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

Background 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. Methods 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 virologic 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). Results 2,262 patients were analyzed (1,122 treatment‑naïve [49.6%], 1,140 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/mm³. Virologic 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 used, 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 increased from 0.44 at baseline to 1.06 at week 48 (p<0.001). No serious adverse events leading to discontinuation were observed. Conclusions High efficacy was observed even among treatment‑naïve patients with very high baseline viral loads, supporting its use in this population.