Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-03-05

Brief Summary

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Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

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Detailed Description

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The study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment

Conditions

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Renal Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Elbasvir/grazoprevir for HCV+ kidney transplant recipients

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor

Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Group Type EXPERIMENTAL

elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)

Intervention Type DRUG

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor

Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Interventions

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elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor

Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Intervention Type DRUG

Other Intervention Names

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Zepatier

Eligibility Criteria

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Inclusion Criteria

1. Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
2. No available living kidney donor
3. Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate \<15mL/min/1.73m2 at the time of screening
5. Weight ≥ 50kg
6. Serum alanine transaminase (ALT) within normal limits

Exclusion Criteria

1. AB blood type
2. Body mass index (BMI \> 35
3. History of liver disease
4. Pregnant or nursing (lactating) women
5. Cardiomyopathy (LV ejection fraction \< 50%)
6. Positive crossmatch or positive donor specific antibodies
7. Human immunodeficiency virus (HIV) positive
8. Hepatitis C virus (HCV) RNA positive
9. Hepatitis B virus (HBV) surface antigen positive
10. Any contraindication to kidney transplant per MGH center protocol

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No