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

Phase 3

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir/Ledipasvir 12W; Drug: Sofosbuvir/Ledipasvir 24W; Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W; Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W

• Registration Number: NCT03061032
• Lead Sponsor: Iran Hepatitis Network

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-17
• Last Update Submitted: 2017-02-17
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23
• Study Start: 2017-03
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Chronic HCV infection
• >18 years old

Exclusion Criteria

• HIV co-infected
• Liver transplanted
• Receiving drugs with suspected interactions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofosbuvir/Ledipasvir for 12W	Sofosbuvir/Ledipasvir 12W	Patients without cirrhosis and previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.
Sofosbuvir/Ledipasvir for 24W	Sofosbuvir/Ledipasvir 24W	Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.
Sofosbuvir/Ledipasvir+Ribavirin for 24W	Sofosbuvir/Ledipasvir plus Ribavirin 24W	Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.
Sofosbuvir/Ledipasvir+Ribavirin for 12W	Sofosbuvir/Ledipasvir plus Ribavirin 12W	Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response	12 weeks after completion of treatment	Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection