Trial Outcomes & Findings for Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE (NCT NCT03998176)

Last Updated: 2023-10-04

Results Overview

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 analyzed by the snapshot algorithm, which defines a participants virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

Week 24

Results posted on

2023-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	B/F/TAF Daily through week 48
Overall Study STARTED	43
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B/F/TAF n=43 Participants Participants will receive B/F/TAF for 48 weeks Bictegravir/emtricitabine/tenofovir alafenamide: B/F/TAF single tablet formulation
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	38 years n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	34 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	35 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	43 participants n=93 Participants

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	B/F/TAF n=43 Participants Daily through week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm	32 Participants

SECONDARY outcome

Timeframe: Week 24

The percentage of participants experiencing grade 3 or greater adverse events at Week 24

Outcome measures

Outcome measures
Measure	B/F/TAF n=43 Participants Daily through week 48
Percentage of Participants With Grade 3 or Greater Adverse Events	12 Participants

SECONDARY outcome

Timeframe: Week 48

The percentage of participants experiencing grade 3 or greater adverse events at Week 48

Outcome measures

Outcome measures
Measure	B/F/TAF n=43 Participants Daily through week 48
Percentage of Participants With Grade 3 or Greater Adverse Events	15 Participants

SECONDARY outcome

Timeframe: Week 48

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 analyzed by the snapshot algorithm, which defines a participants virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Outcome measures

Outcome measures
Measure	B/F/TAF n=43 Participants Daily through week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm	21 Participants

Adverse Events

B/F/TAF

Serious events: 15 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	B/F/TAF n=43 participants at risk Daily through week 48
Investigations Grade 3 or above SAE	34.9% 15/43 • Number of events 27 • 48 weeks

Other adverse events

Other adverse events
Measure	B/F/TAF n=43 participants at risk Daily through week 48
Psychiatric disorders Suicidal Ideation	11.6% 5/43 • Number of events 7 • 48 weeks

Additional Information

Josh Havens

University of Nebraska Medical Center

Phone: 402-559-2674

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place