SOF/VEL±RBV: Efficacy and Safety in GT 3 and 6 HCV Patients

Study Overview
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Brief Summary
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150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.

Detailed Description
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This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.

Official Title
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SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Epclusa (sofosbuvir and velpatasvir)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV RNA ≥ 15 IU/Ml at Screening HCV genotype 3a ,3b and 6 Hepatitis C without decompensated cirrhosis of the liver Exclusion Criteria: Patients failed to previous NS5A-containing DAAs therapy Decompensated cirrhosis HCC Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| genotype 3a HCV<br>genotype 3a hepatitis C | Drug: Epclusa (sofosbuvir and velpatasvir)<br>* Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.<br>|
| genotype 6 HCV<br>genotype 6 hepatitis C | Drug: Epclusa (sofosbuvir and velpatasvir)<br>* Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.<br>|
| genotype 3b HCV<br>genotype 3b hepatitis C | Drug: Epclusa (sofosbuvir and velpatasvir)<br>* Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR12 | HCV RNA <LLOQ at Week 12 after cessation of treatment | 12 weeks |