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

University Hospital for Infectious Diseases, Croatia

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Other

Identifiers

NCT06518213

UHID-09

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

112 participants in 1 patient group

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

Description:

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.