A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF (EYEWITNESS)

A Phase 3b, Multicenter, Single-arm, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to DTG/3TC Single Tablet Regimen Administered Once Daily From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in People Living With HIV of at Least 50 Years of Age Who Are Virologically Suppressed

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV
• Intervention / Treatment: Drug: DTG/3TC

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • GSK Investigational Site
  • Vienna, Austria, 1100
    • GSK Investigational Site
• Belgium
  • Brussels, Belgium, 1200
    • GSK Investigational Site
  • Ghent, Belgium, 9000
    • GSK Investigational Site
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H2L 1N9
      • GSK Investigational Site
• France
  • Nice, France, 6202
    • GSK Investigational Site
  • Orléans, France, 45100
    • GSK Investigational Site
  • Paris, France, 75004
    • GSK Investigational Site
• Germany
  • Freiburg im Breisgau, Germany, 79106
    • GSK Investigational Site
  • Hanover, Germany, 30625
    • GSK Investigational Site
  • München, Germany, 80336
    • GSK Investigational Site
• Italy
  • Milan, Italy, 20142
    • GSK Investigational Site
  • Modena, Italy, 41100
    • GSK Investigational Site
  • Roma, Italy, 161
    • GSK Investigational Site
  • Torino, Italy, 10149
    • GSK Investigational Site
• Mexico
  • Monterrey, Mexico, 64460
    • GSK Investigational Site
  • Mérida, Mexico, 97070
    • GSK Investigational Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3079 DZ
    • GSK Investigational Site
  • Utrecht, Netherlands, 3584 CX
    • GSK Investigational Site
• Portugal
  • Porto, Portugal, 4099-001
    • GSK Investigational Site
  • Porto, Portugal, 4200-319
    • GSK Investigational Site
  • Vila Nova de Gaia, Portugal, 4434-502
    • GSK Investigational Site
• Spain
  • Guadalajara, Spain, 19002
    • GSK Investigational Site
  • Zaragoza, Spain, 50009
    • GSK Investigational Site
  • Catalonia
    • Manresa, Catalonia, Spain, 08243
      • GSK Investigational Site
    • Sabadell, Catalonia, Spain, 8208
      • GSK Investigational Site
• United Kingdom
  • Liverpool, United Kingdom, L7 8XP
    • GSK Investigational Site
  • London, United Kingdom, SE1 9RT
    • GSK Investigational Site
  • London, United Kingdom, SW7 2AZ
    • GSK Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • GSK Investigational Site
  • California
    • Bakersfield, California, United States, 93301
      • GSK Investigational Site
    • Palm Springs, California, United States, 92262
      • GSK Investigational Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20005
      • GSK Investigational Site
  • Florida
    • Ft. Pierce, Florida, United States, 34982
      • GSK Investigational Site
    • Miami, Florida, United States, 33133
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • GSK Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30912
      • GSK Investigational Site
    • Decatur, Georgia, United States, 30033
      • GSK Investigational Site
    • Macon, Georgia, United States, 31201
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02043
      • GSK Investigational Site
  • Michigan
    • Berkley, Michigan, United States, 48072
      • GSK Investigational Site
    • Detroit, Michigan, United States, 48202
      • GSK Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • GSK Investigational Site
  • New York
    • The Bronx, New York, United States, 10467
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • GSK Investigational Site
    • Greensboro, North Carolina, United States, 27401
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401-7684
      • GSK Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44304
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants living with HIV-1 and had documented plasma HIV-1 RNA <50 c/mL within 3 months prior to Screening.
• Participants had been on uninterrupted ART for ≥1 year (except for brief periods [less than 30 days] where all ART had been stopped due to tolerability and/or safety concerns).
• Participants had been on uninterrupted BIC/FTC/TAF for at least 6 months prior to Screening.
• Participants had plasma HIV-1 RNA <50 c/mL at Screening.
• Participants had no known prior regimen switches due to documented virologic failure (defined as a confirmed plasma HIV-1 RNA ≥200 c/mL).
• Participants with unknown full treatment/clinical history beyond 5 years prior to Screening may have been eligible upon discussion and agreement with the medical monitor.

Exclusion Criteria:

• Women participants were pregnant or breastfeeding or planned to become pregnant or breastfeed during the study.
• Participants had any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/cubic millimetre (mm^3) were not exclusionary.
• Participants had signs and symptoms which, in the opinion of the investigator, were suggestive of active severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) infection within 14 days prior to enrolment.
• Participants had severe hepatic impairment (Class C) as determined by Child-Pugh classification.

• Evidence of hepatitis B virus (HBV) infection was based on the results of testing at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows:

  1. Participants positive for HBsAg were excluded;
  2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, were excluded;
  3. Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) were immune to HBV and were not excluded.
• Participants had unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
• Participants had a history of liver cirrhosis with or without hepatitis viral co-infection.
• Participants had untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who were at least 7 days post completed treatment were eligible.
• Participants had a history or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicated their participation.
• Participants had ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
• Participants who, in the investigator's judgment, posed a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation was considered when evaluating for suicide risk.
• Participants had any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major Integrase strand transfer inhibitor (INSTI) resistance associated mutation in any available prior resistance genotype assay test result. All available historical resistance reports with HIV-1 reverse transcriptase or integrase genotypic data were provided to ViiV after screening and before enrollment for review by ViiV Virology.
• Participants had any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipid abnormalities.

Alanine aminotransferase (ALT) was ≥5 times the upper limit of normal (ULN) or ALT was ≥3×ULN and bilirubin was ≥1.5×ULN (>35% direct bilirubin).

- Participants had estimated creatine clearance <30 mL/min per 1.73 square meter (m^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr_R) method.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose combination (FDC); Participants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) Antiretroviral Therapy (ART).

Drug: DTG/3TC; DTG/3TC FDC was administered once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48	Participants with HIV-1 RNA >= 50 c/mL were evaluated. Virologic outcome was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the Week 48 Window. The analysis was done using the modified Snapshot algorithm.	At Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24	The number of participants with plasma HIV-1 RNA >/=50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.	At Week 24
Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 96	Data not available at the time of posting, will be updated at the final results disclosure stage.	At Week 96
Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24	The number of participants with plasma HIV-1 RNA <50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.	At Week 24
Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48	The number of participants with plasma HIV-1 RNA < 50 c/mL at Week 48 was analyzed using the modified Snapshot Algorithm.	At Week 48
Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 96	Data not available at the time of posting, will be updated at the final results disclosure stage.	At Week 96
Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24		At Week 24
Absolute Values for CD4+ Cells Count at Week 48		At Week 48
Absolute Values for CD4+ Cells Count at Week 96	Data not available at the time of posting, will be updated at the final results disclosure stage.	At Week 96
Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 24	The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.	At Week 24
Absolute Values for CD4:CD8 Ratio at Week 48	The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.	At Week 48
Absolute Values for CD4:CD8 Ratio at Week 96	Data not available at the time of posting, will be updated at the final results disclosure stage.	At Week 96
Change From Baseline in CD4+ Cells Count at Week 24		At Week 24 compared to Baseline
Change From Baseline in CD4+ Cells Count at Week 48		At Week 48 compared to Baseline
Change From Baseline in CD4+ Cells Count at Week 96	Data not available at the time of posting, will be updated at the final results disclosure stage.	At Week 96 compared to baseline
Change From Baseline in CD4:CD8 Ratio at Week 24	The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.	At Week 24 compared to Baseline
Change From Baseline in CD4:CD8 Ratio at Week 48	The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.	At Week 48 compared to Baseline
Change From Baseline in CD4:CD8 Ratio at Week 96	Data not available at the time of posting, will be updated at the final results disclosure stage.	At Week 96 compared to baseline
Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 24	Occurrence of disease progression was evaluated through HIV-associated conditions and incidence of disease progression to United States Centers for Disease Control and Prevention (CDC) stage 3 or death.	Up to Week 24
Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 48		Up to Week 48
Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 96		Week 96
Number of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion	Confirmed virologic withdrawal criteria is defined as two consecutive assessments with HIV-1 RNA greater than or equal to (>=)200 c/mL after Day 1 visit.	Up to Week 48
Number of Participants With Viral Resistance After Meeting CVW Criterion	Data not available at the time of posting, will be updated at the final results disclosure stage.	From Week 48 to Week 96
Number of Participants With Treatment Related Non-serious Adverse Events (AEs)	A treatment related non-serious AE is defined as any untoward medical occurrence in a clinical study participant considered related to the study treatment. Any = occurrence of the event regardless of intensity grade	Up to Week 48
Number of Participants With Treatment Related Non-serious AEs	Data not available at the time of posting, will be updated at the final results disclosure stage.	From Week 48 to Week 96
Number of Participants With Any Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.	Up to Week 48
Number of Participants With SAEs	Data not available at the time of posting, will be updated at the final results disclosure stage.	From Week 48 to Week 96
Number of Participants With AEs Leading to Treatment Discontinuation		Up to Week 48
Number of Participants With AEs Leading to Treatment Discontinuation	Data not available at the time of posting, will be updated at the final results disclosure stage.	From Week 48 to Week 96

Collaborators and Investigators

• Sponsor: ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): February 9, 2026

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Lamivudine; Dolutegravir; Emtricitabine; Tenofovir alafenamide; Bictegravir; Biktarvy; Switch study; Dovato; Human Immunodeficiency Virus (HIV)-1; ≥50 years
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 219516; 2022-503137-66-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No