Passerotto R A, Lamanna F, Salvo P F, Iannone V, Steiner R J, Carbone A, Farinacci D, D'Angelillo A, Baldin G, Ciccullo A, Di Giambenedetto S, Torti C, Borghetti A
Dipartimento di Sicurezza e Bioetica, Sezione di Malattie Infettive, Università Cattolica del Sacro Cuore, Roma, Italia.
UOC Malattie Infettive, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia.
Antivir Ther. 2024 Dec;29(6):13596535241306467. doi: 10.1177/13596535241306467.
BIC/FTC/TAF showed efficacy and tolerability in randomized trials as a switch strategy in virologically-suppressed people living with HIV. We evaluated its effectiveness in a real-life setting.
A retrospective monocentric cohort including 431 virologically-suppressed (HIV-RNA <50 copies/ml) people switching to BIC/FTC/TAF in the period 2018-2022 was evaluated. Probabilities of virological failure (VF, i.e.2 consecutive HIV-RNA ≥50 copies/ml or a single HIV-RNA ≥200 copies/ml) and of treatment discontinuation (TD) were estimated by Kaplan-Meier, and predictors of both outcomes were identified through multivariable Cox regression. Analysis-of-variance for repeated measures was used to examine changes in CD4 count and CD4-to-CD8 ratio.
Overall, 16 VF occurred during 22 months of median follow-up time. Estimated probabilities of VF at 1, 2 and 3 years were 2.0% (95% CI 1.04.2%), 2.9% (95% CI 1.5%-5.6%) and 5.5% (95% CI 3.2%-9.2%), respectively. Caucasian ethnicity and a history of previous VF independently predicted VF. TD occurred in 42 cases, predominantly for simplification. One discontinuation due to VF was reported. No predictors of discontinuation were identified. An increase in CD4-to-CD8 ratio over 3 years was evidenced ( < 0.001). Total cholesterol decreased over 3 years ( < 0.001). Triglycerides did not significantly change ( = 0.465).
BIC/FTC/TAF demonstrated high effectiveness, tolerability and safety.
在随机试验中，比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）作为一种转换策略，在病毒学抑制的HIV感染者中显示出疗效和耐受性。我们评估了其在实际临床环境中的有效性。
对一个回顾性单中心队列进行评估，该队列包括2018年至2022年期间431名病毒学抑制（HIV-RNA＜50拷贝/毫升）且转换为BIC/FTC/TAF的患者。通过Kaplan-Meier法估计病毒学失败（VF，即连续两次HIV-RNA≥50拷贝/毫升或单次HIV-RNA≥200拷贝/毫升）和治疗中断（TD）的概率，并通过多变量Cox回归确定这两种结果的预测因素。采用重复测量方差分析来检查CD4细胞计数和CD4与CD8比值的变化。
总体而言，在中位随访时间22个月期间发生了16例病毒学失败。1年、2年和3年时病毒学失败的估计概率分别为2.0%（95%CI 1.0%-4.2%）、2.9%（95%CI 1.5%-5.6%）和5.5%（95%CI 3.2%-9.2%）。白种人种族和既往病毒学失败史是病毒学失败的独立预测因素。42例发生了治疗中断，主要原因是简化治疗方案。报告了1例因病毒学失败导致的治疗中断。未发现治疗中断的预测因素。3年内CD4与CD8比值有所增加（P＜0.001）。总胆固醇在3年内下降（P＜0.001）。甘油三酯无显著变化（P = 0.465）。
BIC/FTC/TAF显示出高效性、耐受性和安全性。
