Hepatitis C (HCV) Cure and Kidney Health

Status unconfirmed

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT03407703

Run by

San Francisco Veterans Affairs Medical Center

People needed

50

Starts

2018-03-27

Expected to finish

2019-12-31

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• San Francisco VA Medical Center — San Francisco, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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