BIKSWITCH Study: Effectiveness and Safety of Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Therapies Not Based on Integrase Inhibitors in Virologically Suppressed HIV‐Infected Patients
Year: 2025
Type: article
Study design: Observational Study
Abstract: Objectives: Beyond initial antiretroviral therapy (ART), bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg (B/F/TAF) has been evaluated as an option for the continuation of treatment for virologically suppressed individuals who switch from other regimens. While treatment-emergent resistance to bictegravir has not been observed in clinical trials, rare case reports have described resistance development during B/F/TAF therapy, typically in the context of suboptimal adherence. Its favourable safety profile, minimal drug-drug interactions and proven virological efficacy suggest that virologically suppressed individuals may benefit from switching to B/F/TAF. Methods: Descriptive, retrospective, observational study of adults with HIV infection receiving effective non-INSTI (integrase strand transfer inhibitors)-based ART who switched to a B/F/TAF, but not all were suppressed. We compared individuals' viral loads, CD4+ lymphocyte counts, glomerular filtration rates, and lipid profiles before the switch and after 24 weeks of B/F/TAF. Safety was also assessed. Results: Seventy-nine individuals switched from non-INSTI-based therapies to B/F/TAF. At 24 weeks after the switch, HIV-1 RNA < 50 copies/mL was reported in 96.1% and 92.4% of participants per protocol and intention-to-treat analysis, respectively, compared to 81.0% at baseline. This represents a 15.1% increase in virologic suppression (viral load < 50 copies/mL) compared to baseline. No significant changes were detected in the CD4+ lymphocyte count, glomerular filtration rate, or lipid profile. Adverse events (AEs) were reported in 5.1% of patients. Three patients discontinued treatment due to AEs. Conclusions: The results of this study suggest that patients can switch to B/F/TAF from non-INSTI-based therapies without compromising the effectiveness or safety of ART.
Source: AIDS Research and Treatment
DOI: 10.1155/arat/8818830
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,000
Funder: Gilead Sciences
OpenAlex ID: W4417361707
