This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease.
This is a multicenter study in HCV infected adult patients who also have either advanced cardiac disease, or advanced lung disease. Advanced cardiac disease is defined as a marked limitation of physical activity, or discomfort upon physical activity. The patients in the advanced cardiac disease group must also have been hospitalized for heart failure within the last 12 months. Advanced lung disease is defined as patients who have been diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). Patients in the COPD group must have abnormalities in their forced expiratory volume (FEV) test, which measures the amount of air exhaled. They may or may not need supplemental oxygen. Patients in the ILD group must have been diagnosed with ILD and require supplement oxygen at all times.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
1 pill once daily of SOF/LDV FDC
Henry Ford Health System
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center - Dept of Gastroenterology
Durham, North Carolina, United States
Harborview Medical Center
Seattle, Washington, United States
Number of Subjects Who Completed 24 Weeks of Therapy
The primary safety endpoint is the number of subjects who complete a full course of therapy.
Time frame: 24 weeks
Number of Subjects With Sustained Virologic Response (SVR) 12
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.
Time frame: 12 weeks after completing treatment
Number of Subjects With Sustained Virologic Response (SVR) 4
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.
Time frame: 4 weeks after completing treatment
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