Trial Outcomes & Findings for Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF (NCT NCT04585737)

Results Overview

percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

222 participants

Primary outcome timeframe

48 weeks

Results posted on

2024-10-17

Participant Flow

The first participant was screened on 10/5/2020 and the last participant's Week 48 visit was on 8/3/2023. Of 235 screened, 222 were enrolled and randomized to switch to DTG/3TC (n=149) or continue B/F/TAF (n=73), 222 received study treatment (ITT-E)

Participant milestones

Participant milestones
Measure	Treatment Group 1 Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
Overall Study STARTED	149	73
Overall Study COMPLETED	133	65
Overall Study NOT COMPLETED	16	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator	Total n=222 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	140 Participants n=5 Participants	62 Participants n=7 Participants	202 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	61 Participants n=7 Participants	186 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	102 Participants n=5 Participants	54 Participants n=7 Participants	156 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	44 Participants n=5 Participants	18 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	149 Participants n=5 Participants	73 Participants n=7 Participants	222 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Primary Outcome Measure is to Evaluate the Efficacy of Switching From B/F/TAF to DTG/3TC Versus Continuing B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: 24 weeks

percentage with HIV-1 RNA ≥50 copies/mL at Week 24 in each treatment arm

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA≥ 50 Copies/mL at Week 24	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 48 weeks

percentage with HIV-1 RNA\<50 copies/mL at Weeks 12, 24 and 48 in each treatment arm

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA<50 Copies/mL at Week 48	127 Participants	59 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: overall number of participants experiencing Grade 2-5, drug-related AEs

Grade 2-5 drug-related AEs and lab abnormalities graded using DAIDS grading scale

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Measure the Incidence and Severity of Grade 2-5 Drug-related Adverse Events and Laboratory Abnormalities (Graded Using DAIDs Grading Scale) Through 48 Weeks	14 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Number of participants who discontinue study treatment and reasons for discontinuation

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Evaluate the Proportion of Participants That Discontinue Treatment Through 48 Weeks in Each Treatment Arm and Reasons for Discontinuation	15 Participants	9 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: change in total cholesterol

Change from Baseline in fasting total cholesterol at Week 48

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Evaluate the Effects of DTG/3TC Once Daily on Fasting Total Cholesterol Over Time Compared to B/F/TAF Through 48 Weeks	-2.3 mg/dL Interval -11.5 to 21.3	3.3 mg/dL Interval -19.0 to 33.5

SECONDARY outcome

Timeframe: 48 weeks

Population: mean change in weight at 48 weeks

Change from Baseline in weight (kg) measured at Week 48

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Evaluate Changes in Weight (kg) in Those Treated With DTG/3TC vs. B/F/TAF Over Time	-1 kg Interval -7.3 to 4.3	0.2 kg Interval -5.8 to 6.1

SECONDARY outcome

Timeframe: 48 weeks

Population: mean change from baseline in weight circumference

Change from Baseline in waist circumference (measured in inches) at Week 48

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Evaluate Changes in Waist Circumference (Inches) in Those Treated With DTG/3TC vs. B/F/TAF Over Time	-0.9 inches Interval -1.6 to 2.3	-0.7 inches Interval -2.1 to 3.8

SECONDARY outcome

Timeframe: 48 weeks

Population: change in BMI over 48 weeks

Change from Baseline in weight (kg) and height (meters) will be used to assess changes in BMI (kg/m2) measured at Week 48

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=149 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
The Secondary Outcome Measure is to Evaluate Changes in BMI (kg/m2) in Those Treated With DTG/3TC vs. B/F/TAF Over Time	-0.6 kg/m2 Interval -1.1 to 0.9	-0.1 kg/m2 Interval -1.3 to 1.6

SECONDARY outcome

Timeframe: 48 weeks

Population: number of participants with treatment-emergent resistance through Week 48

to measure the incidence of observed genotypic resistance to ARVs for subjects meeting Virologic Rebound Criteria

Outcome measures

Outcome measures
Measure	Treatment Group 1 n=12 Participants Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=6 Participants Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
To Assess the Number of Subjects With Genotypic Mutations Affecting Any Component of the Treatment Regimen Among Subjects Meeting Virologic Rebound Criteria (HIV-1 RNA≥50 Copies/mL X2) Using HIV Genotypic and ARCHIVE HIV-DNA Testing	2 Participants	1 Participants

Adverse Events

Treatment Group 1

Serious events: 12 serious events

Other events: 14 other events

Deaths: 0 deaths

Treatment Group 2

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group 1 n=149 participants at risk Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 participants at risk Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
Gastrointestinal disorders Pancreatitis	0.67% 1/149 • Number of events 1 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Infections and infestations COVID-19	0.00% 0/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	4.1% 3/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Cardiac disorders Chest Pain	1.3% 2/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	1.4% 1/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Psychiatric disorders Drug Overdose	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Psychiatric disorders Bipolar Disorder	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Musculoskeletal and connective tissue disorders Left hip pain	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Psychiatric disorders Suicidal Ideation	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Respiratory, thoracic and mediastinal disorders Asthma	1.3% 2/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Infections and infestations Cellulitis	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Nervous system disorders Syncope	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Musculoskeletal and connective tissue disorders Fall	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Musculoskeletal and connective tissue disorders Back Pain	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.67% 1/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.

Other adverse events

Other adverse events
Measure	Treatment Group 1 n=149 participants at risk Treatment Group 1 (n=149): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food. Dolutegravir / Lamivudine Pill: Experimental	Treatment Group 2 n=73 participants at risk Treatment Group 2 (n=73): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food. Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill: Active comparator
Gastrointestinal disorders Nausea	4.7% 7/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
General disorders Fatigue	4.0% 6/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Gastrointestinal disorders Diarrhea	3.4% 5/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Nervous system disorders Headaches	3.4% 5/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Nervous system disorders Insomnia	3.4% 5/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Psychiatric disorders Worsening depression	2.0% 3/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Nervous system disorders Dizziness	2.0% 3/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	0.00% 0/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Gastrointestinal disorders Constipation	1.3% 2/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	1.4% 1/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.
Renal and urinary disorders Proteinuria	0.00% 0/149 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.	1.4% 1/73 • 48 weeks Additional secondary endpoints included safety and tolerability which were evaluated through incidence and severity of AEs, laboratory abnormalities and discontinuations due to AEs at each study visit through Week 48.

Additional Information

Wendy Wert, Clinical Research manager

Orlando Immunology Center

Phone: 4076473960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place