Hepatitis C Virus(HCV) Heart and Lung Study
Condition: Hepatitis C, Chronic; Heart Failure; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Heart Failure
Intervention: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
Intervention description: 1 pill once daily of SOF/LDV FDC
Intervention MeSH terms: Sofosbuvir; Ledipasvir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have
      advanced cardiac disease or advanced lung disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HCV Infection of Genotype 1, 4, 5, or 6

          -  HCV RNA > 103 IU/mL at screening

          -  18 years of age or older

          -  Diagnosis of chronic HCV infection, defined as positive HCV antibody or HCV RNA more
             than 6 months prior to screening OR an assessment of fibrosis F2 or greater prior to
             screening.

        Subjects in the advanced heart failure cohort must meet all HCV criteria, and all of the
        following criteria:

          -  New York Heart Association (NYHA) Class III or IV functional classification

               -  NYHA Class III: Subjects with cardiac disease resulting in marked limitation of
                  physical activity. They are comfortable at rest. Less than ordinary physical
                  activity causes fatigue, palpitation, dyspnea, or anginal pain.

               -  NYHA Class IV: Patient with cardiac disease resulting in inability to carry on
                  any physical activity without discomfort. Symptoms of cardiac insufficiency or of
                  the anginal syndrome may be present even at rest. If any physical activity is
                  undertaken, discomfort is increased.

          -  ejection fraction ≤ 30%

          -  hospitalized for heart failure in last 12 months

        Subjects in the advanced lung disease cohort must have been diagnosed with chronic
        obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) must meet all HCV
        criteria, and meet the following criteria for COPD or ILD:

          -  ILD criteria: diagnosis of interstitial lung disease with chronic supplemental oxygen
             requirement at rest and/or with exertion.

          -  COPD criteria (one of the following):

               -  Forced expiratory volume (FEV1)< 30% predicted

               -  OR any FEV1 with chronic supplemental oxygen requirement at rest and/or with
                  exertion

               -  OR any FEV1 with chronic hypercapnia (baseline partial pressure of arterial
                  carbon dioxide [PaCO2] > 45)

        Exclusion Criteria:

          -  Chronic HCV Infection with Genotype 2 or 3

          -  Treatment with any of the following agents

               -  Amiodarone. Subjects previously treated with amiodarone must have stopped the
                  amiodarone at least 60 days prior to day 1 of SOF/LDV FDC

               -  Carbamazepine, phenytoin, phenobarbital, oxcarbazepine

               -  Rifabutin, rifampin or rifapentine

               -  HIV regimens containing tenofovir or tipranavir/ritonavir

               -  St. John's wort

               -  Rosuvastatin

          -  Have any serious or active medical or psychiatric illness which, in the opinion of the
             investigator, would interfere with subject treatment, assessment, or compliance

          -  History of hepatic encephalopathy or variceal hemorrhage

          -  Hepatitis B surface antigen positive

          -  Abnormal hematological and biochemical parameters, including:

               -  Hemoglobin (Hb) < 8 g/dL

               -  Platelets ≤ 50,000/mm3

               -  alanine aminotransferase (ALT), aspartase aminotransferase (AST), or alkaline
                  phosphatase ≥ 10 times upper limit of normal(ULN)

               -  Total bilirubin > 3 mg/dl

               -  Severe renal impairment creatinine clearance (CrCl), i.e. < 30 mL/min.

          -  History of major organ transplantation with an existing functional graft.

          -  History of clinically-significant drug allergy to nucleoside/nucleotide analogs.

          -  Pregnant women or women planning to become pregnant

          -  Women who are breastfeeding

          -  Active or recent history (≤ 1 year) of drug or alcohol abuse