International journal of antimicrobial agents · 2025
Effectiveness and safety of tenofovir alafenamide fumarate-based therapy compared with tenofovir disoproxil fumarate- and abacavir-based therapy in children and young people living with HIV in Europe.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Epidemiology of Pregnancy and Paediatric Infections International Cohort Collaboration (EPPICC) study group. Electronic address: e.chappell@ucl.ac.uk, Epidemiology of Pregnancy and Paediatric Infections International Cohort Collaboration (EPPICC) study group
Аннотация
OBJECTIVE: This study aimed to describe the uptake of TAF, and to compare the effectiveness and safety of tenofovir alafenamide fumarate (TAF)-based therapy with tenofovir disoproxil fumarate (TDF)- and abacavir (ABC)-based therapy among children and young people living with HIV (CYPLHIV) in real-world settings, using data from the Epidemiology of Pregnancy and Paediatric Infections International Cohort Collaboration (EPPICC) study.
METHODS: The effectiveness and safety outcomes were compared between those on tenofovir TAF, TDF or ABC, among CYPLHIV aged 6 to <25 years.
RESULTS: We included 577 CYPLHIV who received TAF, 428 TDF, and 426 ABC. Among them, 96%, 83% and 55% were ART experienced, the median age at drug start was 15.8, 14.6 and 12.5 years, and the median duration of follow-up was 1.6, 2.3 and 3.0 years, respectively. Among all ART-experienced CYPLHIV at drug start, there was no difference in the proportion virologically suppressed at 48 weeks. However, in those suppressed at drug start, the proportion suppressed at 48 weeks was higher on TDF than on TAF (P = 0.008). There was no difference in time to suppression (amongst unsuppressed at start) or to viral failure. Among those on TAF, there were four serious adverse events, of which one (renal colic) was considered related to TAF and led to drug discontinuation. The rate of treatment-emergent grade ≥1 laboratory events was highest on TAF (adjusted incidence rate ratio vs. TAF: TDF 0.74 (0.56-0.99, P = 0.046); ABC 0.69 (0.53-0.88), P = 0.004). Rates of grade ≥1 low-density lipoprotein and total cholesterol events on TAF were comparable on ABC, but higher than TDF, with no difference in bone/renal markers. There was no significant difference in grade ≥3 events (P > 0.5), although the numbers were small. The risk of discontinuation (for reasons other than optimisation/simplification/unknown reason) was lowest for TAF.
CONCLUSIONS: Virological outcomes were similar across drugs. Rates of any grade laboratory events were highest on TAF, driven by higher rates of lipid events. As TAF uptake increases, studies with long-term follow-up are required.
METHODS: The effectiveness and safety outcomes were compared between those on tenofovir TAF, TDF or ABC, among CYPLHIV aged 6 to <25 years.
RESULTS: We included 577 CYPLHIV who received TAF, 428 TDF, and 426 ABC. Among them, 96%, 83% and 55% were ART experienced, the median age at drug start was 15.8, 14.6 and 12.5 years, and the median duration of follow-up was 1.6, 2.3 and 3.0 years, respectively. Among all ART-experienced CYPLHIV at drug start, there was no difference in the proportion virologically suppressed at 48 weeks. However, in those suppressed at drug start, the proportion suppressed at 48 weeks was higher on TDF than on TAF (P = 0.008). There was no difference in time to suppression (amongst unsuppressed at start) or to viral failure. Among those on TAF, there were four serious adverse events, of which one (renal colic) was considered related to TAF and led to drug discontinuation. The rate of treatment-emergent grade ≥1 laboratory events was highest on TAF (adjusted incidence rate ratio vs. TAF: TDF 0.74 (0.56-0.99, P = 0.046); ABC 0.69 (0.53-0.88), P = 0.004). Rates of grade ≥1 low-density lipoprotein and total cholesterol events on TAF were comparable on ABC, but higher than TDF, with no difference in bone/renal markers. There was no significant difference in grade ≥3 events (P > 0.5), although the numbers were small. The risk of discontinuation (for reasons other than optimisation/simplification/unknown reason) was lowest for TAF.
CONCLUSIONS: Virological outcomes were similar across drugs. Rates of any grade laboratory events were highest on TAF, driven by higher rates of lipid events. As TAF uptake increases, studies with long-term follow-up are required.