G Scotto1. 1. Divisione Malattie Infettive, OO.RR., Foggia, Italy.
Abstract
UNLABELLED: Hepatitis C is a very serious disease. If it is not treated, it leads to chronic hepatitis and cirrhosis in 50% and 20% of cases, respectively. Furthermore, patients with cirrhosis might develop hepatocarcinoma. Interferon seems to be the therapy of choice in the treatment of the disease. However, since the molecule cannot always be used (non-compliant patient; severe side effects; liver-associated pathologies; patient age) alternative therapies have been investigated. Ursodeoxycholic acid (UDCA) stands out among recommended non-antiviral molecules. 74 patients affected by HCV chronic infections were enrolled in this single-blind study. One group (A: 37 patients) was treated with UDCA (600 mg/day for 12 months) and compared with a control group (B: 37 patients) in order to assess the therapy efficacy in reducing cytolysis index and to estimate viraemia and histologic score variation. RESULTS: 13 patients did not complete the study (8 belonging to group A; 5 to group B). 65,5% of the patients treated with UDCA showed ALT reduction; 42,1% of them with complete response. The situation remained unchanged in 15 patients all the treatment along. In the group B, only 12,5% showed a significant ALT reduction. During the follow-up, in 69,4% of group-A responders ALT was found to return to pre-treatment values. No variation was observed in the viraemia and histologic score of patients who had accepted a control biopsy. CONCLUSIONS:UDCA is undoubtedly suitable for reducing cytolysis index in patients with HCV chronic infections. It is well tolerated but it does not modify the disease natural course.
RCT Entities:
UNLABELLED: Hepatitis C is a very serious disease. If it is not treated, it leads to chronic hepatitis and cirrhosis in 50% and 20% of cases, respectively. Furthermore, patients with cirrhosis might develop hepatocarcinoma. Interferon seems to be the therapy of choice in the treatment of the disease. However, since the molecule cannot always be used (non-compliant patient; severe side effects; liver-associated pathologies; patient age) alternative therapies have been investigated. Ursodeoxycholic acid (UDCA) stands out among recommended non-antiviral molecules. 74 patients affected by HCV chronic infections were enrolled in this single-blind study. One group (A: 37 patients) was treated with UDCA (600 mg/day for 12 months) and compared with a control group (B: 37 patients) in order to assess the therapy efficacy in reducing cytolysis index and to estimate viraemia and histologic score variation. RESULTS: 13 patients did not complete the study (8 belonging to group A; 5 to group B). 65,5% of the patients treated with UDCA showed ALT reduction; 42,1% of them with complete response. The situation remained unchanged in 15 patients all the treatment along. In the group B, only 12,5% showed a significant ALT reduction. During the follow-up, in 69,4% of group-A responders ALT was found to return to pre-treatment values. No variation was observed in the viraemia and histologic score of patients who had accepted a control biopsy. CONCLUSIONS: UDCA is undoubtedly suitable for reducing cytolysis index in patients with HCV chronic infections. It is well tolerated but it does not modify the disease natural course.