DAA in the Risk of Recurrence After Curative Treatment of HCC

Summary

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.

Conditions

• Hepatocellular Carcinoma

Interventions

DRUG

Ledipasvir 90mg/Sofosbuvir 400 mg

A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.

DRUG

Ribavirin

A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

  collaborator OTHER

• China Medical University Hospital

  collaborator OTHER

• Chi Mei Medical Hospital

  collaborator OTHER

• Chiayi Christian Hospital

  collaborator OTHER

• National Taiwan University Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Tri-Service General Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  lead OTHER_GOV

Principal Investigators

• Yi-Hsiang Huang, MD, PhD · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2022-06-30

Completion

2022-12-31