Durability of switch regimens based on rilpivirine or on integrase inhibitors, both in association with tenofovir and emtricitabine, in HIV-infected, virologically suppressed patients

BMC Infectious Diseases

Research Article

Marco Merli¹  Silvia Nozza¹  Nicola Gianotti¹  Andrea Poli¹  Laura Galli¹  Alessia Carbone¹  Marco Ripa²  Vincenzo Spagnuolo²  Antonella Castagna²  Adriano Lazzarin²  Nadia Galizzi² 

[1] Infectious Diseases, San Raffaele Scientific Institute, Via Stamira d’Ancona 20, 20127, Milan, Italy;Infectious Diseases, San Raffaele Scientific Institute, Via Stamira d’Ancona 20, 20127, Milan, Italy;Università Vita-Salute San Raffaele, Milan, Italy;

关键词: Rilpivirine;    Raltegravir;    Elvitegravir/cobicistat;    Dolutegravir;    Non-nucleoside reverse transcriptase inhibitors;    Integrase inhibitors;    Switch regimen;    Residual viremia;    Virological suppression;   

DOI  :  10.1186/s12879-017-2831-9

 received in 2017-06-13, accepted in 2017-11-12,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundSwitch strategies based on rilpivirine/tenofovir/emtricitabine or on an integrase inhibitor (InSTI) plus tenofovir/emtricitabine have never been compared in randomized clinical trials. The main aim of the study was to investigate the durability of these two switch regimens in virologically suppressed, HIV-infected patients.MethodsRetrospective analysis of patients who started rilpivirine or an InSTI (both with tenofovir and emtricitabine) with <50 HIV-RNA copies/mL and had at least one HIV-RNA assessed while receiving the study regimen. Virological failure (VF) was defined as two consecutive measurements of HIV-RNA >50 copies/mL. Treatment failure (TF) was define as either VF or discontinuation of any drug of the regimen. Durability was assessed by the Kaplan-Meier method and compared by Log-rank test. Residual viremia was defined as any detectable HIV-RNA below 50 copies/mL, as assed by a real-time PCR assay.ResultsSix hundred seventy-five patients (466 switched to a rilpivirine-, 209 switched to an InSTI-based regimen [18% dolutegravir, 39% raltegravir, 43% elvitegravir/cobicistat] were included in the analysis.The median (interquartile range, IQR) follow-up in the rilpivirine and in the InSTI group was 16.7 (8.8–22.2) and 10.4 (5.4–19.6) months. The 1-year cumulative probabilities (95%CI) of VF and TF were 0.97% (0.36%–2.62%) and 9.73% (7.21%–13.06%) in the rilpivirine group and 1.83% (0.57%–5.77%) and 8.75% (5.25%–14.4%) in the InSTI group, with no difference between groups (p = 0.328 and 0.209 for VF and TF). The proportion of time spent with residual viremia was comparable in the two groups (9% [IQR 0.5%–49%] and 17% [IQR 0.5%–50%] in the rilpivirine and in the InSTI group, p = 0.087).By the multivariable Cox regression model, TF was independently associated with being on therapy with a protease inhibitor vs. a non-nucleoside reverse transcriptase inhibitor at switch (AHR = 0.52; 95%CI = 0.31–0.90; p = 0.018), baseline total/HDL-cholesterol ratio (AHR = 1.19 per 0.5-units increments; 95%CI = 1.06–1.34; p = 0.004), baseline estimated glomerular filtration rate (AHR = 0.78 per 10-units increments; 95%CI = 0.67–0.90; p = 0.001) and baseline hemoglobin (AHR = 0.78 per 1-unit increments; 95%CI = 0.64–0.94; p = 0.009), but not with treatment group (rilpivirine vs. InSTI).ConclusionsIn our clinical practice, the durability of the two regimens was comparable and both showed a very low probability of VF.

【 授权许可】

CC BY   
© The Author(s). 2017