Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

NCT06104306 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GS-US-380-67382023-506660-13
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 18

Brief Summary

The goal of this clinical study is to learn how safe it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint)

  Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale. The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death

  Week 12

• Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint)

  Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days. The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening.

  Week 12

Secondary Outcomes (12)

• Plasma Concentrations of Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 (Predose)

  Day 1 (Predose)

• Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4

  Week 4 (at trough and 2 hours postdose)

• Plasma Concentration of BIC, CAB, and RPV at Week 12

  Week 12 (at trough and 2 hours postdose)

• Plasma Concentration of BIC, CAB, and RPV at Week 24

  Week 24 (at trough and 2 hours postdose)

• Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach

  Week 12

Study Arms (1)

B/F/TAF

EXPERIMENTAL

Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks.

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

Tablets administered orally without regard to food

Also known as: Biktarvy ®

B/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with human immunodeficiency virus type 1 (HIV-1) (PWH) or provider decision to switch off cabotegravir + rilpivirine (CAB+RPV) intramuscular (IM) injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
• Currently virologically suppressed (HIV-1 ribonucleic acid (RNA) \< 50 copies/mL) on CAB+RPV IM injections every 2 months.
• Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections.
• Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV.
• Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit.
• No documented or suspected resistance to bictegravir, emtricitabine, or tenofovir.

You may not qualify if:

• History of B/F/TAF intolerance.
• History of previous integrase strand-transfer inhibitor (INSTI) virologic failure including CAB+RPV.
• Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug.
• Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies)
• Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (18)

Franco Felizarta, MD

Bakersfield, California, 93301, United States

Location

BIOS Clinical Research

Palm Springs, California, 92262, United States

Location

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, 92103, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

Bliss Health

Orlando, Florida, 32806, United States

Location

Indiana University Infectious Diseases Research

Indianapolis, Indiana, 46202, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Las Vegas Research Center

Las Vegas, Nevada, 89106, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

MultiCare Rockwood Main Clinic

Spokane, Washington, 99202, United States

Location

Hamilton Health Sciences-SIS Clinic

Hamilton, L8L2X2, Canada

Location

St. Michael's Hospital

Toronto, M5B 1W8, Canada

Location

University Health Network - Toronto General Hospital

Toronto, M5G 2C4, Canada

Location

CHU Bordeaux - Hopital Saint-Andre

Bordeaux, 33075, France

Location

APHM - Hospital Sainte Marguerite

Marseille, France

Location

CHR Orleans

Orléans, 45100, France

Location

Centre Hospitalier Annecy Genevois

Pringy, 74374, France

Location

HU de Strasbourg - Nouvel Hopital Civil

Strasbourg, France

Location

Related Publications (3)

• Priyanka Arora, Moti Ramgopal, Thomas CS Martin, Hui Liu, Jason T Hindman, Jason Okulicz, Dhananjay D Marathe, Samir Gupta Pharmacokinetics and Safety Data After Switching From Injectable CAB + RPV to Oral B/F/TAF 20th European AIDS Conference (EACS); October 15-18, 2025

  BACKGROUND

• Samir Gupta, Thomas Martin, Cyril Gaultier, Alexandra Kissling, Kathleen Beusterien, Megan Chen, Megan Dunbar, Hui Liu, Brenda Ng, Moti Ramgopal Evaluation of Treatment Satisfaction and Experiences Among People With HIV When Switching to B/F/TAF From CAB + RPV: Results From the Phase 4 EMPOWER Study IDWeek; October 19-22, 2025; Atlanta, GA, USA

  BACKGROUND

• Sharon Walmsley, Moti Ramgopal, Thomas Martin, Jason T Hindman, Hui Liu, Keith Aizen, Jason Okulicz, Samir Gupta A Phase 4 Study to Evaluate the Safety and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV IDWeek; October 19-22, 2025; Atlanta, GA, USA

  BACKGROUND

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: December 13, 2023
• Primary Completion: January 29, 2025
• Study Completion: April 23, 2025
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (10); FR (5); CA (3)