Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC (FRI-STC)

National Hepatology & Tropical Medicine Research Institute

Status and phase: Unknown; Phase 3

Conditions: Hepatitis C, Chronic; Hepatocellular Carcinoma

Treatments: Drug: Ledipasvir; Drug: Simeprevir; Drug: daclatasvir; Drug: Sofosbuvir; Drug: Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02771405

4/2016

Details and patient eligibility

About

The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.

Full description

The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation .

after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :

1. Sofosbuvir+Ribavirin
2. Sofosbuvir+Simeprevir± Ribavirin
3. Sofosbuvir+ Daclatasvir ± Ribavirin
4. Sofosbuvir+ Ledipasvir ± Ribavirin

the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-70 years old
• Confirmed HCV viremia by PCR
• CHILD Pugh "A" or "B7,B8"
• Confirmed HCC either by laboratory ,imaging or histopathological criteria
• Underwent or candidate for curative intervention for HCC (BCLC stage 0 ,A)
• Willing to be treated for HCV and signing informed consent

Exclusion criteria

• Patients below 18 or above 70 years old
• patients with advanced liver condition "CHILD score ≥ B9"
• Patients with advanced HCC status (BCLC≥ B)
• Patients with combined HBV ,HIV infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Sofosbuvir +Ribavirin

Experimental group

Description:

Sofosbuvir 400 mg/day +ribavirin for 24 weeks

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Sofosbuvir+Simeprevir±Ribavirin

Experimental group

Description:

Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Drug: Simeprevir

Sofosbuvir+Daclatasvir±Ribavirin

Experimental group

Description:

Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Drug: daclatasvir

Sofosbuvir+Ledipasvir±Ribavirin

Experimental group

Description:

Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks

Treatment:

Drug: Sofosbuvir

Drug: Ribavirin

Drug: Ledipasvir