Pilot Study of Ezetimibe for Chronic Hepatitis C Virus (HCV) Infection
Status:
Unknown status
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Infection by hepatitis C virus (HCV) affects more than 170 million people in the World and
80.000 in Chile. It causes more deaths than HIV infection in the US and is a leading cause
for liver transplantation in Chile. Even though treatments are evolving with new direct
antiviral agents (DAAs) that are increasing response rates, there are several issues with
these new approaches, including increased toxicity, need for using interferon and ribavirin,
complex algorithms of treatment, high cost, limited effectivity in certain groups (liver
transplant patients) and drug interactions. Treatments targeted at host factors required for
the viral cycle are becoming increasingly explored as an alternative or complement to DAAs.
It has been recently described that Niemann-Pick C1-like 1 (NPC1L1), the intestinal receptor
of cholesterol, serves as an entry factor for HCV. NPC1L1 is, therefore, a key transporter in
the enterohepatic cycle of cholesterol. NPC1L1 can be blocked with ezetimibe, which is an
approved and generally safe drug used for the management of hypercholesterolemia. Our
hypothesis posits that blocking HCV entry to the hepatocyte or intestinal HCV reabsorption
with ezetimibe may have an antiviral effect. In the study, we will administer ezetimibe 20
mg/d to 20 patients with stable chronic hepatitis C for 12 weeks and assess changes in HCV
RNA and core antigen in plasma, bile and feces.