The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Patients will be treated with this drug for 12 weeks post lung transplant.
Duke University Medical Center
Durham, North Carolina, United States
Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Time frame: 12 weeks
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
Adverse events resulting in discontinuation of EPCLUSA
Time frame: 1 year
Number of Patients Eligible for EPCLUSA Treatment
Eligibility for EPCLUSA treatment within 12 months of lung transplant
Time frame: within 12 months of lung transplant
Change in Serum HCV RNA Levels
Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA
Time frame: 12, 24, and 48 weeks after initiation of EPCLUSA
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
Adverse events requiring temporary interruption in EPCLUSA therapy
Time frame: 1 year
Patient Survival
90-day post transplant patient survival
Time frame: 90 days post-transplant
Patient Survival
1 year post transplant patient survival
Time frame: 1 year post-tranplant
Patient Survival
90-day post transplant patient survival in recipients of HCV NAT positive donor organ
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Time frame: 90 days post-transplant
Patient Survival
1 year post transplant patient survival in recipients of HCV NAT positive donor organ
Time frame: 1 year post-transplant