Subjects with Hepatitis C Virus (HCV) infection, genotype 1 or 4 and with hepatocellular carcinoma (HCC) and a complete response to HCC therapy will be randomised to immediate or delayed (6 months) HCV therapy with Elbasvir (MK-8742) and Grazoprevir (MK-5172) \[EBR/GZR\].
Two cohorts (A and B) of patients with chronic HCV infection will be enrolled. Patients will be eligible for enrollment if they fulfill the study inclusion and exclusion criteria and have achieved a complete tumour response (CR) 3 months (+/- 14 days) following HCC treatment * Cohort A: Patients with Barcelona Clinic Liver Cancer (BCLC) stage 0 or A HCC who have received curative therapy defined as either; liver transplantation, surgical resection or local ablation with curative intent and attained a radiologically confirmed CR. (N=50) * Cohort B: Patients who are non-eligible for curative therapy but have attained a radiologically confirmed CR. post embolization or ablative therapy and have chronic HCV infection. (N=50) Given the existing uncertainty regarding the impact of direct acting antiviral (DAA) therapy on HCC recurrence, study participants will be randomized to receive DAA treatment as "immediate" ie upon study enrollment or "delayed" ie treatment commenced ≥ 6months following documentation of complete response based on radiological assessment indicating no residual arterial enhancing disease..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Elbasvir / Grazoprevir
Viral eradication
Eradication of Hepatitis C virus determined by undetectable viral load
Time frame: 12 weeks
HCC recurrence rate following HCC treatment
impact of DAA therapy on 6 and 12 month HCC recurrence rate following HCC treatment
Time frame: 6 and 12 month
Recurrence free survival
Recurrence free survival
Time frame: 5 years
Disease free survival
Disease free survival
Time frame: 5 years
Time to HCC recurrence / progression
Time to HCC recurrence / progression
Time frame: 5 years
Adverse events
Safety and tolerability of Elbasvir/grazoprevir determined by adverse events
Time frame: Up to 5 years
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