Recurrence Rate of Hepatocellular Carcinoma after Treatment of Chronic Hepatitis C Patients with Direct Acting Antivirals: Randomized Controlled Phase 3 Trial (Cautious Trial)

Abstract

epatocellular carcinoma (HCC) is the sixth most common cancer and the third leading cause of cancer-related death worldwide. Whereas in Egypt, it represents the most commonly diagnosed cancer, with about 27,895 new cases in 2020. Notably, HCV represents a major cause of HCC and Egypt had the highest prevalence of HCV infection. With the introduction of the DAA agents in 2014 as an effective HCV treatment, the National Committee for Control of Viral Hepatitis (NCCVH) started a national program to make HCV treatment available for all and covered by the Egyptian government, therefore, by 2018 40% of the total HCV-infected population were treated about more than 2 million patients, with SVR rate above 90%. This in line with the WHO global hepatitis strategy to eradicate viral hepatitis by 2030. Chronic HCV patients with prior history of HCC was a challenging situation in HCV treatment, our NCCVH recommended to receive DAA after more than 4 weeks of HCC treatment and achieving rCR. However, there is a constant controversy about is DAA therapy increase HCC recurrence in patients with history of HCC; some studies were agreed with this hypothesis, while others were against. Therefore, we conducted this study trying to solve this dilemma by prospectively randomize chronic HCV infected patients with prior history of HCC and achieving rCR either to receive DAA or not, also we do second randomization in DAA-treated arm based on the time interval from HCC treatment and DAA therapy with cut-off point at 6 months.