Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
CompletedPhase 3Results postedLast updated 19 March 2025
What this trial tests
Phase 3 trial testing B/F/TAF in HIV-1/HBV Co-Infection in 244 participants. Completed in 7 March 2024.
18 and older, any sex, with HIV-1/HBV Co-Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint)Primary· Week 48
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded-off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
95.0
Blinded Phase: DTG + F/TDF
91.0
Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint)Primary· Week 48
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
63.0
Blinded Phase: DTG + F/TDF
43.4
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot AlgorithmSecondary· Week 96
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which was defined as a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded-off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
87.4
Blinded Phase: DTG + F/TDF
87.7
Change From Baseline in CD4 Cell Count at Week 48Secondary· Baseline, Week 48
Group
Value
95% CI
Blinded Phase: B/F/TAF
200
± 139.3
Blinded Phase: DTG + F/TDF
175
± 124.7
Change From Baseline in CD4 Cell Count at Week 96Secondary· Baseline, Week 96
Group
Value
95% CI
Blinded Phase: B/F/TAF
261
± 161.6
Blinded Phase: DTG + F/TDF
229
± 174.0
Change From Baseline in Percentage of CD4 Cells at Week 48Secondary· Baseline, Week 48
Group
Value
95% CI
Blinded Phase: B/F/TAF
8.43
± 4.1
Blinded Phase: DTG + F/TDF
7.75
± 4.3
Change From Baseline in Percentage of CD4 Cells at Week 96Secondary· Baseline, Week 96
Group
Value
95% CI
Blinded Phase: B/F/TAF
10.69
± 5.047
Blinded Phase: DTG + F/TDF
10.42
± 5.096
Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96Secondary· Week 96
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
74.8
Blinded Phase: DTG + F/TDF
70.5
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) CriteriaSecondary· Week 48
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
73.3
Blinded Phase: DTG + F/TDF
55.3
Percentage of Participants With ALT Normalization at Week 96Secondary· Week 96
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded-off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
71.7
Blinded Phase: DTG + F/TDF
57.4
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48Secondary· Week 48
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
12.6
Blinded Phase: DTG + F/TDF
5.8
Percentage of Participants With HBsAg Loss at Week 96Secondary· Week 96
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off.
Group
Value
95% CI
Blinded Phase: B/F/TAF
22.7
Blinded Phase: DTG + F/TDF
14.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Blinded Phase: B/F/TAF
Serious: 17/121 (14%)
Deaths: 2/122
Blinded Phase: DTG + F/TDF
Serious: 16/122 (13%)
Deaths: 1/122
Open-Label Extension Phase: B/F/TAF From B/F/TAF
Serious: 4/95 (4%)
Deaths: 1/95
Open-Label Extension Phase: B/F/TAF From DTG+F/TDF
The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve and HIV-1 and hepatitis B virus (HBV) adults.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06619288 — Good-first: B/F/TAF As First-line ART
· recruiting
NCT06375304 — The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study
· Phase 4
· not yet recruiting
NCT06104306 — Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
· Phase 4
· completed
NCT05585307 — Study of Novel Antiretrovirals in Participants With HIV-1
· Phase 1
· completed
NCT05122754 — Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection
· Phase 4
· unknown
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 19 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03547908.