EXPANDER-1: Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02781649
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 17.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant.

Condition or Disease	Intervention/Treatment	Phase
End-Stage Renal Disease; Hepatitis C	Drug: Zepatier; Drug: Ribavirin; Drug: Sofosbuvir	Phase 4

Detailed Description

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Hepatitis C treatment will include Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant. The donor hepatitis C genotype will be tested. If the donor has genotype 1a without resistance or genotype 1b treatment will remain GZR/EBR for 12 weeks. If the donor has genotype 1a with resistance variants, then Ribavirin will be added and treatment will be given for 16 weeks starting from the date ribavirin was added. If the donor has hepatitis C genotype 2 or 3, Sofosbuvir will be added and treatment will be for 12 weeks from the date Sofosbuvir was added.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Pilot Study to Determine the Tolerability and Efficacy of Fixed-dose Grazoprevir/Elbasvir Treatment in Hepatitis C Uninfected Recipients of Renal Transplants From Hepatitis C Infected Deceased Donors
• Actual Study Start Date: Jul 20, 2016
• Actual Primary Completion Date: May 3, 2017
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Donor genotype 1a no resistance or 1b Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks	Drug: Zepatier; Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks; Other Names: Fixed dose Grazoprevir /Elbasvir
Experimental: Donor genotype 1a with resistance Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks	Drug: Zepatier; Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks; Other Names: Fixed dose Grazoprevir /Elbasvir ; Drug: Ribavirin; Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses; Other Names: Rebetol, Copegus, Virazole, and Ribasphere
Experimental: Donor genotype 2 or 3 Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks	Drug: Zepatier; Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks; Other Names: Fixed dose Grazoprevir /Elbasvir ; Drug: Sofosbuvir; Sofosbuvir 400 mg daily; Other Names: Sovaldi

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Grade 3 or Higher Treatment-related Adverse Events as US Department of Health and Human Services Common Terminology of Adverse Events (CTCAE) Version 4 [12 weeks after transplant]

   Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.

Secondary Outcome Measures

1. Viral Response [12 weeks after completing treatment]

   This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12

2. Antibody Development [12 weeks]

   Number of kidney transplant recipients who become reactive for HCV antibody

3. Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors [Baseline]

   Number of participants with NS5A resistance mutations in the HCV population from the deceased donors. Number of donors with NS5A resistance mutations

4. IP-10 Elevations [12 weeks]

   Measurement of interferon (IFN)-gamma inducible protein 10 (IP-10) a marker of acute hepatitis C infection.

5. Kidney Function at 6 Months [6 months following transplantation]

   Serum creatinine mg/dL at 6 months following transplantation

6. Kidney Function at 12 Months [12 months following transplantation]

   Serum creatinine mg/dL at 12 months following transplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants ≥ 50 years old

• On the deceased donor kidney waiting list at Johns Hopkins Hospital

• Awaiting a first kidney transplant

• No available living kidney donors

• On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate < 15 ml/min for ≥ past 90 days

• HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis.

• Calculated panel reactive anti-human leukocyte antigen (HLA) antibody (cPRA) below 20 percent

• Female who is:

• practicing total abstinence from sexual intercourse (minimum 1 complete menstrual cycle)

• sexually active with female partners only

• not of childbearing potential: defined as postmenopausal for at least 2 years prior to screening defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by a follicle-stimulating hormone level indicating a postmenopausal state, or surgically sterile: defined as bilateral tubal ligation, bilateral oophorectomy or hysterectomy or has a vasectomized partner(s);

• of childbearing potential and sexually active with male partner(s): currently using at least one effective method of birth control at the time of screening and agree to practice two effective methods of birth control while receiving study drug (as outlined in the participant information and consent form starting with Study Day 1 and for 30 days after stopping study drug, or for 6 months after stopping study drug if receiving RBV (Note: Estrogen-containing hormonal contraceptives, including oral, injectable, implantable, patch and ring varieties, may not be used during study drug treatment).

• Males who are not surgically sterile and are sexually active with female partner(s) of childbearing potential must agree to practice two effective forms of birth control (as outlined in the participant information and consent form) throughout the course of the study, starting with starting with Study Day 1 and for 30 days after stopping study drug, or for 6 months after stopping study drug if receiving ribavirin (RBV)

Exclusion Criteria:

• Plan to receive a multi-organ transplant

• Plan to receive a dual kidney transplant (including en bloc)

• Prior solid organ transplant

• Participating in another study that involves an intervention or investigational product

• Plan to receive a blood type incompatible kidney

• History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA

• Active or unresolved bacterial, viral, or fungal infection that is clinically significant

• History of cirrhosis or pre-existing liver disease such as non-alcoholic steatohepatitis

• History of illicit drug use or alcohol abuse within 12 months prior to screening

• Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University
• Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 11, 2017

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02781649
• Other Study ID Numbers: IRB00089751
• First Posted: May 24, 2016
• Last Update Posted: Sep 6, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Johns Hopkins University: Renal; Transplants; Hepatitis C; HCV-negative; Infected; Donors
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Kidney Failure, Chronic; Ribavirin; Sofosbuvir; Grazoprevir; Elbasvir-grazoprevir drug combination

Study Results

Participant Flow

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Period Title: Overall Study
STARTED	7	0	3
COMPLETED	7	0	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3	Total
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily	Total of all reporting groups
Overall Participants	7	0	3	10
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%	0 0%
Between 18 and 65 years	0 0%	0 NaN	2 66.7%	2 20%
>=65 years	7 100%	0 NaN	1 33.3%	8 80%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	71	61	71
Sex: Female, Male (Count of Participants)
Female	1 14.3%	0 NaN	1 33.3%	2 20%
Male	6 85.7%	0 NaN	2 66.7%	8 80%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN	0 0%	0 0%
Asian	1 14.3%	0 NaN	0 0%	1 10%
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN	0 0%	0 0%
Black or African American	0 0%	0 NaN	1 33.3%	1 10%
White	6 85.7%	0 NaN	2 66.7%	8 80%
More than one race	0 0%	0 NaN	0 0%	0 0%
Unknown or Not Reported	0 0%	0 NaN	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	3 Infinity	10 333.3%
Hepatitis C virus (HCV) antibody negative (Count of Participants)
Count of Participants [Participants]	7 100%	0 NaN	3 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Grade 3 or Higher Treatment-related Adverse Events as US Department of Health and Human Services Common Terminology of Adverse Events (CTCAE) Version 4
Description	Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.
Time Frame	12 weeks after transplant

Outcome Measure Data

Analysis Population Description

There were no participants who received donors found to have hepatitis C genotype 1a with resistance enrolled.

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Measure Participants	7	0	3
Count of Participants [Participants]	0 0%	0 NaN	0 0%

2. Secondary Outcome

Title	Viral Response
Description	This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12
Time Frame	12 weeks after completing treatment

Outcome Measure Data

Analysis Population Description

There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Measure Participants	7	0	3
Count of Participants [Participants]	7 100%	0 NaN	3 100%

3. Secondary Outcome

Title	Antibody Development
Description	Number of kidney transplant recipients who become reactive for HCV antibody
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Measure Participants	7	0	3
Count of Participants [Participants]	3 42.9%	0 NaN	2 66.7%

4. Secondary Outcome

Title	Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors
Description	Number of participants with NS5A resistance mutations in the HCV population from the deceased donors. Number of donors with NS5A resistance mutations
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Measure Participants	7	0	3
Count of Participants [Participants]	0 0%	0 NaN	0 0%

5. Secondary Outcome

Title	IP-10 Elevations
Description	Measurement of interferon (IFN)-gamma inducible protein 10 (IP-10) a marker of acute hepatitis C infection.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Measure Participants	0	0	0

6. Secondary Outcome

Title	Kidney Function at 6 Months
Description	Serum creatinine mg/dL at 6 months following transplantation
Time Frame	6 months following transplantation

Outcome Measure Data

Analysis Population Description

There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Measure Participants	7	0	3
Median (Full Range) [mg/dL]	1.12	0.9

7. Secondary Outcome

Title	Kidney Function at 12 Months
Description	Serum creatinine mg/dL at 12 months following transplantation
Time Frame	12 months following transplantation

Outcome Measure Data

Analysis Population Description

There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.

Arm/Group Title	Donor Genotype 1a no Resistance or 1b	Donor Genotype 1a With Resistance	Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks	Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses	Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
Measure Participants	7	0	3
Median (Full Range) [mg/dL]	1.0	1.3

Adverse Events

Time Frame	Adverse events were collected for 6 months from initiation of treatment
Adverse Event Reporting Description	10 patients overall were at risk of adverse events, none of them from the Donor Genotype 1a With Resistance arm
Arm/Group Title	Donor Genotype 1a no Resistance or 1b		Donor Genotype 1a With Resistance		Donor Genotype 2 or 3
Arm/Group Description	Participants who receive donors found to have hepatitis C genotype 1a without resistance Zepatier one tablet daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks		Participants who receive donors found to have hepatitis C genotype 1a with nonstructural protein 5A associated resistance mutations Zepatier one tablet daily for 16 weeks Ribavirin weight based dosing for 16 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Ribavirin: Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses		Participants who receive donors found to have hepatitis C genotype 2 or 3 Zepatier one tablet daily for 12 weeks Sofosbuvir 400 mg daily for 12 weeks Zepatier: Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks Sofosbuvir: Sofosbuvir 400 mg daily
All Cause Mortality
	Donor Genotype 1a no Resistance or 1b		Donor Genotype 1a With Resistance		Donor Genotype 2 or 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/0 (NaN)		0/3 (0%)
Serious Adverse Events
	Donor Genotype 1a no Resistance or 1b		Donor Genotype 1a With Resistance		Donor Genotype 2 or 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)		0/0 (NaN)		1/3 (33.3%)
Blood and lymphatic system disorders
blood stream infection	1/7 (14.3%)	1	0/0 (NaN)	1	0/3 (0%)	0
Renal and urinary disorders
Urinary tract infection	2/7 (28.6%)	2	0/0 (NaN)	0	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulomonary infection	0/7 (0%)	0	0/0 (NaN)	0	1/3 (33.3%)	1
Other (Not Including Serious) Adverse Events
	Donor Genotype 1a no Resistance or 1b		Donor Genotype 1a With Resistance		Donor Genotype 2 or 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/0 (NaN)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.