Objective:

To assess safety and effectiveness in real world of the switch in the antiretroviral treatment (ART) of tenofovir disoproxil (TDF) to tenofovir alafenamide (TAF) in HIV patients.

Material and methods:

Observational retrospective study during 2017 in which all the patients of the health department under treatment with TAF were included. The population obtained was evaluated and also divided into two non-comparative subgroups according to the switch performed: subgroup 1, from elvitegravir/cobicistat/TDF/emtricitabine (EVG/c/TDF/FTC) to EVG/c/TAF/FTC; and subgroup 2, from TDF/FTC to TAF/FTC.

To evaluate safety, before and after the switch, was measured: creatinine (Cr), urea and glomerular filtration rate (GFR). To evaluate effectiveness was measured viral load (VL) and CD4 lymphocytes (CD4). VL was interpreted as binary variable: responder patients (<20 copies/mL) or non-responder patients. Numerical variables were expressed as medians (Md) and qualitative variables as percentage and interquartile interval (IQR). The statistical tests used were W of Wilcoxon and chi square respectively.

Results:

A sample of 55 patients was obtained. There was a variation, before and after the switch, of Cr=0.9 mg/dL (IQR=0.8-1) to Cr=0.8 mg/dL (IQR=0.7-0.9) (p<0.001), from urea=29 mg/dL (IQR=24-36) to urea=28 mg/dL (IQR=25-34.5) (p=0.06) and from GFR=92.8 mL/min (IQR=79.3-102.1) to GRT=103.6 (IQR=95.9-111.1) (p<0.001).

In terms of effectiveness there was an increase from 51% to 59.9% (p=0.821) responding patients and for CD4 from 668 CD4/mcL (IQR=446-824) to 684 CD4/mcL (IQR=611-807) (p=0.058). The results by subgroups were similar.

Conclusions:

This study showed in real world after the change of tenofovir salt within the same population that a good safety profile is manteined with an improvement of analytical parameters of renal function without affecting its effectiveness.

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