Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters (NCT NCT03960645)
NCT ID: NCT03960645
Last Updated: 2024-06-14
Results Overview
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partum
Results posted on
2024-06-14
Participant Flow
Participants were enrolled at study sites in the Dominican Republic, Thailand and the United States.
33 pregnant women were enrolled in the B/F/TAF group. Neonates born to these women were also enrolled in the study for follow up. A total of 29 neonate participants were enrolled.
Participant milestones
| Measure |
B/F/TAF
Pregnant women participants received fixed dose combination (FDC) tablet of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
Neonates
Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
29
|
|
Overall Study
COMPLETED
|
32
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
B/F/TAF
Pregnant women participants received fixed dose combination (FDC) tablet of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
Neonates
Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
Baseline characteristics by cohort
| Measure |
B/F/TAF
n=33 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
Neonates
n=29 Participants
Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
0 years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
16 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Dominican Republic
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: PK analysis set included all enrolled adult participants who took at least 1 dose of study drug (B/F/TAF), and had at least 1 non-missing concentration value reported by the PK laboratory for the corresponding analytes (BIC, FTC, TAF, and tenofovir diphosphate \[TFV-DP\]). Participants in the PK analysis set with available data were analyzed.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC)
Second Trimester
|
62772.2 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 20242.18
|
|
Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC)
Third Trimester
|
60163.4 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 17482.06
|
|
Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC)
Week 6 Post-partum
|
134820.3 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 36217.30
|
|
Pharmacokinetic (PK) Parameter: AUCtau of Bictegravir (BIC)
Week 12 Post-partum
|
148251.6 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 42189.17
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
FTC: Third Trimester
|
10435.2 h*ng/mL
Standard Deviation 2121.87
|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
FTC: Week 6 Post-partum
|
16277.5 h*ng/mL
Standard Deviation 4023.42
|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
FTC: Week 12 Post-partum
|
15308.5 h*ng/mL
Standard Deviation 3359.83
|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
TAF: Second Trimester
|
235.5 h*ng/mL
Standard Deviation 107.36
|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
TAF: Third Trimester
|
212.1 h*ng/mL
Standard Deviation 95.38
|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
TAF: Week 6 Post-partum
|
374.3 h*ng/mL
Standard Deviation 153.54
|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
TAF: Week 12 Post-partum
|
296.4 h*ng/mL
Standard Deviation 94.37
|
|
PK Parameter: AUCtau of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF)
FTC: Second Trimester
|
10263.8 h*ng/mL
Standard Deviation 2054.35
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: AUClast of BIC, FTC, and TAF
BIC: Second Trimester
|
63187.5 h*ng/mL
Standard Deviation 19814.99
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
BIC: Third Trimester
|
60145.3 h*ng/mL
Standard Deviation 17484.52
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
135058.9 h*ng/mL
Standard Deviation 36348.21
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
148265.3 h*ng/mL
Standard Deviation 42201.47
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
FTC: Second Trimester
|
10258.5 h*ng/mL
Standard Deviation 2049.53
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
FTC: Third Trimester
|
10434.2 h*ng/mL
Standard Deviation 2121.13
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
16329.7 h*ng/mL
Standard Deviation 4095.44
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
15308.5 h*ng/mL
Standard Deviation 3359.79
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
TAF: Second Trimester
|
220.4 h*ng/mL
Standard Deviation 98.98
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
TAF: Third Trimester
|
202.2 h*ng/mL
Standard Deviation 84.98
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
356.7 h*ng/mL
Standard Deviation 151.27
|
|
PK Parameter: AUClast of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
294.3 h*ng/mL
Standard Deviation 97.88
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
Cmax is defined as the maximum observed concentration of drug during the dosing interval.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: Cmax of BIC, FTC, and TAF
BIC: Second Trimester
|
5819.0 ng/mL
Standard Deviation 1752.29
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
BIC: Third Trimester
|
5374.7 ng/mL
Standard Deviation 1393.86
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
9765.5 ng/mL
Standard Deviation 2274.93
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
11025.3 ng/mL
Standard Deviation 2747.42
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
FTC: Second Trimester
|
2639.1 ng/mL
Standard Deviation 965.60
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
FTC: Third Trimester
|
2586.0 ng/mL
Standard Deviation 686.42
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
3394.8 ng/mL
Standard Deviation 951.83
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
3360.0 ng/mL
Standard Deviation 902.47
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
TAF: Second Trimester
|
332.4 ng/mL
Standard Deviation 173.29
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
TAF: Third Trimester
|
270.9 ng/mL
Standard Deviation 113.93
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
506.4 ng/mL
Standard Deviation 249.33
|
|
PK Parameter: Cmax of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
494.6 ng/mL
Standard Deviation 259.51
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: Ctau of BIC and FTC
BIC: Second Trimester
|
1046.4 ng/mL
Standard Deviation 472.68
|
|
PK Parameter: Ctau of BIC and FTC
BIC: Third Trimester
|
1072.4 ng/mL
Standard Deviation 447.03
|
|
PK Parameter: Ctau of BIC and FTC
BIC: Week 6 Post-partum
|
3530.3 ng/mL
Standard Deviation 1354.20
|
|
PK Parameter: Ctau of BIC and FTC
BIC: Week 12 Post-partum
|
3641.9 ng/mL
Standard Deviation 1241.64
|
|
PK Parameter: Ctau of BIC and FTC
FTC: Second Trimester
|
59.8 ng/mL
Standard Deviation 62.17
|
|
PK Parameter: Ctau of BIC and FTC
FTC: Third Trimester
|
51.4 ng/mL
Standard Deviation 13.98
|
|
PK Parameter: Ctau of BIC and FTC
FTC: Week 6 Post-partum
|
152.1 ng/mL
Standard Deviation 271.50
|
|
PK Parameter: Ctau of BIC and FTC
FTC: Week 12 Post-partum
|
81.1 ng/mL
Standard Deviation 27.34
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
Clast is defined as the last observable concentration of drug.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: Clast of BIC, FTC, and TAF
BIC: Second Trimester
|
1141.10 ng/mL
Standard Deviation 631.431
|
|
PK Parameter: Clast of BIC, FTC, and TAF
BIC: Third Trimester
|
1075.13 ng/mL
Standard Deviation 447.847
|
|
PK Parameter: Clast of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
3535.48 ng/mL
Standard Deviation 1371.162
|
|
PK Parameter: Clast of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
3641.88 ng/mL
Standard Deviation 1240.605
|
|
PK Parameter: Clast of BIC, FTC, and TAF
FTC: Second Trimester
|
75.08 ng/mL
Standard Deviation 130.792
|
|
PK Parameter: Clast of BIC, FTC, and TAF
FTC: Third Trimester
|
51.65 ng/mL
Standard Deviation 14.182
|
|
PK Parameter: Clast of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
156.16 ng/mL
Standard Deviation 292.579
|
|
PK Parameter: Clast of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
81.18 ng/mL
Standard Deviation 27.334
|
|
PK Parameter: Clast of BIC, FTC, and TAF
TAF: Second Trimester
|
4.49 ng/mL
Standard Deviation 5.130
|
|
PK Parameter: Clast of BIC, FTC, and TAF
TAF: Third Trimester
|
4.80 ng/mL
Standard Deviation 4.048
|
|
PK Parameter: Clast of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
3.13 ng/mL
Standard Deviation 1.849
|
|
PK Parameter: Clast of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
3.36 ng/mL
Standard Deviation 1.999
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
Tmax is defined as the time (observed time point) of Cmax.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: Tmax of BIC, FTC, and TAF
BIC: Second Trimester
|
2.00 h
Interval 1.0 to 12.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
BIC: Third Trimester
|
2.00 h
Interval 1.0 to 6.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
1.50 h
Interval 0.5 to 12.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
1.50 h
Interval 0.5 to 4.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
FTC: Second Trimester
|
1.50 h
Interval 0.5 to 4.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
FTC: Third Trimester
|
1.50 h
Interval 0.5 to 4.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
1.50 h
Interval 0.5 to 4.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
1.00 h
Interval 0.5 to 3.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
TAF: Second Trimester
|
0.75 h
Interval 0.25 to 4.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
TAF: Third Trimester
|
1.00 h
Interval 0.25 to 3.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
0.75 h
Interval 0.25 to 3.0
|
|
PK Parameter: Tmax of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
0.75 h
Interval 0.25 to 3.0
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
FTC: Third Trimester
|
6.41 h
Interval 4.49 to 7.91
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
BIC: Second Trimester
|
9.09 h
Interval 4.75 to 16.04
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
BIC: Third Trimester
|
9.91 h
Interval 7.53 to 16.24
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
18.24 h
Interval 12.18 to 29.59
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
17.27 h
Interval 4.534 to 26.3
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
FTC: Second Trimester
|
6.43 h
Interval 4.76 to 7.36
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
6.27 h
Interval 4.47 to 7.8
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
5.76 h
Interval 3.83 to 8.19
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
TAF: Second Trimester
|
0.30 h
Interval 0.22 to 0.66
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
TAF: Third Trimester
|
0.28 h
Interval 0.19 to 0.62
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
0.40 h
Interval 0.25 to 0.6
|
|
PK Parameter: t1/2 of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
0.35 h
Interval 0.25 to 0.6
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
CLss/F is defined as the apparent steady-state oral clearance following administration of the drug.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
BIC: Second Trimester
|
911.78 mL/h
Standard Deviation 433.301
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
BIC: Third Trimester
|
902.47 mL/h
Standard Deviation 287.285
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
399.02 mL/h
Standard Deviation 113.214
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
362.40 mL/h
Standard Deviation 95.856
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
FTC: Second Trimester
|
20228.02 mL/h
Standard Deviation 3981.186
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
FTC: Third Trimester
|
19975.85 mL/h
Standard Deviation 4223.365
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
12991.62 mL/h
Standard Deviation 3111.349
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
13645.71 mL/h
Standard Deviation 2830.897
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
TAF: Second Trimester
|
122677.74 mL/h
Standard Deviation 44270.041
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
TAF: Third Trimester
|
135061.19 mL/h
Standard Deviation 44876.970
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
76939.32 mL/h
Standard Deviation 29189.555
|
|
PK Parameter: CLss/F of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
92888.59 mL/h
Standard Deviation 29461.550
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
Vz/F is defined as the apparent volume of distribution of the drug.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
BIC: Second Trimester
|
11896.24 mL
Standard Deviation 4417.149
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
BIC: Third Trimester
|
13406.77 mL
Standard Deviation 4349.429
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
10348.47 mL
Standard Deviation 3713.380
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
8692.59 mL
Standard Deviation 2398.645
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
FTC: Second Trimester
|
181767.32 mL
Standard Deviation 36739.344
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
FTC: Third Trimester
|
184791.79 mL
Standard Deviation 56340.526
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
117384.90 mL
Standard Deviation 35385.941
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
117660.87 mL
Standard Deviation 33240.095
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
TAF: Second Trimester
|
62333.17 mL
Standard Deviation 37242.307
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
TAF: Third Trimester
|
53230.98 mL
Standard Deviation 16727.325
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
44440.06 mL
Standard Deviation 13678.515
|
|
PK Parameter: Vz/F of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
49837.70 mL
Standard Deviation 22019.454
|
SECONDARY outcome
Timeframe: Intensive PK: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose in second trimester (Weeks 20-28), third trimester (Weeks 30-38), Week 6 post-partum, and Week 12 post-partumPopulation: Participants in the PK analysis set with available data were analyzed.
λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
PK Parameter: λz of BIC, FTC, and TAF
BIC: Second Trimester
|
0.077 1/h
Standard Deviation 0.0231
|
|
PK Parameter: λz of BIC, FTC, and TAF
BIC: Third Trimester
|
0.068 1/h
Standard Deviation 0.0125
|
|
PK Parameter: λz of BIC, FTC, and TAF
BIC: Week 6 Post-partum
|
0.040 1/h
Standard Deviation 0.0098
|
|
PK Parameter: λz of BIC, FTC, and TAF
BIC: Week 12 Post-partum
|
0.043 1/h
Standard Deviation 0.0134
|
|
PK Parameter: λz of BIC, FTC, and TAF
FTC: Second Trimester
|
0.113 1/h
Standard Deviation 0.0142
|
|
PK Parameter: λz of BIC, FTC, and TAF
FTC: Third Trimester
|
0.112 1/h
Standard Deviation 0.0173
|
|
PK Parameter: λz of BIC, FTC, and TAF
FTC: Week 6 Post-partum
|
0.114 1/h
Standard Deviation 0.0151
|
|
PK Parameter: λz of BIC, FTC, and TAF
FTC: Week 12 Post-partum
|
0.120 1/h
Standard Deviation 0.0209
|
|
PK Parameter: λz of BIC, FTC, and TAF
TAF: Second Trimester
|
2.227 1/h
Standard Deviation 0.7128
|
|
PK Parameter: λz of BIC, FTC, and TAF
TAF: Third Trimester
|
2.550 1/h
Standard Deviation 0.7519
|
|
PK Parameter: λz of BIC, FTC, and TAF
TAF: Week 6 Post-partum
|
1.777 1/h
Standard Deviation 0.4685
|
|
PK Parameter: λz of BIC, FTC, and TAF
TAF: Week 12 Post-partum
|
1.954 1/h
Standard Deviation 0.4519
|
SECONDARY outcome
Timeframe: At time of deliveryPopulation: Full analysis set included all adult participants who enrolled into the study and took at least 1 dose of study drug (B/F/TAF). Participants in the full analysis set with available data were analyzed.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at the time of delivery was analyzed in B/F/TAF group using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).
Outcome measures
| Measure |
B/F/TAF
n=32 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at the Time of Delivery Using the Missing = Excluded Approach in B/F/TAF Group
|
100.0 percentage of participants
Interval 89.1 to 100.0
|
SECONDARY outcome
Timeframe: At birthPopulation: Neonate full analysis set included neonates who were born to women participating in the study and had been enrolled into the study as well. Participants in the neonate full analysis set with available data were analyzed.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at the time of birth was analyzed in neonates using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).
Outcome measures
| Measure |
B/F/TAF
n=2 Participants
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
|---|---|
|
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Birth Using the Missing = Excluded Approach in Neonates
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
Adverse Events
B/F/TAF
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Neonates
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B/F/TAF
n=33 participants at risk
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
Neonates
n=29 participants at risk
Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug.
|
|---|---|---|
|
Cardiac disorders
Nonreassuring foetal heart rate pattern
|
3.0%
1/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Congenital, familial and genetic disorders
Accessory auricle
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
3.4%
1/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
3.4%
1/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
General disorders
Pyrexia
|
3.0%
1/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Infections and infestations
Covid-19
|
3.0%
1/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
3.4%
1/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
9.1%
3/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
3.4%
1/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
3.0%
1/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
3.0%
1/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
3.4%
1/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Transient tachypnoea of the newborn
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
3.4%
1/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
Other adverse events
| Measure |
B/F/TAF
n=33 participants at risk
Pregnant women participants received FDC tablet of B/F/TAF 50/200/25 mg, orally, once daily for up to 38 weeks (from the second or third trimesters of pregnancy, depending on enrollment, through 12 weeks post-partum).
|
Neonates
n=29 participants at risk
Neonates born to women participants in the study were followed from birth up to 8 weeks of age after obtaining consent from the parent or legal guardian. None of the neonates participating in the study were treated with the study drug.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
3/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Cardiac disorders
Foetal heart rate deceleration abnormality
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
4/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Nervous system disorders
Dizziness
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
12.1%
4/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
6.9%
2/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
6.1%
2/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
0.00%
0/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/33 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
10.3%
3/29 • All-Cause Mortality: From birth up to 8 weeks of age for neonates; From enrollment up to 38 weeks + 30 days for B/F/TAF group. Adverse Events: First dose date up to 38 weeks + 30 days for B/F/TAF group
B/F/TAF:Safety analysis set- all adult participants who took at least 1 dose of study drug. Neonates:Safety analysis set- neonates born to women participating \& had been enrolled into study. None of neonates participating in study were treated. Adverse events (AE) reported for that group are not treatment emergent (TE). TEAE:any AE with onset on/after start of study drug \& no later than 30 days after permanent study drug discontinuation, or any AE leading to premature study drug discontinuation.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER