Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA 50-200 copies/mL | HIV-1 RNA 50-200 copies/mL of plasma after 6 and 12 months of treatment | 6 and 12 months of treatment |
| HIV-1 RNA above 200 copies/mL | HIV-1 RNA above 200 copies/mL of plasma after 6 and 12 months of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josip Begovac, Prof. | University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic'' | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic'' | Zagreb | City of Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34006927 | Result | 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. | |
| 35169590 | 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. |
| Label | URL |
|---|---|
| European AIDS Clinical Society guidelines for the management of people living with HIV in Europe | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 and 12 months of treatment |
| Virological failure | Virological failure (HIV-1 RNA above 50 copies/mL) after 6 and 12 months of treatment with BIC/FTC/TAF | 6 and 12 months of treatment |
| Number of CD4+ T-lymphocytes | Change in the number of CD4+ T-lymphocytes per microL of blood compared to the initial value after 6 and 12 months of treatment | 6 and 12 months of treatment |
| Change in CD4+/CD8+ T-lymphocytes ratio | Change in ratio of CD4+ and CD8+ T-lymphocytes measured after 6 and 12 months of treatment | 6 and 12 months of treatment |
| Side effect to the drug BIC/FTC/TAF | Side effect to the administered medication which required discontinuation of treatment | through study completion, an average of 1 year |
| Change in weight | Change in patient's weight in kilograms measured after 6 and 12 months of treatment | 6 and 12 months of treatment |
| Change in eGFR | Change in estimated glomerular filtration rate (mL/min/1.73 m2) measured after 6 and 12 months of treatment | 6 and 12 months of treatment |
| Change in liver enzymes | Change in liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) concentration (U/L) measured after 6 and 12 months of treatment | 6 and 12 months of treatment |
| Lipids concentration | Change in lipids (total cholesterol, LDL, HDL and triglycerides) concentration (mmol/L) measured after 6 and 12 months of treatment | 6 and 12 months of treatment |
| 38056572 | 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. |
| 36659824 | 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. |
| 38574873 | 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. |
| 35040990 | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |