Hepatitis C Virus(HCV) Heart and Lung Study

NCT02858180 | Completed Phase 4 Results

• 1 other identifier: Pro00069602
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Hepatitis C, Chronic; Heart Failure; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (2)

• Number of Subjects With Sustained Virologic Response (SVR) 12

  12 weeks after completing treatment

• Number of Subjects With Sustained Virologic Response (SVR) 4

  4 weeks after completing treatment

Other Outcomes (1)

• Discontinuation for Adverse Events and Serious Adverse Events

  12 weeks after completing treatment

Study Arms (2)

Heart Failure Cohort

EXPERIMENTAL

Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)

Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)

Lung Disease Cohort

EXPERIMENTAL

Harvoni (sofosbuvir/ledipasvir fixed dose combination) 1 pill once daily Includes 400 mg sofosbuvir and 90 mg ledipasvir

Drug: Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)

Interventions

Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC) DRUG

1 pill once daily of SOF/LDV FDC

Also known as: Harvoni

Heart Failure Cohort; Lung Disease Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic HCV Infection of Genotype 1, 4, 5, or 6
• HCV RNA \> 103 IU/mL at screening
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Gilead Sciences: collaborator

Study Sites (4)

Henry Ford Health System

Detroit, Michigan, 48377, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center - Dept of Gastroenterology

Durham, North Carolina, 27705, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (9)

• Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.

  PMID: 23172780 BACKGROUND

• Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006 May 16;144(10):705-14. doi: 10.7326/0003-4819-144-10-200605160-00004.

  PMID: 16702586 BACKGROUND

• Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.

  PMID: 19330875 BACKGROUND

• Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.

  PMID: 24725239 BACKGROUND

• Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1594-603. doi: 10.1056/NEJMoa1315722. Epub 2014 Apr 10.

  PMID: 24720703 BACKGROUND

• Lee I, Localio R, Brensinger CM, Blumberg EA, Lautenbach E, Gasink L, Amorosa VK, Lo Re V 3rd. Decreased post-transplant survival among heart transplant recipients with pre-transplant hepatitis C virus positivity. J Heart Lung Transplant. 2011 Nov;30(11):1266-74. doi: 10.1016/j.healun.2011.06.003. Epub 2011 Jul 20.

  PMID: 21764330 BACKGROUND

• Fagiuoli S, Minniti F, Pevere S, Farinati F, Burra P, Livi U, Naccarato R, Chiaramonte M. HBV and HCV infections in heart transplant recipients. J Heart Lung Transplant. 2001 Jul;20(7):718-24. doi: 10.1016/s1053-2498(01)00255-8.

  PMID: 11448796 BACKGROUND

• Sahi H, Zein NN, Mehta AC, Blazey HC, Meyer KH, Budev M. Outcomes after lung transplantation in patients with chronic hepatitis C virus infection. J Heart Lung Transplant. 2007 May;26(5):466-71. doi: 10.1016/j.healun.2007.01.037. Epub 2007 Mar 26.

  PMID: 17449415 BACKGROUND

• Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.

  PMID: 24725238 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic; Heart Failure; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Interventions

Sofosbuvir; ledipasvir; ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Andrew Muir, MD
• Organization: Duke University

muir0002@duke.edu

919-684-2052

Study Officials

• Andrew Muir, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 8, 2016
• Study Start: December 1, 2016
• Primary Completion: April 11, 2019
• Study Completion: July 4, 2019
• Last Updated: April 21, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)