Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Phyllis C Tien

Description

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.

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

Details

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.

Keywords

Hepatitis C genotype 1 genotype 4 Hepatitis Elbasvir-grazoprevir drug combination Elbasvir / Grazoprevir Oral Tablet [Zepatier]

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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

Locations

  • University of California, San Francisco accepting new patients by invitation only
    San Francisco California 94115 United States
  • San Francisco VA Medical Center accepting new patients
    San Francisco California 94121 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
San Francisco Veterans Affairs Medical Center
ID
NCT03407703
Lead Scientist
Phyllis C Tien
Study Type
Observational
Last Updated
April 16, 2018