AIDS research and therapy · 2026
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.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Akalın Halis, İnan Asuman, Kaya Bülent, Gökengin Deniz, İnan Dilara, Görenek Levent, Özdemir Hülya Özkan, Altunsoy Adalet, Aydin Mehtap, Şimşek Funda, Çağatay Atahan, Kutlu Selda Sayin, Asan Ali, Atalay Sabri, Birengel Serhat, Korten Volkan, KLİMİK HIV TR Working Group - Turkish Society of Clinical Microbiology and Infectious Diseases(KLİMİK)
Аннотация
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 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).
RESULTS: 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/mm3. 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.
CONCLUSIONS: 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.
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 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).
RESULTS: 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/mm3. 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.
CONCLUSIONS: 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.