Trial Outcomes & Findings for Effects of Biktarvy on CFR in Stable HIV Patients (NCT NCT03656783)

Last Updated: 2023-02-08

Results Overview

Change in global coronary flow reserve, as measured by PET imaging at baseline and 24 weeks after initiation of B/F/TAF therapy. Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired MBFR is defined as a ratio of \<2.0, which is associated with increased cardiovascular risk.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

25 participants

Primary outcome timeframe

baseline and week 24

Results posted on

2023-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	HIV Patients on Stable Therapy Patients with stable HIV treated with abacavir/lamivudine/dolutegravir STR regimens switching to B/F/TAF-CFR
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Biktarvy on CFR in Stable HIV Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV Patients on Stable Therapy n=25 Participants HIV patients on stable therapy switching from Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	56.44 years STANDARD_DEVIATION 6.13 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and week 24

Population: We enrolled men 45 years and over and women 55 years and over with HIV who were stable on a DTG/3TC/ABC regimen with virologic suppression for at least one year, and with at least one coronary risk factor (current smoking, dyslipidemia, hypertension, diabetes, obesity, or a calculated 10-year predicted risk of cardiovascular events of 7.5 percent or over) but without overt cardiovascular disease.

Outcome measures

Outcome measures
Measure	HIV Patients on Stable Therapy n=25 Participants Biktarvy: Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Change in Global CFR	-.05 ratio Interval -0.25 to 0.15

SECONDARY outcome

Timeframe: baseline and 24 weeks

Change (from baseline) in peak-stress global myocardial blood flow (in mL/min/g) at 24 weeks after initiation of B/F/TAF. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired stress MBF is defined as \<1.8 mL/min/g and is associated with increased cardiovascular risk.

Outcome measures

Outcome measures
Measure	HIV Patients on Stable Therapy n=25 Participants Biktarvy: Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Change in Peak Stress Global MBF	0.09 mL/min/g Interval -0.05 to 0.23

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Change in serum biomarkers of inflammation (hs-CRP (in mg/L)) at 24 weeks after initiation of B/F/TAF. Serum biomarkers of inflammation (high sensitivity C-reactive protein) were measured. hs-CRP \> 1 mg/L are considered abnormal and associated with increased cardiovascular risk.

Outcome measures

Outcome measures
Measure	HIV Patients on Stable Therapy n=25 Participants Biktarvy: Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L))	-0.40 mg/L Interval -1.52 to 0.72

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Change in Myocyte Injury and Strain (hs Troponin (in ng/L)) at 24 weeks after initiation of B/F/TAF. Serum biomarkers of myocardial injury/strain (high sensitivity troponin) were measured. hs-troponin \>14 ng/L are considered abnormal and associated with increased cardiovascular risk.

Outcome measures

Outcome measures
Measure	HIV Patients on Stable Therapy n=25 Participants Biktarvy: Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Change in Myocyte Injury and Strain (hs Troponin (in ng/L))	-0.04 ng/L Interval -1.11 to 1.02

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL)) at 24 weeks after initiation of B/F/TAF. Serum biomarkers of myocardial injury/strain (NT-pro-BNP) were measured. NT-proBNP \> 100 pg/mL are considered abnormal and associated with increased cardiovascular risk.

Outcome measures

Outcome measures
Measure	HIV Patients on Stable Therapy n=25 Participants Biktarvy: Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL))	-14.2 pg/mL Interval -43.4 to 15.2

Adverse Events

HIV Patients on Stable

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HIV Patients on Stable n=25 participants at risk HIV patients on stable therapy switching from Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Cardiac disorders Shortness of Breath	8.0% 2/25 • Number of events 2 • Adverse Event data was collected from consent through 24-week End of Treatment visit.

Additional Information

Marcelo Di Carli, MD

Brigham and Women's Hospital

Phone: 6177326290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place