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

Brief summary (registry, in English)

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

What you commit to

• Study type: Observational
• Planned participants: 100
• From 15 Dec 2026 to the primary completion date, 31 Dec 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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