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.
Study Type
OBSERVATIONAL
Enrollment
112
University Hospital for Infectious Diseases ''Dr. Fran Mihaljevic''
Zagreb, City of Zagreb, Croatia
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
Time frame: 12±3 months of ART (BIC/FTC/TAF)
HIV-1 RNA 50-200 copies/mL
HIV-1 RNA 50-200 copies/mL of plasma after 6 and 12 months of treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 and 12 months of treatment
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