drugset / Trial / NCT02734173

Pilot HCV Direct Acting Antiviral Therapy and Metabolism

NCT02734173

Non-randomizedParallel-groupOpen-labelPrevention

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

Timeline

Start
2015-07
Primary completion
2017-02
Completion
2017-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator ABT450r Unknown Oral
Comparator Ribavirin Small molecule Oral
Comparator dasabuvir Small molecule Oral
Comparator ombitasvir Small molecule Oral