Clinical trial NCT06518213: Efficacy and Safety of First-line ART With BIC/FTC/TAF Introduced at the First Clinical Visit
Official title: Efficacy and Safety of First-line Antiretroviral Therapy (ART) With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Introduced at the First Clinical Visit: a Real-life Retrospective Single Arm Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
bictegravir
rapid start
same-day initiation
Lead sponsor: University Hospital for Infectious Diseases, Croatia
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Virological suppression (HIV-1 RNA below 50 copies/mL plasma)
timeFrame: 12±3 months of ART (BIC/FTC/TAF)
Secondary outcomes:
measure: HIV-1 RNA 50-200 copies/mL
timeFrame: 6 and 12 months of treatment
measure: HIV-1 RNA above 200 copies/mL
timeFrame: 6 and 12 months of treatment
measure: Virological failure
timeFrame: 6 and 12 months of treatment
measure: Number of CD4+ T-lymphocytes
timeFrame: 6 and 12 months of treatment
measure: Change in CD4+/CD8+ T-lymphocytes ratio
timeFrame: 6 and 12 months of treatment
measure: Side effect to the drug BIC/FTC/TAF
timeFrame: through study completion, an average of 1 year
measure: Change in weight
timeFrame: 6 and 12 months of treatment
measure: Change in eGFR
timeFrame: 6 and 12 months of treatment
measure: Change in liver enzymes
timeFrame: 6 and 12 months of treatment
measure: Lipids concentration
timeFrame: 6 and 12 months of treatment
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''
state: City Of Zagreb
Study officials:
affiliation: University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''
name: Josip Begovac, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.