Ciccullo Arturo, Baldin Gianmaria, Cervo Adriana, Moschese Davide, Lagi Filippo, Cossu Maria Vittoria, Grimaldi Alessandro, Giacomelli Andrea, Rusconi Stefano, Sterrantino Gaetana, Borghetti Alberto, Antinori Spinello, Mussini Cristina, Di Giambenedetto Simona
Infectious Diseases Unit, San Salvatore Hospital, L'Aquila, Italy.
Infectious Diseases Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
J Antimicrob Chemother. 2025 Jan 3;80(1):175-177. doi: 10.1093/jac/dkae392.
We compared the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) and dolutegravir plus lamivudine (DTG + 3TC) in our cohort of treatment-naive people with HIV (PWH).
In a multicentre cohort of treatment-naive PWH starting a first-line regimen with either dolutegravir plus lamivudine or BIC/FTC/TAF, Kaplan-Meier survival analysis was used to estimate time to virological failure (VF) and time to treatment discontinuation (TD), whereas Cox regression was used to evaluate predictors of VF and TD. Changes in CD4+ cell count were assessed via non-parametric tests, and linear regression analyses were performed to explore predictors of CD4+ cell count changes.
One hundred and seventy individuals were included: 66 started dolutegravir plus lamivudine (DTG group) and 104 started BIC/FTC/TAF (BIC group). During follow-up, we observed two VFs in the DTG group [1.7 per 100 person-years of follow-up (PYFU)] and two in the BIC group (1.7 per 100 PYFU). Estimated probability of remaining free from VF at Week 144 was 95.9% in the DTG group and 95.2% in the BIC group (log-rank P = 0.955). Four TDs were observed in the DTG group (3.4 per 100 PYFU) and 21 in the BIC group (17.6 per 100 PYFU). Estimated probability of maintaining the study regimen at Week 144 was 90.3% in the DTG group and 70.0% in the BIC group; individuals in the BIC group had a higher probability of TD (log-rank P = 0.003). In both groups, the CD4+ count improved significantly during follow-up.
Our study shows that both strategies are effective and safe, with few VFs and TDs due to tolerability issues.
我们比较了比克替拉韦/恩曲他滨/富马酸替诺福韦艾拉酚胺（BIC/FTC/TAF）和多替拉韦加拉米夫定（DTG+3TC）在我们初治HIV感染者（PWH）队列中的有效性和安全性。
在一个多中心队列中，初治的PWH开始使用多替拉韦加拉米夫定或BIC/FTC/TAF的一线治疗方案，采用Kaplan-Meier生存分析来估计病毒学失败（VF）时间和治疗中断（TD）时间，而Cox回归用于评估VF和TD的预测因素。通过非参数检验评估CD4+细胞计数的变化，并进行线性回归分析以探索CD4+细胞计数变化的预测因素。
纳入了170名个体：66人开始使用多替拉韦加拉米夫定（DTG组），104人开始使用BIC/FTC/TAF（BIC组）。在随访期间，我们在DTG组观察到2例VF[每100人年随访（PYFU）中有1.7例]，在BIC组观察到2例（每100 PYFU中有1.7例）。在第144周时，DTG组无VF的估计概率为95.9%，BIC组为95.2%（对数秩检验P=0.955）。在DTG组观察到4例TD（每100 PYFU中有3.4例），在BIC组观察到21例（每100 PYFU中有17.6例）。在第144周时，DTG组维持研究方案的估计概率为90.3%，BIC组为70.0%；BIC组的个体TD概率更高（对数秩检验P=0.003）。在两组中，随访期间CD4+计数均显著改善。
我们的研究表明，两种治疗策略均有效且安全，因耐受性问题导致的VF和TD较少。
