The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Sofosbuvir 400 mg orally once daily
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Simeprevir 150 mg orally once daily
Amr Maged
Cairo, Egypt
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
Time frame: 12 weeks after the last dose of study drugs
Percentage of participants with virologic failure during treatment or relapse after treatment
Time frame: 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
Time frame: Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence
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Daclatasvir 60 mg orally once daily
Ledipasvir 90 mg orally once daily