Trial Outcomes & Findings for Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine (NCT NCT04538040)

NCT ID: NCT04538040

Last Updated: 2024-03-05

Results Overview

Percentage of patients with viral HIV load (VL) \<50 and \<200 copies/mL at 48 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 48 Weeks
• Results posted on: 2024-03-05

Participant Flow

Participant milestones

Measure	Biktarvy + Doravirine Switch bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

Baseline characteristics by cohort

Measure	Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 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	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	19 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	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks

Outcome measures

Measure

Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.

Viral Suppression

100 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study

Outcome measures

Measure

Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.

Tolerability of Study Drug

16 Adverse Events

SECONDARY outcome

Timeframe: Week 48

Assess changes in BMI due to treatment switch

Outcome measures

Measure

Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.

Change in Body Mass Index

-0.2 kg/m2 Standard Deviation .85

SECONDARY outcome

Timeframe: Week 48

Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI). The range of the scale is 0-10, where 0 means it did not have an affect and 10 means it did have an affect.

Outcome measures

Measure	Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Work Productivity and Activity Hours of Work Missed	0 score on a scale Interval 0.0 to 10.0
Work Productivity and Activity Health Problem Affecting Productivity	0 score on a scale Interval 0.0 to 5.0
Work Productivity and Activity Health Problems Affect on Daily Activities	0 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours

Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®)

Outcome measures

Measure	Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
PK Assessment Plasma BIC Cmax	8.55 ug/ml Geometric Coefficient of Variation 33
PK Assessment Plasma DOR Cmax	1.2 ug/ml Geometric Coefficient of Variation 34

SECONDARY outcome

Timeframe: Day 28, Weeks 12, 24, 36, & 48

Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more.

Outcome measures

Measure	Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Adverse Events Assessment Mild Adverse Events	14 Number of AEs
Adverse Events Assessment Moderate Adverse Events	1 Number of AEs
Adverse Events Assessment Severe Adverse Events	1 Number of AEs

SECONDARY outcome

Timeframe: Week 48

Improvement in well-being and sleep inventory as measured by The Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0 and maximum score is 21. A higher score indicates worse quality sleep.

Outcome measures

Measure

Biktarvy + Doravirine Switch n=20 Participants bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.

Wellbeing Improvement

7 score on a scale Interval 1.0 to 15.0

Adverse Events

Biktarvy + Doravirine Switch

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Biktarvy + Doravirine Switch n=20 participants at risk bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch: Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
Metabolism and nutrition disorders New Onset Diabetes Mellitus	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
General disorders Intermittent Headache	10.0% 2/20 • Number of events 2 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma Removal	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Metabolism and nutrition disorders Episode of Hypoglycemia	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Renal and urinary disorders Urinary Tract Infection	5.0% 1/20 • Number of events 2 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Blood and lymphatic system disorders Viral Load of 330	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Gastrointestinal disorders Dysphagia	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Gastrointestinal disorders Loose Stool	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Musculoskeletal and connective tissue disorders Arthritis in Right Hand	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
General disorders Abdominal Pain	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
General disorders Hypertension	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
General disorders Fatigue	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.
Musculoskeletal and connective tissue disorders Neck Sprain	5.0% 1/20 • Number of events 1 • AE data is collected from the screening visit, and up to 30 days after the last dose of study drug, up to 48 weeks.

Additional Information

Lisa Sterman, MD, MPH

Gilead Sciences

Phone: 415-407-8434

Email: Lisa.Sterman@Gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place