Trial Outcomes & Findings for Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV) (NCT NCT03146741)

Last Updated: 2021-11-22

Results Overview

The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR; negative HCV RNA after completing Zepatier therapy) / (number of subjects treated with Zepatier post-heart transplantation)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 24 weeks

Results posted on

2021-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Overall Study STARTED	20
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Overall Study Txp with non-HCV+ heart	4
Overall Study Listeted for MOT	2
Overall Study Physician Decision	2
Overall Study Awaiting txp	2

Baseline Characteristics

Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) n=10 Participants Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Age, Continuous	52.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 weeks

Outcome measures

Outcome measures
Measure	Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) n=10 Participants Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Number of Participants With Post-treatment Sustained Virologic Response (SVR)	9 Participants

PRIMARY outcome

Timeframe: Baseline to 52 weeks

Outcome measures

Outcome measures
Measure	Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) n=10 Participants Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Number of Severe Adverse Events (SAE) Attributable to HCV Therapy Post-heart Transplant	0 Severe adverse event

Adverse Events

Zepatier (Grazoprevir 100mg and Elbasvir 50 mg)

Serious events: 6 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) n=10 participants at risk Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected - in this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines. Note: No subjects experienced treatment failure requiring sofosbuvir. Adverse events were collected the same way for all subjects in the setting of only 1 medication regimen intervention (Zepatier). For that reason we present the results and AEs in 1 arm containing all 10 subjects.
Cardiac disorders Death	10.0% 1/10 • 1 year
Surgical and medical procedures Post-op re-intubation	20.0% 2/10 • 1 year
Gastrointestinal disorders Abdominal infection	10.0% 1/10 • 1 year
Infections and infestations CMV	10.0% 1/10 • 1 year
General disorders Hemorrhagic shock	10.0% 1/10 • 1 year
Gastrointestinal disorders Terminal ileun ulcer	10.0% 1/10 • 1 year
Psychiatric disorders Fall	10.0% 1/10 • 1 year
Gastrointestinal disorders Non-infective gastroenteritis and colitis	10.0% 1/10 • 1 year

Other adverse events

Other adverse events
Measure	Zepatier (Grazoprevir 100mg and Elbasvir 50 mg) n=10 participants at risk Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected - in this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines. Note: No subjects experienced treatment failure requiring sofosbuvir. Adverse events were collected the same way for all subjects in the setting of only 1 medication regimen intervention (Zepatier). For that reason we present the results and AEs in 1 arm containing all 10 subjects.
General disorders Headache	100.0% 10/10 • 1 year

Additional Information

Dr. Peter Reese

University of Pennsylvania

Phone: 215-900-3782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place