HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether patients treated for chronic hepatitis C (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger immune response compared to patients treated after kidney transplant. 25 patients with chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant recipients with chronic kidney disease will be treated with zepatier. Blood markers of immune function will be monitored in both groups to determine their response to therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Grazoprevir

Criteria

Inclusion Criteria:

• At least 18 years of age at the time of screening

• Have stable renal function for one month (30 days) prior to enrollment

• Have Chronic HCV infection prior to transplantation with documented HCV viremia ≥ 1,000 IU/ml at screening and either documented HCV Ab positivity or HCV viremia ≥ 1,000 IU/ml at least 6 months prior to enrollment.

• Documented genotype 1 HCV infection prior to enrollment and after their transplant in the post-transplantation cohort

• HCV disease staging within 12 months prior to enrollment by liver biopsy, transient elastography, or biochemical testing

• Be able to give informed consent and comply with study guidelines

• Women of childbearing age will be required to have a negative pregnancy test at enrollment and use birth control throughout the duration of treatment.

Inclusion Criteria Specific to the Pre-transplant Arm

Patients will either be:

• On the transplant waiting list followed by the University of Maryland's nephrology clinic or the Baltimore VA's nephrology clinic

• On chronic hemodialysis not yet on the transplant list and followed in the University's hemodialysis center or in the University's nephrology clinic

• Have chronic kidney disease with GFR <50

Inclusion Criteria Specific to the Post-transplant Arm

• Patients will have undergone renal transplantation no greater than five years prior to enrollment and will be followed in our University's nephrology and infectious disease clinic. They will all have stable renal function at the time of enrollment.

Exclusion Criteria:

• Documented positive hepatitis B (HBV) surface antigen, and/or HBV DNA prior to enrollment

• Any prior exposure to HCV protease inhibitor therapy

• HIV co-infection if on a protease inhibitor based regimen

• Increase in creatinine of 15% or greater within one month (30 days) of the screening visit

• Evidence of hepatocellular carcinoma at the time of enrollment

• Liver disease caused by an etiology other than HCV

• F4 or decompensated cirrhotic patients

• Child Pugh class B or C

• AST or ALT >350 within 6 months prior to enrollment

• Albumin < 3g/dL at the time of enrollment

• Platelet count < 75 at the time of enrollment

• History of clinically significant allergy or adverse event with protease inhibitors

• Evidence of the acquisition of HCV at the time of or after transplantation

• Pregnant or breastfeeding women

• Cyclosporine; St. John's Wort; Efavirenz; Phenytoin; Carbamazepine; Bosentan; HIV protease inhibitors; modafinil; ketoconazole; or rifampin use within 7 days of enrollment

• Coadministration of more than 20 mg atorvastatin; 10 mg rosuvastatin; 20 mg of fluvastatin, lovastatin or simvastatin