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To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.
The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.
This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Transplant | Experimental | Patients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epclusa | Drug | Patients testing positive for HCV viremia will receive 12 weeks of Epclusa. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV Viremia | Incidence of HCV Viremia | at 2 years |
| Seroconversion | Rate of HCV seroconversion | at 2 years |
| Liver Function Testing | Assessment of Hepatic function | at 2 years |
| Survival | Survival rates | at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rejection | The incidence of rejection | at 2 years |
| Waitlist | Time on waitlist will be assessed | at 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Sanchez, MD | Assistant Professor of Surgery/University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| Label | URL |
|---|---|
| Sofosbuvir | View source |
| Drug Information | View source |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |