Effectiveness and tolerability of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in people with HIV (PWH) in routine clinical practice in Türkiye: 12-month outcomes from the KLIMIK HIV-TR cohort

Phase 3 trials have established the long-term efficacy and safety of BIC/FTC/TAF for both treatment-naïve and treatment-experienced people with HIV (PWH). Real-world evidence in patients with very high baseline viral load remains limited. This was a non-interventional, observational, retrospective analysis across 33 tertiary centers participating in the KLIMIK HIV-TR cohort. Adults (≥ 18 years) who initiated single-tablet BIC/FTC/TAF on or before August 31, 2022 were included. The primary endpoint was virological suppression at week-48, defined as HIV-1 RNA < 200 copies/mL. Suppression was further stratified by baseline viral load (< 100,000; > 100,000; > 1,000,000 copies/mL). 2262 patients were analyzed (1122 treatment-naïve [49.6%], 1140 treatment-experienced [50.4%]). Among treatment-naïve patients, 88.5% had baseline HIV-1 RNA > 100,000 copies/mL and 24.2% > 1,000,000 copies/mL; 55.7% had CD4 < 350 cells/mm 3 . Virological suppression (HIV-1 RNA < 200 copies/mL) in treatment-naïve patients was 95.6% and 98.3% at weeks 24 and 48 respectively. When a threshold of < 50 copies/mL was applied, virological suppression rates at weeks 24 and 48 were 81.9% and 93%, respectively. At week 24, virological suppression (HIV-1 RNA < 50 copies/mL) was lower in those with baseline HIV-1 RNA > 100,000 versus < 100,000 copies/mL (80.4% vs. 93.8%; p < 0.001), and lower in those with baseline HIV-1 RNA > 1,000,000 versus < 1,000,000 copies/mL (67.1% vs. 86.9%; p < 0.001). The median CD4/CD8 ratio in treatment-naïve patients increased from 0.44 at baseline to 1.06 at week 48 ( p < 0.001). In treatment-experienced patients, week 48 virological suppression was 92.2% (HIV-1 RNA < 50 copies/mL) and 96.5% (HIV-1 RNA < 200 copies/mL). No serious adverse events leading to discontinuation were observed. High virological suppression rates were observed among both treatment-naïve patients with very high baseline viral loads and treatment-experienced patients, supporting the effectiveness and safety profile of BIC/FTC/TAF in routine clinical practice.