alexa A sustained viral response is associated with reduced liver-related morbidity and mortality in patients with hepatitis C virus.
Pharmaceutical Sciences

Pharmaceutical Sciences

Advances in Pharmacoepidemiology and Drug Safety

Author(s): Singal AG, Volk ML, Jensen D, Di Bisceglie AM, Schoenfeld PS

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Abstract BACKGROUND & AIMS: The incidences of decompensated cirrhosis (defined by ascites, hepatic encephalopathy, or bleeding esophageal varices), hepatocellular carcinoma (HCC), and liver-related mortality among patients infected with hepatitis C virus (HCV) who achieve a sustained viral response (SVR), compared with patients who fail treatment (treatment failure), are unclear. We performed a meta-analysis to quantify the incidences of these outcomes. METHODS: This meta-analysis included observational cohort studies that followed HCV treatment failure patients; data were collected regarding the incidence of decompensated cirrhosis, HCC, or liver-related mortality and stratified by SVR status. Two investigators independently extracted data on patient populations, study methods, and results by using standardized forms. The agreement between investigators in data extraction was greater than 95\%. Data analysis was performed separately for studies that enrolled only HCV patients with advanced fibrosis. RESULTS: We identified 26 appropriate studies for meta-analysis. Among treatment failure patients with advanced fibrosis, rates of liver-related mortality (2.73\%/year; 95\% confidence interval [CI], 1.38-4.080), HCC (3.22\%/year, 95\% CI, 2.02-4.42), and hepatic decompensation (2.92\%/year; 95\% CI, 1.61-4.22) were substantial. Patients with SVR are significantly less likely than patients who experienced treatment failure to develop liver-related mortality (relative risk [RR], 0.23; 95\% CI, 0.10-0.52), HCC (RR, 0.21; 95\% CI, 0.16-0.27), or hepatic decompensation (RR, 0.16; 95\% CI, 0.04-0.59). CONCLUSIONS: HCV patients with advanced fibrosis who do not undergo an SVR have substantial liver-related morbidity and mortality. Achieving SVR is associated with substantially lower liver-related morbidity and mortality. Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved. This article was published in Clin Gastroenterol Hepatol and referenced in Advances in Pharmacoepidemiology and Drug Safety

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