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

Study Overview
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Brief Summary
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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.

Official Title
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A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: Sofosbuvir
* Drug: Ribavirin
* Drug: LDV/SOF
* Drug: SOF/VEL
* Drug: SOF/VEL/VOX
* Drug: Other SOF-Based Regimen
* Other: Ineligible parent treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SOF+RBV<br>Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years. | Drug: Sofosbuvir<br>* Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.<br>* Other names: PSI-7977;Drug: Ribavirin<br> <br> |
| LDV/SOF<br>Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years. | Drug: LDV/SOF<br>* Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.<br>* Other names: Harvoni®;|
| LDV/SOF+RBV<br>Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years. | Drug: Ribavirin<br> <br> Drug: LDV/SOF<br>* Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.<br>* Other names: Harvoni®;|
| SOF/VEL<br>Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years. | Drug: SOF/VEL<br>* Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.<br>* Other names: Epclusa®;|
| SOF/VEL+RBV<br>Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years. | Drug: Ribavirin<br> <br> Drug: SOF/VEL<br>* Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.<br>* Other names: Epclusa®;|
| SOF/VEL/VOX<br>Participants who were previously treated with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) with or without RBV will be followed up to 5 years. | Drug: Ribavirin<br> <br> Drug: SOF/VEL/VOX<br>* Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.<br>* Other names: Vosevi®;|
| Other SOF-Based<br>Participants who previously received other SOF based regimen will be followed up to 5 years. | Drug: Other SOF-Based Regimen<br>* The other SOF-based regimens may have included the following: BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir) LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg) LDV/SOF + VDV + RBV Simeprevir + SOF TMC-435 (Simeprevir) + VEL/SOF<br>|
| Enrolled From Ineligible Parent Treatment Group<br>Participants were enrolled from ineligible parent treatment group. | Other: Ineligible parent treatment<br>* Participants were enrolled from ineligible parent treatment group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at 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. | Week 240 | 
| Percentage of Participants With Any Liver-Associated Events | The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model. | Enrollment up to 240 weeks | 
| Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 | 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. | Enrollment up to 240 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Resistance Mutations Through Week 240 |  | Enrollment up to 240 weeks | 
| Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 | 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. | Enrollment up to 240 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV Cirrhosis registry, Cirrhosis, Hepatitis C