Follows women with HIV-1 who take bictegravir, emtricitabine and tenofovir

Trial details

Who runs it

Ente Ospedaliero Ospedali Galliera

Trial code

NCT07859904

Record updated

9 October 2026

Original description

Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an exclusively female cohort, aiming to improve treatment personalization and the early identification of risk factors for poor retention and treatment failure in this population.Read full original descriptionShow less

Ambispective Observational Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).

Women are an underrepresented population in clinical studies on HIV and antiretroviral therapy. This study aims to help bridge this gap by providing real-world data on therapeutic management with B/F/TAF (Biktarvy) in an exclusively female cohort, aiming to improve treatment personalization and the early identification of risk factors for poor retention and treatment failure in this population.

This study is single-center, ambispective observational. The retrospective component analyzes medical record data from June 2019 (the date BIC/FTC/TAF became available in Italy) to the study data cutoff. The prospective component involves data collection during routine follow-up visits up to December 31, 2027. No diagnostic or therapeutic procedures beyond standard clinical practice are involved.

The study opulation includes adult women (≥18 years of age) with a confirmed diagnosis of HIV-1 infection who have received at least one prescription for BIC/FTC/TAF at the Infectious Diseases Unit of E.O. Ospedali Galliera in Genoa from June 2019 to the present, with a documented follow-up of at least 6 months.

The primary objective of the study is to determine the 12- and 24-month retention-in-care rates among women treated with B/F/TAF (Biktarvy) and to identify factors associated with treatment maintenance and predictors of treatment discontinuation.

Secondary objectives of the study include:

* Percentage of women achieving/maintaining virologic suppression (<50 copies/mL) at 12 and 24 months during B/F/TAF treatment * Evaluation of treatment persistence with B/F/TAF across different age groups * Analysis of reasons for discontinuing B/F/TAF (adverse events, patient choice, planned switch, other) * Identification of factors associated with virologic failure during B/F/TAF therapy * Evaluation of the impact of menopausal status (pre- vs. post-menopause) on retention and virologic outcomes * Analysis of the effect of the menopausal transition during follow-up on outcomes * Correlation of past virologic history (nadir CD4, peak viremia, previous failures) with outcomes * Evaluation of the impact of prior antiretroviral treatment history (previous lines, drug classes used, documented resistance) * Analysis of demographic and socioeconomic variables associated with treatment persistence and virologic success

Inclusion: Adult women; at least 18 years; documented HIV-1 infection; actively receiving treatment with BIC/FTC/TAF started between 2019 and enrollment date; at lest 6 months follow up after starting BIC/FTC/TAF.

Exclusion: loss to follow up before 6 months from starting BIC/FTC/TAF; unavailability of data/information on follow up after starting BIC/FTC/TAF.

ClinicalTrials.gov NCT07859904