Gagliardini Roberta, Gianotti Nicola, Maggiolo Franco, Cozzi-Lepri Alessandro, Antinori Andrea, Nozza Silvia, Lapadula Giuseppe, De Luca Andrea, Mussini Cristina, Gori Andrea, Saracino Annalisa, Andreoni Massimo, Monforte Antonella d'Arminio
Lazzaro Spallanzani National Institute for Infectious Diseases IRCCS, Rome, Italy.
Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy.
Int J Antimicrob Agents. 2021 Oct;58(4):106406. doi: 10.1016/j.ijantimicag.2021.106406. Epub 2021 Jul 19.
Comparisons between rilpivirine (RPV) and integrase strand transfer inhibitors (INSTIs) in antiretroviral therapy (ART)-naïve HIV-infected individuals are currently lacking. This study aimed to compare, in an observational cohort setting, the durability of treatment with RPV-based and INSTI-based first-line regimens.
Patients who started first-line ARTs based on RPV or INSTIs, with HIV-RNA < 100 000 copies/mL and CD4 cell count > 200 cells/μL were included. The primary endpoint was the cumulative probability of treatment failure (TF = virological failure [confirmed HIV-RNA > 50 copies/mL] or discontinuation of the anchor drug in the regimen), as assessed by the Kaplan-Meier method. A multivariable Cox regression was used to control for potential confounding.
Of the 1991 included patients, 986 started ART with an RPV-based regimen and 1005 with an INSTIs-based regimen. The median (IQR) follow-up was 20 (10, 35) months. The cumulative 2-year probability of TF with RPV (9.1% [95% 7.2, 11.1]) was lower than that observed in the INSTIs group (16.6% [13.8, 19.4], P = 0.0002) but not when compared with dolutegravir (DTG) alone. Starting ART with an INSTIs-based regimen vs. RPV was associated with a higher risk of TF after controlling for potential confounding factors (adjusted hazard ratio, AHR [95% CI]: 1.64 [1.28, 2.10]; P < 0.001). The results were similar when restricting the analysis to single-tablet regimens, although the probability of virological success was higher for INSTIs and DTG.
In ART-naïve patients with low viral loads and high CD4 counts, the risk of treatment failure was lower in those who started RPV-based vs. INSTIs-based regimens other than DTG-based ones.
目前缺乏初治的HIV感染个体中rilpivirine(RPV)与整合酶链转移抑制剂(INSTIs)在抗逆转录病毒治疗(ART)方面的比较。本研究旨在在一个观察性队列研究中比较基于RPV和基于INSTIs的一线治疗方案的治疗持久性。
纳入开始基于RPV或INSTIs的一线抗逆转录病毒治疗、HIV-RNA<100000拷贝/mL且CD4细胞计数>200个/μL的患者。主要终点是治疗失败的累积概率(TF = 病毒学失败[确认HIV-RNA>50拷贝/mL]或方案中主要药物停药),采用Kaplan-Meier方法评估。使用多变量Cox回归来控制潜在的混杂因素。
在纳入的1991例患者中,986例开始使用基于RPV的方案进行抗逆转录病毒治疗,1005例开始使用基于INSTIs的方案。中位(IQR)随访时间为20(10,35)个月。RPV治疗2年的TF累积概率为9.1%[95% 7.2,11.1],低于INSTIs组(16.6%[13.8,19.4],P = 0.0002),但与单独使用dolutegravir(DTG)相比无差异。在控制潜在混杂因素后,开始使用基于INSTIs的方案而非RPV进行抗逆转录病毒治疗与更高的TF风险相关(调整后的风险比,AHR[95% CI]:1.64[1.28,2.10];P<0.001)。当将分析限制在单片复方制剂时结果相似,尽管INSTIs和DTG的病毒学成功概率更高。
在病毒载量低且CD4计数高的初治患者中,开始使用基于RPV而非基于除DTG之外的INSTIs的方案治疗失败的风险更低。