HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2022-10-24

Brief Summary

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Data regarding hepatocellular carcinoma (HCC) recurrence after directly acting antivirals (DAAs) given for hepatitis C virus treatment are contradictory. Surprisingly, some studies reported that DAAs are accompanied with higher HCC recurrence. But, other studies showed no rise or even decrease in HCC recurrence. Most of these studies were retrospective and some were non-randomized prospective studies. Here investigators aim to perform a randomized controlled trial to study this issue.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma Hepatitis C Neoplasm Recurrence Treatment Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

masking for radiologists who assess HCC recurrence only. Patients and physicians: not masked.

Study Groups

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DAAs group

Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV.

Group Type ACTIVE_COMPARATOR

Velpatasvir/Sofosbuvir

Intervention Type DRUG

sofosbuvir / velpatasvir will be given for 12 weeks aiming to eradicate HCV. Ribavirin will be added for Child-Pugh B patients or treatment will be extended for 24 weeks for those who are Ribavirin intolerant.

Postponed DAAs group

Those who will not start DAAs within the 12 months follow up from HCC ablation procedure. Patients of this group will receive DAAs provided that there is no HCC recurrence after the end of 1 year.

Group Type ACTIVE_COMPARATOR

Velpatasvir/Sofosbuvir

Intervention Type DRUG

sofosbuvir / velpatasvir will be given for 12 weeks aiming to eradicate HCV. Ribavirin will be added for Child-Pugh B patients or treatment will be extended for 24 weeks for those who are Ribavirin intolerant.

Interventions

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Velpatasvir/Sofosbuvir

sofosbuvir / velpatasvir will be given for 12 weeks aiming to eradicate HCV. Ribavirin will be added for Child-Pugh B patients or treatment will be extended for 24 weeks for those who are Ribavirin intolerant.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Child-Pugh A and B subjects with hepatitis C related \< 5 cm single or up to 3 hepatocellular carcinomas without any vascular or extrahepatic involvement

Exclusion Criteria

* Those with positive HBsAg, history of alcohol consumption, patients with other known causes of chronic liver disease, patients who have received previous DAAs for HCV and patients who have received previous locoregional treatment for HCC will be excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No