Trial Outcomes & Findings for Hepatitis C Virus(HCV) Heart and Lung Study (NCT NCT02858180)

NCT ID: NCT02858180

Last Updated: 2020-04-21

Results Overview

The primary safety endpoint is the number of subjects who complete a full course of therapy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-04-21

Participant Flow

Between 12/2016 and 12/2018, 15 subjects with chronic HCV and advanced heart failure or chronic HCV and lung disease were enrolled across 4 sites (academic medical centers in the US). Subjects all have genotype 1, 4, 5 or 6 HCV.

Participant milestones

Participant milestones
Measure	Heart Failure Cohort Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Lung Disease Cohort Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC
Overall Study STARTED	10	5
Overall Study COMPLETED	10	3
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Heart Failure Cohort Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Lung Disease Cohort Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Hepatitis C Virus(HCV) Heart and Lung Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heart Failure Cohort n=10 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Lung Disease Cohort n=5 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Total n=15 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 7.5 • n=5 Participants	59.4 years STANDARD_DEVIATION 5.1 • n=7 Participants	60.1 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

The primary safety endpoint is the number of subjects who complete a full course of therapy.

Outcome measures

Outcome measures
Measure	Heart Failure Cohort n=10 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Lung Disease Cohort n=5 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC
Number of Subjects Who Completed 24 Weeks of Therapy	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 weeks after completing treatment

The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 12 weeks after completing therapy.

Outcome measures

Outcome measures
Measure	Heart Failure Cohort n=10 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Lung Disease Cohort n=5 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC
Number of Subjects With Sustained Virologic Response (SVR) 12	10 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks after completing treatment

The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 4 weeks after completing treatment.

Outcome measures

Outcome measures
Measure	Heart Failure Cohort n=10 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Lung Disease Cohort n=5 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC
Number of Subjects With Sustained Virologic Response (SVR) 4	8 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after completing treatment

Assessment for discontinuation due to adverse events and serious adverse events, as addressed by adverse events and laboratory tests. Final study visit is 12 weeks after treatment.

Outcome measures

Outcome measures
Measure	Heart Failure Cohort n=10 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV) Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC	Lung Disease Cohort n=5 Participants Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC): 1 pill once daily of SOF/LDV FDC
Discontinuation for Adverse Events and Serious Adverse Events	0 Participants	0 Participants

Adverse Events

Heart Failure Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lung Disease Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Muir, MD

Duke University

Phone: 919-684-2052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place