DAA in the Risk of Recurrence After Curative Treatment of HCC

For early stage of HCC, surgical resection or radiofrequency ablation (RFA) is the mainstay curative treatments. However, recurrence is still a major issue after the surgery or RFA. Only selected patients are eligible and tolerable to IFN-based treatment after surgical resection and the sustained virological response varied. Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR and being recommended by AASLD and EASL. Mixed HCV genotype infection accounts for 10% of CHC patients in Taiwan. Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi plus rivavirin in the treatment of genotype 2 HCV, as well as mixed genotype 1 and 2 HCV infection. As genotype 1 and 2 are the leading HCV genotypes in Taiwan, It can simplify the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin, not only for genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection. Although an unexpected high recurrence rate in HCC patients under DAA treatment was reported once. However, one recent study showed a low risk of HCC recurrence after DAA treatment. In this study, the investigators plan to enroll 130 HCV-HCC patients after confirming curative treatment for their HCC, either by surgery or RFA. For the cases fulfilling the inclusion/exclusion criteria, a 12 weeks Harvoni plus ribavirin treatment will be provided for all cases (single armed design). The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years. A hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei Veterans General Hospital and Investigated Sites will be recruited as historical controls.

Sex

All

Minimum age

20 Years

Inclusion Criteria:

* Anti-HCV positive and HBsAg-negative
* HCV genotype 1 or 2 infection, mixed infection GT 1 \& 2 is allowed
* HCV RNA ≥ 10,000 IU/ml at the time of screening
* Age \> 20 y/o
* BCLC stage 0 or A HCC confirmed by pathology and receiving the first time of curative treatment
* No recurrence of HCC confirmed by contrast-enhanced image studies (CT or MRI) within 3 months post the curative treatment.
* Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
* Child-Pugh score ≤7

Exclusion Criteria:

* HBV, or HIV coinfection
* Co-existing other malignancy
* Intolerance to ribavirin
* Marked decompensated liver cirrhosis (CTP score\>7)
* Uremia or renal impaired patients (eGFR\<30)