الفهرس 
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Abstract
HCV is the most common blood-borne infection and a leading cause of chronic liver disease. Treatment of HCV with interferon takes a long duration and has many side effects. The use of antioxidant Fish-derived Omega-3s (Omega 300 containing EPA 700 mg ) with INF/ribavirin Combination Therapy is believed to minimize the side effects and to improve adherence and hence improve response to therapy. Reactive oxygen species are part of the human defense mechanisms towards infection and they increase due to hepatitis C virus infection. In this study we aim to study the impact of the concomitant use of antioxidant Fish-derived Omega-3s (Omega 300 containing EPA 700 mg) with INF/ribavirin combination therapy for HCV on response as regards Hb reduction, enzymes level, rate of viral clearance as well as liver biopsy.
The study was conducted in Sohag Centre of Cardiac and Digestive System and patients were selected randomly from patients attending the hepatitis viruses out patient clinic and the Interferon unit.
Total number of 240 patients, all having chronic HCV infection, were included in the study and were randomly divided on two groups.
Test Group: consists of 120 patients received:
1- Pegylated INF-α2a 180µg/wk SC.
2- Ribavirin 15 mg/kg/day orally.
3- Antioxidant regimen (Omega 300 containing EPA 700 mg) twice/day orally.
Control group: consists of 120 patients received:
1- Pegylated INF-α 2a 180µg/wk SC.
2- Ribavirin 15mg/kg/day orally.
All patients were subjected to the following:
Careful history taking and thorough clinical examination with calculation of the body mass index (BMI).
Laboratory tests: complete blood count, liver function tests, coagulation profile, kidney function tests, thyroid function tests, serologic markers for hepatitis B virus, anti-nuclear antibodies, quantitative polymerase chain reaction for HCV RNA, fasting blood glucose level and glycosylated hemoglobin A1C if fasting blood glucose is elevated.
Liver biopsy was performed to all patients before start of their therapy and was interpreted according to METAVIR score.
Follow up:
Patients repeat liver function tests, complete blood count and PCR for HCV RNA at 12 weeks, 24 weeks, and 48 weeks.
Rates of hematological complications were calculated and compared between the two groups
Summary of results:
• There were no significant differences between the two groups as regards demographic data, baseline Hb concentration, WBC’s count and platelet count, ALT, AST, bilirubin, viremia levels and pretreatment biopsy grade of activity and fibrosis on METAVIR score.
• but there was a highly significant difference between both groups in the mean reduction in hemoglobin concentration along therapy in all weeks of follow up.
After 4 weeks:
• There was and a highly significant decline in Hb concentration, WBC’s Count and a highly significant rise in bilirubin level in the control group.
• There was no significant difference between two groups as regards all other parameters.
After 12 weeks:
• There was a highly significant difference between the two groups as regards Hb concentration, WBC’s count and bilirubin level.
• There were no significant differences between two groups as regards rates of ealy virological response (complete and incomplete) and other listed parameters.
After 24 weeks:
• There were significantly lower levels of ALT, AST and bilirubin in the test group.
• There was also significantly lower Hb concentration and WBC count in control group.
• No significant difference was found as regards platelet count, the rate of virological response and the rate of breakthrough .
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At 48 weeks:
• The ALT and bilirubin levels were significantly lower in test group.
• There were no significant differences between two groups as regards AST and platelet count.
• The Hb concentration and WBC’s count are still significantly lower in control group.
• There was no significant difference between the two groups as regards end of therapy response and the rate of breakthrough .
In EPA group, of 120 patients randomized to receive combination therapy with EPA, 34 / 120 (28.4%) patients withdrew from the study befor completing the course of treatment and 86 / 120 (71.6%) patients complete the course of treatment, 15 / 86 (17.5%) patients required RBV dose reduction, while 71 / 86 (82.5%) patients needed no RBV dose reduction.
in Non EPA group, of 120 patients randomized to receive combination therapy without EPA, 40 / 120 (33.4%) patients withdrew from the study befor completing the course of treatment and 80 / 120 (66.6%) patients complete the course of treatment, 22 / 80 (27.5%) patients required RBV dose reduction, while 58 / 80 (72.5%) patients needed no RBV dose reduction.
Conclusion:
from the above mentioned results we can conclude that The use of antioxidant Fish-derived Omega-3s (Omega 300 containing EPA 700 mg ) can prevent serious hematological complications of INF/ribavirin Combination Therapy as treatment associated anemia and can prevent the RBV dose reduction during the course of Combination Therapy.
These results can improve the quality of life and adherence to therapy and this can justify the use of these antioxidant Fish-derived Omega-3s as an adjunctive therapy with pegylated interferon and ribavirin.
• It was also obvious that the antioxidant Fish-derived Omega-3s (Omega 300 containing EPA 700 mg ) had no effect of any kind on the virological response to therapy.
Recommendations:
• We recommend the concomitant use of antioxidant Fish-derived Omega-3s (Omega 300 containing EPA 700 mg ) with INF/ribavirin Combination Therapy as they can decrease the incidence of RBVassociated hemolytic anemia to avoid RBV dose reduction during the early period of combination treatment and thus improving the quality of life and adherence to therapy.