drugset / Trial / NCT03061032

Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients

NCT03061032

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.

Timeline

Start
2017-03
Primary completion
2018-12
Completion
2019-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ledipasvir Small molecule 90 mg
Subject Ribavirin Small molecule 1000 mg
Subject Ribavirin Small molecule 1200 mg
Subject Sofosbuvir Small molecule 400 mg