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Severe adverse events during antiviral therapy in hepatitis C virus cirrhotic patients: A systematic review

Simona Bota1, Ioan Sporea, Roxana Sirli

  • 1Simona Bota, Ioan Sporea, Roxana Şirli, Alina Popescu, Mirela Dănilă, Mihnea Străin, Department of Gastroenterology and Hepatology, University of Medicine and Pharmacy, 300736 Timişoara, Romania.

World Journal of Hepatology
|April 5, 2013
PubMed

Insights

Nearly 15% of hepatitis C virus (HCV) patients with cirrhosis discontinued Pegylated interferon (PegIFN) and ribavirin therapy due to severe adverse events (SAEs). Hematological disorders were the most frequent reason for stopping treatment in these cirrhotic patients.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Hepatitis C virus (HCV) infection in cirrhotic patients presents unique treatment challenges.
  • Standard antiviral therapies, including Pegylated interferon (PegIFN) and ribavirin, are associated with severe adverse events (SAEs).
  • Understanding SAEs leading to treatment discontinuation is crucial for optimizing patient management.

Purpose of the Study:

  • To identify the types and frequency of SAEs that necessitate treatment discontinuation during antiviral therapy for HCV-infected cirrhotic patients.
  • To compare discontinuation rates based on disease severity (Child-Pugh class) and treatment regimens.

Main Methods:

  • A systematic review of published literature up to December 2011 was conducted.
  • Searched databases included PubMed, Medline, Lilacs, Scopus, Ovid, EMBASE, Cochrane, and Medscape.
  • Included studies evaluated SAEs leading to discontinuation of PegIFN (alpha 2a or 2b) plus ribavirin in cirrhotic patients.

Main Results:

  • Seventeen papers involving 1133 patients were reviewed.
  • Overall, 14.5% of patients discontinued therapy due to SAEs.
  • Most common SAEs were hematological disorders (thrombocytopenia/neutropenia, 23.2%), psychiatric disorders (15.5%), and liver decompensation (12.1%).
  • Discontinuation rates were higher in Child-Pugh class B/C patients (22%) compared to class A (11.4%).
  • Sustained virological response rates were significantly lower for genotype 1+4 (20.5%) versus genotype 2+3 (56.5%).

Conclusions:

  • Approximately 14.5% of HCV cirrhotic patients treated with PegIFN and ribavirin required early treatment discontinuation due to SAEs.
  • Hematological disorders were the primary cause of treatment cessation.
  • Disease severity (Child-Pugh class) significantly influenced discontinuation rates due to SAEs.
Abstract

Keywords:
Adverse eventsHepatitis C virusLiver cirrhosisSustained virological response

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