Oral mucosal lesions that are associated with HIV infection can play an important role in guiding the decision to initiate antiretroviral therapy (ART). The incidence of these lesions relative to the timing of ART initiation has not been well characterized. A randomized controlled clinical trial was conducted at the GHESKIO Center in Port-au-Prince, Haiti between 2004 and 2009. 816 HIV-infected ART-naïve participants with CD4 T cell counts between 200 and 350 cells/mm3 were randomized to either immediate ART initiation (early group; N = 408), or initiation when CD4 T cell count was less than or equal 200 cells/mm3 or with the development of an AIDS-defining condition (delayed group; N = 408). Every 3 months, all participants underwent an oral examination. The incidence of oral lesions was 4.10 in the early group and 17.85 in the delayed group (p-value <0.01). In comparison to the early group, there was a significantly higher incidence of candidiasis, hairy leukoplakia, herpes labialis, and recurrent herpes simplex in the delayed group. The incidence of oral warts in delayed group was 0.97 before therapy and 4.27 post-ART initiation (p-value <0.01). In the delayed group the incidence of oral warts post-ART initiation was significantly higher than that seen in the early group (4.27 versus 1.09; p-value <0.01). The incidence of oral warts increased after ART was initiated, and relative to the early group there was a four-fold increase in oral warts if ART was initiated following an AIDS diagnosis. Based upon our findings, candidiasis, hairy leukoplakia, herpes labialis, and recurrent herpes simplex indicate immune suppression and the need to start ART. In contrast, oral warts are a sign of immune reconstitution following ART initiation.
generated more oscillation in plasma levels. For qualitative variables, absolute and relative frequencies were obtained, and for quantitative variables, the median (IQR) were used. For hypothesis contrast, Fisher's exact test or the Mann-Whitney U test was performed according to the type of variable. Results 45 patients were included, 23 received voriconazole and 22 isavuconazole. Median age was 62 years (56-67) for those receiving voriconazole versus 63 years (54-68) for those receiving isavuconazole (p=0.91). 34.8% (n=8) of patients treated with voriconazole achieved concentrations of tacrolimus >20 ng/mL (toxic concentration) within 10 days from the start of the combination compared with 14.3% (n=3) of patients treated with isavuconazole (p=0.1685). The median standard deviation of plasma concentrations was 3.76 ng/mL (2.89-4.5) with voriconazole versus 3.17 ng/mL (1.4-5) with isavuconazole (p=0.272). The proportion of patients who temporarily discontinued tacrolimus treatment due to high level concentrations and associated toxicity was 18.2% (n=4) with isavuconazole versus 34.8% (n=8) with voriconazole (p=0.318). Regarding tolerance to treatment, 28.57% of patients treated with isavuconazole had side effects associated with azole, compared with 82.6% of those treated with voriconazole (p<0.005). Treatment had to be suspended due to these side effects in 47.82% (n=11) of patients treated with voriconazole and in no patient treated with isavuconazole (p<0.005). Conclusion and relevance Treatment with isavuconazole resulted in fewer tacrolimus poisonings, although the difference was not statistically significant. In addition, treatment with isavuconazole was found to be safer, had fewer side effects and did not require antifungal discontinuation.
particularly in treatment modifications of anxiolytics and sedatives.This study suggests that pharmacists may find it difficult to achieve anticholinergic burden reductions by suggesting AD changes to physicians and patients.
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