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Advances emerging in hepatitis management

osis score of three or higher. Based on logistic regression models, inflammation was predicted using the variables albumin (a protein indicating proper liver function) and aspartate aminotransferase (AST) enzyme levels. Fibrosis was predicted in HBeAg+ patients using age, AST, serum alkaline phosphatase (SAP), prothrombin and bilirubin levels as variables. In HBeAg- patients, the best model used the variables of platelets, AST/ALT (aspartate to alanine aminotransferase) ratio and SAP.

The Knodell inflammatory score is a numerical scoring system (0-18) that grades the degree of inflammation in liver biopsies, and the Ishak fibrosis score (0-6) is a scoring system that stages the degree of fibrosis in liver biopsies.

A Phase I/II Dose Escalation Trial Assessing Tolerance, Pharmacokinetics and Antiviral Activity of NM283, a Novel Antiviral Treatment for Hepatitis C (Abstract 107531*)

Current therapies for hepatitis C virus (HCV) have considerable side effects and only induce a sustained virologic response in less than half of patients infected with HCV genotype 1, the most common genotype in the U.S., Europe and Japan (60-70 percent of patients). In this study, researchers from Bach and Godofsky found that a novel hepatitis therapy, NM283, has consistent antiviral activity and is well tolerated in HCV-1 infected chronic hepatitis C patients.

The phase I/II dose escalation trial is investigating NM283, a novel candidate HCV RNA polymerase inhibitor, which has shown anti-flavivirus activity in vitro, and has suppressed viremia in chimpanzees infected with chronic human-derived HCV-1. This preliminary human study is of treatment-nave or experienced adults with HCV-1-associated chronic hepatitis C. A total of 48 patients divided into 12-patient cohorts (randomized 10:2) received NM283 or placebo for 15 days with 14 days of follow-up, at doses of either 50, 100, 200, or 400 milligrams per day, orally.

Dose-related d
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17-May-2004


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