NCT03221582

Impact of Hepatitis C Therapy and Bone Health

Impact of HCV Therapy on Cardiovascular Risk and Bone Health

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Dallas VA Medical Center · Federal
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.

Detailed description

Both HCV and HIV are associated with an increased risk of osteoporosis and osteoporotic fractures among HIV-infected patients and the general population. While HIV significantly increases cardiovascular risk, the contribution of HCV to cardiovascular disease (CVD) is less certain. Increased inflammation could potentially underlie the effect of HCV on CVD, bone health, and other extra-hepatic complications. HCV appears to remain an independent predictor of osteoporotic fractures even after controlling for severity of liver disease. The impact of HCV therapy on inflammation, CVD and bone health is unclear. Our previous studies suggest a beneficial impact of interferon therapy on bone turnover and some CVD markers, while others studies have found on-treatment increases in bone mineral density with interferon-based therapy. Whether these are related to the interferon itself or the virologic response, and whether changes in biomarkers lead to improved fracture risk or CVD morbidity is uncertain. Investigator propose to conduct a prospective analysis of markers of inflammation, immune activation, and bone turnover as well as bone mineral density (BMD) among both HIV/HCV co-infected and HCV mono-infected patients undergoing treatment with the novel direct-acting antiviral elbasvir/grazoprevir (EBR/GZR). Should EBR/GZR therapy significantly improve CV risk and bone health, it would be an additional benefit and indication for its use in HCV therapy.

Conditions

• Human Immunodeficiency Virus
• Hepatitis C

Interventions

Type	Name	Description
DRUG	EBR/GZR	Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.

Timeline

• Start date: 2017-08-28
• Primary completion: 2018-11-26
• Completion: 2018-11-30
• First posted: 2017-07-18
• Last updated: 2019-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study