Extrahepatic Insulin Resistance in Chronic Hepatitis C

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In this pilot study, the investigators plan to treat patients with chronic hepatitis C due to HCV genotype 3 infection using an interferon-free regimen consisting in the administration of ribavirin and sofosbuvir/ledipasvir - a combination of a nucleotide RNA polymerase inhibitor with a non-structural protein 5A inhibitor. Patients will undergo a euglycemic hyperinsulinemic clamp, using tracers, and indirect calorimetry to assess whether the viral suppression induced by this regimen will be capable of reversing the glucose metabolic alterations induced by HCV in both the liver and extrahepatic compartments. Adipose and muscle tissue biopsies will also be performed to assess some specific molecular changes induced by HCV.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Geneva
• Collaborators: Clément Sophie; Gastaldi Giacomo
• Treatments: Ledipasvir; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Histologically confirmed chronic hepatitis C with HCV genotype 3a infection,

• Adult Caucasian patient males or non-pregnant or non-lactating females, aged 18 to 65 at the time of the screening;

• Informed Consent as documented by signature;

• Lack of contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational products.

Exclusion Criteria:

• Cirrhosis;

• Excess active alcohol consumption (>30 g/day in males, >20 g/day in females);

• Active illicit drug use.

• Coinfection with HIV or hepatitis B virus;

• Concomitant medications with clinically significant interactions with the study drugs;

• Women who are pregnant or breast feeding or who intend to become pregnant during the course of the study;

• Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;

• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.);

• Known or suspected non-compliance;

• Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia;

• Participation in another study with any investigational drug within the 30 days preceding and during the present study;

• Enrolment of the investigator, his/her family members, employees and other dependent persons.