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
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Other: Ineligible parent treatmentDrug: Other SOF-Based RegimenDrug: LDV/SOF
- Registration Number
- NCT02292706
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1609
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SOF/VEL+RBV SOF/VEL Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years. SOF/VEL/VOX SOF/VEL/VOX Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years. LDV/SOF+RBV Ribavirin Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years. LDV/SOF+RBV LDV/SOF Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years. LDV/SOF LDV/SOF Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years. SOF/VEL SOF/VEL Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years. Enrolled From Ineligible Parent Treatment Group Ineligible parent treatment Participants were enrolled from ineligible parent treatment group. Other SOF-Based Other SOF-Based Regimen Participants who previously received other SOF based regimen will be followed up to 5 years. SOF/VEL/VOX Ribavirin Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years. SOF+RBV Sofosbuvir Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years. SOF+RBV Ribavirin Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years. SOF/VEL+RBV Ribavirin Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Any Liver-Associated Events Enrollment up to 240 weeks The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model.
Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 Week 240 SVR at Week 240 was defined as HCV RNA\< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter \[IU/mL\]) or last available HCV RNA\< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model.
Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 Enrollment up to 240 weeks Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model.
- Secondary Outcome Measures
Name Time Method Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 Enrollment up to 240 weeks Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 Enrollment up to 240 weeks Reinfection was defined as HCV RNA \> LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study.
Number of Participants With Detectable HCV Resistance Mutations Through Week 240 Enrollment up to 240 weeks
Trial Locations
- Locations (137)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Scripps Clinic Medical Group
🇺🇸La Jolla, California, United States
V.A. Long Beach Medical Center
🇺🇸Long Beach, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente Medical Center
🇺🇸Los Angeles, California, United States
Tarrant County ID Associates
🇺🇸Los Angeles, California, United States
The Liver Center
🇺🇸Pasadena, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Scroll for more (127 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States