Hepatitis C, Chronic, Hepatocellular Carcinoma
Conditions
Keywords
HCV-HCC-DAAs
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
Interventions
DRUGSofosbuvir
Sofosbuvir 400 mg orally once daily
DRUGRibavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUGSimeprevir
Simeprevir 150 mg orally once daily
DRUGdaclatasvir
Daclatasvir 60 mg orally once daily
DRUGLedipasvir
Ledipasvir 90 mg orally once daily
Sponsors
Cairo University
National Hepatology & Tropical Medicine Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment | 12 weeks after the last dose of study drugs |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactMohamed Hassany, MD.
Backup ContactAisha El Sharkawy, MD
Outcome results
None listed