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

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Treatment Complication; Hepatitis C; Neoplasm Recurrence; Hepatocellular Carcinoma

Treatments: Drug: Velpatasvir/Sofosbuvir

Study type: Interventional

Funder types: Other

Identifiers

NCT04653818

0304763

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

DAAs group

Active Comparator group

Description:

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

Treatment:

Drug: Velpatasvir/Sofosbuvir

Postponed DAAs group

Active Comparator group

Description:

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.

Treatment:

Drug: Velpatasvir/Sofosbuvir