Phase 3
Completed N=244
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
HIV-1/HBV Co-Infection
Source: ClinicalTrials.gov NCT03547908 ↗
Enrolled (actual)
244
Serious AEs
9.1%
Results posted
Mar 2023
Primary outcomePrimary: 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) — 95.0; 91.0 percentage of participants — p=0.2113
◆ Published Evidence
Established
59citations · ~20 / year
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial.
Summary
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.
Linked Publications (3)
-
Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial.
-
Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Initiating Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate: A Subanalysis of ALLIANCE Data.
-
Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Through the Open-Label Extension of the ALLIANCE Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
95.0; 91.0 | 0.2113 |
| PRIMARY 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) |
63.0; 43.4 | 0.0023 sig |
| SECONDARY Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm |
87.4; 87.7 | 0.9427 |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 48 |
200; 175 | 0.1701 |
| SECONDARY Change From Baseline in CD4 Cell Count at Week 96 |
261; 229 | 0.1853 |
| SECONDARY Change From Baseline in Percentage of CD4 Cells at Week 48 |
8.43; 7.75 | 0.2839 |
| SECONDARY Change From Baseline in Percentage of CD4 Cells at Week 96 |
10.69; 10.42 | 0.8456 |
| SECONDARY Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96 |
74.8; 70.5 | 0.6367 |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria |
73.3; 55.3 | 0.0655 |
| SECONDARY Percentage of Participants With ALT Normalization at Week 96 |
71.7; 57.4 | 0.1253 |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 |
12.6; 5.8 | 0.0591 |
| SECONDARY Percentage of Participants With HBsAg Loss at Week 96 |
22.7; 14.0 | 0.0655 |
Eligibility Criteria
Key Inclusion Criteria
- Human immunodeficiency virus type 1 (HIV-1) co-infection:
- Must be HIV antiretroviral treatment naive with plasma HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening
- ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine and entecavir, following a diagnosis of HIV-1 infection (except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening)
- Screening genotype report must show sensitivity to emtricitabine (FTC) and tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively, if genotype results from a local laboratory obtained ≤ 90 days prior to screening visit date show sensitivity to these drugs, this genotype will be acceptable to fulfill this inclusion criterion in the event that the genotype obtained at screening is not yet available and all other inclusion/exclusion criteria have been confirmed
- HBV co-infection:
- Must be hepatitis B virus (HBV) treatment naive (defined as < 12 weeks of oral antiviral treatment)
- Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 IU/mL
- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 10 x upper limit of normal (ULN)
- Total bilirubin ≤ 2.5 x ULN
Key Exclusion Criteria
- Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment
- Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
- Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
- Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03547908) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.