Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin HCV Therapy on Insulin Resistance and Lipid Profile (3D)

NCT02734173 Phase 4 COMPLETED

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

Details

Lead sponsor	Ottawa Hospital Research Institute
Phase	Phase 4
Status	COMPLETED
Enrolment	24
Start date	2015-07
Completion	2017-05-31

Conditions

• Hepatitis C

Interventions

• ABT450r-ABT267-ABT333 +/- Ribavirin

Primary outcomes

• Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin Hepatitis C Antiviral Therapy on Insulin Resistance — 30 weeks
  serial insulin sensitivity evaluation

Countries

Canada