Efficacy and Safety of First-line ART With BIC/FTC/TAF Introduced at the First Clinical Visit

NCT06518213 | Completed

• 1 other identifier: UHID-09
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral regimen. Croatia has a centralized care for people living with HIV (PLWH) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. This retrospective cohort study evaluated antiretroviral therapy (ART) naïve PLWH who initiated BIC/FTC/TAF, in a same-day model. The goal of the study is to assess safety and efficacy of this model by collecting information from the electronic database of the Croatian HIV Reference Centre.

Conditions

HIV Infections

Keywords

HIV; bictegravir; rapid start; same-day initiation

Outcome Measures

Primary Outcomes (1)

• Virological suppression (HIV-1 RNA below 50 copies/mL plasma)

  Virological suppression (HIV-1 RNA below 50 copies/mL plasma) after 12±3 months of antiretroviral treatment with first-line ART (BIC/FTC/TAF) initiated at first clinical contact

  12±3 months of ART (BIC/FTC/TAF)

Secondary Outcomes (10)

• HIV-1 RNA 50-200 copies/mL

  6 and 12 months of treatment

• HIV-1 RNA above 200 copies/mL

  6 and 12 months of treatment

• Virological failure

  6 and 12 months of treatment

• Number of CD4+ T-lymphocytes

  6 and 12 months of treatment

• Change in CD4+/CD8+ T-lymphocytes ratio

  6 and 12 months of treatment

Study Arms (1)

Cohort receiving BIC/FTC/TAF as a rapid start, same-day initiation ART

All included subjects (one group, no control group) were started therapy with BIC/FTC/TAF (co-formulated in one tablet of Biktarvy® consisting of 50 mg of bictegravir, 200 mg of emtricitabine and 25 mg of tenofovir alafenamide) within 24 hours of inclusion in care and continued for 12 months.

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

In Croatia, all people living with HIV are treated at the University Hospital for Infectious Diseases (UHID) in Zagreb in the HIV Outpatient Department. Included in the study were all patients who entered HIV care in the period from May 2019 to December 2022 and met the eligibility criteria.

You may qualify if:

• HIV seropositivity confirmed by a fourth generation test
• the subject had not previously taken ART
• ART was started within 24 hours of the first examination

You may not qualify if:

• persons under 18 years of age
• people who are pregnant, breastfeeding or planning to become pregnant
• unacceptable interaction with a drug that the subject is already taking

Sponsors & Collaborators

• University Hospital for Infectious Diseases, Croatia: lead

Study Sites (1)

University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''

Zagreb, City of Zagreb, 10000, Croatia

Location

Related Publications (6)

• Bogdanic N, Bendig L, Lukas D, Zekan S, Begovac J. Timeliness of antiretroviral therapy initiation in the era before universal treatment. Sci Rep. 2021 May 18;11(1):10508. doi: 10.1038/s41598-021-90043-7.

  PMID: 34006927 RESULT

• Mounzer K, Brunet L, Fusco JS, Mcnicholl IR, Diaz Cuervo H, Sension M, Mccurdy L, Fusco GP. Advanced HIV Infection in Treatment-Naive Individuals: Effectiveness and Persistence of Recommended 3-Drug Regimens. Open Forum Infect Dis. 2022 Jan 13;9(3):ofac018. doi: 10.1093/ofid/ofac018. eCollection 2022 Mar.

  PMID: 35169590 RESULT

• Camici M, Gagliardini R, Lanini S, Del Duca G, Mondi A, Ottou S, Plazzi MM, De Zottis F, Pinnetti C, Vergori A, Grilli E, Mastrorosa I, Mazzotta V, Paulicelli J, Bellagamba R, Cimini E, Tartaglia E, Notari S, Tempestilli M, Cicalini S, Amendola A, Abbate I, Forbici F, Fabeni L, Girardi E, Vaia F, Maggi F, Antinori A. Rapid ART initiation with bictegravir/emtricitabine/tenofovir alafenamide in individuals presenting with advanced HIV disease (Rainbow study). Int J Antimicrob Agents. 2024 Jan;63(1):107049. doi: 10.1016/j.ijantimicag.2023.107049. Epub 2023 Dec 5.

  PMID: 38056572 RESULT

• Bachelard A, Isernia V, Charpentier C, Benalycherif A, Mora M, Donadille C, Duvivier C, Lacombe K, El Mouhebb M, Spire B, Landman R, Descamps D, Peytavin G, Assoumou L, Ghosn J; FAST study group. Same-day initiation of bictegravir/emtricitabine/tenofovir alafenamide: Week 48 results of the FAST study-IMEA 055. J Antimicrob Chemother. 2023 Mar 2;78(3):769-778. doi: 10.1093/jac/dkad008.

  PMID: 36659824 RESULT

• Hidalgo-Tenorio C, Sequera S, Vivancos MJ, Vinuesa D, Collado A, Santos IL, Sorni P, Cabello-Clotet N, Montero M, Font CR, Terron A, Galindo MJ, Martinez O, Ryan P, Omar-Mohamed M, Albendin-Iglesias H, Javier R, Ruz MAL, Romero A, Garcia-Vallecillos C. Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naive HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial. Int J Antimicrob Agents. 2024 Jun;63(6):107164. doi: 10.1016/j.ijantimicag.2024.107164. Epub 2024 Apr 2.

  PMID: 38574873 RESULT

• Ambrosioni J, Rojas Lievano J, Berrocal L, Inciarte A, de la Mora L, Gonzalez-Cordon A, Martinez-Rebollar M, Laguno M, Torres B, Ugarte A, Chivite I, Leal L, de Lazzari E, Miro JM, Blanco JL, Martinez E, Mallolas J. Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre. J Antimicrob Chemother. 2022 Mar 31;77(4):1133-1139. doi: 10.1093/jac/dkab481.

  PMID: 35040990 RESULT

Related Links

• European AIDS Clinical Society guidelines for the management of people living with HIV in Europe

MeSH Terms

Conditions

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Josip Begovac, Prof.

  University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 24, 2024
• Study Start: May 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)