DAA in the Risk of Recurrence After Curative Treatment of HCC
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.
Chronic hepatitis C virus (HCV) infection is a major etiology of hepatocellular carcinoma
 (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. According to our previous report, the cumulated recurrence rate for small HCV-HCC was
 72.4% at 5 year. PEG-interferon plus RBV treatment is the standard of care for chronic
 hepatitis C (CHC) in Taiwan. NHIRD data showed that PEG-IFN plus RBV treatment can reduce 12%
 of recurrence rate in 5 years (64% vs 52%) after curative resection of HCC. However, 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. All-oral regimen, being more tolerable and effective
 for HCC patients after curative treatment than IFN-based treatment. 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. Harvoni is an all-oral regimen, being more tolerable and effective for HCC
 patients after surgery than IFN-based treatment. The all oral regimen would be beneficial in
 eradicating HCV viral load and subsequently reduce the risk of recurrence after curative
 resection of HCV-HCC.

 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. The secondary
 objectives of the study are SVR 4/12/24 by DAA, regression of fibrosis, incidence of
 liver-related complications (EV bleeding, ascites) after DAA treatment, and overall survival
 for 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.
 The historical controls include HCV-HCC undergoing curative treatment without Peg-interferon
 plus ribavirin treatment (cohort 1) or with Peg-interferon plus ribavirin treatment (cohort
 2) after curative treatment (surgical resection or RFA) for HCC.
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)