Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Phase 3

• Conditions: Hepatitis C, Chronic; Hepatocellular Carcinoma
• Interventions: Drug: Sofosbuvir; Drug: Ribavirin; Drug: daclatasvir; Drug: Ledipasvir; Drug: Simeprevir

• Registration Number: NCT02771405
• Lead Sponsor: National Hepatology & Tropical Medicine Research Institute

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-05
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-13
• Last Update Posted: 2016-05-13
• Primary Completion: 2019-02
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofosbuvir +Ribavirin	Sofosbuvir	Sofosbuvir 400 mg/day +ribavirin for 24 weeks
Sofosbuvir +Ribavirin	Ribavirin	Sofosbuvir 400 mg/day +ribavirin for 24 weeks
Sofosbuvir+Simeprevir±Ribavirin	Sofosbuvir	Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
Sofosbuvir+Daclatasvir±Ribavirin	Ribavirin	Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
Sofosbuvir+Daclatasvir±Ribavirin	daclatasvir	Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
Sofosbuvir+Ledipasvir±Ribavirin	Sofosbuvir	Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
Sofosbuvir+Ledipasvir±Ribavirin	Ledipasvir	Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
Sofosbuvir+Simeprevir±Ribavirin	Ribavirin	Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
Sofosbuvir+Simeprevir±Ribavirin	Simeprevir	Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
Sofosbuvir+Daclatasvir±Ribavirin	Sofosbuvir	Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
Sofosbuvir+Ledipasvir±Ribavirin	Ribavirin	Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment	12 weeks after the last dose of study drugs

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with virologic failure during treatment or relapse after treatment	from baseline until 12 weeks after the last dose of study drugs
Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC	Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence

Trial Locations

Locations (1)

Amr Maged; 🇪🇬 Cairo, Egypt