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Adverse effects of direct acting antiviral-based regimens in chronic hepatitis C patients: a Brazilian experience

Thalia Medeiros1, Camila de Morais Salviato1, Natalia Fonseca do Rosário1

  • 1Laboratório Multiusuário de Apoio à Pesquisa em Nefrologia e Ciências Médicas, Departamento de Medicina Clínica, Faculdade de Medicina, Universidade Federal Fluminense, Rio de Janeiro, Brazil.

International Journal of Clinical Pharmacy
|October 29, 2017
PubMed

Insights

Direct-acting antivirals (DAA) for hepatitis C (HCV) showed high safety in a Brazilian real-world study. Most patients experienced mild adverse effects like fatigue and headache, with no correlation to treatment history or comorbidities.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Direct-acting antivirals (DAA) are standard for chronic hepatitis C (HCV) treatment.
  • Real-world data on DAA adverse effects (AE) in diverse patient cohorts are limited.

Purpose of the Study:

  • To evaluate the frequency and types of adverse effects (AE) in Brazilian chronic hepatitis C (HCV) patients undergoing DAA therapy.
  • To correlate AE with patient characteristics and treatment history.

Main Methods:

  • An observational, real-world study involving 102 chronic HCV patients treated with DAA for 12 or 24 weeks.
  • Self-reported AE were collected and analyzed.
  • AE were correlated with cirrhosis status, genotype, age, treatment history, and comorbidities.

Main Results:

  • Nearly 90% of patients reported at least one AE, averaging 2.7 symptoms per patient.
  • The most common AE included fatigue (43%), headache (42%), neuropsychiatric symptoms (30%), and nausea (26%).
  • Neuropsychiatric symptoms were more frequent in treatment-experienced patients (41.7% vs. 12.5%).

Conclusions:

  • DAA therapy demonstrated a favorable safety profile in this Brazilian real-world cohort.
  • The high rate of AE did not correlate with patient characteristics or comorbidities, suggesting manageable side effects.
  • All patients achieved sustained virological response, indicating treatment efficacy alongside safety.

Keywords:
Adverse effectsBrazilChronic hepatitis CDirect-acting antiviralSofosbuvir

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