Trial Outcomes & Findings for Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication (NCT NCT03823911)
NCT ID: NCT03823911
Last Updated: 2023-05-22
Results Overview
Change in high-sensitivity C-reactive protein
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
87 participants
Primary outcome timeframe
Baseline to 72 weeks after functional cure of HCV
Results posted on
2023-05-22
Participant Flow
Participant milestones
| Measure |
HIV Mono-Infected
Patients infected with HIV only, and not currently or previously infected with hepatitis C.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
Hepatitis C Mono-Infected
Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
HIV and Hepatitis C Co-Infected
Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
37
|
7
|
|
Overall Study
COMPLETED
|
29
|
24
|
1
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
6
|
Reasons for withdrawal
| Measure |
HIV Mono-Infected
Patients infected with HIV only, and not currently or previously infected with hepatitis C.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
Hepatitis C Mono-Infected
Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
HIV and Hepatitis C Co-Infected
Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
2
|
|
Overall Study
Did not meet eligibility criteria
|
13
|
7
|
4
|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication
Baseline characteristics by cohort
| Measure |
HIV Mono-Infected
n=43 Participants
Patients infected with HIV only, and not currently or previously infected with hepatitis C.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
Hepatitis C Mono-Infected
n=37 Participants
Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
HIV and Hepatitis C Co-Infected
n=7 Participants
Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
58 years
n=7 Participants
|
56 years
n=5 Participants
|
55 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
37 participants
n=7 Participants
|
7 participants
n=5 Participants
|
87 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 72 weeks after functional cure of HCVPopulation: 13 participants were analyzed in the hepatitis C mono-infected group and 1 participant in the HIV-HCV co-infected group since other participants were lost to follow-up and week 72 data was available for these participants only.
Change in high-sensitivity C-reactive protein
Outcome measures
| Measure |
Hepatitis C Mono-Infected
n=13 Participants
Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
HIV and Hepatitis C Co-Infected
n=1 Participants
Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.
Elbasvir / Grazoprevir Oral Tablet \[Zepatier\]: All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRI: Cardiac MRI to assess for myocardial function and fibrosis
|
|---|---|---|
|
Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein
|
0.6 mg/L
Standard Deviation 0.96
|
0 mg/L
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline to 48 weeks after functional cure of HCVPopulation: Data on troponin I and T were not collected for any of the participants, therefore the outcome cannot be reported
Change in the cardiac biomarkers Troponin I and Troponin T
Outcome measures
Outcome data not reported
Adverse Events
HIV Mono-Infected
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hepatitis C Mono-Infected
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
HIV and Hepatitis C Co-Infected
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Poonam Mathur
Institute of Human Virology, University of Maryland School of Medicine
Phone: 410-706-4745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place