Retrospective Review of DTG/3TC Versus BIC/F/TAF Across a Multi Clinic Infectious Disease Organization in Southeast United States

NCT06393387 | Completed FDA Drug

• 1 other identifier: 222132
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This real-world retrospective study describes the clinical efficacy of 2DR (DOVATO® (DTG/3TC)) versus 3DR (BIKTARVY® (BIC/F/TAF)) in PWH, including those with at least 2 social determinants of health indicators, across a multi clinic infectious disease organization in the Southeast United States

Conditions

Hiv; HIV-1-infection; HIV Infections

Keywords

HIV; Social Determinants of Health; Adherence; Viral Suppression; Percent of Days Covered

Outcome Measures

Primary Outcomes (1)

• Viral Suppression

  To evaluate the effectiveness of switching treatment to DTG/3TC vs. BIC/F/TAF through 48 weeks in virally suppressed ART experienced individuals with no interruptions in prior therapy.

  48 Weeks

Secondary Outcomes (8)

• Viral Suppression

  24 Weeks

• Viral Suppression

  48 Weeks

• Viral Suppression

  24 Weeks

• Viral Suppression

  48 Weeks

• Viral Suppression

  24 Weeks

Other Outcomes (7)

• Viral Suppression

  48 Weeks

• Viral Suppression

  48 Weeks

• Viral Suppression

  48 Weeks

Study Arms (2)

Persons with HIV on DTG/3TC

All data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study.

Drug: DTG/3TC versus BIC/F/TAF

Persons with HIV on BIC/F/TAF

All data for PWH, initiated on DTG/3TC or BIC/F/TAF, between May 1, 2019 through January 28, 2023, will be collected for purposes of this retrospective study. 400 PWH on DTG/3TC and 400 PWH on BIC/F/TAF, for a total of 800 PWH, will be selected at random for inclusion in this retrospective study.

Drug: DTG/3TC versus BIC/F/TAF

Interventions

DTG/3TC versus BIC/F/TAF DRUG

A new-user, active comparator, retrospective cohort study design will be employed using inverse probability of treatment weighting to adjust for measured confounders. This study will be conducted as a retrospective chart review and the organization's electronic health record (EHR) will be utilized. Subjects identified as having previously been or currently receiving DTG/3TC or BIC/F/TAF will be assessed for eligibility based on inclusion/exclusion criteria. Subject eligibility will be confirmed by the Principal Investigator (PI).

Persons with HIV on BIC/F/TAF; Persons with HIV on DTG/3TC

Eligibility Criteria

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

Study Population

PWH from all 12 sites in Florida across Midway Specialty Care Center.

You may qualify if:

• Adults, aged 18 years and older;
• Diagnosis of HIV-1;
• Have a history of ART consisting of DTG/3TC or BIC/F/TAF, initiated from May 1, 2019 through January 28, 2023;
• Have at least 48 weeks of clinical follow up after initiation of DTG/3TC or BIC/F/TAF; clinical follow-up can include time post-discontinuation of either index regimen;
• Complete data, for HIV-1 RNA viral load at all study time points, including baseline, through 24 weeks and through 48 weeks;
• Received care from a physician, nurse practitioner or physician assistant at the organization

You may not qualify if:

• Index regimen is BIC/F/TAF and has a history of ART consisting of DTG+3TC or DTG/3TC;
• Index regimen is DTG/3TC and has a history of ART consisting of BIC/F/TAF

Sponsors & Collaborators

• Midway Specialty Care Center: lead

Study Sites (1)

Midway Specialty Care Center

West Palm Beach, Florida, 33401, United States

Location

Related Publications (7)

• Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9.

  PMID: 30420123 BACKGROUND

• Cahn P, Sierra Madero J, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man CY, Urbaityte R, Brandon DJ, Underwood M, Pappa KA, Curtis L, Smith KY, Gartland M, Aboud M, van Wyk J, Wynne B. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy - naive adults with HIV-1 infection. AIDS. 2022 Jan 1;36(1):39-48. doi: 10.1097/QAD.0000000000003070.

  PMID: 34534138 BACKGROUND

• Menza TW, Hixson LK, Lipira L, Drach L. Social Determinants of Health and Care Outcomes Among People With HIV in the United States. Open Forum Infect Dis. 2021 Jun 22;8(7):ofab330. doi: 10.1093/ofid/ofab330. eCollection 2021 Jul.

  PMID: 34307729 BACKGROUND

• van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

  PMID: 31905383 BACKGROUND

• Maggiolo F, Valenti D, Teocchi R, Comi L, Filippo ED, Rizzi M. Adherence to and Forgiveness of 3TC/DTG in a Real-World Cohort. J Int Assoc Provid AIDS Care. 2022 Jan-Dec;21:23259582221101815. doi: 10.1177/23259582221101815.

  PMID: 35695220 BACKGROUND

• Maggiolo F , MD, Valenti D , BSc, Teocchi R , BSc, Comi L , MD, Di Filippo E , MD, Rizzi M , MD. Real World Data on Forgiveness to Uncomplete Adherence to Bictegravir/ Emtricitabine/Tenofovir Alafenamide. J Int Assoc Provid AIDS Care. 2022 Jan-Dec;21:23259582221140208. doi: 10.1177/23259582221140208.

  PMID: 36423244 BACKGROUND

• Rolle CP, Berhe M, Singh T, Ortiz R, Wurapa A, Ramgopal M, Leone PA, Matthews JE, Dalessandro M, Underwood MR, Angelis K, Wynne BR, Merrill D, Nguyen C, van Wyk J, Zolopa AR. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS. 2021 Oct 1;35(12):1957-1965. doi: 10.1097/QAD.0000000000002979.

  PMID: 34115650 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jennifer Kuretski, DNP

  Midway Specialty Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Education

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)