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Hepatitis C (HCV) Cure and Kidney Health

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ClinicalTrials.gov Identifier: NCT03407703
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Phyllis Tien, San Francisco Veterans Affairs Medical Center

Study Description
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Brief Summary:
The purpose of this study is to learn how 12 weeks of HCV treatment with elbasvir and grazoprevir (brand name Zepatier) impacts your kidney function.

Condition or disease Intervention/treatment
Hepatitis C Drug: Elbasvir / Grazoprevir Oral Tablet [Zepatier]

Detailed Description:
Prospective data collection of 25 Genotype 1 or 4 HCV-infected women from the San Francisco Women's Interagency HIV Study (WIHS) site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center who are initiated on Zepatier for 12 weeks (Total n=50). For women and men with HCV genotype 1a infection, only those without baseline NS5A resistance mutations will be included. Blood/urine samples will be collected before initiation of treatment, 4 weeks after treatment initiation, 12 weeks after treatment initiation (end of treatment), 24 weeks after treatment initiation to determine Sustained Virological Response (SVR), and at 48 weeks after treatment initiation.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HCV Cure and Kidney Health: A Prospective, Observational Cohort Study of HCV Genotype 1 and 4 Infected Adults With and Without HIV Infection
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Elbasvir / Grazoprevir Oral Tablet [Zepatier]
    HCV treatment

Outcome Measures
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Primary Outcome Measures :
  1. Glomerular filtration rate and injury [ Time Frame: 1 year ]
    measured by Cystatin C

  2. glomerular filtration rate and injury [ Time Frame: 1 year ]
    measured by Creatinine

  3. glomerular filtration rate and injury [ Time Frame: 1 year ]
    measured by albuminuria

  4. Tubule dysfunction [ Time Frame: 1 year ]
    measured by α1-microglobulin

  5. Tubule dysfunction [ Time Frame: 1 year ]
    measured by beta2-microglobulin

  6. Tubule injury [ Time Frame: 1 year ]
    measured by Interleukin-18

  7. tubule injury [ Time Frame: 1 year ]
    measured by Kidney injury molecule-1

  8. tubule injury [ Time Frame: 1 year ]
    measured by Neutrophil gelatinase-associated lipocalcin (NGAL)

  9. tubule injury [ Time Frame: 1 year ]
    measured by Clusterin

  10. tubule injury [ Time Frame: 1 year ]
    measured by Trefoil factor-3 (TFF-3)


Secondary Outcome Measures :
  1. HCV clearance [ Time Frame: 1 year ]
    measured by HCV viral load

  2. liver fibrosis [ Time Frame: 1 year ]
    liver stiffness measured by transient elastography


Biospecimen Retention:   Samples With DNA
serum, plasma and PBMC (peripheral blood mononuclear cell)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
25 Genotype 1 or 4 HCV-infected women from the San Francisco WIHS site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center
Criteria

Inclusion Criteria:

1. Active Genotype 1 or 4 HCV infection (If with Genotype 1a infection, only those without baseline NS5A resistance mutation will be included; Genotype 4 HCV infection is uncommon in both study populations). Subjects with HIV coinfection are included. We will not exclude patients who have severe Chronic Kidney Disease, are on dialysis, or have undergone kidney transplant.

Exclusion Criteria:

  1. HCV genotype 2, 3, 5, or 6 infection
  2. Previous virologic failure to regimens containing an NS5A inhibitor
  3. Decompensated liver disease (Child-Pugh Class B or C)
  4. Albumin below 3g/dL
  5. Platelet count below 75,000
  6. Any condition that the investigator considers a contraindication to study participation including limited life expectancy
  7. Pregnant or breastfeeding woman
  8. Hepatitis B virus (HBV) surface antigen positive (Note: Patients positive for the HBV core antibody will not be excluded, but will have HBV DNA levels checked and will be monitored while on Direct Acting Antivirals (DAA) therapy and medically managed as considered appropriate)
  9. Documented ongoing nonadherence to prescribed medications or medical treatment, failure to complete HCV disease evaluation appointments and procedures or unable to commit to scheduled followup/monitoring for the duration of treatment
  10. Poor venous access not allowing screening laboratory collection
  11. Known hypersensitivity to elbasvir/grazoprevir
  12. Co-administration with drugs that are 1) strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin); 2) OATP1B1/3 inhibitors (e.g., cyclosporine, darunavir, atazanavir, tipranavir, lopinavir or saquinavir) or 3) efavirenz
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407703


Contacts
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Contact: Phyllis C Tien, MD 415-221-4810 ext 22577 phyllis.tien@ucsf.edu
Contact: Heather S Freasier, MS 415-379-5518 heather.freasier@ucsf.edu

Locations
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United States, California
University of California, San Francisco Enrolling by invitation
San Francisco, California, United States, 94115
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Phyllis C Tien, MD    415-221-4810 ext 22577    phyllis.tien@ucsf.edu   
Contact: Heather Freasier, MS    415-379-5518    heather.freasier@ucsf.edu   
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Phyllis C Tien, MD San Francisco VA Medical Center
More Information
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Responsible Party: Phyllis Tien, Professor of Medicine and Clinical Pharmacy and Staff Physician, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03407703     History of Changes
Other Study ID Numbers: 17-22790
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Phyllis Tien, San Francisco Veterans Affairs Medical Center:
genotype 1
genotype 4
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
MK-5172
Elbasvir-grazoprevir drug combination
Antiviral Agents
Anti-Infective Agents