Status:
UNKNOWN
Hepatitis C (HCV) Cure and Kidney Health
Lead Sponsor:
San Francisco Veterans Affairs Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03407703
Start Date
March 27 2018
End Date
December 31 2019
Last Update
April 18 2018
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94115
2
San Francisco VA Medical Center
San Francisco, California, United States, 94121