Expert review of anti-infective therapy · 2026
Switching from tenofovir disoproxil fumarate to bictegravir/emtricitabine/ tenofovir alafenamide or non-tenofovir alafenamide regimens: a real-world study of safety and efficacy in Chinese people living with HIV.
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Wang Fada, Zheng Liyuan, Song Xiaojing, Zhang Leidan, Chen Ling, Li Yanling, Han Yang, Yu Wei, Cao Wei, Li Taisheng
Аннотация
BACKGROUND: Tenofovir disoproxil fumarate (TDF) carries bone and renal toxicity risks. Data are limited on Chinese people living with HIV (PLWH) switching from TDF-based regimens to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and non-BIC/FTC/TAF.
RESEARCH DESIGN AND METHODS: This retrospective cohort study enrolled virologically-suppressed PLWH receiving TDF (>48 weeks) at PUMCH (2014-2025). We analyzed efficacy/safety at 96 weeks post-switch to BIC/FTC/TAF or non-BIC/FTC/TAF. Primary endpoints: viral suppression, immune recovery, and safety [bone mineral density(BMD)/eGFR/weight/serum lipids], assessed from 48 weeks pre-switch to 96 weeks post-switch.
RESULTS: After screening, 169 of 1,592 PLWH were enrolled (mean age 41 years; 89.3% male; mean TDF duration 67.8 month): 111 switched to BIC/FTC/TAF, 58 to non-BIC/FTC/TAF (25 dolutegravir-based). All BIC/FTC/TAF recipients maintained virologic suppression but one low-level viremia in non-BIC/FTC/TAF, CD4+ T-cell increased similarly (p > 0.05). Pre-switch (48-week on TDF) BMD decreased (spine/hip/femoral neck: -1.78%/-3.03%/-2.39%); At week 96 post-switch, BMD increased (BIC/FTC/TAF: +3.55%/+2.52%/+3.48%; non-BIC/FTC/TAF: +2.18%/+2.19%/+2.8%; p > 0.05). Pre-switch eGFR similarly decreased: -9 mL/min/1.73 m2, post-switch increased (BIC/FTC/TAF +3.6 vs non-BIC/FTC/TAF +5.1, p > 0.05). Pre-switch slight weight gain (+0.27 kg), post-switch: BIC/FTC/TAF (+1.59 kg), dolutegravir (DTG)-based (+3.54 kg), non-DTG/BIC (+0.95 kg). Serum lipids increased in all groups (p > 0.05).
CONCLUSIONS: Switching from TDF to BIC/FTC/TAF or Non-BIC/FTC/TAF was associated with improved bone/renal safety with maintained efficacy in Chinese PLWH. But integrase strand transfer inhibitor(INSTI)-based regimens necessitate monitoring for weight and lipid changes. These findings warrant confirmation in larger studies.
RESEARCH DESIGN AND METHODS: This retrospective cohort study enrolled virologically-suppressed PLWH receiving TDF (>48 weeks) at PUMCH (2014-2025). We analyzed efficacy/safety at 96 weeks post-switch to BIC/FTC/TAF or non-BIC/FTC/TAF. Primary endpoints: viral suppression, immune recovery, and safety [bone mineral density(BMD)/eGFR/weight/serum lipids], assessed from 48 weeks pre-switch to 96 weeks post-switch.
RESULTS: After screening, 169 of 1,592 PLWH were enrolled (mean age 41 years; 89.3% male; mean TDF duration 67.8 month): 111 switched to BIC/FTC/TAF, 58 to non-BIC/FTC/TAF (25 dolutegravir-based). All BIC/FTC/TAF recipients maintained virologic suppression but one low-level viremia in non-BIC/FTC/TAF, CD4+ T-cell increased similarly (p > 0.05). Pre-switch (48-week on TDF) BMD decreased (spine/hip/femoral neck: -1.78%/-3.03%/-2.39%); At week 96 post-switch, BMD increased (BIC/FTC/TAF: +3.55%/+2.52%/+3.48%; non-BIC/FTC/TAF: +2.18%/+2.19%/+2.8%; p > 0.05). Pre-switch eGFR similarly decreased: -9 mL/min/1.73 m2, post-switch increased (BIC/FTC/TAF +3.6 vs non-BIC/FTC/TAF +5.1, p > 0.05). Pre-switch slight weight gain (+0.27 kg), post-switch: BIC/FTC/TAF (+1.59 kg), dolutegravir (DTG)-based (+3.54 kg), non-DTG/BIC (+0.95 kg). Serum lipids increased in all groups (p > 0.05).
CONCLUSIONS: Switching from TDF to BIC/FTC/TAF or Non-BIC/FTC/TAF was associated with improved bone/renal safety with maintained efficacy in Chinese PLWH. But integrase strand transfer inhibitor(INSTI)-based regimens necessitate monitoring for weight and lipid changes. These findings warrant confirmation in larger studies.