A Registry for Participants with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection

Overview

About this study

This Registry will enroll cirrhotic participants with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Willing and able to provide written informed consent
Have either
- Previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon
- OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study
  - These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12
Have achieved SVR either
- In a Gilead-sponsored study, as defined in the treatment protocol
- OR after receiving an all-oral SOF-based regimen outside a clinical study. SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment
Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen
OR will have had cirrhosis confirmed prior to initiation of HCV treatment

Exclusion Criteria

Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Hugo Vargas, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

More information

Publications

Hepatocellular carcinoma (HCC) is the leading cause of death in patients with chronic hepatitis. In this international collaboration, we sought to develop a global universal HCC risk score to predict the HCC development for patients with chronic hepatitis. Read More on PubMed

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