Analysis of baseline laboratory characteristics of HIV-positive patients in Bulgaria treated with bictegravir /emtricitabine/ tenofovir anafelamide (early analysis)

Abstract

Introduction: Bictegravir/Emtricitabine/Tenofovir Anafelamide (B/F/TAF) is a recommended single tablet regimen with good tolerability and safety as well as durability of the virologic response. From its introduction in the country of Bulgaria in April 2021 till November 2021 it was given to 82 patients, followed up and treated in the Department for HIV at the Prof. Ivan Kirov Specialized Hospital for Active Treatment of Infectious and Parasitic Diseases, in 60 (72%) of which the therapeutic regimen was changed mainly from protease – inhibitor-containing regimens. Materials and methods: We present the initial 24-week period of the application of this therapeutic regimen. Our purpose was to analyze the main reasons for a switch of the cART among patients, in which the therapeutic regimen was switched, to analyse the dynamics of the basic immunologic and virologic values of the patients, and to try to analyse the safety and efficacy of the regimen. Results: Patients of nearly all age groups were enrolled in the study. The main therapeutic regimens, from which patients were switched to B/F/TAF were protease inhibitor-based, the main reason being suboptimal viral suppression, followed by simplification of cART. Side effects were the third leading cause for the switch, mainly due to gastrointestinal symptoms. Nearly half of the patients had CD 4+ T-cell count of > 500/mm3 at the time of the switch and undetectable viral load levels. The test statistical analyses of the immunological and virologic levels before and after the administration of B/F/TAF showed statistical significance as far as the viral load was concerned. Analyses of factors of prognostic importance for maintaining stable virologic response showed that CD + T-cell values, CD4:CD8 ratio before administration, VL before administration as well as time of intake proved to be of prognostic value. Cholesterol levels in patients with hypercholesterolemia were significantly lower. Conclusion: A relatively large number of patients were enrolled for a relatively short period of time; B/F/TAF proved to be of good efficacy and safety.