Brief Article
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World J Hepatol. Mar 27, 2013; 5(3): 120-126
Published online Mar 27, 2013. doi: 10.4254/wjh.v5.i3.120
Severe adverse events during antiviral therapy in hepatitis C virus cirrhotic patients: A systematic review
Simona Bota, Ioan Sporea, Roxana Şirli, Alina Popescu, Adriana Maria Neghină, Mirela Dănilă, Mihnea Străin
Simona Bota, Ioan Sporea, Roxana Şirli, Alina Popescu, Mirela Dănilă, Mihnea Străin, Department of Gastroenterology and Hepatology, University of Medicine and Pharmacy, 300736 Timişoara, Romania
Adriana Maria Neghină, Department of Biochemistry and Pharmacology, University of Medicine and Pharmacy, 300736 Timişoara, Romania
Author contributions: Bota S, Sporea I and Şirli R designed the manuscript; Bota S wrote the manuscript; Bota S, Şirli R, Popescu A and Neghină AM acquired the data; Bota S and Neghină AM performed the statistical analysis; Bota S, Sporea I, Şirli R, Popescu A, Dănilă M and Strain M interpreted the data; Sporea I, Şirli R, Popescu A, Neghina AM, Dănilă M and Străin M revised the manuscript draft; Bota S, Sporea I, Şirli R, Popescu A, Neghină AM, Dănilă M and Străin M approved the final version of the article.
Correspondence to: Simona Bota, MD, Department of Gastroenterology, University of Medicine and Pharmacy, 300736 Timişoara, Romania. bota_simona1982@yahoo.com
Telephone: +40-721-656147 Fax: +40-256-488003
Received: June 18, 2012
Revised: November 26, 2012
Accepted: January 17, 2013
Published online: March 27, 2013
Abstract

AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients.

METHODS: We identified all the articles published prior to December 2011 in the PubMed, Medline, Lilacs, Scopus, Ovid, EMBASE, Cochrane and Medscape databases that presented these data in cirrhotic patients. These studies evaluated the rate of SAEs leading to discontinuation of standard care treatment: Pegylated interferon (PegIFN) alpha 2a (135-180 μg/wk) or PegIFN alpha 2b (1 or 1.5 μg/kg per week) and ribavirin (800-1200 mg/d). Patients with genotype 1 + 4 underwent treatment for 48 wk, whereas those with genotypes 2 + 3 were treated for 24 wk.

RESULTS: We included 17 papers in this review, comprising of 1133 patients. Treatment was discontinued due to SAEs in 14.5% of the patients. The most common SAEs were: severe thrombocytopenia and/or neutropenia (23.2%), psychiatric disorders (15.5%), decompensation of liver cirrhosis (12.1%) and severe anemia (11.2%). The proportion of patients who needed to discontinue their therapy due to SAEs was significantly higher in patients with Child-Pugh class B and C vs those with Child-Pugh class A: 22% vs 11.4% (P = 0.003). A similar discontinuation rate was found in cirrhotic patients treated with PegIFN alpha 2a and those treated with PegIFN alpha 2b, in combination with ribavirin: 14.2% vs 13.7% (P = 0.96). The overall sustained virological response rate in cirrhotic patients was 37% (95%CI: 33.5-43.1) but was significantly lower in patients with genotype 1 + 4 than in those with genotype 2 + 3: 20.5% (95%CI: 17.9-24.8) vs 56.5% (95%CI: 51.5-63.2), (P < 0.0001).

CONCLUSION: Fourteen point five percent of HCV cirrhotic patients treated with PegIFN and ribavirin needed early discontinuation of therapy due to SAEs, the most common cause being hematological disorders.

Keywords: Liver cirrhosis; Hepatitis C virus; Adverse events; Sustained virological response