Trial Outcomes & Findings for B/F/TAF Switch Study for HIV-HBV Coinfection (NCT NCT03797014)
NCT ID: NCT03797014
Last Updated: 2023-11-03
Results Overview
Proportion of participants with plasma HBV DNA \<29 IU/mL at Week 24 as defined by Missing=Failure Approach
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
Week 24
Results posted on
2023-11-03
Participant Flow
Participant milestones
| Measure |
B/F/TAF
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
B/F/TAF
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
B/F/TAF Switch Study for HIV-HBV Coinfection
Baseline characteristics by cohort
| Measure |
B/F/TAF
n=28 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
50.1 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
|
HIV RNA PCR <50 copies/mL
|
20 Participants
n=99 Participants
|
|
CD4 count <200 cells/microliter
|
1 Participants
n=99 Participants
|
|
HBV DNA PCR <29 IU/mL
|
22 Participants
n=99 Participants
|
|
HBeAg positive
|
12 Participants
n=99 Participants
|
|
Anti-HBe antibody positive
|
10 Participants
n=99 Participants
|
|
Abnormal ALT
|
4 Participants
n=99 Participants
|
|
Hepatitis D antibody positive
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intention-to-Treat (ITT) population: Enrolled subjects who received at least one study drug.
Proportion of participants with HIV-1 RNA \<50 copies/mL at Week 24 by US FDA Snapshot Algorithm
Outcome measures
| Measure |
B/F/TAF
n=28 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
HIV-1 RNA at Week 24
|
25 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intention-to-Treat Population: All enrolled subjects who received at least one study drug.
Proportion of participants with plasma HBV DNA \<29 IU/mL at Week 24 as defined by Missing=Failure Approach
Outcome measures
| Measure |
B/F/TAF
n=28 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
HBV DNA at Week 24
|
24 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Intention-to-Treat Population: All enrolled subjects who received at least one study drug.
Proportion of participants with HIV-1 RNA \<50 copies/mL at Week 48 by US FDA Snapshot Algorithm
Outcome measures
| Measure |
B/F/TAF
n=28 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
HIV-1 RNA at Week 48
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: Intention-to-Treat Population: All enrolled subjects who received at least one study drug.
Proportion of participants with plasma HBV DNA \<29 IU/mL at Week 48 as defined by Missing=Failure Approach
Outcome measures
| Measure |
B/F/TAF
n=28 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
HBV DNA at Week 48
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: All enrolled subjects with CD4 count values at baseline and at week 24.
Change from baseline in CD4 cell count at Week 24
Outcome measures
| Measure |
B/F/TAF
n=26 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
CD4 Cell Count Change at Week 24
|
32.8 cells/microliter
Standard Deviation 169.1
|
SECONDARY outcome
Timeframe: Baseline; Week 48Population: All enrolled subjects with CD4 count results available at baseline and week 48.
Change from baseline in CD4 cell count at Week 48
Outcome measures
| Measure |
B/F/TAF
n=25 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
CD4 Cell Count Change at Week 48
|
76.6 cells/microliter
Standard Deviation 184.2
|
SECONDARY outcome
Timeframe: Week 24Population: Enrolled subjects with abnormal ALT at baseline
Proportion of participants with normal ALT at Week 24
Outcome measures
| Measure |
B/F/TAF
n=4 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
ALT Normalization at Week 24
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 48Population: All enrolled subjects with abnormal baseline LFTs
Proportion of participants with normal ALT at Week 48
Outcome measures
| Measure |
B/F/TAF
n=4 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
ALT Normalization at Week 48
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 48Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.
Outcome measures
| Measure |
B/F/TAF
n=26 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
HBeAg Loss at Week 48
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 48Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.
Outcome measures
| Measure |
B/F/TAF
n=25 Participants
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
HBsAg Loss at Week 48
|
0 Participants
|
Adverse Events
B/F/TAF
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
B/F/TAF
n=28 participants at risk
Treatment group (1-arm study)
B/F/TAF: Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
17.9%
5/28 • Number of events 5 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • Number of events 2 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
|
Infections and infestations
Abscess, extremity
|
7.1%
2/28 • Number of events 2 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
2/28 • Number of events 2 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
|
Vascular disorders
Hypertension
|
7.1%
2/28 • Number of events 2 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Number of events 2 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
2/28 • Number of events 2 • Adverse events were collected during the entire study participation (48 weeks).
Adverse events were graded according to the Division of AIDS (DIADS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 2.1 (March 2017).
|
Additional Information
Dr. Joel Chua
Institute of Human Virology, University of Maryland Baltimore
Phone: 14107065704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place