Trial Outcomes & Findings for DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant (NCT NCT03208127)

NCT ID: NCT03208127

Last Updated: 2022-07-28

Results Overview

Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: 12 weeks post treatment
• Results posted on: 2022-07-28

Participant Flow

Recruitment occurred between November 2017 and March 2021. 33 subjects underwent liver transplant from an Hepatitis C Virus (HCV) Antibody (Ab) positive donor. 9 subjects received HCV Ab positive/HCV Ribonucleic acid (RNA) (Nucleic Acid Testing (NAT)-) donors and did not receive Direct Acting Antiviral (DAA) treatment. 24 subjects initiated treatment with DAAs.

Enrolled subjects who did not require treatment with direct acting antivirals were excluded from analysis.

Participant milestones

Measure	Treatment With Direct Acting Antiviral Fixed Dose Combination 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks
Overall Study STARTED	24
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment With Direct Acting Antiviral Fixed Dose Combination 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks
Overall Study Death	1

Baseline Characteristics

DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant

Baseline characteristics by cohort

Measure	Treatment With Direct Acting Antiviral Fixed Dose Combination n=24 Participants 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants
Recipient Negative HCV status at time of transplant	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post treatment

Population: 1 subject died and was not included in analysis

Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.

Outcome measures

Measure	Treatment With Direct Acting Antiviral Fixed Dose Combination n=23 Participants 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA	23 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Number of participants receiving at least 1 dose of DAA treatment were included in the analysis

Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.

Outcome measures

Measure	Treatment With Direct Acting Antiviral Fixed Dose Combination n=24 Participants 12 weeks of HCV treatment with medically appropriate direct acting antiviral Treatment with Direct Acting Antiviral tablet: HCV Treatment for 12 Weeks
Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values	0 Participants

Adverse Events

Treatment With Direct Acting Antiviral Fixed Dose Combination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond Chung, MD

Massachusetts General Hospital

Phone: 617-724-7562

Email: chung.raymond@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place