Bictegravir’s effect on persistent low-level viremia and immunological response. BELAIR study: A pilot prospective observational study

BackgroundReal-world experience with low-level viremia (LLV) remains under reported, leading to limited knowledge about the clinical management and impact of persistent LLV on subsequent emergence of drug resistance and virologic failure (VF). The aim of this study was to assess the effect of bictegravir on the virologic outcomes in treatment-experienced people with HIV (PWHIV) with persistent LLV.Patients and MethodsAn observational, prospective study in which treatment-experienced PWHIV experiencing LLV were included after switch to BIC/TAF/FTC. Baseline demographic and clinical characteristics were collected from the participants' medical records. CD4 + T-cell counts, CD4/CD8 ratios, and HIV-RNA levels were evaluated 2, 6, 12, 18, and 24 months after initiation of BIC/TAF/FTC. Statistical analysis of the data was performed using IBM Statistical Package for Social Sciences (SPSS), version 19.0 (IBM Corp., Armonk, NY, USA).ResultsA total number of 31 PWHIV, 21 males, with a mean age of 47.08 ± 7.48 years, were included. The current ART regimen before switch was based on Integrase Strand Transfer Inhibitors (INSTIs) in 30 PWH (96.8%). The mean CD4 + T-cell count after bictegravir initiation (619.45 ± 181.71, <i>p</i> < 0.001) was significantly elevated compared to the baseline mean CD4 + T-cell count (485.85 ± 166.92). Two months after bictegravir initiation, viral suppression was achieved at 58.1% (n = 18), and at 90.3% (n = 28) at 12 months, which was maintained at 18 and 24 months. A significant gradual elevation of CD4/CD8 ratio was also observed (0.51 ± 0.30 before switch vs 0.69 ± 0.35 at 12 months, <i>p</i> < 0.001).ConclusionThe results of the present study indicate that BIC/TAF/FTC may improve the immunological response and reduce the proportion of PWHIV experiencing persistent LLV. Further studies in larger patient series are needed to determine the full beneficial role of bictegravir.