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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Tablet administered orally once daily, without regard to food
Tablet administered orally once daily, without regard to food
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)
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.
Time frame: Week 48
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)
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.
Time frame: Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
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.
Time frame: Week 96
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline, Week 48
Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline, Week 96
Change From Baseline in Percentage of CD4 Cells at Week 48
Time frame: Baseline, Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
50 mg tablet administered orally once daily, without regard to food
200/300 mg tablet administered orally once daily, without regard to food
Tablet administered orally once daily, without regard to food
Midway Immunology & Research
Ft. Pierce, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Be Well Medical Center
Berkley, Michigan, United States
The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
Houston, Texas, United States
Beijing Ditan Hospital Capital Medical University
Beijing, China
Beijing YouAn Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
The First Hospital of Changsha
Changsha, China
Chengdu Public Health Clinical Center
Chengdu, China
Guangzhou Eighth people's Hospital
Guangzhou, China
...and 59 more locations
Change From Baseline in Percentage of CD4 Cells at Week 96
Time frame: Baseline, Week 96
Percentage of Participants With Plasma HBV DNA < 29 IU/mL at 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.
Time frame: Week 96
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria
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.
Time frame: Week 48
Percentage of Participants With ALT Normalization at 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.
Time frame: Week 96
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at 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.
Time frame: Week 48
Percentage of Participants With HBsAg Loss at 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.
Time frame: Week 96