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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elbasvir / Grazoprevir Oral Tablet [Zepatier] | Drug | HCV treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate and injury | measured by Cystatin C | 1 year |
| glomerular filtration rate and injury | measured by Creatinine | 1 year |
| glomerular filtration rate and injury | measured by albuminuria | 1 year |
| Tubule dysfunction | measured by α1-microglobulin | 1 year |
| Tubule dysfunction | measured by beta2-microglobulin | 1 year |
| Tubule injury | measured by Interleukin-18 | 1 year |
| tubule injury | measured by Kidney injury molecule-1 | 1 year |
| tubule injury | measured by Neutrophil gelatinase-associated lipocalcin (NGAL) | 1 year |
| tubule injury | measured by Clusterin | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| HCV clearance | measured by HCV viral load | 1 year |
| liver fibrosis | liver stiffness measured by transient elastography | 1 year |
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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:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phyllis C Tien, MD | Contact | 415-221-4810 | 22577 | phyllis.tien@ucsf.edu |
| Heather S Freasier, MS | Contact | 415-379-5518 | heather.freasier@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Phyllis C Tien, MD | San Francisco VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Enrolling by invitation | San Francisco | California | 94115 | United States | |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 1, 2024 | |
| Reset | Jul 30, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2024 | Jul 30, 2024 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000589335 | elbasvir |
| C578009 | grazoprevir |
| C000611265 | elbasvir-grazoprevir drug combination |
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serum, plasma and PBMC (peripheral blood mononuclear cell)
| tubule injury | measured by Trefoil factor-3 (TFF-3) | 1 year |
| San Francisco VA Medical Center |
| Recruiting |
| San Francisco |
| California |
| 94121 |
| United States |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |