). Two AEs were reported in the GLE/PIB group (n=37): one patient on quetiapine at a dose <300mg/day experienced extrapyramidal symptoms, leading to DAA discontinuation, and another paliperidone-treated experienced sedation, necessitating a dose reduction. The findings highlight DDIs risks in HCV patients on antipsychotics or with substance addiction, particularly with GLE/PIB. Comprehensive clinical follow-up is essential to optimise treatment and improve patient safety. Electronic medical records (BIG-PAC® database) were used to analyse adult HCV patients  treated with glecaprevir/pibrentasvir (GLE/PIB) or sofosbuvir/velpatasvir (SOF/VEL) between 2017-2020. The study included 1,620 HCV patients, 985 identified as PWUD and 187 as antipsychotic users, 75% of which were also PWUD. In the PWUD cohort, cardiovascular (CV) comorbidities were the most frequent; 22.7% patients were at risk of DDIs with CV, being the risk higher in GLE/PIB-treated (36.8%) versus SOF/VEL (13.7%) (p<0.001). Cardiovascular AEs were more common in the GLE/PIB group. In the antipsychotic cohort, quetiapine was the most prescribed antipsychotic comedication (26.2%), followed by paliperidone (17.6%) and olanzapine (17.1%). Fifty-one per cent of those on GLE/PIB were at risk of DDIs versus 23% on SOF/VEL (p<0.001). Two AEs were reported in the GLE/PIB group (n=37): one patient on quetiapine at a dose <300mg/day experienced extrapyramidal symptoms, leading to DAA discontinuation, and another paliperidone-treated experienced sedation, necessitating a dose reduction. The findings highlight DDIs risks in HCV patients on antipsychotics or with substance addiction, particularly with GLE/PIB. Comprehensive clinical follow-up is essential to optimise treatment and improve patient safety.

Biografía del autor/a

Francisco Pascual, Socidrogalcohol, Barcelona

Asesor de CAARFE. Investigador Grupo Prevengo UMH. Coordinador UCA-Alcoi. Grupo Ibero Ciência

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Publicado

2026-03-31

Número

Vol. 38 Núm. 1 (2026)

Sección

Originales