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

Condition(s) studied

Investigational drug(s) / intervention(s)

Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF): Evaluation of retention in care and description of clinical characteristics of HIV-infected women treated with Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF). Most published studies treatment of women with Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) recruited very few women and focused on efficacy and safety. This study focuses on partecipants' characteristcs and their interaction with retention in care

Study summary

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

Eligibility

Primary outcome measure(s)

• Retention in care rate — 2019-2027

Trial sites (1)

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