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

Gilead Sciences

Status: Terminated

Conditions: Hepatitis C Virus Infection

Treatments: Drug: Other SOF-Based Regimen; Other: Ineligible parent treatment; Drug: Ribavirin; Drug: LDV/SOF; Drug: SOF/VEL; Drug: Sofosbuvir; Drug: SOF/VEL/VOX

Study type: Observational

Funder types: Industry

Identifiers

NCT02292706

GS-US-337-1431

2014-001249-26 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.

Enrollment: 1,609 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < lower limit of quantification (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 individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

1,609 participants in 8 patient groups

SOF+RBV

Description:

Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years.

Treatment:

Drug: Ribavirin

Drug: Sofosbuvir

LDV/SOF

Description:

Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years.

Treatment:

Drug: LDV/SOF

LDV/SOF+RBV

Description:

Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years.

Treatment:

Drug: Ribavirin

Drug: LDV/SOF

SOF/VEL

Description:

Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years.

Treatment:

Drug: SOF/VEL

SOF/VEL+RBV

Description:

Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.

Treatment:

Drug: Ribavirin

Drug: SOF/VEL

SOF/VEL/VOX

Description:

Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years.

Treatment:

Drug: SOF/VEL/VOX

Drug: Ribavirin

Other SOF-Based

Description:

Participants who previously received other SOF based regimen will be followed up to 5 years.

Treatment:

Drug: Other SOF-Based Regimen

Enrolled From Ineligible Parent Treatment Group

Description:

Participants were enrolled from ineligible parent treatment group.

Treatment:

Other: Ineligible parent treatment