Eight versus twelve weeks of sofosbuvir-velpatasvir in treatment-naive non-cirrhotic patients with chronic hepatitis C virus infection: Study protocol for a multicentric, open labelled, randomized, non-inferiority trial (RESOLVE trial).

ABSTRACT:

Background

Hepatitis C virus (HCV) is a common cause of liver cirrhosis and hepatocellular carcinoma. Globally, nearly 71 million people have chronic HCV infection, and approximately 399,000 dies annually. In patients without cirrhosis, HCV infection is treated with 12 weeks of sofosbuvir/velpatasvir combination. Results from available small, single-centre observational studies suggest that the sofosbuvir/velpatasvir combination given for 8 weeks may be as effective as the standard 12 weeks of treatment. We propose to compare the treatment response of 12 weeks versus 8 weeks of sofosbuvir/velpatasvir in non-cirrhotic people with chronic HCV infection.

Methods

This multicentric, randomized, open-label, non-inferiority trial will include 880 (2 arms x 440) treatment naïve, vir

SUBMITTER: Awasthi A 

PROVIDER: S-EPMC10194938 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature