833 LIVER FIBROSIS ASSESSMENT IN CHRONIC HEPATITIS C: EVOLUTION OF CLINICAL PRACTICE IN A LARGE COHORT OF 4546 PATIENTS BETWEEN 2003 AND 2006

POSTERSadministered as oral monotherapy in treating chronic hepatitis C genotype 4. Methods: 50 patients with chronic hepatitis C genotype 4 were enrolled in the trial at two centers in Egypt.Liver biopsy was obtained from each patient before enrollment.Patients were sequentially randomized to receive one NTZ 500 mg tablet or a matching placebo tablet twice daily for 24 weeks.Physical examination, standard laboratory hematologic and chemistry tests and HCV viral load by RT-PCR were performed every 4 weeks during treatment.The primary endpoint was ETR (HCV RNA <10 IU/mL at end of treatment).Analysis is intent to treat.Results: Baseline viral loads, BMI, fibrosis, age, sex and other demographic and disease-related characteristics were similar for the two groups.Seven of 23 patients in the NTZ treatment group achieved undetectable serum HCV RNA compared to 0 of 24 in the placebo group (P = 0.004).Each of these 7 responders maintained their responses through the end of treatment.Each of the responders had viral loads 385,000 IU/ml at baseline and were free of complications such as cirrhosis, uncontrolled diabetes mellitus or hepatitis B co-infection.Four responders were followed up 24 weeks after the end of treatment and maintained their responses (P < 0.05).Patients not achieving undetectable HCV RNA did not show any significant reduction in viral load or ALT.Adverse events were typically mild-to-moderate and occurred with similar frequency and severity in the NTZ and placebo treatment groups Conclusions: This study confirms antiviral activity of nitazoxanide observed in HCV replicon assays and indicates that the drug is safe for administration in patients with chronic hepatitis C.