Pilot HCV Direct Acting Antiviral Therapy and Metabolism

• Status: Completed
• Trial end date: 2017-05-31
• Target enrollment: 0
• Participant gender: All

Summary

There is compelling data supporting the pursuit of research into the effects of HCV antivirals on metabolic homeostasis. As a further rationale and justification, the experience with HIV antiretrovirals has clearly demonstrated that antiviral medications can produce profound changes in glucose metabolism, lipid profile and other measures of metabolic homeostasis. This establishes biological plausibility for this focus of research in HCV.

The new knowledge created from this research will:

1. Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral regimen.

2. Provide insight as to whether there are metabolic advantages with RBV-free compared to RBV-containing HCV regimens. This is particularly relevant given the current uncertainty regarding the need for RBV in IFN-free, oral DAA regimens.

3. Provide insight into the impact of cirrhosis on metabolic milieu before, during and after HCV antiviral therapy

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: AbbVie
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• HCV RNA evidence of HCV infection

• Documented history of chronic HCV RNA infection with Genotype 1

• Able to provide informed consent

• Available for ongoing follow-up if required

Exclusion Criteria:

• <18 years old

• Evidence of decompensated liver disease

• HOMA IR< 2.0

• HIV seropositivity

• Chronic HBV/HIV infection

• Use of immune suppressing medications

• Active malignancy