Evaluación del cambio de las concentraciones de 25-hidroxivitamina D tras iniciar tratamiento con calcifediolen pacientes VIH

Résumé

Background and objectives: Vitamin D deficiency is very common in HIV infected patients, which leads to harmful effects at the musculoskeletal, cardiovascular, metabolic and immune levels. To date, few studies have been carried out in this population that allow us to establish the optimal dose of vitamin D supplementation, and the recommendations of scientific societies are not uniform. The main objective of our study was to compare, in HIV infected patientes and with plasma levels of 25-hydroxyvitamin D (25 (OH) D) below than 20 ng/ml, different treatment regimens with calcifediol (using doses of 0.266 mg, and higher doses of 3 mg), in order to assess whether blood levels of 25 (OH) D rise equally at 12, 24 and 48 weeks of supplementation. In addition, the prevalence of osteopenia and the associated factors were evaluated. Material and methods: An observational, descriptive and analytical study of a prospective cohort, which included HIV infected patients on stable antiretroviral treatment with 25 (OH) D deficiency (determined by automated immunoassays). The primary endpoint for deciding whether or not the treatments were different was the effect of the interaction of both study factors (time and treatment) on 25 (OH) D levels. To evaluate this effect, a mixed ANOVA was used, and the Bonferroni correction was applied for multiple comparisons. Osteopenia was identified by performing a bone densitometry, applying a binary logistic regression analysis to determine the associated independent risk factors. The data were analyzed with the statistical packages SPSS Statistics version 24.0 and the free software 'R'. Results: One hundred and twelve patients were analyzed, divided according to the treatment received. Group 1 (n = 61) received the standard regimen, calcifediol 0.266 mg per week for 12 weeks and subsequently 0.266 mg every 2 weeks. Groups 2 and 3 received calcifediol 3mg: group 2 (n = 28) 3 mg every 12 weeks, and group 3 (n = 23) 3 mg every 4 weeks for 12 weeks and subsequently 3 mg every 12 weeks. In the comparison of the standard regimen (0.266 mg) with that of high doses (3 mg), a significant effect of the interaction of the factors “treatment group” and “time” was observed on the plasma levels of 25 (OH) D, F (3,285) = 6.414, p <0.001, partial η2 = 0.063. A significant interaction of these factors was also observed, on plasma 25 (OH) D levels, when comparing the three treatment groups, F (6, 282) = 11.968, p <0.001, partial η2 = 0.203. There was an increase in 25 (OH) D concentrations from the baseline visit to 12, 24 and 48 weeks of treatment in the three therapies, which was only significant (p <0.001) in the standard regimen and group 3. At the 48 weeks, statistically significant differences were observed in the levels of 25 (OH) D between group 2 and the standard regimen, the mean being much higher in the latter (40.49 vs 22.72 ng / ml). Similarly, in this week, the proportion of patients who reached levels of 25 (OH) D> 20 ng / ml, was significantly higher in the standard regimen (89.8%), followed by group 3 (68.4 %) and group 2 (56%). The prevalence of osteopenia was 48.1%, and the independent predictors of this were: age <50 years (OR = 0.160; 95% CI [0.051 - 0.505]; p = 0.002), body mass index (OR = 0.883; 95% CI [0.788 - 0.991]; p = 0.034) and total TCD8 lymphocytes (OR = 1.002; 95% CI [1.000 - 1.003]; p = 0.018). Spanish nationality was also an independent risk factor for hip osteopenia (OR = 10.797; 95% CI [1.32 - 88.17]; p = 0.026). Conclusions: Both calcifediol 0.266 mg and the supplementation with calcifediol 3 mg achieved an increase in plasma concentrations of 25 (OH) D at 48 weeks. The most satisfactory results were obtained with the standard regimen (0.266 mg), which achieved a significant increase in 25 (OH) D during the entire follow-up period, reaching sufficiency levels in a high percentage of patients compared to the rest of the regimens. The prevalence of osteopenia was high in our population. Age, low body mass index, Spanish nationality, and total TCD8 lymphocyte count were associated with an increased risk of loss of bone mineral density.