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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,609
- 试验地点
- 137
- 主要终点
- Percentage of Participants With Any Liver-Associated Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 SVR
- •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.
排除标准
- •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.
研究组 & 干预措施
SOF+RBV
Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years.
干预措施: Sofosbuvir (Drug)
SOF+RBV
Participants who were previously treated with sofosbuvir (SOF) along with ribavirin (RBV) will be followed up to 5 years.
干预措施: Ribavirin (Drug)
LDV/SOF
Participants who were previously treated with ledipasvir/sofosbuvir (LDV/SOF) will be followed up to 5 years.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV
Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years.
干预措施: Ribavirin (Drug)
LDV/SOF+RBV
Participants who were previously treated with LDV/SOF along with ribavirin will be followed up to 5 years.
干预措施: LDV/SOF (Drug)
SOF/VEL
Participants who were previously treated with sofosbuvir/velpatasvir (SOF/VEL) will be followed up to 5 years.
干预措施: SOF/VEL (Drug)
SOF/VEL+RBV
Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.
干预措施: Ribavirin (Drug)
SOF/VEL+RBV
Participants who were previously treated with SOF/VEL along with RBV will be followed up to 5 years.
干预措施: SOF/VEL (Drug)
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.
干预措施: Ribavirin (Drug)
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.
干预措施: SOF/VEL/VOX (Drug)
Other SOF-Based
Participants who previously received other SOF based regimen will be followed up to 5 years.
干预措施: Other SOF-Based Regimen (Drug)
Enrolled From Ineligible Parent Treatment Group
Participants were enrolled from ineligible parent treatment group.
干预措施: Ineligible parent treatment (Other)
结局指标
主要结局
Percentage of Participants With Any Liver-Associated Events
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Number of Participants With Detectable HCV Resistance Mutations Through Week 240(Enrollment up to 240 weeks)