Trial Outcomes & Findings for Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant (NCT NCT03625687)

NCT ID: NCT03625687

Last Updated: 2023-04-25

Results Overview

Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: 12 weeks post last dose of treatment with DAA
• Results posted on: 2023-04-25

Participant Flow

Recruitment occurred between February 2019 and December 2020.

19 subjects received transplant with an HCV Ab positive organ. 3 of the 19 subjects received an HCV Ab positive/HCV RNA negation (NAT negative) transplant and did not irequire DAA therapy per protocol. 16 subjects received HCV Ab positive/HCV RNA positive (NAT positive) transplant and initiated DAA therapy.

Participant milestones

Measure	Treatment With Direct Acting Antiviral for HCV 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral (Mavyret) HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication (Mavyret)
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment With Direct Acting Antiviral for HCV 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral (Mavyret) HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication (Mavyret)
Overall Study Death	1

Baseline Characteristics

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant

Baseline characteristics by cohort

Measure	Treatment With Direct Acting Antiviral for HCV n=16 Participants 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral (Mavyret) HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	16 Participants n=93 Participants
Recipient HCV negative status at time of consent	16 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 weeks post last dose of treatment with DAA

Population: Number of subjects completing full course of treatment

Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=15 Participants 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication
Undetectable Blood HCV RNA Level	15 Participants

SECONDARY outcome

Timeframe: 8 weeks

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

Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab results as compared to baseline/pretreatment values per patient

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=16 Participants 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication
Number of Participants With Treatment Emergent Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 8 weeks

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

Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results

Outcome measures

Measure	Treatment With Direct Acting Antiviral for HCV n=16 Participants 8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret) Clinically prescribed direct acting antiviral HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication
Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)	0 Participants

Adverse Events

Treatment With Direct Acting Antiviral for HCV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 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: 6177247562

Email: Chung.Raymond@mgh.harvard.edu

Results disclosure agreements

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