This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: * Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive * Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Spectrum Medical Group
Phoenix, Arizona, United States
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient'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.
Time frame: Week 24
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
The percentage of participants with HBV DNA \< 29 IU/mL at Week 24 was calculated using the missing = failure method.
Time frame: Week 24
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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.
Time frame: Week 48
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
The percentage of participants with HBV DNA \< 29 IU/mL at Week 48 was calculated using the missing = failure method.
Time frame: Week 48
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24
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 postbaseline visit.
Time frame: Baseline; Week 24
Percentage of Participants With Normalized ALT at 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 postbaseline visit.
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AHF Research Center
Beverly Hills, California, United States
Peter J. Ruane MD, Inc.
Los Angeles, California, United States
Anthony Mills MD, Inc
Los Angeles, California, United States
Whitman Walker Health
Washington D.C., District of Columbia, United States
Barry M. Rodwick MD
Clearwater, Florida, United States
Gary J Richmond M.D.,P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
AIDS Health Foundation/WPA
Miami Beach, Florida, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, United States
...and 14 more locations
Time frame: Baseline; Week 48
Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time frame: Baseline; Week 24
Percentage of Participants With Seroconversion to Anti-HBs at Week 48
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time frame: Baseline; Week 48
Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time frame: Baseline; Week 24
Percentage of Participants With Seroconversion to Anti-HBe at Week 48
Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.
Time frame: Baseline; Week 48
Change From Baseline in FibroTest® Score at Week 24
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Time frame: Baseline; Week 24
Change From Baseline in FibroTest® Score at Week 48
The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
Time frame: Baseline; Week 48