Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients (HepCC-2)

Iran Hepatitis Network

Status and phase: Unknown; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W; Drug: Sofosbuvir/Ledipasvir 12W; Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W; Drug: Sofosbuvir/Ledipasvir 24W

Study type: Interventional

Funder types: Other

Identifiers

NCT03061032

IHN10002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HCV infection
• >18 years old

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Sofosbuvir/Ledipasvir for 12W

Experimental group

Description:

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.

Treatment:

Drug: Sofosbuvir/Ledipasvir 12W

Sofosbuvir/Ledipasvir+Ribavirin for 12W

Experimental group

Description:

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.

Treatment:

Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W

Sofosbuvir/Ledipasvir for 24W

Experimental group

Description:

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.

Treatment:

Drug: Sofosbuvir/Ledipasvir 24W

Sofosbuvir/Ledipasvir+Ribavirin for 24W

Experimental group

Description:

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.

Treatment:

Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W