Chronic Liver Disease
Co-infections and Related Conditions (CRC)
The aim of this study was to evaluate the role of Metformin in preventing the progression and promoting the regression of liver fibrosis in individuals that are either co-infected with HCV-HIV or mono-infected with HCV (hepatitis C virus), have insulin resistance (IR), and are receiving antiviral HCV-treatment.
A build-up of scar tissue is part of the healing process of the liver when it is injured. However, this scar tissue can cause the liver to become stiffer and not function properly. When this happens, it is called liver fibrosis and can lead to cirrhosis and end-stage liver disease. Hepatitis, which affects the liver, prevents this organ from operating properly and can lead to a number of health issues throughout the body, including insulin resistance.
Insulin resistance occurs when the insulin secreted by the body does not work as effectively as it should and higher levels of insulin are needed to have the same effect. If left untreated, IR can progress and develop into type 2 diabetes. There is a known relationship between HCV and IR. It is believed that IR in HCV-infected patients may impact the effectiveness of HCV antiviral therapy and liver outcomes. Specifically, a number of studies in HCV-HIV co-infected patients and HCV mono-infected patients have found that liver disease (fibrosis) progresses quicker in HCV-infected patients with IR.
Metformin, a type of drug known as an insulin sensitizer, can delay or prevent the onset of diabetes in non-infected people. This drug also improves treatment outcomes in those infected with HCV. What we don’t know about this drug is whether it can prevent the development of diabetes and liver fibrosis in patients receiving treatment for HCV.
This study aimed to enrol 60 research participants at The Ottawa Hospital. It involved 8 visits over 52 weeks.
This was a randomized study, meaning participants would have the same chance of being placed in either group. Participants would be assigned through a computer selection process to one of the two treatment groups. This study was open-label which means that both the participant and their doctor will knew which group they were in.
Group 1: received Metformin.
Group 2: did not receive Metformin; this is the control group and acted as a comparison group
ALL participants received education on lifestyle and diet changes that help reduce the progression of liver disease. The change in liver fibrosis over time would be compared between the two treatment groups.
This study was terminated early due to futility analysis.
If you would like more information on this clinical study, please contact the Principal Investigator or visit clinicaltrials.gov.