Information on the stage of liver fibrosis is essential in managing chronic hepatitis C (CHC) patients. However, most models for predicting liver fibrosis are complicated and separate formulas are needed to predict significant fibrosis and cirrhosis. The aim of our study was to construct one simple model consisting of routine laboratory data to predict both significant fibrosis and cirrhosis among patients with CHC. Consecutive treatment-naive CHC patients who underwent liver biopsy over a 25-month period were divided into 2 sequential cohorts: training set (n ؍ 192) and validation set (n ؍ 78). The best model for predicting both significant fibrosis (Ishak score > 3) and cirrhosis in the training set included platelets, aspartate aminotransferase (AST), and alkaline phosphatase with an area under ROC curves (AUC) of 0.82 and 0.92, respectively. A novel index, AST to platelet ratio index (APRI), was developed to amplify the opposing effects of liver fibrosis on AST and platelet count. The AUC of APRI for predicting significant fibrosis and cirrhosis were 0.80 and 0.89, respectively, in the training set. Using optimized cut-off values, significant fibrosis could be predicted accurately in 51% and cirrhosis in 81% of patients. The AUC of APRI for predicting significant fibrosis and cirrhosis in the validation set were 0.88 and 0.94, respectively. In conclusion, our study showed that a simple index using readily available laboratory results can identify CHC patients with significant fibrosis and cirrhosis with a high degree of accuracy. Application of this index may decrease the need for staging liver biopsy specimens among CHC patients. (HEPATOLOGY 2003;38:518-526.)
The 2009 update of the American Association for the Study of Liver Diseases (AASLD) Practice Guidelines for Management of Chronic Hepatitis B are now posted online at www.aasld.org. This is the fourth version of this guideline; the last version was published in 2007. 1 The key changes in the 2009 version are new recommendations for first-line and second-line antiviral agents. Since the last update, tenofovir disoproxil fumarate (Viread) was approved by the U.S. Food and Drug Administration for treatment of chronic hepatitis B based on the results of two double-blind randomized trials showing a superiority of tenofovir compared to adefovir. In the trial on patients positive for hepatitis B e antigen (HBeAg), 48 weeks of treatment with tenofovir resulted in a significantly higher proportion of patients with undetectable serum hepatitis B virus (HBV) DNA assay by polymerase chain reaction (76% versus 13%), alanine aminotransferase normalization (68% versus 54%), and hepatitis B surface antigen loss (3% versus 0%), with similar rates of histologic response (74% versus 68%) and HBeAg seroconversion (21% versus 18%) compared to treatment with adefovir. 2 In the trial on HBeAg-negative patients, 48 weeks of treatment with tenofovir resulted in significantly more patients with undetectable serum HBV DNA by polymerase chain reaction assay (93% versus 63%) than adefovir and similar proportions of patients achieving alanine aminotransferase normalization (76% versus 77%) or histologic response (72% versus 69%). 2 Tenofovir resistance was not detected in any of the patients after up to 96 weeks treatment, but pa-
Among patients with HBeAg-positive chronic hepatitis B, the rates of histologic, virologic, and biochemical improvement are significantly higher with entecavir than with lamivudine. The safety profile of the two agents is similar, and there is no evidence of viral resistance to entecavir. (ClinicalTrials.gov number, NCT00035633.).
Among patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue, the rates of histologic improvement, virologic response, and normalization of alanine aminotransferase levels were significantly higher at 48 weeks with entecavir than with lamivudine. The safety profile of the two agents was similar, and there was no evidence of viral resistance to entecavir. (ClinicalTrials.gov number, NCT00035789.).
Once-daily oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients infected with HCV genotype 1, 2, or 3, including patients with no response to prior therapy with telaprevir or boceprevir. (Funded by Bristol-Myers Squibb and Pharmasset (Gilead); A1444040 ClinicalTrials.gov number, NCT01359644.).
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