NCT03547908

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

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1/HBV Co-Infection

Interventions

Type	Name	Description
DRUG	B/F/TAF	50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
DRUG	Placebo to match DTG	Tablet administered orally once daily, without regard to food
DRUG	Placebo to match F/TDF	Tablet administered orally once daily, without regard to food
DRUG	DTG	50 mg tablet administered orally once daily, without regard to food
DRUG	F/TDF	200/300 mg tablet administered orally once daily, without regard to food
DRUG	Placebo to match B/F/TAF	Tablet administered orally once daily, without regard to food

Timeline

• Start date: 2018-05-30
• Primary completion: 2022-02-25
• Completion: 2024-03-07
• First posted: 2018-06-06
• Last updated: 2025-03-19
• Results posted: 2023-03-15

Locations

69 sites across 14 countries: United States, China, Dominican Republic, France, Greece, Hong Kong, Japan, Malaysia, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study