Hepatitis C (HCV) Cure and Kidney Health

Sponsor

San Francisco Veterans Affairs Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT03407703

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Locations

21.2

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Mar 27, 2018

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Outcome Measures

Primary Outcome Measures

Glomerular filtration rate and injury [1 year]
measured by Cystatin C
glomerular filtration rate and injury [1 year]
measured by Creatinine
glomerular filtration rate and injury [1 year]
measured by albuminuria
Tubule dysfunction [1 year]
measured by α1-microglobulin
Tubule dysfunction [1 year]
measured by beta2-microglobulin
Tubule injury [1 year]
measured by Interleukin-18
tubule injury [1 year]
measured by Kidney injury molecule-1
tubule injury [1 year]
measured by Neutrophil gelatinase-associated lipocalcin (NGAL)
tubule injury [1 year]
measured by Clusterin
tubule injury [1 year]
measured by Trefoil factor-3 (TFF-3)

Secondary Outcome Measures

HCV clearance [1 year]
measured by HCV viral load
liver fibrosis [1 year]
liver stiffness measured by transient elastography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:

HCV genotype 2, 3, 5, or 6 infection
Previous virologic failure to regimens containing an NS5A inhibitor
Decompensated liver disease (Child-Pugh Class B or C)
Albumin below 3g/dL
Platelet count below 75,000
Any condition that the investigator considers a contraindication to study participation including limited life expectancy
Pregnant or breastfeeding woman
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)
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
Poor venous access not allowing screening laboratory collection
Known hypersensitivity to elbasvir/grazoprevir
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

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94115
2	San Francisco VA Medical Center	San Francisco	California	United States	94121