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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06518213

Enrollment

112

Registered

2024-07-24

Start date

2019-05-01

Completion date

2024-03-31

Last updated

2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, bictegravir, rapid start, same-day initiation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Virological suppression (HIV-1 RNA below 50 copies/mL plasma)	12±3 months of ART (BIC/FTC/TAF)	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

Secondary

Measure	Time frame	Description
HIV-1 RNA above 200 copies/mL	6 and 12 months of treatment	HIV-1 RNA above 200 copies/mL of plasma after 6 and 12 months of treatment
Virological failure	6 and 12 months of treatment	Virological failure (HIV-1 RNA above 50 copies/mL) after 6 and 12 months of treatment with BIC/FTC/TAF
Number of CD4+ T-lymphocytes	6 and 12 months of treatment	Change in the number of CD4+ T-lymphocytes per microL of blood compared to the initial value after 6 and 12 months of treatment
Change in CD4+/CD8+ T-lymphocytes ratio	6 and 12 months of treatment	Change in ratio of CD4+ and CD8+ T-lymphocytes measured after 6 and 12 months of treatment
HIV-1 RNA 50-200 copies/mL	6 and 12 months of treatment	HIV-1 RNA 50-200 copies/mL of plasma after 6 and 12 months of treatment
Change in weight	6 and 12 months of treatment	Change in patient's weight in kilograms measured after 6 and 12 months of treatment
Change in eGFR	6 and 12 months of treatment	Change in estimated glomerular filtration rate (mL/min/1.73 m2) measured after 6 and 12 months of treatment
Change in liver enzymes	6 and 12 months of treatment	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
Lipids concentration	6 and 12 months of treatment	Change in lipids (total cholesterol, LDL, HDL and triglycerides) concentration (mmol/L) measured after 6 and 12 months of treatment
Side effect to the drug BIC/FTC/TAF	through study completion, an average of 1 year	Side effect to the administered medication which required discontinuation of treatment

Countries

Croatia

Outcome results