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

N

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

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)

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

Trial contacts and locations

1

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Central trial contact

Mohamed Hassany, MD.; Aisha El Sharkawy, MD

Data sourced from clinicaltrials.gov

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